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
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2014
1 active site
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
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 13, 2015
CompletedFirst Posted
Study publicly available on registry
July 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFebruary 23, 2016
February 1, 2016
10 months
July 13, 2015
February 22, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Knee extension range of motion
Assessed with active supine knee extension and supine straight leg raise using digital inclinometer
7-8 days
Secondary Outcomes (5)
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)
7-8 days
Global Rating of Change
7-8 days
knee range of motion during squat
7-8 days
Study Arms (2)
Sham Needling intervention, Control
SHAM COMPARATORSham dry needling, group does not receive true dry needling intervention.
Dry Needling Intervention, experimental
EXPERIMENTALGroup receives true dry needling intervention.
Interventions
Trigger point dry needling to hamstring muscle group.
Superficial palpation of trigger point, skin is not punctured.
Eligibility Criteria
You may qualify if:
- Department of Defense healthcare beneficiaries
- years old
- atraumatic knee pain greater than 2 weeks in duration
- Lack of 20 degrees or more of active supine knee extension
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Keller Army Community Hospital
West Point, New York, 10996, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Mason, DPT
Keller Army Community Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Sports Physical Therapy Fellow
Study Record Dates
First Submitted
July 13, 2015
First Posted
July 15, 2015
Study Start
November 1, 2014
Primary Completion
September 1, 2015
Study Completion
October 1, 2015
Last Updated
February 23, 2016
Record last verified: 2016-02