Myofascial Pain SyndromeNCT02802202
Validation of a Pressure Pain Threshold Scale in Patients Diagnosed With Myofascial Pain Syndrome and Fibromyalgia
An observational study of Myofascial Pain Syndrome and Fibromyalgia, run by California State University, Dominguez Hills.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain Syndrome, Fibromyalgia
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
About this study
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.
Read the detailed description
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:
- 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.
- 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.
- 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 demographic information which included age, height, weight, arm dominance.
Following completion of the paperwork, all participants underwent testing from the primary investigator which was conducted between the hours of 8 am and 2pm. Participants were instructed to refrain from taking any related medication (e.g. pain medication) prior to testing. All participants underwent the same testing procedures and were blinded from the examiner's scores and other participants enrolled in the study.
For the reliability portion of the study, a total of 20 participants (10 MPS/FM and 10 control group) underwent 2 days of testing. Each testing session lasted approximately 45 minutes. After the reliability portion was complete, all other recruited subjects underwent 1 day of testing which lasted approximately 45 minutes.
The testing process consisted of 2-parts which were based upon the American College of Rheumatology (ACR) diagnostic criteria for FM. The protocol required the examiner to apply pressure to 18 pre-determined and 2 control points up to 4kg/cm2 at a rate of 1kg per second for a total of 4 seconds at each point, one time.12, 13 For Part I, the examiner applied a gradually increasing pressure using the thumb and digital pressure sensor at each pre-determined tender point. For Part II, the examiner applied a gradual increasing pressure using the algometer to the pre-determined tender points. For both Part I and II, the participant recorded their level of discomfort at each tender point using the MTPS and VAS pain scales once the examiner reached 4kg/cm2 of pressure or once a maximum level of pressure was felt. Participants were able to stop testing at any time. The examiner simultaneously recorded the patient's response using the PPTS scale for each tender point.
Collected data was transferred to SPSS v.22 (IBM SPSS, Chicago, IL). Means, standard error of mean (SEM), 95% confidence intervals (95% CI), and ranges of the descriptive data from each group was calculated. Group differences were calculated using the independent t-test. Six clinical questions were measured in this investigation which required specific parametric and non-parametric (ordinal data) statistical calculations. The P-value was considered significant at the .05 level using a two-tailed test (α2 =.05) for all clinical questions.
- Conditions
- Myofascial Pain Syndrome, Fibromyalgia
- Keywords
- Palpation, Chronic Pain, Muscle
- Medical subject headings
- Myofascial Pain Syndromes, Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold Scale
0-4 ordinal ranked scale (0-no pain to 4-intolerable pain)
Measured: Baseline
Secondary outcomes (2)
Visual Analog Pain Scale
Patient Related Outcome Measure for Pain
Measured: Baseline
Manual Tender Point Survey (MTPS)
The MTPS is a version of the 11-point numeric pain rating scale for pain (ordinal scale)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJan 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- California State University, Dominguez Hills
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Cheatham, California State University, Dominguez Hills
- Investigators
- Scott W Cheatham, DPT, PhD, Principal investigator, CSUDH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802202
- Sponsor's protocol ID
- #15-116
- Status last verified
- Jun 2016
- First submitted
- 5 Jun 2016
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19914876Park 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.
PubMed 22506152Alonso-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.
PubMed 21368661Alonso-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.
PubMed 22935970Kothari 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.
PubMed 24398392Sterling 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.
PubMed 21885903Cheatham 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.
PubMed 29456445
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Pressure Pain Threshold Scale in Patients Diagnosed With Myofascial Pain Syndrome and Fibromyalgia
- ClinicalTrials.gov ID
- NCT02802202
- Acronym / sponsor ID
- #15-116
- Conditions
- Myofascial Pain Syndrome, Fibromyalgia
- Keywords
- Palpation, Chronic Pain, Muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- California State University, Dominguez HillsUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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:
- 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.
- 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.
- 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 demographic information which included age, height, weight, arm dominance.
Following completion of the paperwork, all participants underwent testing from the primary investigator which was conducted between the hours of 8 am and 2pm. Participants were instructed to refrain from taking any related medication (e.g. pain medication) prior to testing. All participants underwent the same testing procedures and were blinded from the examiner's scores and other participants enrolled in the study.
For the reliability portion of the study, a total of 20 participants (10 MPS/FM and 10 control group) underwent 2 days of testing. Each testing session lasted approximately 45 minutes. After the reliability portion was complete, all other recruited subjects underwent 1 day of testing which lasted approximately 45 minutes.
The testing process consisted of 2-parts which were based upon the American College of Rheumatology (ACR) diagnostic criteria for FM. The protocol required the examiner to apply pressure to 18 pre-determined and 2 control points up to 4kg/cm2 at a rate of 1kg per second for a total of 4 seconds at each point, one time.12, 13 For Part I, the examiner applied a gradually increasing pressure using the thumb and digital pressure sensor at each pre-determined tender point. For Part II, the examiner applied a gradual increasing pressure using the algometer to the pre-determined tender points. For both Part I and II, the participant recorded their level of discomfort at each tender point using the MTPS and VAS pain scales once the examiner reached 4kg/cm2 of pressure or once a maximum level of pressure was felt. Participants were able to stop testing at any time. The examiner simultaneously recorded the patient's response using the PPTS scale for each tender point.
Collected data was transferred to SPSS v.22 (IBM SPSS, Chicago, IL). Means, standard error of mean (SEM), 95% confidence intervals (95% CI), and ranges of the descriptive data from each group was calculated. Group differences were calculated using the independent t-test. Six clinical questions were measured in this investigation which required specific parametric and non-parametric (ordinal data) statistical calculations. The P-value was considered significant at the .05 level using a two-tailed test (α2 =.05) for all clinical questions.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pressure Pain Threshold Scale
Time frame: Baseline
0-4 ordinal ranked scale (0-no pain to 4-intolerable pain)
2 secondary outcomes
Visual Analog Pain Scale
Time frame: Baseline
Manual Tender Point Survey (MTPS)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Background: PubMed 19914876Ge 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.
- Background: PubMed 22506152Park 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.
- Background: PubMed 21368661Alonso-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.
- Background: PubMed 22935970Alonso-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.
- Background: PubMed 24398392Kothari 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.
- Background: PubMed 21885903Sterling 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.
- Derived from this study: PubMed 29456445Cheatham 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott W Cheatham, DPT, PhD principal investigator
CSUDH
Questions about this trial
What is this clinical trial studying?
An observational study of Myofascial Pain Syndrome and Fibromyalgia, run by California State University, Dominguez Hills.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Pain Threshold Scale (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02802202, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2016.