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Dry Needling and Stretching vs. Stretching Alone on Hamstring Flexibility in Patients With Knee Pain

Primary Purpose

Mobility Limitation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dry Needling
Sham Needling
Sponsored by
Keller Army Community Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mobility Limitation

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Department of Defense healthcare beneficiaries
  • 18-40 years old
  • atraumatic knee pain greater than 2 weeks in duration
  • Lack of 20 degrees or more of active supine knee extension

Exclusion Criteria:

  • History of herniated lumbar disc/radiculopathy
  • Prior surgery in the hip, knee or back
  • Self-Reported Pregnancy
  • History of blood borne pathogens/infectious disease/active infection/metal allergy
  • Knee pain of traumatic origin, instability, joint line tenderness, or positive meniscal tests
  • Participants who are not fluent in English
  • Previous history of TDN
  • Bleeding disorders or currently taking anti-coagulant medications

Sites / Locations

  • Keller Army Community Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham Needling intervention, Control

Dry Needling Intervention, experimental

Arm Description

Sham dry needling, group does not receive true dry needling intervention.

Group receives true dry needling intervention.

Outcomes

Primary Outcome Measures

Knee extension range of motion
Assessed with active supine knee extension and supine straight leg raise using digital inclinometer

Secondary Outcome Measures

knee pain with squat recorded on visual analog scale
knee pain with step down test recorded on visual analog scale
lower extremity functional scale (LEFS)
Self Report Functional Outcome measure
Global Rating of Change
Self Report Functional Outcome measure
knee range of motion during squat
knee flexion measured with standard goniometer during squat

Full Information

First Posted
July 13, 2015
Last Updated
February 22, 2016
Sponsor
Keller Army Community Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02498704
Brief Title
Dry Needling and Stretching vs. Stretching Alone on Hamstring Flexibility in Patients With Knee Pain
Official Title
The Effectiveness of Dry Needling and Stretching vs. Stretching Alone on Hamstring Flexibility in Patients With Knee Pain: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keller Army Community Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purposes of this double-blinded, randomized controlled trial are (1) to determine if the addition of trigger point dry needling (TDN) to a standard stretching program results in greater improvements in hamstring flexibility versus stretching alone in a population with atraumatic knee pain; (2) measure length of time that flexibility gains are maintained, (3) assess resulting movement mechanics and (4) assess patient reported changes in pain. Findings will potentially lead to insights as to the benefit of applying this intervention to additional body regions.
Detailed Description
In this study, up to 40 subjects with a history of atraumatic knee pain will be randomized into 2 groups of up to 20 subjects per group (1 experimental group and 1 control group). Subjects in the experimental group will receive TDN intervention with hamstring stretching while subjects in the control group will receive an alternative needling intervention with hamstring stretching. After meeting all inclusion criteria, all subjects will undergo the following tests: supine active knee extension, the active straight leg raise test, deep squat, and a single leg step down from a 6 inch step. Subjects who measure less than 20° from full extension on the active knee extension test will be excluded. Hamstring tightness has been operationally defined as having greater than 20° loss of knee extension as measured with the femur held at 90° of hip flexion.[1] Manual palpation of the bilateral biceps femoris, semitendinosus, and semimembranosus will be performed to detect the presence of myofascial trigger points (TPs) in groups 1 and 2. Dry needling will be performed to all detected TPs by a provider trained and experienced in TDN. Post TDN, all tests will be immediately repeated and at each follow up the subject will complete the Global Rating of Change survey (GROC) and Lower Extremity Functional Scale (LEFS). Post intervention, subjects in experimental group 1 will be given a standing hamstring stretch to perform 1 repetition held for 30 seconds, repeated 3 times daily. These parameters have been shown to be effective at improving flexibility.[2] Subjects will be instructed by demonstration and will be provided with a handout of stretching instructions. Subjects will be given an exercise log to record home exercise compliance. Subjects in group 2 will be given an alternative needling intervention followed by a standing hamstring stretch to perform 3 times per day, 1 repetition held for 30 seconds. Alternative needling intervention will be performed to give the appearance of regular TDN intervention; however, no needle penetration will be performed. Following alternative needling intervention, subjects will be instructed by demonstration and will be provided with a handout of hamstring stretching instructions. Home exercise compliance will be recorded at each follow up. Follow up measurements will be recorded between 1-2 days, 3-4 days, and 7-8 days post intervention. All tests will be repeated. One additional session of TDN and alternative needling intervention will be performed at day 3-4.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham Needling intervention, Control
Arm Type
Sham Comparator
Arm Description
Sham dry needling, group does not receive true dry needling intervention.
Arm Title
Dry Needling Intervention, experimental
Arm Type
Experimental
Arm Description
Group receives true dry needling intervention.
Intervention Type
Procedure
Intervention Name(s)
Dry Needling
Intervention Description
Trigger point dry needling to hamstring muscle group.
Intervention Type
Other
Intervention Name(s)
Sham Needling
Intervention Description
Superficial palpation of trigger point, skin is not punctured.
Primary Outcome Measure Information:
Title
Knee extension range of motion
Description
Assessed with active supine knee extension and supine straight leg raise using digital inclinometer
Time Frame
7-8 days
Secondary Outcome Measure Information:
Title
knee pain with squat recorded on visual analog scale
Time Frame
7-8 days
Title
knee pain with step down test recorded on visual analog scale
Time Frame
7-8 days
Title
lower extremity functional scale (LEFS)
Description
Self Report Functional Outcome measure
Time Frame
7-8 days
Title
Global Rating of Change
Description
Self Report Functional Outcome measure
Time Frame
7-8 days
Title
knee range of motion during squat
Description
knee flexion measured with standard goniometer during squat
Time Frame
7-8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Department of Defense healthcare beneficiaries 18-40 years old atraumatic knee pain greater than 2 weeks in duration Lack of 20 degrees or more of active supine knee extension Exclusion Criteria: History of herniated lumbar disc/radiculopathy Prior surgery in the hip, knee or back Self-Reported Pregnancy History of blood borne pathogens/infectious disease/active infection/metal allergy Knee pain of traumatic origin, instability, joint line tenderness, or positive meniscal tests Participants who are not fluent in English Previous history of TDN Bleeding disorders or currently taking anti-coagulant medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Mason, DPT
Organizational Affiliation
Keller Army Community Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keller Army Community Hospital
City
West Point
State/Province
New York
ZIP/Postal Code
10996
Country
United States

12. IPD Sharing Statement

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Dry Needling and Stretching vs. Stretching Alone on Hamstring Flexibility in Patients With Knee Pain

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