Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain. (MeLoPe)

Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain. An Open-label Randomized Controlled Multicenter Trial.

Low back pain is the second most common reason for medical consultation in France and affects 60 to 80% of the working population. Patients with acute episodes of non-specific low back pain recover within 6 to 8 weeks, but recurrence is common and 7 to 10% of patients will experience persistent pain and disability for more than 3 months. Given their low efficacy and the risks associated with nonsteroidal anti-inflammatory drugs or opioids (nearly 60% of all opioids prescribed in the United States), the scientific literature does not support the use of pharmacological treatments. The international recommendations strongly suggest using non-pharmacological therapies, including physical exercise, rehabilitation, and spinal manipulation.Spinal manipulation (SM) is a common choice of therapy in primary care. In the patient's imagination "getting manipulated when in pain leads to heavy use of these manual therapies in a medical (manual medicine and medical osteopathy) or non-medical setting (manual therapy, osteopathy, and chiropractic). However, the evidence of effectiveness is weak in the chronic phase (only in the short term) and contradictory for the acute or subacute phases of low back pain. Pain and function are improved at 6 weeks, but the results are not clinically relevant. There is a lack of evidence regarding efficacy because the trials on spinal manipulations are of poor quality. A meta-analysis has recently reported that SMs are associated with a very limited risk of harm, making them a reasonable treatment option. Therefore, it seems necessary to demonstrate the specific effect of MVs in order to justify their use in primary care, support their wider use around the world, and reinforce recommendations for non-pharmacological treatment of low back pain.

Study Overview

• Status: Not yet recruiting
• Conditions: Back Pain Lower Back Chronic
• Intervention / Treatment: Other: Spinal or peripheral manipulation of the lower back to treat lower back pain

Detailed Description

Low back pain is a common musculoskeletal condition that affects 60 to 80% of the working population at least once in their lifetime. Patients with acute episodes of non-specific low back pain recover within 6 to 8 weeks, but recurrence is common and 7 to 10% of them will experience persistent pain and disability for more than 3 months. It is the second most common reason for medical consultation in France.

The scientific literature does not support the use of pharmacological treatments given their low efficacy and the risks associated with prescribing nonsteroidal anti-inflammatory drugs or opioids (which account for nearly 60% of all opioids prescribed in the United States). It is therefore easy to understand why the international recommendations strongly suggest using non-pharmacological therapies, including physical exercise, rehabilitation, and spinal manipulation.

Spinal manipulation (SM) is a very common therapy of choice in primary care, enjoying popularity beliefs rooted in the patient's imagination ("getting manipulated when you're in pain"), leading to heavy use of these manual therapies in a medical (manual medicine and medical osteopathy) or non-medical setting (manual therapy, osteopathy, and chiropractic). However, evidence of effectiveness is considered weak in the chronic phase (only in the short term) and contradictory for the acute or subacute phases of low back pain. Pain and function are improved at 6 weeks, but the results are not clinically relevant. The main reason for this lack of evidence is that efficacy trials concerning spinal manipulations are, at best, of poor quality for a number of reasons: SMs are very often combined with other strategies (exercises, medication, rehabilitation, etc.), which limits the assessment of a specific effect; manual therapies are very diverse, limiting comparability; the time required to assess the effects is often long (more than 4 weeks), comparable to the usual time required for pain to resolve; comparative trials are of low power, limiting the ability to demonstrate a difference; The use of a placebo comparator to test the effect of MV is not trivial and must be carefully defined, particularly for physicians who do not consider placebo to be an alternative in standard care. As far as we know, there has only been one RTC against placebo, the results of which were negative (n=240).

A meta-analysis has recently reported that SMs are associated with a very limited risk of harm, making them a reasonable treatment option. Therefore, it seems necessary to demonstrate the specific effect of MVs in order to justify their use in primary care, support their wider use around the world, and reinforce recommendations for non-pharmacological treatment of low back pain.

The hypothesis is that patients receiving spinal manipulations will experience greater pain relief in the short term (7 to 10 days after treatment) than patients receiving peripheral manipulations.

Patients in the experimental group (spinal manipulation) should also show improvement in their pain in the medium term, their functional abilities, their physical and work avoidance scores, catastrophizing, and the occurrence of lumbar flare-ups up to three months of follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 416
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anissa MEGZARI; Phone Number: +33466684236; Email: drc@chu-nimes.fr
• Study Contact Backup: Name: Arnaud DUPEYRON, Professor; Phone Number: +33 4.66.68.34.59; Email: arnaud.dupeyron@umontpellier.fr

Study Locations

• France
  • Gard
    • Nîmes, Gard, France, 30029
      • Nimes University Hospital
      • Contact: Alexis HOMS, Dr.; Phone Number: +334.66.68.34.59; Email: alexis.homs@chu-nimes.fr
      • Principal Investigator: Jean Olivier CHATEAU, Dr.
      • Principal Investigator: Paul CURBILIER, Dr.
      • Principal Investigator: François DASQUE, Dr.
      • Principal Investigator: Olivier DUMAY, Dr.
      • Principal Investigator: Christiane GROSS, Dr.
      • Principal Investigator: Antoine GUINOISEAU, Dr.
      • Principal Investigator: Sébastien HINGRAY, Dr.
      • Principal Investigator: Cédric LETERTRE, Dr.
      • Principal Investigator: Stéphane RENON, Dr.
      • Principal Investigator: Benoit REQUIER, Dr.
      • Principal Investigator: Pierre REQUIER, Dr.
      • Principal Investigator: Romain REY, Dr.
      • Principal Investigator: Marc ROZENBLAT, Dr.
      • Principal Investigator: Antoine STABILE, Dr.
      • Principal Investigator: Philippe STEMER, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients seeking treatment for low back pain present for less than 3 months, with an average intensity greater than 50 on a visual analog scale of 0-100 in the previous 48 hours.
• Patients able to complete online questionnaires.
• Patients who have given their free and informed consent.
• Patients who are affiliated with or beneficiaries of a health insurance plan.

Exclusion Criteria:

