TPI Medication Comparison - Ketorolac, Lidocaine, or Dexamethasone
NCT ID: NCT03028012
Last Updated: 2020-11-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
10 participants
INTERVENTIONAL
2017-05-02
2019-05-01
Brief Summary
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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.
Purpose/Specific Aims
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).
Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ketorolac
Participants may be randomized to receive Ketorolac for their TPI.
Ketorolac
Participants may be randomized to receive Ketorolac for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.
Lidocaine
Participants may be randomized to receive Lidocaine for their TPI.
Lidocaine
Participants may be randomized to receive Lidocaine for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.
Dexamethasone
Participants may be randomized to receive Dexamethasone for their TPI.
Dexamethasone
Participants may be randomized to receive Dexamethasone for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.
Interventions
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Ketorolac
Participants may be randomized to receive Ketorolac for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.
Lidocaine
Participants may be randomized to receive Lidocaine for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.
Dexamethasone
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. At least one active trigger point
Exclusion Criteria
2. Receiving anticoagulant medication
3. History of bleeding disorder
4. Pregnant or breast feeding women
5. Gastrointestinal ulceration
6. Pre-existing renal disease
7. Pre-existing congestive heart failure
8. Diabetes mellitus
9. Prior myocardial infarction or stroke
10. Fibromyalgia
18 Years
100 Years
ALL
Yes
Sponsors
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University of Utah
OTHER
Responsible Party
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Daniel Cushman
Assistant Professor
Principal Investigators
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Dan Cushman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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University of Utah Orthopaedic Center
Salt Lake City, Utah, United States
Countries
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References
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol and Informed Consent Form
Other Identifiers
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98370
Identifier Type: -
Identifier Source: org_study_id