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

Low Back Pain Clinical Trial

— REACTIVE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05213845
• Other study ID #: GHR 1206
• Secondary ID: 2021-A02319-32
• Status: Terminated
• Phase: N/A
• Start date: February 17, 2022
• Est. completion date: January 13, 2023

Study information

• Verified date: February 2022
• Source: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 13, 2023
• Est. primary completion date: January 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
France	Cabinet de masso-kinésithérapie	Mulhouse

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain intensity	Pain intensity will be measured with a Visual Analog Pain Scale, from 0 (no pain) to 10 (pain of maximum intensity)	Posttreatment (2 months)
Secondary	Fear Avoidance Beliefs Questionnaire (FABQ)	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.	Posttreatment (2 months)
Secondary	Active range of motion of lumbar flexion and lumbar extension	Active range of motion of lumbar flexion and lumbar extension will be measured with two inclinometers.	Posttreatment (2 months)