Using Saline for Myofascial Pain Syndromes (USAMPS)

Myofascial Pain Syndrome Clinical Trial

— USAMPS  

Official title:

Using Saline for Myofascial Pain Syndromes (USAMPS)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02120261
• Other study ID #: HSC-MS-14-0072
• Status: Terminated
• Phase: Phase 4
• Start date: May 2014
• Est. completion date: November 2016

Study information

• Verified date: April 2019
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Somatoform Disorders
• Syndrome

Intervention

Drug:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Lyndon Baines Johnson General Hospital	Houston	Texas
United States	Memorial Hermann Hospital Texas Medical Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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	Duration of Pain Relief	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.	16 days