Pain and Anterior Cruciate Ligament ReconstructionNCT03506685
Effectiveness of Dry Needling and STM on Pain Management for Anterior Cruciate Ligament Reconstruction (ACLR)
A study testing Dry needling and STM in people with Pain and Anterior Cruciate Ligament Reconstruction, run by Keller Army Community Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Pain and Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Dry needling and STM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-40 Department of Defense( DOD) beneficiaries (17 if Cadet)
- Scheduled for ACL Reconstruction Surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Keller Army Community Hospital
West Point, New York, 10996
About this study
Official title: 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.
- Being tested
- Dry needling and STM
- Keywords
- dry needling, ACL reconstruction, knee ROM, pain management, opioid use
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needling and STMOther
dry needling and soft tissue mobilization
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Dry needling and STM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical pain rating scale
validated outcome measure for pain ranging from 0-10
Measured: change from baseline, 2 days post-op, 1 week, 2 week, 3 week, 4 week
Secondary outcomes (3)
Lower extremity functional scale
validated measure to assess disability and function for the lower extremity on a scale of 0-80
Measured: 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
Measured: change from baseline, 2 days post-op, 1 week, 2 week, 3 week, 4 week
knee range of motion
measured with goniometer
Measured: change from baseline, 2 days post-op, 1 week, 2 week, 3 week, 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start1 Jun 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Why it stopped: Unable to reach agreement with PT \& surgeons on protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain and Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x5 mixed model anova
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keller Army Community Hospital
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jamie Morris, Keller Army Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506685
- Sponsor's protocol ID
- 18KACH002
- Status last verified
- Apr 2018
- First submitted
- 30 Mar 2018
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Dry Needling and Soft Tissue Mobilization in the Management of Pain Post Anterior Cruciate Ligament (ACL) Reconstruction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03506685
- Acronym / sponsor ID
- 18KACH002
- Keywords
- dry needling, ACL reconstruction, knee ROM, pain management, opioid use
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to reach agreement with PT \& surgeons on protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Keller Army Community HospitalUS federal agency
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 24 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2x5 mixed model anova
| Arm | Type | Receives |
|---|---|---|
| control group Standard ACL protocol | No intervention | –This group will receive the standard ACL protocol rehab |
| Dry needling and STM group | Experimental | Other: Dry needling and STMThis group will also receive the standard ACL protocol in addition to STM and DN |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-40 Department of Defense( DOD) beneficiaries (17 if Cadet)
- Scheduled for ACL Reconstruction Surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry needling and STMdry needling and soft tissue mobilization | Other | Dry needling and STM group |
Primary outcome
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
3 secondary outcomes
Lower extremity functional scale
Time frame: 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
knee range of motion
Time frame: change from baseline, 2 days post-op, 1 week, 2 week, 3 week, 4 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling and STM in people with Pain and Anterior Cruciate Ligament Reconstruction, run by Keller Army Community Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical pain rating scale (time frame: change from baseline, 2 days post-op, 1 week, 2 week, 3 week, 4 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.