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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
Sponsor:
Information provided by (Responsible Party):
Daniel Cushman, University of Utah

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).


Condition or disease Intervention/treatment Phase
Myofascial Pain Drug: Ketorolac Drug: Lidocaine Drug: Dexamethasone Phase 4

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Ketorolac
Participants may be randomized to receive Ketorolac for their TPI.
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.
Other Name: Toradol

Experimental: Lidocaine
Participants may be randomized to receive Lidocaine for their TPI.
Drug: 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.
Other Name: Xylocaine

Experimental: Dexamethasone
Participants may be randomized to receive Dexamethasone for their TPI.
Drug: 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 Name: Decadron




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. NRS improvement [ Time Frame: 3 months ]
    Measured on NRS from 0-10.

  2. Brief pain inventory (BPI) improvement [ Time Frame: 3 months ]
    Participant will self-report their brief pain inventory at each of the four subsequent injections.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Matthew Brobeck, BS 801-581-5328 matthew.brobeck@hsc.utah.edu
Contact: Dan Cushman, MD 801-587-5458 dan.cushman@hsc.utah.edu

Locations
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United States, Utah
University of Utah Orthopaedic Center Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Matthew Brobeck    801-581-5328    matthew.brobeck@hsc.utah.edu   
Principal Investigator: Stuart Willick, MD         
Sub-Investigator: Daniel Cushman, MD         
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Dan Cushman, MD University of Utah

Publications:
Simons DG, Travell JG, Simons LS. Travell & Simons' Myofascial Pain and Dysfunction: The Trigger Point Manual. Upper half of body. Vol. 1. Vol 1: Wolters Kluwer Health; 1999.
Drewes AM, Andreasen A, Poulsen LH. Injection Therapy for Treatment of Chronic Myofascial Pain. J Musculoskelet Pain. 2010;1(3-4):289-294.

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Responsible Party: Daniel Cushman, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT03028012     History of Changes
Other Study ID Numbers: 98370
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daniel Cushman, University of Utah:
Trigger Point Injections
steroid
nsaid

Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Dexamethasone
Dexamethasone acetate
Lidocaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic