Study Stopped
Unable to reach agreement with PT \& surgeons on protocol
Effectiveness of Dry Needling and STM on Pain Management for Anterior Cruciate Ligament Reconstruction (ACLR)
The Effectiveness of Dry Needling and Soft Tissue Mobilization in the Management of Pain Post Anterior Cruciate Ligament (ACL) Reconstruction: A Randomized Controlled Trial
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The purpose of this study is to determine if dry needling (DN) and soft tissue mobilization (STM) is superior to standard treatment protocol for affecting pain, pain medication usage and measurements of range of motion (ROM) after ACL reconstruction surgery compared to a standard treatment protocol. Measurements of pain, pain medication usage, lower extremity functional scale (LEFS) and ROM will be taken day 2 post op and 1 week, 2 weeks, 3 weeks, and 4 weeks post op. It is hypothesized that the inclusion of DN and STM will acutely decrease the demand for pain medication and improve objective measurements when compared to a standard treatment protocol. Findings will potentially lead to insights as to the benefit of applying these interventions to help decrease the demand for pain medication post-surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2018
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2018
CompletedFirst Posted
Study publicly available on registry
April 24, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedSeptember 23, 2025
April 1, 2018
1 year
March 30, 2018
September 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Numerical pain rating scale
validated outcome measure for pain ranging from 0-10
change from baseline, 2 days post-op, 1 week, 2 week, 3 week, 4 week
Secondary Outcomes (3)
Lower extremity functional scale
change from baseline, 2 days post-op, 1 week, 2 week, 3 week, 4 week
Global rate of change
change from baseline, 2 days post-op, 1 week, 2 week, 3 week, 4 week
knee range of motion
change from baseline, 2 days post-op, 1 week, 2 week, 3 week, 4 week
Study Arms (2)
control group Standard ACL protocol
NO INTERVENTIONThis group will receive the standard ACL protocol rehab
Dry needling and STM group
EXPERIMENTALThis group will also receive the standard ACL protocol in addition to STM and DN
Interventions
Eligibility Criteria
You may qualify if:
- Age 18-40 Department of Defense( DOD) beneficiaries (17 if Cadet)
- Scheduled for ACL Reconstruction Surgery
You may not qualify if:
- Self-Reported Pregnancy
- History of blood borne pathogens/infectious disease/active infection/metal allergy
- Bleeding disorders or currently taking anti-coagulant medications
- Participants who are not fluent in English
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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal Investigator
Study Record Dates
First Submitted
March 30, 2018
First Posted
April 24, 2018
Study Start
June 1, 2018
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
September 23, 2025
Record last verified: 2018-04