November 22, 2011 — Both brief cognitive behavioral therapy (CBT) delivered by telephone and exercise can yield "substantial, significant, and clinically meaningful" improvements in global health in adults with chronic widespread pain, according to a new study from the United Kingdom.
The study, by John McBeth, PhD, from the Arthritis Research UK Primary Care Centre, Keele University, Staffordshire, and colleagues, was published online November 14 in the Archives of Internal Medicine.
Non-opioid-based alternatives to chronic pain management are "desperately needed," Seth A. Berkowitz, MD, and Mitchell H. Katz, MD, from the Los Angeles County Department of Health Services, California, point out in an accompanying editorial. The current study makes "an important contribution" to that goal, they write.
"An Important Contribution"
In their article, the researchers note that no drugs are currently approved in the United Kingdom for chronic, widespread pain, the cardinal feature of fibromyalgia. In addition, none of the 3 drugs currently approved in the United States (duloxetine hydrochloride, milnacipram hydrochloride, and pregabalin) adequately controls the multiple symptoms of fibromyalgia.
Current guidelines recommend pharmacological, physical, and psychological therapies, although the value of individual therapies is unclear. Traditional CBT has shown promise for fibromyalgia, and telephone-based CBT (TCBT) is potentially more acceptable, accessible, and cost-effective.
Dr. McBeth's team randomly assigned 442 patients meeting American College of Rheumatology criteria for chronic widespread pain to 6 months of TCBT, graded exercise, both interventions, or usual care (control group).
TCBT was delivered by a trained therapist and involved an initial assessment and 7 weekly sessions, each lasting 30 to 45 minutes, plus 1 session 3 and 6 months after randomization. The exercise intervention involved 6 monthly sessions led by a fitness instructor who took a 1-day training session on exercise for chronic pain. Exercisers were also encouraged to be physically active and work out at least twice a week on their own.
Usual care was delivered by the patients' family physician, and the precise nature of the care was not known.
TCBT, Exercise Bests Usual Care
At the end of the intervention (6 months), and at 9 months after randomization, significantly more patients in the TCBT, exercise, and combined groups reported a positive outcome compared with those patients the usual care group. A positive outcome was defined as feeling "much better" or "very much better" on a standard self-rated global assessment scale.
Table 1. Percentage Reporting Positive Outcome at 6 and 9 Months
| Group | 6 Months | 9 Months |
| Usual care (%) | 8 | 8 |
| TCBT (%) | 30 | 33 |
| Exercise (%) | 35 | 24 |
| TCBT + exercise (%) | 37 | 37 |
"Receiving both interventions was associated with a slight improvement in outcome but were not substantially better than single treatments," Dr. McBeth and colleagues note in their report.
"It's interesting that the TCBT continued to show improvements over time, while the benefits of exercise began to decrease with time (as is usual in exercise interventions)," Dr. McBeth told Medscape Medical News.
After adjusting for age, sex, center, and baseline predictors of outcome, the likelihood of a positive outcome was significantly higher with TCBT, exercise, or both, relative to usual care.
Table 2. Adjusted Odds of Feeling "Much Better" or "Very Much Better" at 6 and 9 Months
| Group | 6 Months, Adjusted Odds Ratio (95% Confidence Interval) | 9 Months, Adjusted Odds Ratio (95% Confidence Interval) |
| TCBT | 5.0 (2.0 - 12.5) | 5.4 (2.3 - 12.8) |
| Exercise | 6.2 (2.5 - 15.1) | 3.6 (1.5 - 8.5) |
| TCBT + exercise | 7.1 (2.9 - 17.2) | 6.2 (2.7 - 14.4) |
Despite meaningful improvements in self-rated global health with TCBT and exercise, there was no apparent effect on chronic pain grade, the investigators report.
Increased Availability at Lower Cost
Although CBT and physical exercise are recommended for patients with chronic widespread pain, evidence to date in support of these modalities is equivocal, Dr. McBeth and colleagues note in their article.
"I think this has risen, in part, due to methodological limitations in some previous studies," such as small sample sizes, Dr. McBeth told Medscape Medical News. "However, the results of 2 recently published meta-analyses were also equivocal."
He says there are several possible reasons why CBT and exercise had a significant effect in their study.
"Our study was conducted among patients presenting to primary, rather than secondary, care, with possibly lower levels of factors such as psychological distress that may influence response to treatment," he explained. Also, "the therapists delivering treatment were very experienced, and adherence to the treatment was very high possibly due to the nature of treatment delivery (ie, patients weren't required to get to a therapists office)."
Delivering CBT by telephone should "increase treatment availability at lower costs," Dr. McBeth predicted.
Although an economic analysis suggested that in the short follow-up period TCBT was not more cost-effective than usual care, "there was a trend towards cost-effectiveness. It will be interesting to follow these patients up for a longer period to determine whether, over the longer term, TCBT is a more cost-effective option," Dr. McBeth said.
Dr. Katz told Medscape Medical News that CBT "done in person or by phone could save money because patients will get fewer unnecessary tests and medications and specialty visits."
Putting Patients in Charge
In their commentary, Dr. Katz and Dr. Berkowitz note that CBT and exercise "represent a management strategy that puts patients firmly in charge. The skills learned in CBT, for example, are available after hours and over long weekends and do not require monthly refills. Moreover, because CBT can be administered by telephone, this intervention is convenient and can be made available to a wide range of patients."
"As practicing physicians who treat many patients with chronic pain, we welcome additional research that seeks to minimize the use of pharmacotherapy, with its unclear efficacy and attendant consequences, in favor of a regimen that focuses, in a truly patient-centered way, on teaching skills for self-management of symptoms and return to meaningful lives," they write.
The study was supported by an award from Arthritis Research UK. The study team and commentary writers have disclosed no relevant financial relationships.
Arch Intern Med. Published online November 14, 2011. Abstract, Editorial