NCT06955923

Trigger Point Injection in Reducing Pain Following Total Knee Arthroplasty

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: David Grant U.S. Air Force Medical Center · Federal
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the ability of trigger point injections completed immediately following a total knee arthroplasty decrease pain scores and opioid use compared to sham injections. Given the current state of opioid dependency in the United States there needs to be a more focused attempt at treating post-operative pain without use of opioids. Given the manipulation of soft tissue during a total knee arthroplasty there seems to be a high correlation with pain and myofascial pain syndrome. This study will include an experimental (trigger point injection) and control (sham injection) group who are all undergoing a total knee arthroplasty. This is a pilot study that will include a maximum of 100 total patients (although it is planned for the study to be much smaller with a planned 10-15 patients per group). The procedure that will be completed is a trigger point injection with use of 1% lidocaine without epinephrine along the distal aspect of the vastus medialis and lateralis, proximal aspect of the medial and lateral gastrocnemius muscle bellies. The sham injection will be completed by pressing the needle against the skin without injecting any fluid. There will be a "blind" between the patient and the needle with both arms of the study. These patients will be followed up on POD1, and during weeks 2 and 6 follow-up where they will be given questionnaires to assess pain (visual analogue scale) and opioid use, and asked to bring their opioid medications to the clinic to assess the morphine milligrams equivalent (MME).

Conditions

• Trigger Point Pain, Myofascial

Interventions

Type	Name	Description
DRUG	Trigger point injection (lidocaine)	A trigger point injection utilizing lidocaine 1% without epinephrine will be injected into several muscles bellies immediately following surgery to halt a trigger point from forming. One group will receive this type of intervention and the sham group will not receive any type of injection.
OTHER	Sham Comparator	This arm of the study will not receive any injection.

Timeline

• Start date: 2025-05-30
• Primary completion: 2025-08-25
• Completion: 2025-08-26
• First posted: 2025-05-02
• Last updated: 2026-02-12
• Results posted: 2026-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study