RECRUITING

Trigger Point Injection in Reducing Pain Following Total Knee Arthroplasty

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Trigger Point Injection in Reducing Pain Following Total Knee Arthroplasty

Quick Facts

Study Start:2025-05-30
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06955923

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 45 years or older
  2. * Planned to undergo primary total knee arthroplasty
  3. * Able to speak, read, and understand English
  4. * Willing to complete a study questionnaires
  5. * Willing to bring in their medications to be counted
  6. * DoD beneficiaries
  7. * No allergy to lidocaine
  8. * Not fearful of needles.
  1. * Chronic opioid users (daily use of prescribed opioids for at least 90 days)
  2. * Diagnosed with Fibromyalgia
  3. * Non-English speaking
  4. * Unable to read English
  5. * Unable to understand English
  6. * Pregnant
  7. * Allergy to lidocaine
  8. * Not willing to complete study questionnaires
  9. * Not willing to bring in their medications to be counted
  10. * Not a DoD beneficiary
  11. * Fearful of needles

Contacts and Locations

Study Contact

Dustin L Bennett
CONTACT
203-815-5721
dustin.l.bennett4.mil@health.mil
Ashley M Dalessandro
CONTACT

Principal Investigator

Dustin L Bennett
PRINCIPAL_INVESTIGATOR
David Grant

Study Locations (Sites)

David Grant Medical Center
Fairfield, California, 94535
United States

Collaborators and Investigators

Sponsor: David Grant U.S. Air Force Medical Center

  • Dustin L Bennett, PRINCIPAL_INVESTIGATOR, David Grant

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-30
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2025-05-30
Study Completion Date2025-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Trigger Point Pain, Myofascial