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

Primary Purpose

Low Back Pain

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Spine flexion/extension active range of motion exercises
Sponsored by
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring rehabilitation, active range of motion, kinesiophobia, physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cabinet de masso-kinésithérapie

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with chronic low back pain

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Pain intensity
Pain intensity will be measured with a Visual Analog Pain Scale, from 0 (no pain) to 10 (pain of maximum intensity)
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.
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.

Full Information

First Posted
January 17, 2022
Last Updated
January 20, 2023
Sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
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1. Study Identification

Unique Protocol Identification Number
NCT05213845
Brief Title
Spine Rehabilitation Using Spine Flexion / Extension Full Active Range of Motion for Patients With Chronic Low Back Pain
Acronym
REACTIVE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
insufficient recruitment to meet the objectives in time
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
January 13, 2023 (Actual)
Study Completion Date
January 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
rehabilitation, active range of motion, kinesiophobia, physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with chronic low back pain
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Spine flexion/extension active range of motion exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
Roland-Morris disability questionnaire
Description
The Roland-Morris questionnaire is a 24-item self report questionnaire assessing physical disability, ranging from 0 (no disability) to 24 (severe disability).
Time Frame
Posttreatment (2 months)
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity will be measured with a Visual Analog Pain Scale, from 0 (no pain) to 10 (pain of maximum intensity)
Time Frame
Posttreatment (2 months)
Title
Fear Avoidance Beliefs Questionnaire (FABQ)
Description
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.
Time Frame
Posttreatment (2 months)
Title
Active range of motion of lumbar flexion and lumbar extension
Description
Active range of motion of lumbar flexion and lumbar extension will be measured with two inclinometers.
Time Frame
Posttreatment (2 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cabinet de masso-kinésithérapie
City
Mulhouse
ZIP/Postal Code
68100
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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