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Effectiveness of Dry Needling and STM on Pain Management for ACLR

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03506685
Recruitment Status : Unknown
Verified April 2018 by david hulsizer, Keller Army Community Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 24, 2018
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
david hulsizer, Keller Army Community Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain and Anterior Cruciate Ligament Reconstruction Other: Dry needling and STM Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2x5 mixed model anova
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Dry Needling and Soft Tissue Mobilization in the Management of Pain Post ACL Reconstruction: A Randomized Controlled Trial
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
 Other: Dry needling and STM
dry needling and soft tissue mobilization


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. knee range of motion [ Time Frame: change from baseline, 2 days post-op, 1 week, 2 week, 3 week, 4 week ]
    measured with goniometer


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506685


Contacts
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Contact: David K Hulsizer, DPT 845-938-5109 david.k.hulsizer.mil@mail.mil

Locations
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United States, New York
Keller Army Community Hospital
West Point, New York, United States, 10996
Contact: david hulsizer, DPT    845-938-5109    david.k.hulsizer.mil@mail.mil   
Sponsors and Collaborators
Keller Army Community Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: david hulsizer, principal Investigator, Keller Army Community Hospital
ClinicalTrials.gov Identifier: NCT03506685    
Other Study ID Numbers: 18KACH002
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No PHI or PII data will be share however may share outcome measures for data analysis based on subject ID.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by david hulsizer, Keller Army Community Hospital:
dry needling
ACL reconstruction
knee ROM
pain management
opioid use