Hamstring TightnessNCT02516137
Hamstring Tightness
A study testing Dry needling, Blunt needle placement and Standard hamstring stretching exercise in people with Hamstring Tightness, run by Emory University at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hamstring Tightness
- What is being tested?
- Dry needling, Blunt needle placement and Standard hamstring stretching exercise
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2015to 31 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory Clinic
Atlanta, Georgia, 30322
Emory University
Atlanta, Georgia, 30322
About this study
Official title: 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.
Read the 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.
- Conditions
- Hamstring Tightness
- Being tested
- Dry needling, Sham needling, Blunt needle placement, Standard hamstring stretching exercise
- Keywords
- Dry needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingProcedure or surgery
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.
Sham needlingProcedure or surgery
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.
Blunt needle placementProcedure or surgery
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.
Standard hamstring stretching exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling group | Experimental | 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. Receives: Procedure: Dry needling; Other: Standard hamstring stretching exercise |
| Sham dry needling group | Sham comparator | 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. Receives: Procedure: Sham needling; Other: Standard hamstring stretching exercise |
| No needling group | Placebo comparator | 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. Receives: Procedure: Blunt needle placement; Other: Standard hamstring stretching exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hamstring muscle extensibility
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.
Measured: Baseline, at 5 weeks from baseline
Change in unilateral hop for distance test scores
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.
Measured: Baseline, at 5 weeks from baseline
Change in crossover hop for distance tests scores
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.
Measured: Baseline, at 5 weeks from baseline
Secondary outcomes (1)
Change in dynamometry pressure readings
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.
Measured: Baseline, at 5 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startJul 2015
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hamstring TightnessStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Johanson, Emory University
- Investigators
- Marie Johanson, PT, PhD, OCS, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516137
- Sponsor's protocol ID
- IRB00077095
- Status last verified
- Jun 2017
- First submitted
- 3 Aug 2015
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Dry Needling Among Asymptomatic Individuals With Hamstring Tightness
- ClinicalTrials.gov ID
- NCT02516137
- Acronym / sponsor ID
- IRB00077095
- Conditions
- Hamstring Tightness
- Keywords
- Dry needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 5 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dry needling group | Experimental | Procedure: Dry needling, Other: Standard hamstring stretching exerciseSubjects 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. |
| Sham dry needling group | Sham comparator | Procedure: Sham needling, Other: Standard hamstring stretching exerciseSubjects 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. |
| No needling group | Placebo comparator | Procedure: Blunt needle placement, Other: Standard hamstring stretching exerciseSubjects 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry needlingDry 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. | Procedure or surgery | Dry needling group |
| Sham needlingSham 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. | Procedure or surgery | Sham dry needling group |
| Blunt needle placementBlunt 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. | Procedure or surgery | No needling group |
| Standard hamstring stretching exerciseSubjects will be instructed to stretch the back of their thighs, once a day for 3 repetitions, holding for 30 seconds each time performed bilaterally. | Other | Dry needling group, No needling group, Sham dry needling group |
Primary outcome
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.
Change in unilateral hop for distance test scores
Time frame: Baseline, at 5 weeks from baseline
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.
Change in crossover hop for distance tests scores
Time frame: Baseline, at 5 weeks from baseline
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.
1 secondary outcome
Change in dynamometry pressure readings
Time frame: Baseline, at 5 weeks from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Johanson, PT, PhD, OCS principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling, Blunt needle placement and Standard hamstring stretching exercise in people with Hamstring Tightness, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hamstring muscle extensibility (time frame: Baseline, at 5 weeks from baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017.