Effectiveness of Dry Needling and STM on Pain Management for ACLR

Study Overview
=================
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.

Official Title
-----------------
The Effectiveness of Dry Needling and Soft Tissue Mobilization in the Management of Pain Post ACL Reconstruction: A Randomized Controlled Trial

Conditions
-----------------
Pain and Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
-----------------
* Other: Dry needling and STM


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2x5 mixed model anova
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group Standard ACL protocol<br>This group will receive the standard ACL protocol rehab | |
| Experimental: Dry needling and STM group<br>This group will also receive the standard ACL protocol in addition to STM and DN | Other: Dry needling and STM<br>* dry needling and soft tissue mobilization<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower extremity functional scale | 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 | 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 | measured with goniometer | change from baseline, 2 days post-op, 1 week, 2 week, 3 week, 4 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dry needling, ACL reconstruction, knee ROM, pain management, opioid use