Influence of Verbal Suggestion on the Therapeutic Effect of the Joint Manipulation

Influence of Verbal Suggestion on the Therapeutic Effect of the Joint Manipulation of the Lumbar Spine in Patients with Chronic Non-specific Low Back Pain

The aim of the study is to evaluate the influence of verbal suggestion on the therapeutic effect of the joint manipulation of the lumbar spine in patients with chronic non-specific low back pain in relation to the pain level, stress, disability, function, sleepiness, tissue temperature and selected blood biochemical markers.

The study participants will be randomly assigned (sealed allocation envelopes) to the following groups:

• Group A (test intervention + placebo communication)
• Group B (test intervention + nocebo communication)
• Group C (test intervention + neutral communication)

The study will mainly consist of the three stages, i.e. before the intervention, immediately after the intervention and 24 hours later.

Study Overview

• Status: Completed
• Conditions: Back Pain
• Intervention / Treatment: Other: Lumbar manipulation; Other: Positive communication - placebo; Other: Negative communication - nocebo; Other: Neutral communication

Detailed Description

Pain is complex in nature and is closely related to the secretion of biochemical markers such as cortisol, serotonin and oxytocin. Higher levels of inflammatory markers, cytokines and chemokines have been found in patients with low back pain, which ultimately affect the clinical manifestations observed in the patients.

One of the methods of physiotherapeutic treatment of spinal disorders involving manual diagnostic and therapeutic techniques is manual therapy. In the therapy, among others, joint manipulation techniques are used. However, the mechanisms underlying the effects of the joint manipulation on the body have not been fully explained. Undoubtedly, one of the main mechanisms of action of manual therapy is pain modulation.

In recent years, research has been increasingly focusing on manipulation in a psychological context, including mechanisms of fear-avoidance, pain catastrophizing and kinesiophobia. Furthermore, manipulation can affect immune and endocrine system responses.

One of the significant non-specific effects accompanying any medical procedure is a placebo effect. The way health care professionals discuss, describe and inform patients about characteristic symptoms of a given disease its prevention, diagnosis and treatment, influences the patients' feelings and expectations, which in turn affect their psycho-biological reactions, subjective perception and treatment outcomes.

The appropriate choice of words by clinicians influences patients' responses to medical treatments and procedures, whether active or sham. The way in which information about the outcome of a treatment is communicated to patients can induce the reinforcing effects of a given treatment (placebo) or reverse the clinically proven effects of an active treatment, or even increase its adverse outcomes in the form of a nocebo effect.

The aim of the study is to evaluate the influence of verbal suggestion on the therapeutic effect of the joint manipulation of the lumbar spine in patients with chronic non-specific low back pain in relation to the pain level, stress, disability, function, sleepiness, tissue temperature and selected blood biochemical markers.

Research questions:

1. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the pain level?
2. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the stress level?
3. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the kinesiophobia level?
4. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the lumbar spine range of motion?
5. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the disability level?
6. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to sleepiness?
7. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the tissue temperature of the lumbar spine region?
8. Does the type of verbal suggestion influence the effects of the joint manipulation in relation to the selected blood biochemical markers (cortisol, serotonin and oxytocin)?

The participants will be selected for the study from the group of students from John Paul II University in Biała Podlaska, Poland. The participation in the study will be voluntary.

The study will mainly consist of the three stages, i.e. before the intervention, immediately after the intervention and 24 hours later. Once, before the intervention, a scale will be used for the subjective assessment of the expectations for the treatment outcomes based on the GRoC methodology. The other research tools will be used in two stages: an information questionnaire (before the intervention and 24 hours after the intervention) and a scale for the subjective assessment of the treatment outcomes based on the GRoC methodology (immediately after the intervention and 24 hours later).

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Lublin Voivodeship
    • Biała Podlaska, Lublin Voivodeship, Poland, 21-500
      • John Paul II University in Biała Podlaska

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• participants with low back pain lasting more than 3 months,
• participants who have not been taking any non-steroidal anti-inflammatory drugs (NSAIDs) for at least one week prior to the start of the study,
• participants who are not taking any steroid drugs,
• participants who have never had the joint manipulation before,
• participants within the age range of 19-30 years,
• written consent to participate in the study.

