Clinical trial NCT05213845: Spine Rehabilitation Using Spine Flexion / Extension Full Active Range of Motion for Patients With Chronic Low Back Pain
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
Overall status: TERMINATED
Phase: NA
Conditions: Low Back Pain
Keywords: rehabilitation
active range of motion
kinesiophobia
physiotherapy
Lead sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Roland-Morris disability questionnaire
timeFrame: Posttreatment (2 months)
Secondary outcomes:
measure: Pain intensity
timeFrame: Posttreatment (2 months)
measure: Fear Avoidance Beliefs Questionnaire (FABQ)
timeFrame: Posttreatment (2 months)
measure: Active range of motion of lumbar flexion and lumbar extension
timeFrame: Posttreatment (2 months)
Other outcomes:
Locations:
city: Mulhouse
country: France
facility: Cabinet de masso-kinésithérapie
Study officials:
References: