Using Saline for Myofascial Pain Syndromes (USAMPS)

The University of Texas System (UT)

Status and phase: Terminated; Phase 4

Conditions: Myofascial Pain Syndrome

Treatments: Drug: Normal Saline; Drug: Lidocaine Hydrochloride; Drug: Triamcinolone acetonide

Study type: Interventional

Funder types: Other

Identifiers

NCT02120261

HSC-MS-14-0072

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups

TPI with Normal Saline

Experimental group

Description:

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.

Treatment:

Drug: Normal Saline

TPI with Lidocaine & Triamcinolone Acetonide

Active Comparator group

Description:

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.

Treatment:

Drug: Lidocaine Hydrochloride

Drug: Triamcinolone acetonide