Spine Rehabilitation Using Spine Flexion / Extension Full Active Range of Motion for Patients With Chronic Low Back Pain (REACTIVE)

Assessment of Spine Rehabilitation Program Using Spine Flexion and Extension Full Active Range of Motion for Patients With Chronic Low Back Pain : a Monocentric Prospective Cohort Study

The main objective of this study is to assess efficacy of a spine rehabilitation program, using spine flexion and extension full active range of motion, on physical disability of patients with chronic low back pain.

Study Overview

• Status: Terminated
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: Spine flexion/extension active range of motion exercises

Detailed Description

Secondary objectives

The other objectives of this study are to assess the impact of spine rehabiliation program using spine flexion and extension full active range of motion on :

• pain intensity ;
• kinesiophobia
• active range of motion of lumbar flexion and lumbar extension

Conduct of research

After receiving the written consent of the study, participants will benefit from 5 sessions of spine flexion and extension full active range of motion exercises. The following tests and questionnaires will be performed before (baseline) and after (posttreatment) the 5 sessions :

• Visual Analogue Pain Scale,
• Fear Avoidance Beliefs Questionnaire (FABQ),
• Double-inclinometer to measure active range of motion of lumbar flexion and lumbar extension.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Mulhouse, France, 68100
    • Cabinet de masso-kinésithérapie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Medical prescription for chronic low back pain rehabilitation
• Evolution of low back pain for at least 3 months
• No treatment or rehabilitation for low back pain performed within 12 months before enrollment
• Written informed consent given

Exclusion Criteria:

• Spinal fracture or previous spinal surgery
• Cognitive impairments that prevent from understanding the rehabilitation exercises
• Patient with insufficient understanding or expression in French
• Non-mechanical pain : gradually worsening pain, present at rest and especially at night
• Neurological symptom : deficit in the control of bladder and anal sphincters, motor weakness of lower limbs, Cauda equina syndrome
• Pubis paresthesia (or perineum)
• Severe trauma (such as fall from height, traffic accident)
• Unexplained weight loss
• History of cancer
• Drug use or long-term use of corticosteroid
• Spinal deformity
• Altered general condition
• Patient with signs of neurological impairment : positive Lasegue test (Straight Leg Raise Test) or positive Slump test, or DN4 questionnaire greater than or equal to 4
• Patient suffering from a central or peripheral neurological pathology
• Patient taking a level II (weak opiates) or III (morphine and related substances) analgesic treatment
• Patient under guardianship, curatorship or legal protection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Patients with chronic low back pain

Procedure: Spine flexion/extension active range of motion exercises; Five full active range of motion rehabilitation sessions will be scheduled. Four or the five following full active range of motion exercises will be performed during one rehabilitation session : spine flexion and extension (quadrupedic position), lumbar flexion and extension (sitting position), posterior and anterior pelvic tilt (sitting and standing position), lumbar flexion and extension (standing position) and Jefferson Curl exercise. All five rehabilitation sessions must be performed within 60 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Roland-Morris disability questionnaire	The Roland-Morris questionnaire is a 24-item self report questionnaire assessing physical disability, ranging from 0 (no disability) to 24 (severe disability).	Posttreatment (2 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity will be measured with a Visual Analog Pain Scale, from 0 (no pain) to 10 (pain of maximum intensity)	Posttreatment (2 months)
Fear Avoidance Beliefs Questionnaire (FABQ)	The FABQ is a patient reported questionnaire which specifically focuses on how patient's fear-avoidance beliefs about physical activity may affect and contribute to his/her low back pain and resulting disability.	Posttreatment (2 months)
Active range of motion of lumbar flexion and lumbar extension	Active range of motion of lumbar flexion and lumbar extension will be measured with two inclinometers.	Posttreatment (2 months)

Collaborators and Investigators

• Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2022
• Primary Completion (Actual): January 13, 2023
• Study Completion (Actual): January 13, 2023

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: rehabilitation; physiotherapy; kinesiophobia; active range of motion
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: GHR 1206; 2021-A02319-32 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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