Overview

This trial has been terminated.

Condition myofascial pain syndrome
Treatment trigger point injection
Phase phase 4
Sponsor The University of Texas Health Science Center, Houston
Start date May 2014
End date November 2016
Trial size 51 participants
Trial identifier NCT02120261, HSC-MS-14-0072

Summary

This study is a prospective, randomized, double-blinded trial involving adult patients diagnosed with Myofascial Pain Syndromes (MPS). The purpose of this research study is to compare if there is a therapeutic difference between trigger point injections of normal saline and conventional drug mix (local anesthesic + steroid) in treating MPS. In particular, we will find out about the pain level and duration before and after injection.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Trigger point injection with 1 mL of normal saline solution
trigger point injection
study medication mix (1 mL) or Sterile normal saline (1 mL) are injected in the most tender segment (trigger point) of the compromised muscle
(Active Comparator)
Trigger point injection with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL)
trigger point injection
study medication mix (1 mL) or Sterile normal saline (1 mL) are injected in the most tender segment (trigger point) of the compromised muscle

Primary Outcomes

Measure
Change of Pain Intensity before and at two weeks after treatment
time frame: 1) right before treatment with trigger point injection, 2) at two weeks after treatment

Secondary Outcomes

Measure
Duration of Pain
time frame: two weeks after treatment
Change of Pain Intensity before and 2 - 5 minutes after treatment
time frame: 1) right before treatment with trigger point injection, 2) 2 - 5 minutes after treatment with trigger point injection

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Using Saline for Myofascial Pain Syndromes (USAMPS)
Principal investigator Carlos Roldan, MD
Description This study is a prospective, randomized, double-blinded trial involving adult patients diagnosed with Myofascial Pain Syndromes (MPS). The purpose of this research study is to compare if there is a therapeutic difference between trigger point injections of normal saline and conventional drug mix (lidocaine+ triamcinolone acetonide) in treating MPS. In particular, we will find out about the pain level and duration before and after injection. Enrolled patients will be randomly assigned to receive trigger point injection that contains either saline (arm one) or conventional drug mix (arm two) to treat their muscle pain. Upon discharge, patients will receive instructions for regular active muscle stretching as a plan to restore their muscle functions. Patients will be asked about their pain level before and after treatment. In addition, patients will be followed up two weeks after treatment to find out about their pain status and treatment satisfaction. Currently, there is no standard protocol or studies in the emergency department for treating patients with MPS. The results from this study can potentially improve pain management in the emergency department.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston.