NCT02516137

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
Last Updated

June 5, 2017

Status Verified

June 1, 2017

Enrollment Period

1.9 years

First QC Date

August 3, 2015

Last Update Submit

June 1, 2017

Conditions

Keywords

Dry needling

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Change in dynamometry pressure readings

    Baseline, at 5 weeks from baseline

Study Arms (3)

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.

Procedure: Dry needlingOther: 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.

Procedure: Sham needlingOther: 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.

Procedure: Blunt needle placementOther: Standard hamstring stretching exercise

Interventions

Dry needlingPROCEDURE

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.

Dry needling group
Sham needlingPROCEDURE

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.

Sham dry needling group

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.

No needling group

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.

Dry needling groupNo needling groupSham dry needling group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Marie Johanson, PT, PhD, OCS

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 5, 2015

Study Start

July 1, 2015

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

June 5, 2017

Record last verified: 2017-06

Locations