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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.

Detailed Summary:

The purpose of this investigation was to develop a valid and reliable PPTS in order to provide an objective means of assessing pressure pain threshold and to create a reliable method of communication among clinicians. Eighty-four participants (N=84) were enrolled in the study and assigned to three groups: FM (N=28), MPS (N=28), and control group (N=28). Participants were recruited from three sites. All participants were aged 18 to 65 years and met the inclusion criteria for 1 of the 3 groups. All participants were required to read, speak and write English as needed to complete forms and consent. The following criteria for each group was as follows:

  1. Control group: Individuals with no current or prior diagnosis consistent with MPS or FM. No current injuries or integumentary abnormalities at the designated palpation sites.
  2. MPS group: Individuals with a diagnosis of MPS that does not meet the American College of Rheumatology (ACR) diagnostic criteria for FM. No current injuries or integumentary abnormalities at the designated palpation sites.
  3. FM group: Individuals who met the criteria for a diagnosis of FM based upon the ACR diagnostic criteria. No current injuries or integumentary abnormalities at the designated palpation sites.

Prior to testing, participants filled out a screening questionnaire with questions that represent the exclusion criteria which were used to determine ineligibility for this study. Participants who met the inclusion criteria and consented to participate were enrolled in the study. A California State University Dominguez Hills approved consent was read and signed by all participants prior to beginning data collection. Following consent, participant filled out a questionnaire to provide demographi
Sponsor: California State University, Dominguez Hills

Current Primary Outcome: Pressure Pain Threshold Scale [ Time Frame: Baseline ]

0-4 ordinal ranked scale (0-no pain to 4-intolerable pain)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Visual Analog Pain Scale [ Time Frame: Baseline ]
    Patient Related Outcome Measure for Pain
  • 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)


Original Secondary Outcome: Same as current

Information By: California State University, Dominguez Hills

Dates:
Date Received: June 5, 2016
Date Started: January 2015
Date Completion:
Last Updated: June 15, 2016
Last Verified: June 2016