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Validation of a Pressure Pain Threshold Scale in Patients Diagnosed With Myofascial Pain Syndrome and Fibromyalgia

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ClinicalTrials.gov Identifier: NCT02802202
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : June 16, 2016
Sponsor:
Information provided by (Responsible Party):
Scott Cheatham, California State University, Dominguez Hills

Brief Summary:
To date, there are no valid and reliable pressure pain threshold scales for use in research or clinical practice. The existing manual palpation protocols and scales have limited support in the literature and our knowledge has not advanced since these scales were proposed in the 1990's. Therefore, the purpose of this investigation was to develop a valid and reliable PPTS in order to provide an objective means of assessing pressure pain thresholds and create a reliable method of communication among clinicians for individuals with a diagnoses characterized by MPS and FM. These conditions were chosen based on their high prevalence among chronic pain conditions and are also dependent upon the manual palpation examination for their diagnosis.

Condition or disease
Myofascial Pain Syndrome Fibromyalgia

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 84 participants
Time Perspective: Prospective
Official Title: Validation of a Pressure Pain Threshold Scale in Patients Diagnosed With Myofascial Pain Syndrome and Fibromyalgia
Study Start Date : January 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Group/Cohort
Fibromyalgia
Individuals who met the criteria for a diagnosis of FM based upon the ACR diagnostic criteria.
Myofascial Pain Syndrome
Individuals with a diagnosis of MPS that does not meet the American College of Rheumatology (ACR) diagnostic criteria for FM.
Control
Individuals with no current or prior diagnosis consistent with MPS or FM.



Primary Outcome Measures :
  1. Pressure Pain Threshold Scale [ Time Frame: Baseline ]
    0-4 ordinal ranked scale (0-no pain to 4-intolerable pain)


Secondary Outcome Measures :
  1. Visual Analog Pain Scale [ Time Frame: Baseline ]
    Patient Related Outcome Measure for Pain

  2. Manual Tender Point Survey (MTPS) [ Time Frame: Baseline ]
    The MTPS is a version of the 11-point numeric pain rating scale for pain (ordinal scale)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

3 groups of participants were recruited for this study:

  • Control group: Individuals with no current or prior diagnosis consistent with Myofascial Pain Syndrome (MPS) or Fibromyalgia (FM).
  • MPS group: Individuals with a diagnosis of MPS that does not meet the American College of Rheumatology (ACR) diagnostic criteria for FM.
  • FM group: Individuals who met the criteria for a diagnosis of FM based upon the ACR diagnostic criteria.
Criteria

Inclusion Criteria:

  • Control group: Individuals with no current or prior diagnosis consistent with Myofascial Pain Syndrome (MPS) or Fibromyalgia (FM).
  • MPS group: Individuals with a diagnosis of MPS that does not meet the American College of Rheumatology (ACR) diagnostic criteria for FM.
  • FM group: Individuals who met the criteria for a diagnosis of FM based upon the ACR diagnostic criteria.

Exclusion Criteria:

  • Current neurologic conditions (e.g. Multiple Sclerosis)
  • Current metabolic conditions (e.g. Diabetic Neuropathy)
  • Current systemic conditions (e.g. Rheumatoid Arthritis)
  • Any skin or connective tissue problems (e.g. Marfan Syndrome)
  • Current symptoms of numbness, tingling, burning, coldness, or pain in your back, hands, or feet.
  • Any prior surgeries that may affect their ability to participate in this study.
  • A pacemaker or electrical implant that may be affected by electronic equipment.
  • Currently taking medications that may alter a subject's sensation or affect their ability to participate in this study.
  • Current shingles or post-herpetic neuralgia.
  • Current open skin wounds on your neck, arms, back, or legs
  • Current injuries at the designated palpation sites.
  • Currently having other medical conditions or limited function that might affect participation.
  • The ability to tolerate testing duration and procedures.
  • The ability to understand and complete all consent forms and questionnaires.

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): NCT02802202


Sponsors and Collaborators
California State University, Dominguez Hills
Investigators
Principal Investigator: Scott W Cheatham, DPT, PhD CSUDH

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Scott Cheatham, Assistant Professor (Division of Kinesiology), California State University, Dominguez Hills
ClinicalTrials.gov Identifier: NCT02802202     History of Changes
Other Study ID Numbers: #15-116
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Scott Cheatham, California State University, Dominguez Hills:
Palpation
Chronic Pain
Muscle

Additional relevant MeSH terms:
Syndrome
Myofascial Pain Syndromes
Fibromyalgia
Somatoform Disorders
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Mental Disorders