- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03506685
Effectiveness of Dry Needling and STM on Pain Management for Anterior Cruciate Ligament Reconstruction (ACLR)
September 17, 2025 updated by: Jamie Morris, Keller Army Community Hospital
The Effectiveness of Dry Needling and Soft Tissue Mobilization in the Management of Pain Post Anterior Cruciate Ligament (ACL) Reconstruction: A Randomized Controlled Trial
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
West Point, New York, United States, 10996
- Keller Army Community Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 18-40 Department of Defense( DOD) beneficiaries (17 if Cadet)
- Scheduled for ACL Reconstruction Surgery
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group Standard ACL protocol
This group will receive the standard ACL protocol rehab
|
|
|
Experimental: Dry needling and STM group
This group will also receive the standard ACL protocol in addition to STM and DN
|
dry needling and soft tissue mobilization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical pain rating scale
Time Frame: change from baseline, 2 days post-op, 1 week, 2 week, 3 week, 4 week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lower extremity functional scale
Time Frame: change from baseline, 2 days post-op, 1 week, 2 week, 3 week, 4 week
|
validated measure to assess disability and function for the lower extremity on a scale of 0-80
|
change from baseline, 2 days post-op, 1 week, 2 week, 3 week, 4 week
|
|
Global rate of change
Time Frame: change from baseline, 2 days post-op, 1 week, 2 week, 3 week, 4 week
|
validated measure of self reported overall change in injury or condition ranging from -7 to 7
|
change from baseline, 2 days post-op, 1 week, 2 week, 3 week, 4 week
|
|
knee range of motion
Time Frame: change from baseline, 2 days post-op, 1 week, 2 week, 3 week, 4 week
|
measured with goniometer
|
change from baseline, 2 days post-op, 1 week, 2 week, 3 week, 4 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2018
Primary Completion (Actual)
June 1, 2019
Study Completion (Actual)
June 1, 2019
Study Registration Dates
First Submitted
March 30, 2018
First Submitted That Met QC Criteria
April 23, 2018
First Posted (Actual)
April 24, 2018
Study Record Updates
Last Update Posted (Estimated)
September 23, 2025
Last Update Submitted That Met QC Criteria
September 17, 2025
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18KACH002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
No Protected Health Information (PHI) or Personally Identifiable Information (PII) data will be share however may share outcome measures for data analysis based on subject identification.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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