Clin Rheumatol (2012) 31:1041–1045
DOI 10.1007/s10067-012-1966-8
ORIGINAL ARTICLE
A cohort-controlled trial of the addition of customized foot
orthotics to standard care in fibromyalgia
Robert Ferrari
Received: 26 January 2012 / Revised: 22 February 2012 / Accepted: 27 February 2012 / Published online: 20 March 2012
# Clinical Rheumatology 2012
Abstract 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 67con-
secutive 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 Re-
vised 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
R. Ferrari (*)
Department of Medicine, 13-103 Clinical Sciences Building,
University of Alberta,
11350-83 Avenue,
Edmonton, Alberta, Canada T6G 2P4
e-mail: rferrari@shaw.ca
Control group (reduction of 9.9±5.9 vs. 4.3±4.4, respec-
tively), 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 func-
tioning in the short term.
Keywords Fibromyalgia . Orthotics
Introduction
It is well recognized that fibromyalgia patients often have
diffuse and severe lower limb pain, as well as low back pain.
Measures of function in fibromyalgia patients typically in-
clude assessment of difficulty in activities related to low
back combined with lower limb pain, such as walking,
climbing stairs, and sitting for prolonged periods [1]. Al-
though a recent study has suggested that customized foot
orthotics may be beneficial in chronic, non-specific low
back pain with lower limb [2], there remains a paucity of
trials confirming their effectiveness. There are reasons, from
a biomechanical perspective [3–7], to prescribe orthotics,
but trials in primary care practice settings, and in a wide
variety of clinical populations are required before their
routine use can be recommended. Cambron et al. [2] mea-
sured the change in perceived Oswestry Disability Index
scores in subjects with chronic low back pain at the end of
6 weeks of orthotic treatment, compared with no orthotics.
They found that improvements in Oswestry Disability Index
scores were greater at 6 weeks in the group treated with
customized foot orthotics compared with a wait-list control
1042
group. Furthermore, they demonstrated that these improve-
ments were apparent within the first 6 weeks of orthotic
usage, and, although persisting up to 12 weeks, there was no
further improvement in the period from 6 to 12 weeks of
orthotic usage. In other words, clinical benefit, if it occurred,
was evident in the first 6 weeks of orthotics usage. This has
been observed in another, uncontrolled trial [8]. Subjects in
Cambron et al.’s study, however, were primarily drawn from
the community by advertisement, and they did not specifi-
cally target a clinical population.
As exercise therapy, including weight-bearing exercises
are increasingly prescribed to fibromyalgia patients to im-
prove overall fitness, measures that improve lower limb pain
in particular, or facilitate walking and other weight-bearing
exercises, are desirable. The purpose of this study was to
determine the effectiveness of customized foot orthotics in
addition to usual care (a complex intervention of medica-
tions and exercise) in fibromyalgia, as measured by the
Revised Fibromyalgia Impact Questionnaire.
Methods
Participants
During the period of 4 months in early 2009, the author was
acting as a consultant in two nearby primary care clinics in
Edmonton, Alberta, Canada. Both clinics served similar
clinical populations near the inner city, mainly lower socio-
economic and worker populations. Primary care physicians
referred patients with musculoskeletal disorders, especially
chronic pain, to the author. At one clinic, there was the space
and administrative support to provide customized foot or-
thotics immediately at the time of the initial consultation
visit. At the second clinic, this was not available for at least
3 months. The author had been routinely collecting data
using the Revised Fibromyalgia Impact Questionnaire
(FIQR) in fibromyalgia patients as well as data concerning
current medication use, before and after exercise therapy
and other treatments, typically re-assessing patients at 6–
8 weeks post-consultation. Thus, the circumstances between
these two clinics, and the available pre- and post-treatment
FIQR Scores and medication status in all patients seen in
follow-up, provided an ideal opportunity for a cohort-
controlled trial of customized foot orthotics. That is, the
same consultant was involved in patient care at both clinics,
using the same exercise therapist (physiotherapist) for both
clinics. Further, to simplify the study and analyses, all sub-
jects were female. Data was collected by the author in both
practices, and approval for this was obtained from the Col-
lege of Physicians and Surgeons of Alberta, as part of an
ethics approval for practice audit of various clinical popula-
tions studied by the author.
Clin Rheumatol (2012) 31:1041–1045
Interventions and groups
Orthotics group
This group was formed from all consecutively referred
fibromyalgia patients, in a 4-month period in 2009. Refer-
ring physicians were encouraged to specifically refer
patients with known diagnoses of fibromyalgia, and who
met the 1990 American College of Rheumatology Criteria
for fibromyalgia [9]. The author, after an appropriate history
and physical examination, prescribed a standard therapeutic
approach, which included education, referral to one specific
physiotherapist for further spinal assessment and a tailored
spinal exercise program (that generally ran for 6–7 weeks),
and advice to continue follow-up with the primary care
physician for analgesics. The author and the primary care
physicians at the clinic routinely, as part of their usual
practice, avoided prescribing other modalities, such as in-
jection procedures, chiropractic therapy, acupuncture, or
massage therapy, but allowed patients to seek these out if
they so desired. The primary care physicians also had a
typical medication regimen, which included any of non-
steroidal anti-inflammatory drugs, acetaminophen products,
gabapentin and duloxetine. They tended not to use antipsy-
chotics or sedatives (benzodiazepines). These patients had
already had appropriate investigations to rule out fractures,
radiculopathies, and other non-benign causes of pain.
Patients were asked to continue with their current medica-
tions until re-evaluated, but could also attend their primary
care physician in the interval if warranted. They were also
encouraged to reduce analgesic use if they noted improve-
ments in pain in subsequent weeks.
