Trigger Point Injection in Reducing Pain Following Total Knee Arthroplasty

NCT06955923 | Completed Phase 2 Results FDA Drug

• 1 other identifier: FDG20240079H
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pain Scores on the Visual Analog Scale

  1\. Change in Visual Analog Scale (VAS) pain scores The VAS is a numbered scale assessing pain severity using a number which describes the average level of pain since being discharged. Participants are to put a hash mark "/" on a numbered scale ranging from 0-100. Zero (0) is no pain and 100 is severe intolerable pain

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (1)

• Opioid Use

  From enrollment to the end of treatment at 6 weeks

Study Arms (2)

Experimental group - participants receiving trigger point injections

EXPERIMENTAL

The participant will receive trigger point injections with 1% lidocaine without epinephrine in two muscles in the thigh and two muscles in the calf immediately after having knee replacement surgery.

Drug: Trigger point injection (lidocaine)

Sham comparator - Participants not receiving trigger point injections

SHAM COMPARATOR

The patient will not receive an injection, but instead a façade of an injection by having the same physical set-up to prepare for an injection (the same as for the experimental group), but there will be a barrier between the patient's view and the syringe so that he/she will not know an injection was not given.

Other: Sham Comparator

Interventions

Trigger point injection (lidocaine) DRUG

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.

Experimental group - participants receiving trigger point injections

Sham Comparator OTHER

This arm of the study will not receive any injection.

Sham comparator - Participants not receiving trigger point injections

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 45 years or older
• Planned to undergo primary total knee arthroplasty
• Able to speak, read, and understand English
• Willing to complete a study questionnaires
• Willing to bring in their medications to be counted
• DoD beneficiaries
• No allergy to lidocaine
• Not fearful of needles.

You may not qualify if:

• Chronic opioid users (daily use of prescribed opioids for at least 90 days)
• Diagnosed with Fibromyalgia
• Non-English speaking
• Unable to read English
• Unable to understand English
• Pregnant
• Allergy to lidocaine
• Not willing to complete study questionnaires
• Not willing to bring in their medications to be counted
• Not a DoD beneficiary
• Fearful of needles

Sponsors & Collaborators

• David Grant U.S. Air Force Medical Center: lead

Study Sites (1)

David Grant Medical Center

Fairfield, California, 94535, United States

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Convenience sampling, Hawthorne effect, Sample Size, Peri-articular musculature targeted, Generalizability

Results Point of Contact

• Title: Dustin Bennett
• Organization: U.S. Air Force

dustin.l.bennett4.mil@health.mil

707-423-3568

Study Officials

• Dustin L Bennett

  David Grant

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 2, 2025
• Study Start: May 30, 2025
• Primary Completion: August 25, 2025
• Study Completion: August 26, 2025
• Last Updated: February 12, 2026
• Results First Posted: February 12, 2026

Record last verified: 2026-01

Locations

US (1)