Immediate Effect of Hamstring Stretching in Patients With Chronic Low Back Pain (EFIM1)
July 31, 2026 updated by: University Hospital, Clermont-Ferrand
Thigh muscles flexibility deficits contribute to handicap in chronic low back pain patients.
The study aims to evaluate the immediate effect of thigh muscles stretching in patients with chronic low back pain.
The investigation team suppose that flexibility improvement could be detected by instrumented clinical measurements and such difference could be related to psycho-social factors evaluated by questionnaires.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary objective of the study is to evaluate the immediate effect of the hamstring muscle stretching in patients presenting chronic low back pain.
The secondary objectives are: (1) to evaluate intra- and interrater reliability, construct validity and responsiveness of the hamstring flexibility measurements (Active Knee Extension [AKE], Straight Leg Rise [SLR]) realised with digital inclinometer, (2) to evaluate factors that potentially could influence immediate effect of the hamstring stretching, specifically psycho-social factors Fear Avoidance Belief Questionnaire (FABQ), Hospital Anxiety and Depression scale (HAD), neuropathic pain presence (DN4).
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Clermont-Ferrand, France, 63000
- University Hospital, Clermont Ferrand
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Nîmes, France
- CHU de Nîmes
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age between 18 and 60 years
- Chronic low back pain (>3 months) with or without pain irradiation to lower limb
- Hamstring flexibility deficit (AKE <80° and FTF>5cm)
Exclusion Criteria:
- Pregnancy or breastfeeding,
- Condition of restricted mental/legal autonomy (ex. guardianship) ,
- No social security insurance,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: hamstring stretching
Participants' lower limb will be positioned in maximal hip flexion and gradually moved to maximal knee extension by physical therapist.
The procedure will take one minute for each lower limb.
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Participants' lower limb will be positioned in maximal hip flexion and gradually moved to maximal knee extension by physical therapist.
The procedure will take one minute for each lower limb.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Active Knee Extension test (AKE)
Time Frame: Day 1
|
Description: Participant positioned in supine lying will actively extend his knee while keeping his hip joint in 90 degrees of flexion.
Hip position will be verified by digital inclinometer and maintained with a barre indicating vertical position of the participants' thigh.
The range of motion will be recorded with digital inclinometer positioned on the tibial craft of the exanimated limb.
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Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Straight Leg Rise test (SLR)
Time Frame: Day 1 before stretching, Day 1 after stretching
|
Participant positioned in supine lying, examiner rise his lower limb, with knee extended.
Examiner stops the movement when participant declare pain or tension onset than the range of motion is recorded in degree with digital inclinometer positioned on the tibial craft of the exanimated limb.
|
Day 1 before stretching, Day 1 after stretching
|
|
Fingertip-to-floor distance (FTF)
Time Frame: Day 1 before stretching, Day 1 after stretching
|
Participant try to reach the floor with his fingertip by bending forward in the same time knees are kept extended.
The distance between fingertips and floor are measured in centimetres by examiner.
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Day 1 before stretching, Day 1 after stretching
|
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Fear Avoidance Belief Questionnaire (FABQ)
Time Frame: Day 1
|
Questionnaire evaluating belief about physical activity and work activity.
The The FABQ is divided into 2 parts, (1)physical activity (minimum score 0, maximum score 24) and (2) work (minimum score 0, maximum score 42).
A higher score indicates more strongly held fear avoidance beliefs.
|
Day 1
|
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Ostwestry Disability Index
Time Frame: Day 1
|
Questionnaire evaluating pain and function in low back pain patients.
Maximum score 100%, minimum score 0%, A higher score indicates greater disability.
|
Day 1
|
|
Anxiety and Depression scale
Time Frame: Day 1
|
Questionnaire evaluating anxiety and depression, Hospital Anxiety and Depression scale.
The scale is devided into 2 parts: (1) anxiety (minimum score 0, maximum sore 21) and (2) depression (minimum score 0, maximum sore 21).
A higher score indicates greater anxiety or greater depression.
|
Day 1
|
|
Neuropathic pain presence
Time Frame: Day 1
|
Questionnaire evaluating existence of the neuropathic pain, Neuropathic pain presence (DN4).
Minimum score 0, maximum sore 10.
The score equal or superior to 4 indicate the presence of neuropathic pain.
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 3, 2020
Primary Completion (Actual)
May 9, 2022
Study Completion (Actual)
May 9, 2022
Study Registration Dates
First Submitted
September 3, 2020
First Submitted That Met QC Criteria
September 15, 2020
First Posted (Actual)
September 16, 2020
Study Record Updates
Last Update Posted (Actual)
August 3, 2026
Last Update Submitted That Met QC Criteria
July 31, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBHP 2019 DOBIJA
- 2019-A03000-57 (Registry Identifier: ID-RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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