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

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
manual hamstring stretching
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Chronic low back pain, Hamstring flexibility, Hamstring stretching, Immediate stretching effect

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • University Hospital, Clermont Ferrand
  • CHu de Nîmes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

hamstring stretching

Arm Description

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.

Outcomes

Primary Outcome Measures

Active Knee Extension test (AKE)
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

Straight Leg Rise test (SLR)
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)
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)
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
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
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
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.

Full Information

First Posted
September 3, 2020
Last Updated
May 11, 2022
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT04551326
Brief Title
Immediate Effect of Hamstring Stretching in Patients With Chronic Low Back Pain
Acronym
EFIM1
Official Title
Immediate Effect of Hamstring Stretching in Patients With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 3, 2020 (Actual)
Primary Completion Date
May 9, 2022 (Actual)
Study Completion Date
May 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Chronic low back pain, Hamstring flexibility, Hamstring stretching, Immediate stretching effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hamstring stretching
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
manual hamstring stretching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Active Knee Extension test (AKE)
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Straight Leg Rise test (SLR)
Description
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.
Time Frame
Day 1 before stretching, Day 1 after stretching
Title
Fingertip-to-floor distance (FTF)
Description
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.
Time Frame
Day 1 before stretching, Day 1 after stretching
Title
Fear Avoidance Belief Questionnaire (FABQ)
Description
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.
Time Frame
Day 1
Title
Ostwestry Disability Index
Description
Questionnaire evaluating pain and function in low back pain patients. Maximum score 100%, minimum score 0%, A higher score indicates greater disability.
Time Frame
Day 1
Title
Anxiety and Depression scale
Description
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.
Time Frame
Day 1
Title
Neuropathic pain presence
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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,
Facility Information:
Facility Name
University Hospital, Clermont Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
CHu de Nîmes
City
Nîmes
Country
France

12. IPD Sharing Statement

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

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