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FibromyalgiaNCT03270449

Community-based Intervention for Fibromyalgia: A Pilot Trial

A study testing Multidisciplinary intervention in people with Fibromyalgia, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Fibromyalgia (FM) is a multi-factorial chronic pain condition characterized by fluctuating and heterogeneous symptoms. This leads to both reduced patient function and quality of life and consequentially, significant economic burden on the society. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Fibromyalgia
What is being tested?
Multidisciplinary intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteCanada
Study dates
15 Sep 2017to 30 Jun 2019
Phase
Interventional
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • formal diagnosis of FM
  • resident of Penticton or surrounding area
  • adults, aged 19 and older
  • fluent in English or bring a family member/friend to assist with translation
  • capacity to provide informed consent

Who cannot join

  • patients with a severe and/or chronic medical or psychiatric condition that would impact ability to participate in the intervention
  • patients who are pregnant or lactating

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Balfour Medical Centre

    Penticton, British Columbia, V2A 4Z1

Other trials in Canada

About this study

Official title: A Multi-disciplinary, Community-based Group Intervention for Fibromyalgia: A Pilot Randomized Controlled Trial

Fibromyalgia (FM) is a multi-factorial chronic pain condition characterized by fluctuating and heterogeneous symptoms. This leads to both reduced patient function and quality of life and consequentially, significant economic burden on the society. Although numerous pharmaceutical and multi-treatment approaches exist, there is lack of an integrated multidisciplinary model of care for these patients. Such a system is hypothesized to be beneficial for the patients and would help them regain function and significantly improve their quality of life. The primary aim of this pilot clinical trial is to evaluate the effectiveness of an integrated community-based multidisciplinary model of care for FM patients in Penticton and surrounding areas. The comprehensive 10 week intervention will provide care from a team of health care providers (psychiatrist, physiotherapist, certified exercise therapist, dietitian, rheumatologist, and mental health clinician). Patients will also attend a peer led pain self-management support group provided by the Arthritis Society. The study aims at educating these patients about self-management of their symptoms such as chronic pain, weight, sleep and mood disorders. The integration of health care between the different providers will be achieved by "huddle" sessions that will be conducted on a monthly basis. The evaluation of the study outcomes will be based on the RE-AIM framework. Data will be collected through patient questionnaires, healthcare utilization data, and interviews with providers. Data analysis will involve thematic analysis of qualitative data and statistical methods for quantitative data.

Conditions
Fibromyalgia
Being tested
Multidisciplinary intervention
Keywords
fibromyalgia, community-based, multidisciplinary
Medical subject headings
Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multidisciplinary interventionOther

    10 week multidisciplinary education and exercise

Study groups in NCT03270449
Study groupRoleWhat they receive
Multidisciplinary interventionExperimentalThe 10-week intervention will include twice weekly 1-2 hours sessions with multiple professional team members to undergo education and exercise sessions. The multidisciplinary team will consist of a rheumatologist, rheumatology nurse, dietitian, physiotherapist, a trained exercise therapist, a physiologist who specializes in pain management, a psychiatrist and a mental health clinician. All intervention team members have expertise in working with individuals with chronic pain conditions. General disease information, current best practices and techniques such as self-pain management, pacing, sleep hygiene, approach to a healthy lifestyle and weight loss will be discussed. The total number of hours for the 10 week intervention is 31 hours.
Receives: Other: Multidisciplinary intervention
Usual careNo interventionUsual care involves being referred to the local rheumatologist involved in the study. The rheumatologist and the rheumatology nurse will see the control group patients during a one hour one on one consultation appointment. During that time the patient's history will be taken, physical exam performed and investigations analyzed. If a diagnosis of fibromyalgia is confirmed, the rheumatologist and nurse will counsel the patient and provide resources for self directed management. Unless there is a concern of an alternative diagnosis, follow up will not be arranged.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient-perceived quality of care

    Patient assessment of care received as measured by the Patient Assessment of Chronic Illness Care Questionnaire

    Measured: Change from baseline in perceived quality of care at 10 weeks and 6 months

Secondary outcomes (4)

  1. Daily function #1

    Physical disease and mental health related functioning as measured by Revised-Fibromyalgia Impact Questionnaire

    Measured: Change from baseline in daily function at 10 weeks and 6 months

  2. Daily function #2

    Mental health related functioning as measured by Hospital Anxiety and Depression scale

    Measured: Change from baseline in daily function at 10 weeks and 6 months

  3. Health care utilization (physician visits)

    Number of physician visits

    Measured: Change from baseline in physician visits at 6 months

  4. Health care utilization (emergency visits)

    Number of emergency department visits

    Measured: Change from baseline in emergency department visits at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2017
  2. Study start15 Sep 2017
  3. Primary completion30 Jun 2019
  4. Study completion30 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03270449
Sponsor's protocol ID
H17-01782
Status last verified
Oct 2019
First submitted
21 Aug 2017
Last updated
9 Oct 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fitzcharles MA, Ste-Marie PA, Goldenberg DL, Pereira JX, Abbey S, Choiniere M, Ko G, Moulin DE, Panopalis P, Proulx J, Shir Y; National Fibromyalgia Guideline Advisory Panel. 2012 Canadian Guidelines for the diagnosis and management of fibromyalgia syndrome: executive summary. Pain Res Manag. 2013 May-Jun;18(3):119-26. doi: 10.1155/2013/918216.

