Trigger Point Injection in Reducing Pain Following Total Knee Arthroplasty

David Grant U.S. Air Force Medical Center

Status and phase: Enrolling; Phase 2

Conditions: Trigger Point Pain, Myofascial

Treatments: Other: Sham Comparator; Drug: Trigger point injection (lidocaine)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06955923

FDG20240079H

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Experimental group - participants receiving trigger point injections

Experimental group

Description:

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.

Treatment:

Drug: Trigger point injection (lidocaine)

Sham comparator - Participants not receiving trigger point injections

Sham Comparator group

Description:

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.

Treatment:

Other: Sham Comparator