Exclusion Criteria:

• participants who are students of physiotherapy,
• participants with a BMI >33,
• participants after a lumbar spine surgery,
• participants who, in the 6 months prior to the start of the study, suffered from a lumbar spine injury,
• participants with diabetes,
• participants with rheumatic diseases,
• participants with endometriosis,
• participants with endocrine diseases,
• participants with acute inflammation in the lumbar spine region and sciatica symptoms.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (test intervention + placebo communication); Participants who will undergo the joint manipulation of the lumbar spine region and receive positive communication - placebo.	Other: Lumbar manipulation; Participant lies in the supine position, a physiotherapist faces the participant's side that will be manipulated. The participant interlocks their fingers behind their neck. Then the physiotherapist turns the participant on their side and performs a short thrust across the participant's pelvis in a posterior and inferior direction. The manipulation will be carried out on the symptomatic side, based on the participant's indication of the painful side. If the participant is unable to indicate the more symptomatic side, the physiotherapist performing the procedure will select the side. If no audible cavitation occurs during the manipulation, the physiotherapist will attempt to manipulate the opposite side. A maximum of 2 attempts per side will be allowed.; Other: Positive communication - placebo; Participants from Group A who will undergo the joint manipulation of the lumbar spine region and receive the following information: "Joint manipulation is a very effective method of treating spinal disorders, which will significantly reduce the low back pain you are experiencing" (positive communication - placebo).
Experimental: Group B (test intervention + nocebo communication); Participants who will undergo the joint manipulation of the lumbar spine region and receive negative communication - nocebo.	Other: Lumbar manipulation; Participant lies in the supine position, a physiotherapist faces the participant's side that will be manipulated. The participant interlocks their fingers behind their neck. Then the physiotherapist turns the participant on their side and performs a short thrust across the participant's pelvis in a posterior and inferior direction. The manipulation will be carried out on the symptomatic side, based on the participant's indication of the painful side. If the participant is unable to indicate the more symptomatic side, the physiotherapist performing the procedure will select the side. If no audible cavitation occurs during the manipulation, the physiotherapist will attempt to manipulate the opposite side. A maximum of 2 attempts per side will be allowed.; Other: Negative communication - nocebo; Participants form Group B who will undergo the joint manipulation of the lumbar spine region and receive the following information: "Joint manipulation is not an effective method of treating spinal disorders, thus it may temporarily increase the low back pain you are experiencing" (negative communication - nocebo).
Other: Group C (test intervention + neutral communication); Participants who will undergo the joint manipulation of the lumbar spine region and receive neutral communication.	Other: Lumbar manipulation; Participant lies in the supine position, a physiotherapist faces the participant's side that will be manipulated. The participant interlocks their fingers behind their neck. Then the physiotherapist turns the participant on their side and performs a short thrust across the participant's pelvis in a posterior and inferior direction. The manipulation will be carried out on the symptomatic side, based on the participant's indication of the painful side. If the participant is unable to indicate the more symptomatic side, the physiotherapist performing the procedure will select the side. If no audible cavitation occurs during the manipulation, the physiotherapist will attempt to manipulate the opposite side. A maximum of 2 attempts per side will be allowed.; Other: Neutral communication; Participants from Group C who will undergo the joint manipulation of the lumbar spine region and receive the following information: "Joint manipulation has not been verified for its effectiveness in affecting your level of low back pain" (neutral communication).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale (NRS)	The participant gives a score expressed in numbers from 0 to 10	Before the intervention, immediately after the intervention and 24 hours later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tampa Scale of Kinesiophobia (TSK)	The 17 item TSK total scores range from 17 to 68, where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.	Before the intervention, immediately after the intervention and 24 hours later
Back Pain Function Scale (BPFS)	In the Back Pain Function Scale (BFPS), the participant assesses twelve actions related to everyday life activity in a scale of 0 to 5. The results fall within a range of 0 to 60 points, whereby the higher the final result, the lower the level of pain.	Before the intervention, immediately after the intervention and 24 hours later
Perceived Stress Scale (PSS-10)	The scale consists of 10 questions, with answers scored from 0 to 4.	Before the intervention, immediately after the intervention and 24 hours later
