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

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ClinicalTrials.gov Identifier: NCT02120261
Recruitment Status : Terminated (lack of activity, Primary researcher moved to another institution)
First Posted : April 22, 2014
Results First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Carlos Roldan, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Myofascial Pain Syndrome Drug: Normal Saline Drug: Lidocaine Hydrochloride Drug: Triamcinolone acetonide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using Saline for Myofascial Pain Syndromes (USAMPS)
Study Start Date : May 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: TPI with 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.
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.

Active Comparator: TPI with Lidocaine & 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.
Drug: 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.

Drug: 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.




Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: baseline ]
    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. Pain Intensity [ Time Frame: at discharge (a few minutes after receiving intervention) ]
    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.

  3. Pain Intensity [ Time Frame: 2 weeks ]
    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 :
  1. Duration of Pain Relief [ Time Frame: 16 days ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120261


Locations
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United States, Texas
Lyndon Baines Johnson General Hospital
Houston, Texas, United States, 77026
Memorial Hermann Hospital Texas Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Carlos Roldan, MD The University of Texas Health Science Center, Houston

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Responsible Party: Carlos Roldan, Associate Professor of EMS, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02120261     History of Changes
Other Study ID Numbers: HSC-MS-14-0072
First Posted: April 22, 2014    Key Record Dates
Results First Posted: May 1, 2019
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Carlos Roldan, The University of Texas Health Science Center, Houston:
Myofascial Pain Syndrome
trigger point injection

Additional relevant MeSH terms:
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Syndrome
Somatoform Disorders
Myofascial Pain Syndromes
Fibromyalgia
Disease
Pathologic Processes
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Lidocaine
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids