TPI Medication Comparison - Ketorolac, Lidocaine, or Dexamethasone

Myofascial Pain Clinical Trial

Official title:

Double-blind, Prospective Comparison of Medications Used in Trigger Point Injections - Ketorolac, Lidocaine, or Dexamethasone

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03028012
• Other study ID #: 98370
• Status: Terminated
• Phase: Phase 4
• Start date: May 2, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: November 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Myofascial Pain

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	University of Utah Orthopaedic Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a Responder Rate Greater Than 50% on the Numeric Rating Pain Scale (NRS) Improvement	Participants in this study underwent TPIs by the following method. The needle was inserted into the trigger point with the goal of eliciting a local twitch responses(LTRs). When a LTR was obtained, 0.1mL of randomized drug was injected into that location within the muscle. This was repeated until LTRs disappeared, or 1.0mL had been injected, whichever came first. This was performed in a similar manner for all affected muscles, up to a maximum of 2mL. Participants self-report their brief pain inventory at each of their injections (up to four subsequent injections) based off of the standardized Numeric Rating pain Scale (NRS). The NRS is nationally recognized numeric scale from zero to ten, with zero being an example of no pain, one to three would demonstrate mild pain, four to six would be moderate pain, seven to nine would be severe pain and a ten would be the worst pain possible. Improvement in BPI was determined if their NRS score went down with each injection(s).	Pre-Post Injections Up to Three Months
Secondary	Numeric Rating Pain Scale (NRS) at Baseline and Three Months.	TPI were treated with a needle inserted into the trigger point with the goal of eliciting a local twitch responses(LTRs). When a LTR was obtained, 0.1mL of randomized drug was injected into that location within the muscle. This was repeated until LTRs disappeared, or 1.0mL had been injected, whichever came first. Such was performed in a similar manner for all affected muscles, up to a maximum of 2mL. Participants self-report their brief pain inventory at each of their injections (up to four subsequent injections) based off of the standardized Numeric Rating pain Scale (NRS). The NRS is nationally recognized numeric scale from zero to ten, with zero being an example of no pain,one to three would demonstrate mild pain, four to six would be moderate pain, seven to nine would be severe pain and a ten would be the worst pain possible. Improvement in BPI was determined if their NRS score went down with each injection(s).	Pre-Injection and Three Month Post Injection(s)
Secondary	Brief Pain Inventory (BPI) - Modified	The BPI was evaluated on a scale from 0-10. Zero would mean no interference and 10 would be calculated at complete interferences. We used a 7-point questionnaire about pain. All scores were calculated at baseline and three months.	Baseline and Three Months