Clinical trial NCT03028012: TPI Medication Comparison - Ketorolac, Lidocaine, or Dexamethasone
Official title: Double-blind, Prospective Comparison of Medications Used in Trigger Point Injections - Ketorolac, Lidocaine, or Dexamethasone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Myofascial Pain
Keywords: Trigger Point Injections
steroid
nsaid
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With a Responder Rate Greater Than 50% on the Numeric Rating Pain Scale (NRS) Improvement
timeFrame: Pre-Post Injections Up to Three Months
Secondary outcomes:
measure: Numeric Rating Pain Scale (NRS) at Baseline and Three Months.
timeFrame: Pre-Injection and Three Month Post Injection(s)
measure: Brief Pain Inventory (BPI) - Modified
timeFrame: Baseline and Three Months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedic Center
state: Utah
Study officials:
affiliation: University of Utah
name: Dan Cushman, MD
role: PRINCIPAL_INVESTIGATOR
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