• Patients with a history of back surgery, undergoing corticosteroid or morphine treatment, with acute or chronic inflammatory diseases, with psychiatric illness, or with low back pain lasting more than 3 months.
• Patients who have already undergone spinal manipulation for low back pain with the investigator.
• Patients participating or having participated in a therapeutic or drug study in the 3 months prior to their inclusion in this protocol.
• Patients in a period of exclusion determined by another study.
• Patients under legal protection, guardianship, or conservatorship.
• Patients unable to give their consent.
• Patients for whom it is impossible to provide informed consent.
• Pregnant or breastfeeding patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPINE MANIPULATION (SM); The physician determines the level(s) with segmental dysfunction(s), checks the conditions for performing MV (free directions of trunk movement, absence of red flags), which consists of a dynamic push at high speed and low amplitude, a lateral rotation push in flexion performed on one or more vertebral segments where minor intervertebral disturbances are located (patient lying on their side). The rationale behind this approach is to treat minor intervertebral disturbances causing lumbar pain by activating a reflex mechanism that allows muscle relaxation.	Other: Spinal or peripheral manipulation of the lower back to treat lower back pain; The patient will receive treatment for lower back pain (spinal or peripheral manipulation) according to their assignment group.; Other Names: Physiotherapy
Active Comparator: PERIPHERAL MANIPULATION (PM); The doctor determines the level(s) with segmental dysfunction(s), then performs peripheral treatment using osteopathic techniques, offering comprehensive treatment for the patient. Mobilization and palpation are localized in the lower limbs (knee and ankle), the abdomen with massage of the psoas muscles, the upper limbs (shoulder and elbow), and the cervical spine with high-amplitude, low-speed mobilization without thrusting. The rationale behind this approach is the treatment of an overall imbalance causing back pain and requiring rebalancing.	Other: Spinal or peripheral manipulation of the lower back to treat lower back pain; The patient will receive treatment for lower back pain (spinal or peripheral manipulation) according to their assignment group.; Other Names: Physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term effectiveness (7 to 10 days) of spinal manipulation (SM) on pain over the last 24/48 hours in acute and subacute low back pain : experimental group	Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours	Day 0
Short-term effectiveness (7 to 10 days) of spinal manipulation (SM) on pain over the last 24/48 hours in acute and subacute low back pain : experimental group	Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours	Day 7
Short-term effectiveness (7 to 10 days) of spinal manipulation (SM) on pain over the last 24/48 hours in acute and subacute low back pain : experimental group	Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours	Day 10
Short-term effectiveness (7 to 10 days) of peripheral manipulation (PM) on pain over the last 24/48 hours in acute and subacute low back pain : control group	Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours	Day 0
Short-term effectiveness (7 to 10 days) of peripheral manipulation (PM) on pain over the last 24/48 hours in acute and subacute low back pain : control group	Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours	Day 7
Short-term effectiveness (7 to 10 days) of peripheral manipulation (PM) on pain over the last 24/48 hours in acute and subacute low back pain : control group	Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours	Day 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of lower back pain and lower limb pain (above the knee) in the experimental group (SM)	Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).	Day 1 to 2
Evolution of lower back pain and lower limb pain (above the knee) in the control group (PM)	Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).	Day 1 to 2
Evolution of lower back pain and lower limb pain (above the knee) in the experimental group (SM)	Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).	Day 7 - 10
Evolution of lower back pain and lower limb pain (above the knee) in the control group (PM)	Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).	Day 7 - 10
Evolution of lower back pain and lower limb pain (above the knee) in the experimental group (SM)	Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).	Week 3
Evolution of lower back pain and lower limb pain (above the knee) in the control group (PM)	Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).	Week 3
Evolution of lower back pain and lower limb pain (above the knee) in the experimental group (SM)	Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).	Month 1
Evolution of lower back pain and lower limb pain (above the knee) in the control group group (PM)	Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).	Month 1
Evolution of lower back pain and lower limb pain (above the knee) in the experimental group (SM)	Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).	Month 3
Evolution of lower back pain and lower limb pain (above the knee) in the control group (PM)	Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).	Month 3
Changes in movement avoidance due to pain in the experimental group (SM)	Measured according to the Fear Avoidance Beliefs Questionnaire (FABQ) score for physical avoidance and work avoidance. The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24). The questionnaire takes approximately 10 minutes to complete.	Day 0
Changes in movement avoidance due to pain in the experimental group (SM)	Measured according to the Fear Avoidance Beliefs Questionnaire (FABQ) score for physical avoidance and work avoidance. The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24). The questionnaire takes approximately 10 minutes to complete.	Day 7 to 10
Changes in movement avoidance due to pain in the experimental group (SM)	Measured according to the Fear Avoidance Beliefs Questionnaire (FABQ) score for physical avoidance and work avoidance. The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24). The questionnaire takes approximately 10 minutes to complete.	Month 1
Changes in movement avoidance due to pain in the experimental group (SM)	Measured according to the Fear Avoidance Beliefs Questionnaire (FABQ) score for physical avoidance and work avoidance. The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24). The questionnaire takes approximately 10 minutes to complete.	Month 3
Changes in movement avoidance due to pain in the control group (PM)	Measured according to the Fear Avoidance Beliefs Questionnaire (FABQ) score for physical avoidance and work avoidance. The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24). The questionnaire takes approximately 10 minutes to complete.	Day 0
Changes in movement avoidance due to pain in the control group (PM)	Measured according to the Fear Avoidance Beliefs Questionnaire (FABQ) score for physical avoidance and work avoidance. The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24). The questionnaire takes approximately 10 minutes to complete.	Day 7 to 10
Changes in movement avoidance due to pain in the control group (PM)	Measured according to the Fear Avoidance Beliefs Questionnaire (FABQ) score for physical avoidance and work avoidance. The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24). The questionnaire takes approximately 10 minutes to complete.	Month 1
Changes in movement avoidance due to pain in the control group (PM)	Measured according to the Fear Avoidance Beliefs Questionnaire (FABQ) score for physical avoidance and work avoidance. The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24). The questionnaire takes approximately 10 minutes to complete.	Month 3
Catastrophizing in the experimental group (SM)	Catastrophizing will be measured using the PCS (Pain Catastrophizing Scale). The PCS is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale.Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Subscale Scores: Rumination: Items 8,9,10,11 Magnification: Items 6,7,13 Helplessness: Items 1,2,3,4,5,12. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.	Day 0
Catastrophizing in the experimental group (SM)	Catastrophizing will be measured using the PCS (Pain Catastrophizing Scale). The PCS is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale.Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Subscale Scores: Rumination: Items 8,9,10,11 Magnification: Items 6,7,13 Helplessness: Items 1,2,3,4,5,12. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.	Day 7 to 10
Catastrophizing in the experimental group (SM)	Catastrophizing will be measured using the PCS (Pain Catastrophizing Scale). The PCS is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale.Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Subscale Scores: Rumination: Items 8,9,10,11 Magnification: Items 6,7,13 Helplessness: Items 1,2,3,4,5,12. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.	Month 1
Catastrophizing in the experimental group (SM)	Catastrophizing will be measured using the PCS (Pain Catastrophizing Scale). The PCS is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale.Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Subscale Scores: Rumination: Items 8,9,10,11 Magnification: Items 6,7,13 Helplessness: Items 1,2,3,4,5,12. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.	Month 3
Catastrophizing in the control group (PM)	Catastrophizing will be measured using the PCS (Pain Catastrophizing Scale). The PCS is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale.Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Subscale Scores: Rumination: Items 8,9,10,11 Magnification: Items 6,7,13 Helplessness: Items 1,2,3,4,5,12. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.	Day 0
Catastrophizing in the control group (PM)	Catastrophizing will be measured using the PCS (Pain Catastrophizing Scale). The PCS is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale.Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Subscale Scores: Rumination: Items 8,9,10,11 Magnification: Items 6,7,13 Helplessness: Items 1,2,3,4,5,12. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.	Day 7 to 10
Catastrophizing in the control group (PM)	Catastrophizing will be measured using the PCS (Pain Catastrophizing Scale). The PCS is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale.Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Subscale Scores: Rumination: Items 8,9,10,11 Magnification: Items 6,7,13 Helplessness: Items 1,2,3,4,5,12. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.	Month 1
Catastrophizing in the control group (PM)	Catastrophizing will be measured using the PCS (Pain Catastrophizing Scale). The PCS is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale.Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Subscale Scores: Rumination: Items 8,9,10,11 Magnification: Items 6,7,13 Helplessness: Items 1,2,3,4,5,12. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.	Month 3
Functional disability in the experimental group (SM)	Functional disability will be measured according to the Roland Morris Disability Questionnaire (RMDQ). The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore range from 0 to 24. The original version of the Roland Morris Disability Questionnaire was published by Roland and Morris in 1983. A review of articles on the questionnaire was published in 2000 (Roland & Fairbank 2000). It comprises 24 items and measures the functional disability of patients with low back pain. This self-administered questionnaire is quick, easy to use, reliable, valid, and sensitive to changes in clinical status, suggesting that its use could be generalized in contexts ranging from epidemiological or clinical research to the individual assessment of patients with low back pain in everyday clinical practice. The questionnaire takes approximately 5 minutes to complete.	Day 0
Functional disability in the experimental group (SM)	Functional disability will be measured according to the Roland Morris Disability Questionnaire (RMDQ). The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore range from 0 to 24. The original version of the Roland Morris Disability Questionnaire was published by Roland and Morris in 1983. A review of articles on the questionnaire was published in 2000 (Roland & Fairbank 2000). It comprises 24 items and measures the functional disability of patients with low back pain. This self-administered questionnaire is quick, easy to use, reliable, valid, and sensitive to changes in clinical status, suggesting that its use could be generalized in contexts ranging from epidemiological or clinical research to the individual assessment of patients with low back pain in everyday clinical practice. The questionnaire takes approximately 5 minutes to complete.	Month 1
Functional disability in the experimental group (SM)	Functional disability will be measured according to the Roland Morris Disability Questionnaire (RMDQ). The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore range from 0 to 24. The original version of the Roland Morris Disability Questionnaire was published by Roland and Morris in 1983. A review of articles on the questionnaire was published in 2000 (Roland & Fairbank 2000). It comprises 24 items and measures the functional disability of patients with low back pain. This self-administered questionnaire is quick, easy to use, reliable, valid, and sensitive to changes in clinical status, suggesting that its use could be generalized in contexts ranging from epidemiological or clinical research to the individual assessment of patients with low back pain in everyday clinical practice. The questionnaire takes approximately 5 minutes to complete.	Month 3
Functional disability in the control group (PM)	Functional disability will be measured according to the Roland Morris Disability Questionnaire (RMDQ). The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore range from 0 to 24. The original version of the Roland Morris Disability Questionnaire was published by Roland and Morris in 1983. A review of articles on the questionnaire was published in 2000 (Roland & Fairbank 2000). It comprises 24 items and measures the functional disability of patients with low back pain. This self-administered questionnaire is quick, easy to use, reliable, valid, and sensitive to changes in clinical status, suggesting that its use could be generalized in contexts ranging from epidemiological or clinical research to the individual assessment of patients with low back pain in everyday clinical practice. The questionnaire takes approximately 5 minutes to complete.	Day 0
Functional disability in the control group (PM)	Functional disability will be measured according to the Roland Morris Disability Questionnaire (RMDQ). The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore range from 0 to 24. The original version of the Roland Morris Disability Questionnaire was published by Roland and Morris in 1983. A review of articles on the questionnaire was published in 2000 (Roland & Fairbank 2000). It comprises 24 items and measures the functional disability of patients with low back pain. This self-administered questionnaire is quick, easy to use, reliable, valid, and sensitive to changes in clinical status, suggesting that its use could be generalized in contexts ranging from epidemiological or clinical research to the individual assessment of patients with low back pain in everyday clinical practice. The questionnaire takes approximately 5 minutes to complete.	Month 1
Functional disability in the control group (PM)	Functional disability will be measured according to the Roland Morris Disability Questionnaire (RMDQ). The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore range from 0 to 24. The original version of the Roland Morris Disability Questionnaire was published by Roland and Morris in 1983. A review of articles on the questionnaire was published in 2000 (Roland & Fairbank 2000). It comprises 24 items and measures the functional disability of patients with low back pain. This self-administered questionnaire is quick, easy to use, reliable, valid, and sensitive to changes in clinical status, suggesting that its use could be generalized in contexts ranging from epidemiological or clinical research to the individual assessment of patients with low back pain in everyday clinical practice. The questionnaire takes approximately 5 minutes to complete.	Month 3
