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

The Effectiveness of Dry Needling and Stretching vs. Stretching Alone on Hamstring Flexibility in Patients With Knee Pain: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Mobility Limitation
• Intervention / Treatment: Other: Sham Needling; Procedure: Dry Needling

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • West Point, New York, United States, 10996
      • Keller Army Community Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Needling intervention, Control; Sham dry needling, group does not receive true dry needling intervention.	Other: Sham Needling; Superficial palpation of trigger point, skin is not punctured.
Experimental: Dry Needling Intervention, experimental; Group receives true dry needling intervention.	Procedure: Dry Needling; Trigger point dry needling to hamstring muscle group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee extension range of motion	Assessed with active supine knee extension and supine straight leg raise using digital inclinometer	7-8 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
knee pain with squat recorded on visual analog scale		7-8 days
knee pain with step down test recorded on visual analog scale		7-8 days
lower extremity functional scale (LEFS)	Self Report Functional Outcome measure	7-8 days
Global Rating of Change	Self Report Functional Outcome measure	7-8 days
knee range of motion during squat	knee flexion measured with standard goniometer during squat	7-8 days

Collaborators and Investigators

• Sponsor: Keller Army Community Hospital
• Investigators: Principal Investigator: John Mason, DPT, Keller Army Community Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: July 13, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimate): July 15, 2015

Study Record Updates

• Last Update Posted (Estimate): February 23, 2016
• Last Update Submitted That Met QC Criteria: February 22, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mobility Limitation
• Other Study ID Numbers: 403645-1