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

NCT02802202 | Completed

• 1 other identifier: #15-116
• Study Type: observational
• Target: 84
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myofascial Pain Syndrome; Fibromyalgia

Keywords

Palpation; Chronic Pain; Muscle

Outcome Measures

Primary Outcomes (1)

• Pressure Pain Threshold Scale

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

  Baseline

Secondary Outcomes (2)

• Visual Analog Pain Scale

  Baseline

• Manual Tender Point Survey (MTPS)

  Baseline

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• California State University, Dominguez Hills: lead

Related Publications (7)

• Ge HY, Wang Y, Danneskiold-Samsoe 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.

  PMID: 19914876 BACKGROUND

• 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.

  PMID: 22506152 BACKGROUND

• Alonso-Blanco C, Fernandez-de-las-Penas C, Morales-Cabezas M, Zarco-Moreno P, Ge HY, Florez-Garcia 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.

  PMID: 21368661 BACKGROUND

• Alonso-Blanco C, Fernandez-de-Las-Penas C, de-la-Llave-Rincon AI, Zarco-Moreno P, Galan-Del-Rio 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.

  PMID: 22935970 BACKGROUND

• 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.

  PMID: 24398392 BACKGROUND

• Sterling M. Pressure algometry: what does it really tell us? J Orthop Sports Phys Ther. 2011 Sep;41(9):623-4. doi: 10.2519/jospt.2011.0106. Epub 2011 Aug 31. No abstract available.

  PMID: 21885903 BACKGROUND

• Cheatham SW, Kolber MJ, Mokha GM, Hanney WJ. Concurrent validation of a pressure pain threshold scale for individuals with myofascial pain syndrome and fibromyalgia. J Man Manip Ther. 2018 Feb;26(1):25-35. doi: 10.1080/10669817.2017.1349592. Epub 2017 Jul 9.

  PMID: 29456445 DERIVED

MeSH Terms

Conditions

Myofascial Pain Syndromes; Fibromyalgia; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Scott W Cheatham, DPT, PhD

  CSUDH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Division of Kinesiology)

Study Record Dates

• First Submitted: June 5, 2016
• First Posted: June 16, 2016
• Study Start: January 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 16, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share