A cohort-controlled trial of the addition of customized foot orthotics to standard care in fibromyalgia.

Customized foot orthotics are widely prescribed for patients with chronic, non-specific low back pain and lower limb pain, but there are few trials demonstrating effectiveness, and none for fibromyalgia. A total of 67 consecutive patients presenting with chronic, widespread pain, who met the 1990 American College of Rheumatology criteria for fibromyalgia, were included in the study. A total of 32 subjects were prescribed a spinal exercise therapy program along with analgesics. These subjects formed the Control group. A second group, comprised of 35 subjects, received the same therapy, along with customized foot orthotics (Orthotics group). All subjects completed the Revised Fibromyalgia Impact Questionnaire (FIQR) at the initiation of the study and at 8 weeks follow-up. The number of subjects using any type of prescription analgesic or other medication for chronic pain at baseline and at 8 weeks was also recorded. A total of 30 subjects in the Control group and 33 in the Orthotics group completed the study. All subjects completed the baseline and 8-week FIQR. The two groups were well matched in terms of age (45.3 ± 11.5 years in the Orthotics group vs. 47.2 ± 8.7 years in the cohort Control), medication use, duration of pain (6.5 ± 4.3 years in the Orthotics group vs. 6.2 ± 3.4 years in the cohort Control group), as well as baseline FIQR scores (55.2 ± 11.0 in the Orthotics group vs. 56.3 ± 12.2 in the cohort Control group). At 8 weeks, the Orthotics group had a greater reduction in the FIQR score than the cohort Control group (reduction of 9.9 ± 5.9 vs. 4.3 ± 4.4, respectively), and this was mainly due to changes in the 'function' domain of the FIQR (reduction of 19.6 ± 9.4 in the Orthotics group vs. 8.1 ± 4.3 in the cohort Control group). As part of a complex intervention, in a cohort-controlled trial of primary care patients with fibromyalgia, the addition of custom-made foot orthotics to usual care appears to improve functioning in the short term.