Immediate Effect of Hamstring Stretching in Patients With Chronic Low Back Pain
EFIM1
2 other identifiers
interventional
90
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2020
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 3, 2020
CompletedFirst Submitted
Initial submission to the registry
September 3, 2020
CompletedFirst Posted
Study publicly available on registry
September 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 9, 2022
CompletedMay 12, 2022
February 1, 2022
1.8 years
September 3, 2020
May 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Day 1
Secondary Outcomes (6)
Straight Leg Rise test (SLR)
Day 1 before stretching, Day 1 after stretching
Fingertip-to-floor distance (FTF)
Day 1 before stretching, Day 1 after stretching
Fear Avoidance Belief Questionnaire (FABQ)
Day 1
Ostwestry Disability Index
Day 1
Anxiety and Depression scale
Day 1
- +1 more secondary outcomes
Study Arms (1)
hamstring stretching
EXPERIMENTALParticipants' 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Pregnancy or breastfeeding,
- Condition of restricted mental/legal autonomy (ex. guardianship) ,
- No social security insurance,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Hospital, Clermont Ferrand
Clermont-Ferrand, 63000, France
CHu de Nîmes
Nîmes, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2020
First Posted
September 16, 2020
Study Start
July 3, 2020
Primary Completion
May 9, 2022
Study Completion
May 9, 2022
Last Updated
May 12, 2022
Record last verified: 2022-02