A U.K. research group has launched what they say is the first ever randomized clinical trial conducted with the objective of preventing the onset of chronic widespread pain (CWP — the characteristic feature of fibromyalgia).
Led by Clinical Professor of Epidemiology and department Chair Gary J. Macfarlane and Study Coordinator Marcus Beasley of the Epidemiology Group at the University of Aberdeen School of Medicine Institute of Applied Health Sciences School of Medicine and Dentistry in Aberdeen, UK, the research team, which includes investigators from other U. Aberdeen departments, the University of Huddersfield, at Huddersfield, UK, Keele University, at Keele, UK, and the University of Manchester, Manchester, UK, will recruit persons at high risk of developing CWP and they will be randomly allocated to receive either usual care or eight sessions of Cognitive Behaviour Therapy (CBT) delivered by telephone. Potentially eligible subjects will be identified through a large-scale population survey.
The University of Aberdeen Epidemiology Group conducts work on the epidemiology of specific clinical conditions, with a focus on modifiable risk factors, to inform the design of clinical trials and public health interventions. The study is being funded by Arthritis Research UK, with treatment costs from the National Health Service’s (NHS) Grampian, Highland and Greater Glasgow and Clyde health boards.
In an Open Access article published in the journal BMC Musculoskeletal Disorders entitled “The Maintaining Musculoskeletal Health (MAmMOTH) Study: Protocol for a randomized trial of cognitive behavioural therapy versus usual care for the prevention of chronic widespread pain“ (BMC Musculoskelet Disord. 2016 Apr 26;17(1):179. DOI: 10.1186/s12891-016-1037-4), coauthors Gary J. Macfarlane, Marcus Beasley, Gordon Prescott, Paul McNamee, Philip Keeley, Majid Artus, John McBeth, Philip Hannaford, Gareth T. Jones, Neil Basu, John Norrie, and Karina Lovell explain that cognitive behavioural therapy (CBT) has been shown to improve outcomes for patients with fibromyalgia, and prediction models have now been developed to identify groups at high-risk of developing CWP. The researchers propose that it would be beneficial to be able to discover how to prevent development of CWP in these people because of the high cost of clinically addressing CWP symptoms which as noted above, once established are difficult to manage.
The researchers note in their study profile that it is known from many studies that once patients have developed CWP or fibromyalgia, managing their symptoms is extremely challenging for both doctors and patients. Also costly in terms of both individual, societal and health expenditures.
The investigative team observes that fibromyalgia is associated with lost work productivity, psychological ill health, and poor quality of life, and is one of the most common reasons for referral to a rheumatologist. For example, they note that in the United States, mean per-patient costs (including pain and nonpain-related medication, physician consultations, tests and procedures, and emergency department visits) in the six months following a new diagnosis of fibromyalgia have been reported as $3481 — comparable to patients with rheumatoid arthritis but resulting in even worse quality of life.
They observe that current guidelines recommend pharmacological, physical, and psychological therapies although the importance attributed to individual therapies is inconsistent, and that there is good evidence that for musculoskeletal pain conditions generally, the longer the duration of symptoms, the less likely that symptoms are to improve, including with specific interventions — particularly so for CWP which, once developed, is challenging to manage.
More encouragingly, they cite a recently completed study funded by Arthritis Research UK’s finding that a course of cognitive behaviour therapy delivered by telephone, or an exercise regime, can substantially improve the likelihood of fibromyalgia/CWP symptoms improving, and identified prevention as a research priority, observing that there are several reasons why it may be desirable to try to prevent CWP onset, including that the majority of CWP patients do not have important symptom improvement with current management (even within trials), noting that prediction models from epidemiological studies have been developed to identify high-risk patients, which makes such an approach feasible.
The investigators now plan to offer this therapy to patients who are at a high risk of developing CWP (but who have not developed it yet) to see whether onset can be prevented.
The team will test the hypothesis that among patients who are identified as at high-risk, a short course of telephone-delivered CBT (tCBT) reduces the onset of CWP, and will further determine the cost-effectiveness of such a preventative intervention.
The study will consist of a two-arm randomized trial testing a course of tCBT against controls receiving usual care for prevention of CWP. Eligible participants will be identified from a screening questionnaire sent to patients registered at general practices within the three above-mentioned Scottish health boards. Those who return questionnaires indicating they’ve visited their doctor for regional pain during the past six months, and who have at least two of: sleep problems, maladaptive behaviour response to illness, or high number of somatic symptoms, will be invited to participate.
After giving consent, participants will be randomly allocated to either the tCBT or usual care cohorts. The investigators say their aim is to recruit 473 participants to each treatment arm. Participants in the tCBT group will have an initial assessment with a CBT therapist by telephone, then six weekly sessions, with booster sessions at three and six months after commencement of treatment. Participants in the usual care group will receive no additional intervention. Follow-up questionnaires measuring the same items as the screening survey questionnaire will be sent at three, twelve, and twenty-four months after the start of treatment. The main outcome will be CWP at the twelve-month questionnaire. The development of new chronic widespread pain, as defined by ACR 1990 criteria for fibromyalgia and assessed by questionnaire at follow-up will be compared between participants in the two treatment arms.
Th investigators observe that this will be the first trial of an intervention aimed at preventing fibromyalgia or CWP, with the study results expected to help inform future treatments for prevention of chronic pain, and aetiological models of its development.
The study’s ClinicalTrials.gov Identifier is NCT02668003. Trial registration and more details on its methodology can be found at: https://www.clinicaltrials.gov/ct2/show/NCT02668003
BMC Musculoskeletal Disorders
University of Aberdeen School of Medicine Epidemiology Group