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

Not Applicable

Terminated

• Conditions: Low Back Pain
• Interventions: Procedure: Spine flexion/extension active range of motion exercises

• Registration Number: NCT05213845
• Lead Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

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.

Study Timeline

• Study First Submitted: 2022-01-17
• Study First Submitted QC: 2022-01-17
• Study First Posted: 2022-01-28
• Status Verified: 2022-02
• Study Start: 2022-02-17
• Primary Completion: 2023-01-13
• Study Completion: 2023-01-13
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with chronic low back pain	Spine flexion/extension active range of motion exercises	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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)

Trial Locations

Locations (1)

Cabinet de masso-kinésithérapie; 🇫🇷 Mulhouse, France