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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Atlanta, Georgia, United States, 30322
        • Emory Clinic

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
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.
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.
Procedure: 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.
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.
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Baseline, at 5 weeks from baseline
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.
Baseline, at 5 weeks from baseline
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.
Baseline, at 5 weeks from baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Baseline, at 5 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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