Stress Numerical Rating Scale-11	The participant gives a score expressed in numbers from 0 to 10.	Before the intervention, immediately after the intervention and 24 hours later
Roland-Morris Disability Questionnaire (RMDQ)	The participant is asked to tick a statement when it applies to him/her that specific day; this makes it possible to follow changes in time. The end score is the sum of the ticked boxes. The score ranges from 0 (no disability) to 24 (max. disability) depending on the questionnaire used. Roland and Morris omitted describing the various levels of disability (for example, 40%-60% of disability is severe).	Before the intervention, immediately after the intervention and 24 hours later
Epworth Sleepiness Scale (ESS)	The ESS is a self-administered questionnaire with 8 questions. The participants are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities.	Before the intervention and 24 hours later
The assessment of the pain levels with the Baseline dolorimeter	The measurement will be taken in the forward lying position at the level of the three segments: L3, L4 and L5, at three points: the spinous process and on its both sides (2 cm from the spinous process laterally) in the area of the extensor muscles of the lumbar spine. A participant will be asked to report when they feel pain at an intensity of 1/10, and a researcher will read the pressure on the dolorimeter.	Before the intervention, immediately after the intervention and 24 hours later
Tests with a thermal imaging camera (FLIR E54, USA)	The measurement will be taken in the forward lying position at the level of the three segments: L3, L4 and L5, at three points: the spinous process and on its both sides (2 cm from the spinous process laterally) in the area of the extensor muscles of the lumbar spine.The result will be marked in degrees Celsius.	Before the intervention, immediately after the intervention and 24 hours later
Tests with the Medi-Mouse (Switzerland)	The assessment of the range of motion of the lumbar spine flexion and extension.The result will be expressed in degrees.	Before the intervention, immediately after the intervention and 24 hours later
Scale for the subjective assessment of the expectations for the treatment outcomes based on the GRoC methodology	15-point Likert scale - from -7 (lowest expectations) to +7 (highest expectations).	Before the intervention
Scale for the subjective assessment of the treatment outcomes based on the GRoC methodology	15-point Likert scale - from -7 (significant worsening of symptoms) to +7 (significant improvement).	Immediately after the intervention and 24 hours later
Serological test - cortisol	During the blood collection, the participants will be placed in a sitting position. Before the blood collection, the following information should be reported: susceptibility to bleeding (bleeding diathesis), susceptibility to fainting during blood collection. In order to determine cortisol levels, the laboratory tests (with the use of immunoenzymatic methods (ELISA tests)) will be performed at the Medical Laboratory of the Innovation Research Center of John Paul II University in Biała Podlaska. The result will be expressed in nmol/L.	Before the intervention, immediately after the intervention and 24 hours later
Serological test - serotonin	During the blood collection, the participants will be placed in a sitting position. Before the blood collection, the following information should be reported: susceptibility to bleeding (bleeding diathesis), susceptibility to fainting during blood collection. In order to determine serotonin levels, the laboratory tests (with the use of immunoenzymatic methods (ELISA tests)) will be performed at the Medical Laboratory of the Innovation Research Center of John Paul II University in Biała Podlaska. The result will be expressed in ng/ml.	Before the intervention, immediately after the intervention and 24 hours later
Serological test - oxytocin	During the blood collection, the participants will be placed in a sitting position. Before the blood collection, the following information should be reported: susceptibility to bleeding (bleeding diathesis), susceptibility to fainting during blood collection. In order to determine oxytocin levels, the laboratory tests (with the use of immunoenzymatic methods (ELISA tests)) will be performed at the Medical Laboratory of the Innovation Research Center of John Paul II University in Biała Podlaska. The result will be expressed in mU/l.	Before the intervention, immediately after the intervention and 24 hours later

Collaborators and Investigators

• Sponsor: John Paul II University in Biała Podlaska
• Investigators: Study Chair: Kamil Zaworski, Ph.D., John Paul II University in Biała Podlaska

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2024
• Primary Completion (Actual): December 16, 2024
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Back Pain; Placebo Effect; Musculoskeletal Manipulations; Nocebo Effect
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: JohnPaul2U

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Analytical data will be available through direct contact with the research team and in the publication process as supplementary materials.
• IPD Sharing Time Frame: From the completion of the research for the next five years.
• IPD Sharing Access Criteria: Direct contact with the research team.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No