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) ImprovementPrimary· 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
Group
Value
95% CI
Ketorolac
1
Lidocaine
0
Dexamethasone
0
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
Group
Value
95% CI
Ketorolac
8
Participant Number 3 at 3 Months
Group
Value
95% CI
Ketorolac
3
Participant Number 8 at Baseline
Group
Value
95% CI
Ketorolac
5
Participant Number 8 at 3 Months
Group
Value
95% CI
Ketorolac
3
Brief Pain Inventory (BPI) - ModifiedSecondary· 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
Group
Value
95% CI
Ketorolac
8
Participant Number #3 at 3 Months
Group
Value
95% CI
Ketorolac
3
Participant Number #8 at Baseline
Group
Value
95% CI
Ketorolac
5
Participant #8 at 3 Months
Group
Value
95% CI
Ketorolac
3
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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Sponsor: as reported to ClinicalTrials.gov by University of Utah
Last refreshed: 18 November 2020
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.