    PubMed 23748251

  • Schaefer C, Chandran A, Hufstader M, Baik R, McNett M, Goldenberg D, Gerwin R, Zlateva G. The comparative burden of mild, moderate and severe fibromyalgia: results from a cross-sectional survey in the United States. Health Qual Life Outcomes. 2011 Aug 22;9:71. doi: 10.1186/1477-7525-9-71.

    PubMed 21859448

  • Lachaine J, Beauchemin C, Landry PA. Clinical and economic characteristics of patients with fibromyalgia syndrome. Clin J Pain. 2010 May;26(4):284-90. doi: 10.1097/AJP.0b013e3181cf599f.

    PubMed 20393262

  • Thompson JM, Luedtke CA, Oh TH, Shah ND, Long KH, King S, Branda M, Swanson R. Direct medical costs in patients with fibromyalgia: Cost of illness and impact of a brief multidisciplinary treatment program. Am J Phys Med Rehabil. 2011 Jan;90(1):40-6. doi: 10.1097/PHM.0b013e3181fc7ff3.

    PubMed 20975520

  • Winkelmann A, Perrot S, Schaefer C, Ryan K, Chandran A, Sadosky A, Zlateva G. Impact of fibromyalgia severity on health economic costs: results from a European cross-sectional study. Appl Health Econ Health Policy. 2011 Mar 1;9(2):125-36. doi: 10.2165/11535250-000000000-00000.

    PubMed 21332254

  • Bellato E, Marini E, Castoldi F, Barbasetti N, Mattei L, Bonasia DE, Blonna D. Fibromyalgia syndrome: etiology, pathogenesis, diagnosis, and treatment. Pain Res Treat. 2012;2012:426130. doi: 10.1155/2012/426130. Epub 2012 Nov 4.

    PubMed 23213512

  • Gaglio B, Shoup JA, Glasgow RE. The RE-AIM framework: a systematic review of use over time. Am J Public Health. 2013 Jun;103(6):e38-46. doi: 10.2105/AJPH.2013.301299. Epub 2013 Apr 18.

    PubMed 23597377

  • Richards L, Morse J. Read me first for a users guide to qualitative methods. (3rd ed.) Sage Publications, Inc. 2013.

  • Verbeke G, Molenberghs G. Linear mixed models for longitudinal data. Springer Science & Business Media; 2009.

  • Glasgow RE, Wagner EH, Schaefer J, Mahoney LD, Reid RJ, Greene SM. Development and validation of the Patient Assessment of Chronic Illness Care (PACIC). Med Care. 2005 May;43(5):436-44. doi: 10.1097/01.mlr.0000160375.47920.8c.

    PubMed 15838407

  • Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL. The Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther. 2009;11(4):R120. doi: 10.1186/ar2783. Epub 2009 Aug 10.

    PubMed 19664287

  • Nam S, Tin D, Bain L, Thorne JC, Ginsburg L. Clinical utility of the Hospital Anxiety and Depression Scale (HADS) for an outpatient fibromyalgia education program. Clin Rheumatol. 2014 May;33(5):685-92. doi: 10.1007/s10067-013-2377-1. Epub 2013 Sep 1.

    PubMed 23995734

  • Cappelleri JC, Bushmakin AG, McDermott AM, Dukes E, Sadosky A, Petrie CD, Martin S. Measurement properties of the Medical Outcomes Study Sleep Scale in patients with fibromyalgia. Sleep Med. 2009 Aug;10(7):766-70. doi: 10.1016/j.sleep.2008.09.004. Epub 2009 Jan 29.

    PubMed 19185539

  • Tait RC, Chibnall JT. Development of a brief version of the Survey of Pain Attitudes. Pain. 1997 Apr;70(2-3):229-35. doi: 10.1016/s0304-3959(97)03330-7.

    PubMed 9150298

Questions about this trial

What is this clinical trial studying?

A study testing Multidisciplinary intervention in people with Fibromyalgia, run by University of British Columbia at 1 site in Canada.

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 5 inclusion and 2 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 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Patient-perceived quality of care (time frame: Change from baseline in perceived quality of care at 10 weeks and 6 months). 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 NCT03270449, which also lists 14 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 9 Oct 2019; AzTrials last refreshed its copy on 29 Oct 2026.

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