A Phase 2 interventional study of Trigger point injection (lidocaine) and Sham Comparator in Trigger Point Pain, Myofascial, sponsored by David Grant U.S. Air Force Medical Center. Completed at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by David Grant U.S. Air Force Medical Center · Phase 2, Interventional, and Treatment
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).
339 studies on the registry are indexed under Myofascial Pain Syndromes; 66 are open to participants now.
This study's enrollment of 11 is below the median of 50 across 307 interventional studies indexed under Myofascial Pain Syndromes.
Browse Myofascial Pain Syndromes studies →David Grant U.S. Air Force Medical Center is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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)
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
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.
This arm of the study will not receive any injection.
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
Time frame: From enrollment to the end of treatment at 6 weeks
Opioid Use
1\. Compare the total opioid use between study groups (experimental, sham comparator). Opioid use will be measured during their inpatient stay using the Medication Administration Record (MAR) Summary in the electronic medical record; and completing an Opioid Use questionnaire and counting the number of pills remaining during post-operative/follow-up study visits. Inpatient opioid use will be calculated by using the morphine dosage and number of doses per day. Outpatient opioid use will be obtained by reviewing responses to the Opioid Use questionnaire and counting the number of pills remaining from the prescription given at the time of discharge. Participants will be asked to bring their medication (opioids) to their post-operative/follow-up study visits. This method will allow the investigator to measure total opioid use (injectable and pill) during their inpatient and outpatient course.
Time frame: From enrollment to the end of treatment at 6 weeks
| Milestone | Experimental Group - Participants Receiving Trigger Point Injections | Sham Comparator - Participants Not Receiving Trigger Point Injections |
|---|---|---|
| Started | 6 | 5 |
| Post operative day (pod) 1 | 6 | 5 |
| Week 2 | 6 | 5 |
| Week 6 | 3 | 3 |
| Completed | 3 | 3 |
| Not completed | 3 | 2 |
| Withdrew: Limited timeline for follow-up restricted total number of participants for the last follow-up interv | 3 | 2 |
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
| Pain Scores on the Visual Analog Scale | Experimental Group - Participants Receiving Trigger Point Injections | Sham Comparator - Participants Not Receiving Trigger Point Injections |
|---|---|---|
| Change from Baseline to Post Operative Day (POD) 1 | 51 ± 29.51 | 55 ± 22.64 |
| Change from POD1 to week 2 follow-up | 40 ± 14.49 | 42 ± 24.9 |
| Change from week 2 to week 6 follow-up | 30 ± 32.79 | 28.33 ± 18.93 |
1\. Compare the total opioid use between study groups (experimental, sham comparator). Opioid use will be measured during their inpatient stay using the Medication Administration Record (MAR) Summary in the electronic medical record; and completing an Opioid Use questionnaire and counting the number of pills remaining during post-operative/follow-up study visits. Inpatient opioid use will be calculated by using the morphine dosage and number of doses per day. Outpatient opioid use will be obtained by reviewing responses to the Opioid Use questionnaire and counting the number of pills remaining from the prescription given at the time of discharge. Participants will be asked to bring their medication (opioids) to their post-operative/follow-up study visits. This method will allow the investigator to measure total opioid use (injectable and pill) during their inpatient and outpatient course.
| MME | Experimental Group - Participants Receiving Trigger Point Injections | Sham Comparator - Participants Not Receiving Trigger Point Injections |
|---|---|---|
| POD1 | 50.08 ± 36.89 | 68.60 ± 33.8 |
| week 2 | 23.09 ± 12.21 | 19.09 ± 16.69 |
| week 6 | 1.33 ± 2.1 | 0 ± 0 |
Collected over from enrollment until the 6 week post-operative follow-up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental Group - Participants Receiving Trigger Point Injections | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Sham Comparator - Participants Not Receiving Trigger Point Injections | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | Experimental Group - Participants Receiving Trigger Point Injections | Sham Comparator - Participants Not Receiving Trigger Point Injections | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 1 | 3 |
| >=65 years | 4 | 4 | 8 |
| Sex: Female, Male(Participants) | Experimental Group - Participants Receiving Trigger Point Injections | Sham Comparator - Participants Not Receiving Trigger Point Injections | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 5 | 3 | 8 |
| BMI(kg/m^2) | Experimental Group - Participants Receiving Trigger Point Injections | Sham Comparator - Participants Not Receiving Trigger Point Injections | Total |
|---|---|---|---|
| Mean | 28.07 ± 2.15 | 33.84 ± 4.29 | 30.96 ± 3.22 |
| Number of Participants who are Military Retired or Military Dependents(Participants) | Experimental Group - Participants Receiving Trigger Point Injections | Sham Comparator - Participants Not Receiving Trigger Point Injections | Total |
|---|---|---|---|
| Dependents | 1 | 2 | 3 |
| Retired | 5 | 3 | 8 |
| Race and Ethnicity Not Collected(Participants) | Experimental Group - Participants Receiving Trigger Point Injections | Sham Comparator - Participants Not Receiving Trigger Point Injections | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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Studies of the drug tested here: Lidocaine
David Grant U.S. Air Force Medical Center