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Using Saline for Myofascial Pain Syndromes (USAMPS) (USAMPS)

Primary Purpose

Myofascial Pain Syndrome

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Normal Saline
Lidocaine Hydrochloride
Triamcinolone acetonide
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome focused on measuring Myofascial Pain Syndrome, trigger point injection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lyndon Baines Johnson General Hospital
  • Memorial Hermann Hospital Texas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TPI with Normal Saline

TPI with Lidocaine & Triamcinolone Acetonide

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 14, 2014
Last Updated
April 11, 2019
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT02120261
Brief Title
Using Saline for Myofascial Pain Syndromes (USAMPS)
Acronym
USAMPS
Official Title
Using Saline for Myofascial Pain Syndromes (USAMPS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
lack of activity, Primary researcher moved to another institution
Study Start Date
May 2014 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome
Keywords
Myofascial Pain Syndrome, trigger point injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TPI with Normal Saline
Arm Type
Experimental
Arm Description
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.
Arm Title
TPI with Lidocaine & Triamcinolone Acetonide
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Normal Saline
Intervention Description
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
Intervention Name(s)
Lidocaine Hydrochloride
Intervention Description
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
Intervention Name(s)
Triamcinolone acetonide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
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.
Time Frame
baseline
Title
Pain Intensity
Description
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.
Time Frame
at discharge (a few minutes after receiving intervention)
Title
Pain Intensity
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Duration of Pain Relief
Description
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.
Time Frame
16 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Roldan, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lyndon Baines Johnson General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States
Facility Name
Memorial Hermann Hospital Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Using Saline for Myofascial Pain Syndromes (USAMPS)

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