A Phase 4 interventional study of Normal Saline and Lidocaine Hydrochloride in Myofascial Pain Syndrome, sponsored by The University of Texas Health Science Center, Houston. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-01.
Sponsored by The University of Texas Health Science Center, Houston · Phase 4, Interventional, and Treatment
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.
1,143 studies on the registry are indexed under Myofascial Pain Syndromes; 137 are open to participants now.
This study's enrollment of 51 is below the median of 60 across 937 interventional studies indexed under Myofascial Pain Syndromes.
Browse Myofascial Pain Syndromes studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
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Exclusion Criteria:
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.
Drug: Normal Saline
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.
Drug: Lidocaine Hydrochloride · Drug: Triamcinolone acetonide
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.
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.
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.
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
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)
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
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
| Milestone | TPI With Normal Saline | TPI With Lidocaine & Triamcinolone Acetonide |
|---|---|---|
| Started | 23 | 25 |
| Completed | 23 | 25 |
| Not completed | 0 | 0 |
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.
| units on a scale | TPI With Normal Saline | TPI With Lidocaine & Triamcinolone Acetonide |
|---|---|---|
| Pain Intensity | 7.69 ± 1.87 | 7.44 ± 2.04 |
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.
| units on a scale | TPI With Normal Saline | TPI With Lidocaine & Triamcinolone Acetonide |
|---|---|---|
| Pain Intensity | 1.52 ± 2.22 | 1.76 ± 2.86 |
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.
| units on a scale | TPI With Normal Saline | TPI With Lidocaine & Triamcinolone Acetonide |
|---|---|---|
| Pain Intensity | 4.29 ± 3.66 | 4.14 ± 3.17 |
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.
| days | TPI With Normal Saline | TPI With Lidocaine & Triamcinolone Acetonide |
|---|---|---|
| Duration of Pain Relief | 3 (1 to 16) | 1 (0 to 15) |
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TPI With Normal Saline | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| TPI With Lidocaine & Triamcinolone Acetonide | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Age, Categorical(Participants) | TPI With Normal Saline | TPI With Lidocaine & Triamcinolone Acetonide | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 23 | 25 | 48 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | TPI With Normal Saline | TPI With Lidocaine & Triamcinolone Acetonide | Total |
|---|---|---|---|
| Female | 17 | 18 | 35 |
| Male | 6 | 7 | 13 |
| Race/Ethnicity, Customized(Participants) | TPI With Normal Saline | TPI With Lidocaine & Triamcinolone Acetonide | Total |
|---|---|---|---|
| Race/Ethnicity — Hispanic | 12 | 13 | 25 |
| Race/Ethnicity — African American or Black | 8 | 8 | 16 |
| Race/Ethnicity — White | 3 | 3 | 6 |
| Race/Ethnicity — Asian | 0 | 1 | 1 |
| Region of Enrollment(Participants) | TPI With Normal Saline | TPI With Lidocaine & Triamcinolone Acetonide | Total |
|---|---|---|---|
| United States | 23 | 25 | 48 |
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of May 2014, a primary completion of Nov 2016 and a completion of Nov 2016. It does not say whether these dates are actual or estimated.
Results were first posted in May 2019, 2 years 6 months after primary completion.
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This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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