TPI Medication Comparison - Ketorolac, Lidocaine, or Dexamethasone

NCT03028012 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 98370
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Myofascial Pain

Keywords

Trigger Point Injections; steroid; nsaid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Numeric Rating Pain Scale (NRS) at Baseline and Three Months.

  Pre-Injection and Three Month Post Injection(s)

• Brief Pain Inventory (BPI) - Modified

  Baseline and Three Months

Study Arms (3)

Ketorolac

EXPERIMENTAL

Participants may be randomized to receive Ketorolac for their TPI.

Drug: Ketorolac

Lidocaine

EXPERIMENTAL

Participants may be randomized to receive Lidocaine for their TPI.

Drug: Lidocaine

Dexamethasone

EXPERIMENTAL

Participants may be randomized to receive Dexamethasone for their TPI.

Drug: Dexamethasone

Interventions

Ketorolac DRUG

Participants may be randomized to receive Ketorolac for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.

Also known as: Toradol

Ketorolac

Lidocaine DRUG

Participants may be randomized to receive Lidocaine for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.

Also known as: Xylocaine

Lidocaine

Dexamethasone DRUG

Participants may be randomized to receive Dexamethasone for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.

Also known as: Decadron

Dexamethasone

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women age 18 or over
• At least one active trigger point

You may not qualify if:

• Allergy or contraindication to any NSAID, CS, or local anesthetic
• Receiving anticoagulant medication
• History of bleeding disorder
• Pregnant or breast feeding women
• Gastrointestinal ulceration
• Pre-existing renal disease
• Pre-existing congestive heart failure
• Diabetes mellitus
• Prior myocardial infarction or stroke
• Fibromyalgia

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

Related Publications (45)

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  BACKGROUND

MeSH Terms

Interventions

Ketorolac; Ketorolac Tromethamine; Lidocaine; Dexamethasone; Calcium Dobesilate

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Limitations and Caveats

Early termination of this study due to low subject enrollment, lack of participant follow-up to substantiated end of study measures. There was not enough reported data to provide statistically pertinent or relevant analysis.

Results Point of Contact

• Title: Dr. Daniel Cushman
• Organization: University of Utah Physical Medicine and Rehabilitation Orthopedics

heidi.hansen@hsc.utah.edu

8015852373

Study Officials

• Dan Cushman, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 14, 2017
• First Posted: January 23, 2017
• Study Start: May 2, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: November 18, 2020
• Results First Posted: November 18, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)