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

Sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace (Other)

Overall Status

Recruiting

CT.gov ID

NCT05213845

Collaborator

(none)

Enrollment

Location

Arm

15.4

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Procedure: Spine flexion/extension active range of motion exercises	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

65 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 17, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Roland-Morris disability questionnaire [Posttreatment (2 months)]
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 [Posttreatment (2 months)]
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) [Posttreatment (2 months)]
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 [Posttreatment (2 months)]
Active range of motion of lumbar flexion and lumbar extension will be measured with two inclinometers.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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