Using Saline for Myofascial Pain Syndromes (USAMPS)

Phase 4

Terminated

• Conditions: Myofascial Pain Syndrome
• Interventions: Drug: Normal Saline; Drug: Lidocaine Hydrochloride; Drug: Triamcinolone acetonide

• Registration Number: NCT02120261
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-14
• Study First Submitted QC: 2014-04-17
• Study First Posted: 2014-04-22
• Study Start: 2014-05
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2019-04
• Results First Submitted: 2019-04-11
• Results First Submitted QC: 2019-04-11
• Last Update Submitted: 2019-04-11
• Results First Posted: 2019-05-01
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TPI with Normal Saline	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.
TPI with Lidocaine & Triamcinolone Acetonide	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.
TPI with Lidocaine & Triamcinolone Acetonide	Lidocaine 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.

Primary Outcome Measures

Name	Time	Method
Pain Intensity	2 weeks	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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Memorial Hermann Hospital Texas Medical Center; 🇺🇸 Houston, Texas, United States

Lyndon Baines Johnson General Hospital; 🇺🇸 Houston, Texas, United States