NCT02498704

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

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

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

November 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

10 months

First QC Date

July 13, 2015

Last Update Submit

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 COMPARATOR

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

Other: Sham Needling

Dry Needling Intervention, experimental

EXPERIMENTAL

Group receives true dry needling intervention.

Procedure: Dry Needling

Interventions

Dry NeedlingPROCEDURE

Trigger point dry needling to hamstring muscle group.

Dry Needling Intervention, experimental

Superficial palpation of trigger point, skin is not punctured.

Sham Needling intervention, Control

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Mobility Limitation

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • John Mason, DPT

    Keller Army Community Hospital

    PRINCIPAL INVESTIGATOR

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

Locations