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

NCT ID: NCT05213845

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-17
• Study Completion Date: 2023-01-13

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with chronic low back pain

Group Type: OTHER

Spine flexion/extension active range of motion exercises

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cabinet de masso-kinésithérapie

Mulhouse, , France

Countries

France

Other Identifiers

2021-A02319-32

Identifier Type: OTHER

Identifier Source: secondary_id

GHR 1206

Identifier Type: -

Identifier Source: org_study_id