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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03506685
Other study ID # 18KACH002
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 30, 2018
Last updated April 23, 2018
Start date June 1, 2018
Est. completion date December 1, 2019

Study information

Verified date April 2018
Source Keller Army Community Hospital
Contact David K Hulsizer, DPT
Phone 845-938-5109
Email david.k.hulsizer.mil@mail.mil
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Pain and Anterior Cruciate Ligament Reconstruction

Intervention

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

Locations

Country Name City State
United States Keller Army Community Hospital West Point New York

Sponsors (1)

Lead Sponsor Collaborator
Keller Army Community Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary knee range of motion measured with goniometer change from baseline, 2 days post-op, 1 week, 2 week, 3 week, 4 week