Trigger Point Pain, MyofascialPhase 2NCT06955923
Trigger Point Injection in Reducing Pain Following Total Knee Arthroplasty
A Phase 2 study testing Trigger point injection (lidocaine) in people with Trigger Point Pain, Myofascial, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Trigger Point Pain, Myofascial
- What is being tested?
- Trigger point injection (lidocaine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2025to 26 Aug 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
David Grant Medical Center
Fairfield, California, 94535
About this study
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).
- Conditions
- Trigger Point Pain, Myofascial
- Being tested
- Trigger point injection (lidocaine), Sham Comparator
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigger point injection (lidocaine)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 ComparatorOther
This arm of the study will not receive any injection.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group - participants receiving trigger point injections | Experimental | 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. Receives: Drug: Trigger point injection (lidocaine) |
| Sham comparator - Participants not receiving trigger point injections | Sham comparator | 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. Receives: Other: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores on the Visual Analog Scale
- 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
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (1)
Opioid Use
- 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.
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start30 May 2025
- Primary completion25 Aug 2025
- Study completion26 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Trigger Point Pain, MyofascialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Grant U.S. Air Force Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Dustin L Bennett, Principal investigator, David Grant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955923
- Sponsor's protocol ID
- FDG20240079H
- Status last verified
- Jan 2026
- First submitted
- 25 Apr 2025
- Last updated
- 12 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trigger Point Injection in Reducing Pain Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06955923
- Acronym / sponsor ID
- FDG20240079H
- Conditions
- Trigger Point Pain, Myofascial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- David Grant U.S. Air Force Medical CenterUS federal agency
- Study start
- 30 May 2025 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 26 Aug 2025 (actual)
- First posted
- 2 May 2025 (actual)
- Results
- Posted 12 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group - participants receiving trigger point injections | Experimental | Drug: Trigger point injection (lidocaine)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 - Participants not receiving trigger point injections | Sham comparator | Other: Sham ComparatorThe 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Experimental group - participants receiving trigger point injections |
| Sham ComparatorThis arm of the study will not receive any injection. | Other | Sham comparator - Participants not receiving trigger point injections |
Primary outcome
Pain Scores on the Visual Analog Scale
Time frame: From enrollment to the end of treatment at 6 weeks
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
1 secondary outcome
Opioid Use
Time frame: From enrollment to the end of treatment at 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dustin L Bennett principal investigator
David Grant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trigger point injection (lidocaine) in people with Trigger Point Pain, Myofascial, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores on the Visual Analog Scale (time frame: From enrollment to the end of treatment at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.