Using Saline for Myofascial Pain Syndromes (USAMPS)

Phase 4TerminatedNCT02120261

The University of Texas Health Science Center, Houston51 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Myofascial Pain Syndrome

Interventions

Normal SalineDRUG

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.

Lidocaine HydrochlorideDRUG

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.

Triamcinolone acetonideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Lyndon Baines Johnson General Hospital

Houston, Texas, United States

Memorial Hermann Hospital Texas Medical Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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