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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

Tracking Information
First Submitted Date  ICMJE September 3, 2020
First Posted Date  ICMJE September 16, 2020
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE July 3, 2020
Estimated Primary Completion Date July 3, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immediate Effect of Hamstring Stretching in Patients With Chronic Low Back Pain
Official Title  ICMJE Immediate Effect of Hamstring Stretching in Patients With Chronic Low Back Pain
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Low-back Pain
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Other: manual hamstring stretching
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 15, 2020)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 3, 2022
Estimated Primary Completion Date July 3, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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,
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lise Laclautre 0473754963 promo_interne_drci@chu-clermontferrand.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04551326
Other Study ID Numbers  ICMJE RBHP 2019 DOBIJA
2019-A03000-57 ( Registry Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor  ICMJE University Hospital, Clermont-Ferrand
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Clermont-Ferrand
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP