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NCT03028012

TPI Medication Comparison - Ketorolac, Lidocaine, or Dexamethasone

Terminated Phase 4 Results posted Last updated 18 November 2020
What this trial tests

Phase 4 trial testing Ketorolac in Myofascial Pain in 10 participants. Terminated before completion.

Timeline
2 May 2017
Primary endpoint
1 May 2019
1 May 2019

Quick facts

Lead sponsorUniversity of Utah
PhasePhase 4
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment10
Start date2 May 2017
Primary completion1 May 2019
Estimated completion1 May 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Utah

Who can join

Adults 18 to 100, any sex, with Myofascial Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With a Responder Rate Greater Than 50% on the Numeric Rating Pain Scale (NRS) Improvement Primary · Pre-Post Injections Up to Three Months

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

GroupValue95% CI
Ketorolac1
Lidocaine0
Dexamethasone0
Numeric Rating Pain Scale (NRS) at Baseline and Three Months. Secondary · Pre-Injection and Three Month Post Injection(s)

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 nationa

Participant Number 3 at Baseline
GroupValue95% CI
Ketorolac8
Participant Number 3 at 3 Months
GroupValue95% CI
Ketorolac3
Participant Number 8 at Baseline
GroupValue95% CI
Ketorolac5
Participant Number 8 at 3 Months
GroupValue95% CI
Ketorolac3
Brief Pain Inventory (BPI) - Modified Secondary · Baseline and Three Months

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.

Participant Number #3 at Baseline
GroupValue95% CI
Ketorolac8
Participant Number #3 at 3 Months
GroupValue95% CI
Ketorolac3
Participant Number #8 at Baseline
GroupValue95% CI
Ketorolac5
Participant #8 at 3 Months
GroupValue95% CI
Ketorolac3

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Ketorolac

Trials testing the same drug.

Other recruiting trials for Myofascial Pain

Currently open trials in the same condition.

Other University of Utah trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03028012.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing