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

NCT05213845 | Terminated

• 2 other identifiers: GHR 12062021-A02319-32
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

rehabilitation; active range of motion; kinesiophobia; physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain intensity

  Posttreatment (2 months)

• Fear Avoidance Beliefs Questionnaire (FABQ)

  Posttreatment (2 months)

• Active range of motion of lumbar flexion and lumbar extension

  Posttreatment (2 months)

Study Arms (1)

Patients with chronic low back pain

OTHER

Procedure: Spine flexion/extension active range of motion exercises

Interventions

Spine flexion/extension active range of motion exercises 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

Patients with chronic low back pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Cabinet de masso-kinésithérapie

Mulhouse, 68100, France

Location

MeSH Terms

Conditions

Low Back Pain; Kinesiophobia

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 28, 2022
• Study Start: February 17, 2022
• Primary Completion: January 13, 2023
• Study Completion: January 13, 2023
• Last Updated: January 25, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)