Trial Outcomes & Findings for TPI Medication Comparison - Ketorolac, Lidocaine, or Dexamethasone (NCT NCT03028012)

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

Pre-Post Injections Up to Three Months

Results posted on

2020-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	Ketorolac Participants may be randomized to receive Ketorolac for their TPI. Ketorolac: Participants may be randomized to receive 1mL of 1% lidocaine + 1mL of 30mg/mL Ketorolac for their TPI. Participants will be allowed to have subsequent injections, which is standard practice. They may receive up to four injections, spaced at least 1 week apart. 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. Lidocaine: Participants may be randomized to receive 2mL of 1% Lidocaine for their TPI. Participants will be allowed to have subsequent injections, which is standard practice39-43. They may receive up to four injections, spaced at least 1 week apart. 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. Dexamethasone: Participants may be randomized to receive 1mL of 1% lidocaine+1mL of 4mg/mL Dexamethasone for their TPI. Participants will be allowed to have subsequent injections, which is standard practice39-43. They may receive up to four injections, spaced at least 1 week apart. This randomized study will compare the efficacy of the three substances used in TPIs.
Overall Study STARTED	4	3	3
Overall Study COMPLETED	2	0	0
Overall Study NOT COMPLETED	2	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Ketorolac Participants may be randomized to receive Ketorolac for their TPI. Ketorolac: Participants may be randomized to receive 1mL of 1% lidocaine + 1mL of 30mg/mL Ketorolac for their TPI. Participants will be allowed to have subsequent injections, which is standard practice. They may receive up to four injections, spaced at least 1 week apart. 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. Lidocaine: Participants may be randomized to receive 2mL of 1% Lidocaine for their TPI. Participants will be allowed to have subsequent injections, which is standard practice39-43. They may receive up to four injections, spaced at least 1 week apart. 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. Dexamethasone: Participants may be randomized to receive 1mL of 1% lidocaine+1mL of 4mg/mL Dexamethasone for their TPI. Participants will be allowed to have subsequent injections, which is standard practice39-43. They may receive up to four injections, spaced at least 1 week apart. This randomized study will compare the efficacy of the three substances used in TPIs.
Overall Study Lost to Follow-up	2	3	3

Baseline Characteristics

TPI Medication Comparison - Ketorolac, Lidocaine, or Dexamethasone

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketorolac n=4 Participants Participants may be randomized to receive Ketorolac for their TPI. 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 n=3 Participants Participants may be randomized to receive Lidocaine for their TPI. 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 n=3 Participants Participants may be randomized to receive Dexamethasone for their TPI. 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.	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Age, Continuous	54 years n=5 Participants	40 years n=7 Participants	47 years n=5 Participants	48 years n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized White/Caucasion	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Region of Enrollment United States	4 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	10 participants n=4 Participants

PRIMARY outcome

Timeframe: Pre-Post Injections Up to Three Months

Population: Participants in other ARM's did not complete survey

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).

Outcome measures

Outcome measures
Measure	Ketorolac n=2 Participants Participants may be randomized to receive Ketorolac for their TPI. Ketorolac: Participants may be randomized to receive 1mL of 1% lidocaine + 1mL of 30mg/mL Ketorolac for their TPI. Participants will be allowed to have subsequent injections, which is standard practice. They may receive up to four injections, spaced at least 1 week apart. 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. Lidocaine: Participants may be randomized to receive 2mL of 1% Lidocaine for their TPI. Participants will be allowed to have subsequent injections, which is standard practice39-43. They may receive up to four injections, spaced at least 1 week apart. 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. Dexamethasone: Participants may be randomized to receive 1mL of 1% lidocaine+1mL of 4mg/mL Dexamethasone for their TPI. Participants will be allowed to have subsequent injections, which is standard practice39-43. They may receive up to four injections, spaced at least 1 week apart. This randomized study will compare the efficacy of the three substances used in TPIs.
Number of Participants With a Responder Rate Greater Than 50% on the Numeric Rating Pain Scale (NRS) Improvement	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-Injection and Three Month Post Injection(s)

Population: This study was terminated early due to low enrollment. Zero participants completed the Lidocaine and Dexamethasone arm.

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).

Outcome measures

Outcome measures
Measure	Ketorolac n=2 Participants Participants may be randomized to receive Ketorolac for their TPI. Ketorolac: Participants may be randomized to receive 1mL of 1% lidocaine + 1mL of 30mg/mL Ketorolac for their TPI. Participants will be allowed to have subsequent injections, which is standard practice. They may receive up to four injections, spaced at least 1 week apart. 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. Lidocaine: Participants may be randomized to receive 2mL of 1% Lidocaine for their TPI. Participants will be allowed to have subsequent injections, which is standard practice39-43. They may receive up to four injections, spaced at least 1 week apart. 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. Dexamethasone: Participants may be randomized to receive 1mL of 1% lidocaine+1mL of 4mg/mL Dexamethasone for their TPI. Participants will be allowed to have subsequent injections, which is standard practice39-43. They may receive up to four injections, spaced at least 1 week apart. This randomized study will compare the efficacy of the three substances used in TPIs.
Numeric Rating Pain Scale (NRS) at Baseline and Three Months. Participant Number 3 at Baseline	8 score on a scale	—	—
Numeric Rating Pain Scale (NRS) at Baseline and Three Months. Participant Number 3 at 3 Months	3 score on a scale	—	—
Numeric Rating Pain Scale (NRS) at Baseline and Three Months. Participant Number 8 at Baseline	5 score on a scale	—	—
Numeric Rating Pain Scale (NRS) at Baseline and Three Months. Participant Number 8 at 3 Months	3 score on a scale	—	—

SECONDARY outcome

Timeframe: Baseline and Three Months

Population: Participants in other ARM's did not complete surveys

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=2 Participants Participants may be randomized to receive Ketorolac for their TPI. Ketorolac: Participants may be randomized to receive 1mL of 1% lidocaine + 1mL of 30mg/mL Ketorolac for their TPI. Participants will be allowed to have subsequent injections, which is standard practice. They may receive up to four injections, spaced at least 1 week apart. 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. Lidocaine: Participants may be randomized to receive 2mL of 1% Lidocaine for their TPI. Participants will be allowed to have subsequent injections, which is standard practice39-43. They may receive up to four injections, spaced at least 1 week apart. 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. Dexamethasone: Participants may be randomized to receive 1mL of 1% lidocaine+1mL of 4mg/mL Dexamethasone for their TPI. Participants will be allowed to have subsequent injections, which is standard practice39-43. They may receive up to four injections, spaced at least 1 week apart. This randomized study will compare the efficacy of the three substances used in TPIs.
Brief Pain Inventory (BPI) - Modified Participant Number #3 at Baseline	8 score on a scale	—	—
Brief Pain Inventory (BPI) - Modified Participant Number #3 at 3 Months	3 score on a scale	—	—
Brief Pain Inventory (BPI) - Modified Participant Number #8 at Baseline	5 score on a scale	—	—
Brief Pain Inventory (BPI) - Modified Participant #8 at 3 Months	3 score on a scale	—	—

Adverse Events

Ketorolac

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexamethasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Cushman

University of Utah Physical Medicine and Rehabilitation Orthopedics

Phone: 8015852373

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place