Myofascial Pain Syndrome
Conditions
Keywords
Myofascial Pain Syndrome, trigger point injection
Brief summary
This study involves adult patients diagnosed with Myofascial Pain Syndromes (MPS). The purpose of this research study is to determine if there is a therapeutic difference between trigger point injection (TPI) of normal saline and conventional drug mix (local anesthesic + steroid) in treating MPS.
Interventions
DRUGNormal Saline
Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
DRUGLidocaine Hydrochloride
Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
DRUGTriamcinolone acetonide
Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients diagnosed with MPS of the trapezius, gluteus medius/minimus, iliocostalis thoracis-lumborum, quadratus Lumborum, or paraspinal muscles in the emergency department.
Exclusion criteria
* Patients allergic to lidocaine and/or steroids. * Pregnant women. * Prisoners. * Patients who are cognitively impaired and/or unable to consent for the study. * Age \< 18. * Signs of localized infection or skin breakdown at the injection site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | baseline | The level of pain intensity is quantified using a standard 0-10 Numerical Rating Scale with 10 being the most severe pain intensity and 0 the absence of pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Pain Relief | 16 days | If the patient experienced pain relief with the trigger point injection and the pain came back later, the number of days after the injection at which the pain had returned was recorded. |
Countries
United States
Participant flow
Pre-assignment details
3 participants who were enrolled did not start the study.
Participants by arm
| Arm | Count |
|---|---|
| TPI With Normal Saline Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle. | 23 |
| TPI With Lidocaine & Triamcinolone Acetonide Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle. | 25 |
| Total | 48 |
Baseline characteristics
| Characteristic | TPI With Normal Saline | TPI With Lidocaine & Triamcinolone Acetonide | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 25 Participants | 48 Participants |
| Race/Ethnicity, Customized Race/Ethnicity African American or Black | 8 Participants | 8 Participants | 16 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 12 Participants | 13 Participants | 25 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 3 Participants | 3 Participants | 6 Participants |
| Region of Enrollment United States | 23 Participants | 25 Participants | 48 Participants |
| Sex: Female, Male Female | 17 Participants | 18 Participants | 35 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 25 |
| other Total, other adverse events | 0 / 23 | 0 / 25 |
| serious Total, serious adverse events | 0 / 23 | 0 / 25 |
Outcome results
Primary
Pain Intensity
The level of pain intensity is quantified using a standard 0-10 Numerical Rating Scale with 10 being the most severe pain intensity and 0 the absence of pain.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TPI With Normal Saline | Pain Intensity | 7.69 units on a scale | Standard Deviation 1.87 |
| TPI With Lidocaine & Triamcinolone Acetonide | Pain Intensity | 7.44 units on a scale | Standard Deviation 2.04 |
Primary
Pain Intensity
The level of pain intensity is quantified using a standard 0-10 Numerical Rating Scale with 10 being the most severe pain intensity and 0 the absence of pain.
Time frame: at discharge (a few minutes after receiving intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TPI With Normal Saline | Pain Intensity | 1.52 units on a scale | Standard Deviation 2.22 |
| TPI With Lidocaine & Triamcinolone Acetonide | Pain Intensity | 1.76 units on a scale | Standard Deviation 2.86 |
Primary
Pain Intensity
The level of pain intensity is quantified using a standard 0-10 Numerical Rating Scale with 10 being the most severe pain intensity and 0 the absence of pain.
Time frame: 2 weeks
Population: Pain intensity was not measured in 6 subjects in the TPI with Normal Saline arm and 4 subjects in the TPI with Lidocaine \& Triamcinolone Acetonide arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TPI With Normal Saline | Pain Intensity | 4.29 units on a scale | Standard Deviation 3.66 |
| TPI With Lidocaine & Triamcinolone Acetonide | Pain Intensity | 4.14 units on a scale | Standard Deviation 3.17 |
Secondary
Duration of Pain Relief
If the patient experienced pain relief with the trigger point injection and the pain came back later, the number of days after the injection at which the pain had returned was recorded.
Time frame: 16 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TPI With Normal Saline | Duration of Pain Relief | 3 days |
| TPI With Lidocaine & Triamcinolone Acetonide | Duration of Pain Relief | 1 days |