Pain management in the experimental group (SM)	The use of analgesics (Non-steroidal anti-inflammatory drugs, painkillers), lumbar braces, or osteopathic interventions will be recorded.	In the week prior to inclusion
Pain management in the control group (PM)	The use of analgesics (Non-steroidal anti-inflammatory drugs, painkillers), lumbar braces, or osteopathic interventions will be recorded.	In the week prior to inclusion
Pain management in the experimental group (SM)	The use of analgesics (Non-steroidal anti-inflammatory drugs, painkillers), lumbar braces, or osteopathic interventions will be recorded.	Day 7 - 10 days
Pain management in the control group (PM)	The use of analgesics (Non-steroidal anti-inflammatory drugs, painkillers), lumbar braces, or osteopathic interventions will be recorded.	Day 7 - 10 days
Pain management in the experimental group (SM)	The use of analgesics (Non-steroidal anti-inflammatory drugs, painkillers), lumbar braces, or osteopathic interventions will be recorded.	Week 3
Pain management in the control group (PM)	The use of analgesics (Non-steroidal anti-inflammatory drugs, painkillers), lumbar braces, or osteopathic interventions will be recorded.	Week 3
Pain management in the experimental group (SM)	The use of analgesics (Non-steroidal anti-inflammatory drugs, painkillers), lumbar braces, or osteopathic interventions will be recorded.	Month 1
Pain management in the control group (PM)	The use of analgesics (Non-steroidal anti-inflammatory drugs, painkillers), lumbar braces, or osteopathic interventions will be recorded.	Month 1
Pain management in the experimental group (SM)	The use of analgesics (Non-steroidal anti-inflammatory drugs, painkillers), lumbar braces, or osteopathic interventions will be recorded.	Month 3
Pain management in the control group (PM)	The use of analgesics (Non-steroidal anti-inflammatory drugs, painkillers), lumbar braces, or osteopathic interventions will be recorded.	Month 3
Need for a second consultation in the experimental group (SM)	The need for a second consultation with the manual physician within one month of the first consultation will be recorded	Day 0 to Month 1
Need for a second consultation in the control group (PM)	The need for a second consultation with the manual physician within one month of the first consultation will be recorded	Day 0 to Month 1
Number of medical visits in the experimental group (SM)	The number of medical visits made by the patient as part of their treatment for low back pain at each follow-up visit will be recorded	Day 7 - 10
Number of medical visits in the control group (PM)	The number of medical visits made by the patient as part of their treatment for low back pain at each follow-up visit will be recorded	Day 7 - 10
Number of medical visits in the experimental group (SM)	The number of medical visits made by the patient as part of their treatment for low back pain at each follow-up visit will be recorded	Month 1
Number of medical visits in the control group (PM)	The number of medical visits made by the patient as part of their treatment for low back pain at each follow-up visit will be recorded	Month 1
Number of medical visits in the experimental group (SM)	The number of medical visits made by the patient as part of their treatment for low back pain at each follow-up visit will be recorded	Month 3
Number of medical visits in the control group (PM)	The number of medical visits made by the patient as part of their treatment for low back pain at each follow-up visit will be recorded	Month 3
Occurrence and frequency of lumbar flare-ups in the 3 months following manipulation in the experimental group (SM)	The number of flare-ups, defined as episodes of low back pain greater than 50 out of 100 on the visual analog scale lasting more than 24 hours will be recorded. yes/no and if so, how many? Data collection via an online application made available to the patient.	Month 1
Occurrence and frequency of lumbar flare-ups in the 3 months following manipulation in the experimental group (SM)	The number of flare-ups, defined as episodes of low back pain greater than 50 out of 100 on the visual analog scale lasting more than 24 hours will be recorded. yes/no and if so, how many? Data collection via an online application made available to the patient.	Month 3
Occurrence and frequency of lumbar flare-ups in the 3 months following manipulation in the control group (PM)	The number of flare-ups, defined as episodes of low back pain greater than 50 out of 100 on the visual analog scale lasting more than 24 hours will be recorded. yes/no and if so, how many? Data collection via an online application made available to the patient.	Month 1
Occurrence and frequency of lumbar flare-ups in the 3 months following manipulation in the control group (PM)	The number of flare-ups, defined as episodes of low back pain greater than 50 out of 100 on the visual analog scale lasting more than 24 hours will be recorded. yes/no and if so, how many? Data collection via an online application made available to the patient.	Month 3

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Chronic; Spinal manipulation; Back
• Additional Relevant MeSH Terms: Organizing Pneumonia; Neurologic Manifestations; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Graft vs Host Disease; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bronchiolitis Obliterans Syndrome; Pain; Therapeutics; Rehabilitation; Physical Therapy Modalities
• Other Study ID Numbers: RESPIR/2022/AD-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No