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Immediate Effect of Hamstring Stretching in Patients With Chronic Low Back Pain (EFIM1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04551326
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Other: manual hamstring stretching Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate Effect of Hamstring Stretching in Patients With Chronic Low Back Pain
Actual Study Start Date : July 3, 2020
Estimated Primary Completion Date : July 3, 2022
Estimated Study Completion Date : July 3, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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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.
 Other: manual 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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,
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04551326


Contacts
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Contact: Lise Laclautre 0473754963 promo_interne_drci@chu-clermontferrand.fr

Locations
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France
University Hospital, Clermont Ferrand Recruiting
Clermont-Ferrand, France, 63000
Contact: Lise Laclautre    0473754963    promo_interne_drci@chu-clermontferrand.fr   
Principal Investigator: Lech DOJIBA         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
More Information
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT04551326    
Other Study ID Numbers: RBHP 2019 DOBIJA
2019-A03000-57 ( Registry Identifier: ID-RCB )
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Chronic low back pain
Hamstring flexibility
Hamstring stretching
Immediate stretching effect
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations