Trigger Point Injection in Reducing Pain Following Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-30

Study Completion Date

2025-09-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Trigger Point Pain, Myofascial

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental group - participants receiving trigger point injections

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.

Group Type EXPERIMENTAL

Trigger point injection (lidocaine)

Intervention Type 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.

Sham comparator - Participants not receiving trigger point injections

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.

Group Type SHAM_COMPARATOR

Sham Comparator

Intervention Type OTHER

This arm of the study will not receive any injection.

Interventions

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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.

Intervention Type DRUG

Sham Comparator

This arm of the study will not receive any injection.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No