Trigger Point Injection in Reducing Pain Following Total Knee Arthroplasty

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
David Grant Medical Center
RECRUITING
Fairfield
Contact Information
Primary
Dustin L Bennett
dustin.l.bennett4.mil@health.mil
203-815-5721
Backup
Ashley M Dalessandro
Time Frame
Start Date: 2025-05-30
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 100
Treatments
Experimental: 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.
Sham_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: David Grant U.S. Air Force Medical Center

This content was sourced from clinicaltrials.gov