Clinical Trial: Using Saline for Myofascial Pain Syndromes (USAMPS)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Using Saline for Myofascial Pain Syndromes (USAMPS)

Brief 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.

Detailed 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 (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.
Sponsor: The University of Texas Health Science Center, Houston

Current Primary Outcome: 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 ]

Change is being assessed. Specifically, changes in the level of pain intensity, which is quantified using a standard 0-10 Numerical Rating Scale with 10 being the most severe pain intensity and 0 the absence of pain, before and at two weeks after trigger point injection will be assessed.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Duration of Pain [ Time Frame: two weeks after treatment ]
    If patient experienced pain relief with the trigger point injection and the pain came back later, the number of days after the injection in which the pain had returned will be recorded.
  • 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 ]
    Change is being assessed. Specifically, changes in the level of pain intensity, which is quantified using a standard 0-10 Numerical Rating Scale with 10 being the most severe pain intensity and 0 the absence of pain, before and 2 - 5 minutes after trigger point injection will be assessed.


Original Secondary Outcome: Same as current

Information By: The University of Texas Health Science Center, Houston

Dates:
Date Received: April 14, 2014
Date Started: May 2014
Date Completion:
Last Updated: November 7, 2016
Last Verified: November 2016