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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02516137
Other study ID # IRB00077095
Secondary ID
Status Completed
Phase N/A
First received August 3, 2015
Last updated June 1, 2017
Start date July 2015
Est. completion date May 31, 2017

Study information

Verified date June 2017
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 (blunt needle) in addition to a standard stretching program.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date May 31, 2017
Est. primary completion date May 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Dry needling
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 needling
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 placement
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.
Other:
Standard hamstring stretching exercise
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.

Locations

Country Name City State
United States Emory Clinic Atlanta Georgia
United States Emory University Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline, at 5 weeks from baseline
Primary 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. Baseline, at 5 weeks from baseline
Primary 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. Baseline, at 5 weeks from baseline
Secondary 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. Baseline, at 5 weeks from baseline
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