TPI Medication Comparison - Ketorolac, Lidocaine, or Dexamethasone
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - 100 |
Updated: | 5/4/2018 |
Start Date: | May 2, 2017 |
End Date: | March 20, 2020 |
Contact: | Matthew Brobeck, BS |
Email: | matthew.brobeck@hsc.utah.edu |
Phone: | 801-581-5328 |
Double-blind, Prospective Comparison of Medications Used in Trigger Point Injections - Ketorolac, Lidocaine, or Dexamethasone
Hypothesis
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).
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).
Background
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).
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).
Inclusion Criteria:
1. Men or women age 18 or over
2. At least one active trigger point
Exclusion Criteria:
1. Allergy or contraindication to any NSAID, CS, or local anesthetic
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
We found this trial at
1
site
Salt Lake City, Utah 84108
Principal Investigator: Stuart Willick, MD
Phone: 801-581-5328
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