Trigger Point Injection for Pain After Knee Surgery

Overseen By Dustin L Bennett

Age: 18+

Sex: Any

Trial Phase: Phase 2

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

Must not be taking: Opioids

Disqualifiers: Fibromyalgia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: Immediate post-operative period

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether trigger point injections, a type of pain relief injection, can reduce pain and the need for opioids after knee replacement surgery. Participants will receive either actual trigger point injections or a sham (fake) injection. The aim is to identify a non-opioid method for managing post-surgery pain. Individuals scheduled for knee replacement surgery who are not afraid of needles might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to innovative pain management solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, chronic opioid users are excluded, so if you are using opioids daily, you may not be eligible to participate.

Is there any evidence suggesting that trigger point injections are likely to be safe for humans?

Research has shown that trigger point injections, which involve injecting a local pain reliever like lidocaine into specific muscle areas, are generally well-tolerated. Studies have demonstrated their effectiveness in reducing pain for people with myofascial pain syndrome, a condition that often occurs after knee surgeries. These injections have been used safely in other treatments, with the pain relievers providing benefits and causing few side effects. Since this trial is in Phase 2, earlier studies have already indicated that the treatment is safe for humans. However, any new treatment can have risks, so discussing any concerns with the trial team is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard pain management options like opioids or NSAIDs after knee surgery, trigger point injections offer a unique approach by directly targeting muscle areas with 1% lidocaine to relieve pain. This method focuses on reducing pain at specific muscle sites in the thigh and calf, potentially minimizing the need for systemic medications and their associated side effects. Researchers are excited about this technique because it could provide fast, localized pain relief and enhance recovery after knee surgery without the risk of addiction or significant side effects that often accompany traditional pain medications.

What evidence suggests that trigger point injections might be an effective treatment for pain after knee surgery?

This trial will compare the effectiveness of trigger point injections with a sham comparator for managing pain after knee surgery. Studies have shown that trigger point injections can reduce pain following knee surgery. In one study, patients who received these injections experienced less pain during the first month after their knee replacement, a period typically marked by severe pain. Another study found these injections more effective than placebo treatments for managing pain from myofascial pain syndrome, a condition characterized by tight and sore muscles. When combined with physical therapy, these injections also reduced long-term pain after knee surgery. Overall, evidence suggests that trigger point injections may effectively manage pain after knee surgery. ^{1 2 5 6 7}

Who Is on the Research Team?

Dustin L Bennett

Principal Investigator

David Grant

Are You a Good Fit for This Trial?

This trial is for patients undergoing total knee arthroplasty who may experience post-operative pain potentially linked to myofascial pain syndrome. The study aims to include a small group of 10-15 patients per arm, totaling up to 100 participants.

Inclusion Criteria

DoD beneficiaries

Able to speak, read, and understand English

Willing to bring in their medications to be counted

Exclusion Criteria

Pregnant

Allergy to lidocaine

Chronic opioid users (daily use of prescribed opioids for at least 90 days)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive trigger point injections or sham injections immediately following total knee arthroplasty

Immediate post-operative period

1 visit (in-person)

Follow-up

Participants are monitored for pain and opioid use with follow-up visits on POD1, and during weeks 2 and 6

6 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Trigger Point Injection

Trial Overview The study tests if trigger point injections with lidocaine can reduce pain and opioid use after knee surgery compared to sham injections (no fluid injected). Patients won't know which treatment they receive. They'll be assessed on the first day after surgery and at weeks 2 and 6.

How Is the Trial Designed?

Group I: Experimental group - participants receiving trigger point injections Experimental Treatment 1 Intervention

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 II: Sham comparator - Participants not receiving trigger point injections Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

David Grant U.S. Air Force Medical Center

Lead Sponsor

Trials

30

Recruited

2,300+

Published Research Related to This Trial

Multimodal analgesia that minimizes opioid use after surgery can reduce postoperative pain and the risk of complications, highlighting the importance of using non-opioid analgesics like NSAIDs, gabapentinoids, and regional anesthesia techniques.

