Using Saline for Myofascial Pain Syndromes (USAMPS)

NCT ID: NCT02120261

Last Updated: 2019-05-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-11-30

Brief Summary

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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

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Conditions

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Myofascial Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Normal Saline

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Lidocaine Hydrochloride

Intervention Type DRUG

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 acetonide

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Carlos Roldan

Associate Professor of EMS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos Roldan, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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Lyndon Baines Johnson General Hospital

Houston, Texas, United States

Site Status

Memorial Hermann Hospital Texas Medical Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-MS-14-0072

Identifier Type: -

Identifier Source: org_study_id

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