NCT03506685

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

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 24, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

September 23, 2025

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

March 30, 2018

Last Update Submit

September 17, 2025

Conditions

Keywords

dry needlingACL reconstructionknee ROMpain managementopioid use

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 INTERVENTION

This group will receive the standard ACL protocol rehab

Dry needling and STM group

EXPERIMENTAL

This group will also receive the standard ACL protocol in addition to STM and DN

Other: Dry needling and STM

Interventions

dry needling and soft tissue mobilization

Dry needling and STM group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

PainAgnosia

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 2x5 mixed model anova
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

Locations