- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06837753
Hamstring Stretching Effective on Nonspecific Low Back Pain (Hams)
February 19, 2025 updated by: Eylül Pınar KISA, Biruni University
Does Hamstring Stretching Effective on Nonspecific Low Back Pain?"
Low back pain is one of the most common complaints in the world and can be considered a universal health problem for humanity.
Low back pain is a multifactorial disease with multiple etiologies.
Risk factors are difficult to identify.
It is reported in the literature that 70-80% of the world's population has low back pain at some point in their lives, and 95% of this pain is mechanical.
Mechanical low back pain (MBA) can be described as a clinical picture that develops as a result of overuse, strain, traumatization or deformation of the structures that make up the spine.
In order to define low back pain mechanically, all organic causes such as inflammatory, infectious, tumoral, metabolic causes, fractures and pain reflected from internal organs must be excluded.
The most common diseases that cause low back pain are; They are caused by mechanical factors and degenerative diseases.
Mechanical and static stresses can lead to joint blockage, restricting the range of motion of the joint along with pain.
Non-Specific many factors affect low back pain.
Kim and Shin reported that asymmetry of hip extension range of motion of both hip joints was associated with nonspecific low back pain rather than simple hip extension range of motion, and they found that limiting hip extension was compensatory.
Study Overview
Study Type
Interventional
Enrollment (Actual)
46
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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İstanbul
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İ̇stanbul, İstanbul, Turkey, 34720
- Eylül Pınar Kısa
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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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with complaints of low back pain,
- NLBP for at least 12 weeks,
- finger-to-ground distance greater than 0 cm; a passive straight-leg raising -(SLR) angle of less than 80°, measured with a hand-held goniometer;
- normal mobility of the hip;
- passive knee extension ≥25°,
- VAS score between 3 and 7 will be included.
Exclusion Criteria:
- People with a history of hamstring injury in the last two years,
- fractures in the spine or lower extremities,
- pregnancy,
- leg length difference of more than 2 cm,
- and obesity will be excluded from the study.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: exercise group
Exercise program and 3 way hamstring strech will be applied.
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It consist of traditional exercises.
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Other: control group
Just Exercise program will be applied.
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It consist of traditional exercises.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain status
Time Frame: 0-8 week
|
Pain status Patients pain status were evaluated with VAS between 0 and 10 for low back pain during movement.
(No pain at 0 points, severe pain at 10 points)
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0-8 week
|
|
Flexibility assessment
Time Frame: 0-8 week
|
During Single Leg Raise, subjects were asked to indicate (by pushing a button) the beginning of pain or an unpleasant tension sensation in the dorsal part of the thigh off the knee.
This first sensation of pain was recorded as a function of the pelvic-femoral angle.
Subjects were also instructed to push the button and to say "stop" when they could no longer tolerate more movement or stretch; at that point, the leg raise was stopped.
The stretch tolerance was defined by the extensibility of the hamstrings.
Note that the subjects stopped the leg raise.
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0-8 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functionality index
Time Frame: 0-8 week
|
Functional Rating Index (FDI) was obtained by combining similar structures of the neck disability index and the Osweestry low back pain disability index, and its validity and reliability have been proven.
The validity and reliability of the Turkish version of this survey was conducted by Bayar et al. in 2004.
FDI consists of 10 parts that measure the function of the spinal musculoskeletal (waist, neck pain) system and pain.
Eight address activities of daily living that may be affected by the spinal condition.
Two of them address 2 different characteristics of pain.
Using a 5-choice scale for each item, the amount of current pain or perceived ability to function is ranked by selecting 5 response points.
0=no pain or full function, 1=mild pain or mild limitation, 2=moderate pain or moderate limitation, 3=severe pain or severe limitation, 4=worst pain or inability to function.
Scoring varies between 0-40, and as the score increases, functional status worsens
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0-8 week
|
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FUNCTIONAL STATUS
Time Frame: 0-8 week
|
It consists of 10 questions, each scored between 0 and 5, assessing pain, personal care, lifting loads, walking, sitting, standing, sleeping, social life, traveling and the degree of change in pain.
The maximum score is 50 and the total score is multiplied by two and the result is given as a percentage.
Evaluation; It is done with the formula score/total score (50) x 100 = %.
This form is a form with proven validity and reliability in Turkish for patients with chronic low back pain, used to evaluate treatment results and compare different treatment
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0-8 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 12, 2023
Primary Completion (Actual)
January 1, 2024
Study Completion (Actual)
August 10, 2024
Study Registration Dates
First Submitted
December 13, 2023
First Submitted That Met QC Criteria
February 19, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 19, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hamstring
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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