Following assessment, each patient completed the FIQR.
The author then obtained foam impressions of each patient
in the seated position, with the patient asked to relax their
lower limb and allow the examiner to place downward
pressure on the knee, along the axis of the tibia with the
knee flexed to 90 degrees. This created the foam impression.
All subjects received a standardized orthotic composed of
Footmaxx® Premium Allsport orthotic (Footmaxx, Toronto,
Ontario, Canada) composed of a semi-rigid module, vinyl
reinforcement, polyurethane foam cushioning, and large
profile metatarsal pad aligned with the third metatarsal ray
and placed distal to the semi-rigid module. Subjects were
provided lifts for correction of leg length discrepancies if
measured to be 1.5 cm or greater, and the lift was provided
at a measure of half this discrepancy. None of the subjects
received valgus or varus postings. Subjects received their
orthotics within 1 week of the moulding, and all received the
same general instruction on usage and footwear. By the time
of follow-up, 8 weeks later, subjects would have had the
opportunity to be using orthotics for up to 7 weeks. Thus,
for the purposes of creating a cohort for analysis, patients in
Clin Rheumatol (2012) 31:1041–1045
this clinic who met the inclusion and exclusion criteria
(discussed below), who received the prescribed customized
foot orthotics, were deemed to be the Orthotics Group.
Cohort control group
These subjects were taken from patients consecutively re-
ferred to the author, at a nearby, second primary care clinic.
Again, the primary care physicians were asked to refer
patients with fibromyalgia, as stated above. The author
undertook the same clinic activities as stated above for the
Orthotics group, including the completion of the FIQR and
referral for exercise therapy. This group was advised that
orthotics treatment would become available in the near
future, or that they could seek out orthotics currently at
other locations. As orthotics are not yet a standard or proven
therapy in this clinical group, and as they could be offered at
a later date, no ethical concerns regarding standard of care
are raised.
Inclusion/exclusion criteria
The inclusion criteria were age over 17 years, able to read
and write English at the grade 8 level or higher, and meeting
the American College of Rheumatology criteria for fibro-
myalgia. Exclusion criteria included current use of custom-
ized foot orthotics, neurological disorder (including sciatica
with objective neurological signs), cancer, spinal stenosis,
spinal or lower limb surgery, recent or complicated fracture,
known inflammatory arthropathy, severe osteoarthritis of
the lower limb joints, prosthetic joints, amputation, or con-
genital lower limb deformity. Mild to moderate lower limb
joint osteoarthritis was not an exclusion, as this is a common
condition in primary care, especially in older patients with
fibromyalgia. Subjects in the cohort Control group were
excluded if they obtained orthotics during the study period.
Referring physicians were aware of these criteria in order to
refer patients who were likely to meet the criteria on further
evaluation by the author.
Outcomes
At baseline, subjects completed the FIQR [9]. The FIQR has
21 individual questions. All questions are based on an 11-
point numeric rating scale of 0 to 10, with 10 being ‘worst’.
All questions are framed in the context of the past 7 days.
There are three linked sets of domains: (a) ‘function’ (con-
tains nine questions), (b) ‘overall impact’ (contains two
questions), and (c) ‘symptoms’ (contains ten questions).
The scoring of the FIQR is as follows: the summed score
for function (range 0–90) is divided by 3, the summed score
for overall impact (range 0–20) is not changed, and the
summed score for symptoms (range 0–100) is divided by
1043
2. The total FIQR is the sum of the three modified domain
scores. The total maximal score of the FIQR is 100.
After 8 weeks, on clinical follow-up with the author,
subjects completed again the FIQR. In addition, at baseline
and at follow-up, the medications the claimant was using,
including type and number of different classes of medica-
tions, were recorded to determine if the subject was using
some form of prescribed analgesic, as well as any other
medications that could be for chronic pain (e.g., antidepres-
sants, sedatives, anxiolytics, gabapentin). No data was
gathered on compliance with orthotics use. No data was
gathered on the dosage of medications or use of over-the-
counter medications. No data was gathered regarding other
treatment modalities sought by the subject. Compliance with
the exercise therapy program was documented as per the
judgement of the treating therapist, who considered that
attendance to at least 75% of all scheduled appointments
was required to meet the definition of compliance.
Sample size and statistical methods
Sample size was based on the aforementioned studies [2, 8],
wherein a significant change in a disability score was noted
in a cohort of 30 subjects or less. As the time period of the
study was limited to a 4-month period in early 2009, a
convenience sample of at least 60 subjects, at least 30 in
each group, was sought. Data was analysed using SPSS
11.0 (MacIntosh version). Descriptive statistics were calcu-
lated for the cohorts, as were baselines and follow-up
scores for FIQR. The mean change in the FIQR scores
between groups at follow-up was compared by Student’s
t-test. Proportions of subjects with compliance with exer-
cise therapy and use of prescription analgesics at baseline
and follow-up were compared using the chi-square test with
Yates correction.
Results
In forming the Orthotics group, 42 patients had been re-
ferred, and seven were excluded (two did not read or write
English at a grade 8 level, two recent spinal surgery, one
severe hip osteoarthritis, and two had obtained orthotics
elsewhere). In forming the Control group, 36 subjects were
referred. Of these, four were excluded (one polymyalgia
rheumatic, one rheumatoid arthritis, two had obtained or-
thotics elsewhere). Thus, there were 35 subjects in the
Orthotics group and 32 subjects in the Control group at
baseline. Of these, two subjects were lost to follow-up in
the Orthotics group and two subjects were lost to follow-up
in the Control group. Thus, follow-up data was available for
33 subjects in the Orthotics group and 30 subjects in the
Control group.
1044 Clin Rheumatol (2012) 31:1041–1045

