Fibromyalgia Clinical Trial
Official title:
Validation of a Pressure Pain Threshold Scale in Patients Diagnosed With Myofascial Pain Syndrome and Fibromyalgia
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Time Perspective: Prospective
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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California State University, Dominguez Hills |
Alonso-Blanco C, Fernández-de-Las-Peñas C, de-la-Llave-Rincón AI, Zarco-Moreno P, Galán-Del-Río F, Svensson P. Characteristics of referred muscle pain to the head from active trigger points in women with myofascial temporomandibular pain and fibromyalgia syndrome. J Headache Pain. 2012 Nov;13(8):625-37. doi: 10.1007/s10194-012-0477-y. Epub 2012 Aug 31. — View Citation
Alonso-Blanco C, Fernández-de-las-Peñas C, Morales-Cabezas M, Zarco-Moreno P, Ge HY, Florez-García M. Multiple active myofascial trigger points reproduce the overall spontaneous pain pattern in women with fibromyalgia and are related to widespread mechanical hypersensitivity. Clin J Pain. 2011 Jun;27(5):405-13. doi: 10.1097/AJP.0b013e318210110a. — View Citation
Ge HY, Wang Y, Danneskiold-Samsøe B, Graven-Nielsen T, Arendt-Nielsen L. The predetermined sites of examination for tender points in fibromyalgia syndrome are frequently associated with myofascial trigger points. J Pain. 2010 Jul;11(7):644-51. doi: 10.1016/j.jpain.2009.10.006. Epub 2009 Nov 14. — View Citation
Kothari SF, Kothari M, Zambra RF, Baad-Hansen L, Svensson P. Standardization of muscle palpation- methodological considerations. Clin J Pain. 2014 Feb;30(2):174-82. doi: 10.1097/AJP.0b013e31828c893d. — View Citation
Park G, Kim CW, Park SB, Kim MJ, Jang SH. Reliability and usefulness of the pressure pain threshold measurement in patients with myofascial pain. Ann Rehabil Med. 2011 Jun;35(3):412-7. doi: 10.5535/arm.2011.35.3.412. Epub 2011 Jun 30. — View Citation
Sterling M. Pressure algometry: what does it really tell us? J Orthop Sports Phys Ther. 2011 Sep;41(9):623-4. doi: 10.2519/jaspt.2011.01.06. Epub 2011 Aug 31. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pressure Pain Threshold Scale | 0-4 ordinal ranked scale (0-no pain to 4-intolerable pain) | Baseline | No |
Secondary | Visual Analog Pain Scale | Patient Related Outcome Measure for Pain | Baseline | No |
Secondary | Manual Tender Point Survey (MTPS) | The MTPS is a version of the 11-point numeric pain rating scale for pain (ordinal scale) | Baseline | No |
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