Myofascial Pain
Conditions
Keywords
Trigger Point Injections, steroid, nsaid
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).
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).
Interventions
DRUGKetorolac
Participants may be randomized to receive Ketorolac for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.
DRUGLidocaine
Participants may be randomized to receive Lidocaine for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.
DRUGDexamethasone
Participants may be randomized to receive Dexamethasone for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketorolac 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. | 4 |
| Lidocaine 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. | 3 |
| Dexamethasone 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. | 3 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 | 3 |
Baseline characteristics
| Characteristic | Ketorolac | Lidocaine | Dexamethasone | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 2 Participants | 8 Participants |
| Age, Continuous | 54 years | 40 years | 47 years | 48 years |
| Race/Ethnicity, Customized White/Caucasion | 4 Participants | 3 Participants | 3 Participants | 10 Participants |
| Region of Enrollment United States | 4 participants | 3 participants | 3 participants | 10 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 4 | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 | 0 / 3 |
Outcome results
Primary
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).
Time frame: Pre-Post Injections Up to Three Months
Population: Participants in other ARM's did not complete survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketorolac | Number of Participants With a Responder Rate Greater Than 50% on the Numeric Rating Pain Scale (NRS) Improvement | 1 Participants |
| Lidocaine | Number of Participants With a Responder Rate Greater Than 50% on the Numeric Rating Pain Scale (NRS) Improvement | 0 Participants |
| Dexamethasone | Number of Participants With a Responder Rate Greater Than 50% on the Numeric Rating Pain Scale (NRS) Improvement | 0 Participants |
Secondary
Brief Pain Inventory (BPI) - Modified
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
Population: Participants in other ARM's did not complete surveys
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ketorolac | Brief Pain Inventory (BPI) - Modified | Participant Number #3 at Baseline | 8 score on a scale |
| Ketorolac | Brief Pain Inventory (BPI) - Modified | Participant Number #3 at 3 Months | 3 score on a scale |
| Ketorolac | Brief Pain Inventory (BPI) - Modified | Participant Number #8 at Baseline | 5 score on a scale |
| Ketorolac | Brief Pain Inventory (BPI) - Modified | Participant #8 at 3 Months | 3 score on a scale |
Secondary
Numeric Rating Pain Scale (NRS) at Baseline and Three Months.
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)
Population: This study was terminated early due to low enrollment. Zero participants completed the Lidocaine and Dexamethasone arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ketorolac | Numeric Rating Pain Scale (NRS) at Baseline and Three Months. | Participant Number 8 at 3 Months | 3 score on a scale |
| Ketorolac | Numeric Rating Pain Scale (NRS) at Baseline and Three Months. | Participant Number 3 at Baseline | 8 score on a scale |
| Ketorolac | Numeric Rating Pain Scale (NRS) at Baseline and Three Months. | Participant Number 3 at 3 Months | 3 score on a scale |
| Ketorolac | Numeric Rating Pain Scale (NRS) at Baseline and Three Months. | Participant Number 8 at Baseline | 5 score on a scale |