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TPI Medication Comparison - Ketorolac, Lidocaine, or Dexamethasone

Sponsor
University of Utah (Other)
Overall Status
Terminated
CT.gov ID
NCT03028012
Collaborator
(none)
10
Enrollment
1
Location
3
Arms
24
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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
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).

Study Design

Study Type:
Interventional
Actual Enrollment :
10 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
Actual Primary Completion Date :
May 1, 2019
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • Decadron

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With a Responder Rate Greater Than 50% on the Numeric Rating Pain Scale (NRS) Improvement [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 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).

    Secondary Outcome Measures

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

    2. Brief Pain Inventory (BPI) - Modified [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Utah Orthopaedic Center Salt Lake City Utah United States 84108

    Sponsors and Collaborators

    • University of Utah

    Investigators

    • Principal Investigator: Dan Cushman, MD, University of Utah

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Daniel Cushman, Assistant Professor, University of Utah
    ClinicalTrials.gov Identifier:
    NCT03028012
    Other Study ID Numbers:
    • 98370
    First Posted:
    Jan 23, 2017
    Last Update Posted:
    Nov 18, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Daniel Cushman, Assistant Professor, University of Utah
    Trigger Point Injections
    steroid
    nsaid
    Additional relevant MeSH terms:
    Dexamethasone
    Ketorolac
    Lidocaine

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Ketorolac Lidocaine Dexamethasone
    Arm/Group Description 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. 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. 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.
    Period Title: Overall Study
    STARTED 4 3 3
    COMPLETED 2 0 0
    NOT COMPLETED 2 3 3

    Baseline Characteristics

    Arm/Group Title Ketorolac Lidocaine Dexamethasone Total
    Arm/Group Description 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. 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. 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 of all reporting groups
    Overall Participants 4 3 3 10
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    3
    75%
    3
    100%
    2
    66.7%
    8
    80%
    >=65 years
    1
    25%
    0
    0%
    1
    33.3%
    2
    20%
    Age (years) [Mean (Full Range) ]
    Mean (Full Range) [years]
    54
    40
    47
    48
    Sex: Female, Male (Count of Participants)
    Female
    3
    75%
    2
    66.7%
    3
    100%
    8
    80%
    Male
    1
    25%
    1
    33.3%
    0
    0%
    2
    20%
    Race/Ethnicity, Customized (Count of Participants)
    White/Caucasion
    4
    100%
    3
    100%
    3
    100%
    10
    100%
    Region of Enrollment (participants) [Number]
    United States
    4
    100%
    3
    100%
    3
    100%
    10
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With a Responder Rate Greater Than 50% on the Numeric Rating Pain Scale (NRS) Improvement
    Description 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).
    Time Frame Pre-Post Injections Up to Three Months

    Outcome Measure Data

    Analysis Population Description
    Participants in other ARM's did not complete survey
    Arm/Group Title Ketorolac Lidocaine Dexamethasone
    Arm/Group Description 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. 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. 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.
    Measure Participants 2 0 0
    Count of Participants [Participants]
    1
    25%
    0
    0%
    0
    0%
    2. Secondary Outcome
    Title Numeric Rating Pain Scale (NRS) at Baseline and Three Months.
    Description 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).
    Time Frame Pre-Injection and Three Month Post Injection(s)

    Outcome Measure Data

    Analysis Population Description
    This study was terminated early due to low enrollment. Zero participants completed the Lidocaine and Dexamethasone arm.
    Arm/Group Title Ketorolac Lidocaine Dexamethasone
    Arm/Group Description 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. 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. 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.
    Measure Participants 2 0 0
    Participant Number 3 at Baseline
    8
    Participant Number 3 at 3 Months
    3
    Participant Number 8 at Baseline
    5
    Participant Number 8 at 3 Months
    3
    3. Secondary Outcome
    Title Brief Pain Inventory (BPI) - Modified
    Description 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.
    Time Frame Baseline and Three Months

    Outcome Measure Data

    Analysis Population Description
    Participants in other ARM's did not complete surveys
    Arm/Group Title Ketorolac Lidocaine Dexamethasone
    Arm/Group Description 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. Participants 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. 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. 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.
    Measure Participants 2 0 0
    Participant Number #3 at Baseline
    8
    Participant Number #3 at 3 Months
    3
    Participant Number #8 at Baseline
    5
    Participant #8 at 3 Months
    3

    Adverse Events

    Time Frame Adverse event data was collected over a 3 month period.
    Adverse Event Reporting Description
    Arm/Group Title Ketorolac Lidocaine Dexamethasone
    Arm/Group Description 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. 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. 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.
    All Cause Mortality
    Ketorolac Lidocaine Dexamethasone
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/4 (0%) 0/3 (0%) 0/3 (0%)
    Serious Adverse Events
    Ketorolac Lidocaine Dexamethasone
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/4 (0%) 0/3 (0%) 0/3 (0%)
    Other (Not Including Serious) Adverse Events
    Ketorolac Lidocaine Dexamethasone
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/4 (0%) 0/3 (0%) 0/3 (0%)

    Limitations/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.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Daniel Cushman
    Organization University of Utah Physical Medicine and Rehabilitation Orthopedics
    Phone 8015852373
    Email heidi.hansen@hsc.utah.edu
    Responsible Party:
    Daniel Cushman, Assistant Professor, University of Utah
    ClinicalTrials.gov Identifier:
    NCT03028012
    Other Study ID Numbers:
    • 98370
    First Posted:
    Jan 23, 2017
    Last Update Posted:
    Nov 18, 2020
    Last Verified:
    Nov 1, 2020