Using Saline for Myofascial Pain Syndromes (USAMPS)

NCT02120261 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: HSC-MS-14-0072
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

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.

Conditions

Myofascial Pain Syndrome

Keywords

Myofascial Pain Syndrome; trigger point injection

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  2 weeks

Secondary Outcomes (1)

• Duration of Pain Relief

  16 days

Study Arms (2)

TPI with Normal Saline

EXPERIMENTAL

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

TPI with Lidocaine & Triamcinolone Acetonide

ACTIVE COMPARATOR

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

Interventions

Normal Saline 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 Normal Saline

Lidocaine Hydrochloride 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.

TPI with Lidocaine & Triamcinolone Acetonide

Triamcinolone acetonide 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.

TPI with Lidocaine & Triamcinolone Acetonide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients diagnosed with MPS of the trapezius, gluteus medius/minimus, iliocostalis thoracis-lumborum, quadratus Lumborum, or paraspinal muscles in the emergency department.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (2)

Lyndon Baines Johnson General Hospital

Houston, Texas, 77026, United States

Location

Memorial Hermann Hospital Texas Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Saline Solution; Lidocaine; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Carlos J. Roldan, MD
• Organization: The University of Texas Health Science Center at Houston

Carlos.J.Roldan@uth.tmc.edu

Study Officials

• Carlos Roldan, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of EMS

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 22, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 1, 2019
• Results First Posted: May 1, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)