Non-opioid analgesics generally have a low risk of adverse events when used appropriately, although certain medications like α-2 agonists and gabapentinoids may have specific risks, emphasizing the need for standardized protocols to enhance patient safety and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of treatment options available for postoperative pain. Jin, Z., Lee, C., Zhang, K., et al.[2021]

In a study of 60 patients who underwent total knee arthroplasty (TKA), those receiving perineural injection therapy (PIT) showed significantly better pain management and functional outcomes compared to those receiving standard postoperative care, as measured by the WOMAC and VAS scores.

PIT demonstrated high clinical efficacy with 93.5% of patients reporting excellent or good outcomes, while also being a cost-effective and safe treatment option with minimal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Perineural Injections Combined with Standard Postoperative Total Knee Arthroplasty Protocols in the Management of Chronic Postsurgical Pain After Total Knee Arthroplasty. Güzel, İ., Gül, D., Akpancar, S., et al.[2021]

In a study of 150 patients undergoing arthroscopic ACL reconstruction, intra-articular injection of 5 mg morphine significantly reduced postoperative pain compared to a placebo, leading to lower analgesic requirements in the first 12 hours after surgery.

Morphine was found to be the most effective pain reliever among the opioids tested, while methadone showed the least response, suggesting that morphine is a valuable addition to local anesthetics for pain management in knee surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comparison effects of intra-articular injection of different opioids on postoperative pain relieve after arthroscopic anterior cruciate ligament reconstruction: A randomized clinical trial study. Arti, H., Mehdinasab, SA.[2022]

In a study of 63 patients undergoing knee arthroscopy, the combination of ropivacaine, morphine, and ketorolac provided significantly better pain relief compared to bupivacaine or ropivacaine alone, especially at 8 and 24 hours post-surgery.

The combination treatment not only reduced the need for additional pain medication but also improved patients' daily activities and satisfaction without increasing side effects, indicating a safer and more effective pain management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of intra-articular bupivacaine, ropivacaine, or a combination of ropivacaine, morphine, and ketorolac on postoperative pain relief after ambulatory arthroscopic knee surgery: a randomized double-blind study. Ng, HP., Nordström, U., Axelsson, K., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3623120/

Efficacy of Myofascial Trigger Point Dry Needling in the ... In conclusion, a single dry needling treatment of MTrP under anaesthesia reduced pain in the first month after knee arthroplasty, when pain was the most severe.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7409136/

Effects of Trigger Point Dry Needling for the Management ... The results suggest that TrP dry needling may be effective for the management of pain and related disability associated with knee pain (low to moderate evidence); ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2013/694941

Efficacy of Myofascial Trigger Point Dry Needling in the ... This study demonstrates that dry needling is superior to placebo in controlling myofascial pain after a knee arthroplasty.

4. jospt.org jospt.org/doi/10.2519/jospt.2017.7089

Dry Needling Combined With Physical Therapy in Patients ... After dry needling combined with therapeutic exercises, patients who had chronic pain following TKA showed clinically significant improvements ...

5. researchgate.net researchgate.net/publication/342583366_Effects_of_Trigger_Point_Dry_Needling_for_the_Management_of_Knee_Pain_Syndromes_A_Systematic_Review_and_Meta-Analysis

(PDF) Effects of Trigger Point Dry Needling for the ... Conclusion: Low to moderate evidence suggests a positive effect of trigger point dry needling on pain and related disability in patellofemoral ...

6. withpower.com withpower.com/trial/phase-2-myofascial-pain-syndromes-5-2025-05fef

Trigger Point Injection for Pain After Knee Surgery This study will evaluate the ability of trigger point injections completed immediately following a total knee arthroplasty decrease pain scores and opioid ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9116734/

Trigger Point Injections - PMC - PubMed Central - NIH Outcomes data for trigger point injections have shown analgesic benefit with the use of local anesthetics, corticosteroids, and botulinum toxins for myofascial ...