- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02516137
Hamstring Tightness
June 1, 2017 updated by: Marie Johanson, Emory University
Clinical Effects of Dry Needling Among Asymptomatic Individuals With Hamstring Tightness
The purpose of this study is to find out if individuals with tight hamstring muscles who receive dry needling in addition to a standard stretching exercise program, show an improvement in hamstring tightness and function compared to individuals with tight hamstrings who receive either sham dry needling or no needling (blunt needle) in addition to a standard stretching program.
Study Overview
Status
Completed
Conditions
Detailed Description
Tightness of the hamstring muscles is a risk factor for injury.
Currently, there is no data on the effect of dry needling on hamstring extensibility or functional performance measures among asymptomatic individuals with hamstring muscle tightness.
The investigator wants to assess if individuals with tight hamstring muscles who receive dry needling in addition to a standard stretching exercise program, exhibit reduced hamstring tightness and improved functional performance compared to individuals with tight hamstrings who receive either sham dry needling or no needling (blunt needle) in addition to a standard stretching program.
Study Type
Interventional
Enrollment (Actual)
28
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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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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Atlanta, Georgia, United States, 30322
- Emory Clinic
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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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Hamstring 90/90 extensibility goniometric measurement of more than 20 degrees of knee flexion bilaterally
- Ability to perform a squat to 90 degrees of knee flexion without assistance of the upper extremities
- Asymptomatic during walking
Exclusion Criteria:
- History of systemic neurological or arthritic condition
- History of bony or peripheral nerve trauma or surgery lower extremities
- History of treatment with dry needling
- No contraindications to dry needling
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dry needling group
Subjects with tight hamstrings will receive dry needling to the hamstrings with the needle inserted into the muscle tissue in addition to a standard hamstring stretching exercise program.
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Dry needling will be performed on two points over the hamstring muscles on the randomly determined side.
Points 2 cm distal to the ischial tuberosity and halfway between the ischial tuberosity and popliteal crease within the medial and lateral muscle bellies will be identified and the skin cleansed with rubbing alcohol.
A Seirin L- type 50 mm needle will be inserted into each of the two points to a depth no greater than three-quarters length of the needle into the hamstring muscle for 30 seconds using a vertical pistoning technique and then statically up to 10 minutes.
Subjects will be instructed to stretch the back of their thighs, once a day for 3 repetitions, holding for 30 seconds each time performed bilaterally.
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Sham Comparator: Sham dry needling group
Subjects with tight hamstrings will receive sham dry needling to the hamstrings with the needle inserted into the subcutaneous tissue in addition to a standard hamstring stretching exercise program.
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Subjects will be instructed to stretch the back of their thighs, once a day for 3 repetitions, holding for 30 seconds each time performed bilaterally.
Sham dry needling will be performed on two points over the hamstring muscles on the randomly determined side.
Points 2 cm distal to the ischial tuberosity and halfway between the ischial tuberosity and popliteal crease within the medial and lateral muscle bellies will be identified and the skin cleansed with rubbing alcohol.
The plastic tube of a Seirin L- type 50 mm needle will be placed against the skin and the needle will be tapped once so that it is inserted subcutaneously no deeper than 5 mm for 30 seconds using a vertical pistoning technique and then statically up to 10 minutes in each location.
|
Placebo Comparator: No needling group
Subjects with tight hamstrings will receive no needling but have the tip of a blunt needle handle placed on the skin over the hamstrings in addition to a standard hamstring stretching exercise program.
|
Subjects will be instructed to stretch the back of their thighs, once a day for 3 repetitions, holding for 30 seconds each time performed bilaterally.
Blunt needle placement will be performed on two points over the hamstring muscles on the randomly determined side.
Points 2 cm distal to the ischial tuberosity and halfway between the ischial tuberosity and popliteal crease within the medial and lateral muscle bellies will be identified and the skin cleansed with rubbing alcohol.
A blunt needle handle is inserted into a plastic tube which will be placed over the identified points for 30 seconds and then for an additional 10 minutes each.
The blunt needle handle only touches the skin without puncturing it.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in hamstring muscle extensibility
Time Frame: Baseline, at 5 weeks from baseline
|
Bilateral 90/90 hamstring muscle extensibility passive range of motion (PROM) measurements will be assessed using a goniometer.
The goniometer measures the angle of the joint at both extremes of the range of motion (ROM).
An increase in the passive range of motion (PROM) indicates increased hamstring muscle extensibility.
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Baseline, at 5 weeks from baseline
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Change in unilateral hop for distance test scores
Time Frame: Baseline, at 5 weeks from baseline
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The functional performance of the hamstring muscles will be assessed by using the unilateral hop for distance test.
The subjects will be instructed to stand on the leg to be tested and hop and land on the same limb.
The distance hopped, measured at the level of the great toe, will be measured (centimeters).
Scores will be recorded as absolute distance (in centimeters).
An increase in the score (distance covered) from baseline to 5 weeks from baseline indicates better functional performance of the hamstrings.
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Baseline, at 5 weeks from baseline
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Change in crossover hop for distance tests scores
Time Frame: Baseline, at 5 weeks from baseline
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The functional performance of the hamstring muscles will be assessed by using the crossover hop for distance test.
The subjects will be instructed to hop forward 3 times while alternately crossing over a marking.
The total distance hopped forward will be recorded.
The heel of the hop leg will be used to determine the length of the jump.
Crossover hop limb symmetry index (LSI) scores for knee function within normal ranges are generally greater than 95%.
An increase in the crossover hop limb symmetry index (LSI) from baseline to 5 weeks from baseline indicates better functional performance of the hamstrings.
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Baseline, at 5 weeks from baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in dynamometry pressure readings
Time Frame: Baseline, at 5 weeks from baseline
|
The strength of the hamstrings will be assessed using a hand-held dynamometer.The subjects will be asked to exert maximal force against the dynamometer and the reading is recorded.
Scores are based on force production in kilograms or pounds; kilograms (0-90), pounds (0-200).
Higher pressure scores indicate better muscle strength of the hamstring muscles.
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Baseline, at 5 weeks from baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marie Johanson, PT, PhD, OCS, Emory University
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
July 1, 2015
Primary Completion (Actual)
May 31, 2017
Study Completion (Actual)
May 31, 2017
Study Registration Dates
First Submitted
August 3, 2015
First Submitted That Met QC Criteria
August 3, 2015
First Posted (Estimate)
August 5, 2015
Study Record Updates
Last Update Posted (Actual)
June 5, 2017
Last Update Submitted That Met QC Criteria
June 1, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00077095
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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