TPI Medication Comparison - Ketorolac, Lidocaine, or Dexamethasone
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|ClinicalTrials.gov Identifier: NCT03028012|
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : May 2, 2018
The main hypothesis of this study is that anti-inflammatory medications (ketorolac or dexamethasone) will provide longer-lasting and greater pain relief than just lidocaine in trigger point injections where a local twitch response is evoked at the time of the injection.
The primary objective of this study is to compare the efficacy of three substances used in TPIs with a LTR identified at the time of the injection: a CS (dexamethasone), a NSAID (ketorolac), or only a local anesthetic (lidocaine).
|Condition or disease||Intervention/treatment||Phase|
|Myofascial Pain||Drug: Ketorolac Drug: Lidocaine Drug: Dexamethasone||Phase 4|
Trigger point injections (TPIs) are a commonly-performed procedures by physicians for the treatment of myofascial pain, specifically targeting myofascial trigger points (MTrPs). Commonly injected substances include local anesthetic, botulinum toxin, or corticosteroid (CS), though non-steroidal anti-inflammatory drugs (NSAIDs) and other substances have been reported. A Cochrane review found that intramuscular injection of local anesthetic demonstrated moderate evidence of benefit for mechanical neck disorders; no other treatment demonstrated greater benefit.
Great variation is seen in how TPIs are performed, however. The standard method was described by Simons and Travell, and is often cited. Hong et al. demonstrated that, similar to the technique described by Simons and Travell, obtaining a local twitch response (LTR) was the most important factor in producing pain relief. Further research by Shah et al., which demonstrated an inflammatory component to MTrPs, also showed a decrease in inflammatory cytokines following trigger point injections that obtained a LTR. Despite these findings, most studies do not use the LTR method in their TPI techniques.
Prior studies demonstrated that most patients obtain significant relief from TPI, but did not identify differences between injection of CS or other substances. However, none of these studies identified LTRs in their injection techniques.
As can be learned from a review of the published literature on muscular trigger points, the cause of this condition is unknown, and no single treatment approach has been established as a clearly accepted gold standard treatment. There is evidence, however, that there is an inflammatory component associated with trigger points and that obtaining a local twitch response is associated with a decrease in local inflammation at the site of a trigger point. The combination of injecting an anti-inflammatory medication and obtaining a local twitch response has never been studied. The purpose of this study is to examine the comparative effectiveness of injectable substances on patient outcome after a TPI with LTR identified, namely a CS (dexamethasone), a NSAID (ketorolac), or only a local anesthetic (lidocaine).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Double-blind, Prospective Comparison of Medications Used in Trigger Point Injections - Ketorolac, Lidocaine, or Dexamethasone|
|Actual Study Start Date :||May 2, 2017|
|Estimated Primary Completion Date :||February 20, 2020|
|Estimated Study Completion Date :||March 20, 2020|
Participants may be randomized to receive Ketorolac for their TPI.
Participants may be randomized to receive Ketorolac for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.
Other Name: Toradol
Participants may be randomized to receive Lidocaine for their TPI.
Participants may be randomized to receive Lidocaine for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.
Other Name: Xylocaine
Participants may be randomized to receive Dexamethasone for their TPI.
Participants may be randomized to receive Dexamethasone for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.
Other Name: Decadron
- Responder (>50% NRS relief) [ Time Frame: 3 months ]Participant will complete questionnaire using pre and post-injection numeric rating scale (NRS) from 0-10 with regards to the trigger point(s).
- NRS improvement [ Time Frame: 3 months ]Measured on NRS from 0-10.
- Brief pain inventory (BPI) improvement [ Time Frame: 3 months ]Participant will self-report their brief pain inventory at each of the four subsequent injections.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028012
|Contact: Matthew Brobeck, BSfirstname.lastname@example.org|
|Contact: Dan Cushman, MDemail@example.com|
|United States, Utah|
|University of Utah Orthopaedic Center||Recruiting|
|Salt Lake City, Utah, United States, 84108|
|Contact: Matthew Brobeck 801-581-5328 firstname.lastname@example.org|
|Principal Investigator: Stuart Willick, MD|
|Sub-Investigator: Daniel Cushman, MD|
|Principal Investigator:||Dan Cushman, MD||University of Utah|