Table 1 Characteristics of subjects in the Orthotics group and Control group at baseline

Group Age (years; mean ± SD, range) Chronic pain duration FIQR (mean ± SD, range) ‘Function’ (score out of 90 maximum)
(years; mean ± SD, range) (mean ± SD, range)

Control (n032) 47.2±8.7, 29–60 6.2±3.4, 3–17 56.3±12.2, 24–80 55.8±7.7, 46–66
Orthotics (n035) 45.3±11.5, 20–69 6.5±4.3, 2–23 55.2±11.0, 35–82 57.8±8.7, 33–76

‘Function’0sum of scores from the function domain of the FIQR. The maximum score is 90 and the minimum is 0. Higher scores indicate lower
functioning

The baseline characteristics of the subjects in the Orthotics
group and Control group are shown in Table 1. There were no
significant differences between groups. At follow-up, the
therapist-reported compliance with exercise therapy was
51% in the Orthotics group and 46% in the Control group,
with no difference between groups. There were no differences
between groups in the proportion of subjects using any type of
analgesic, and specifically no difference in the proportion of
subjects using non-steroidal anti-inflammatory drugs, narcotics,
non-narcotic containing acetaminophen products, antidepres-
sants, or gabapentin.
As shown in Table 2, at 8 weeks, the groups differed in the
total FIQR score: the Orthotics group had a lower total FIQR
score (p<0.05). More specifically, they had a lower total score
in the ‘function’ domain of the FIQR than the Control group
(p<0.05). At 8 weeks, there were no differences between
groups in the proportion of subjects using any type of analge-
sic, and specifically no difference in the proportion of subjects
using non-steroidal anti-inflammatory drugs, narcotics, non-
narcotic containing acetaminophen products, antidepressants,
or gabapentin. No data was available, however, on the dosages
used. There was no statistically significant correlation between
any of age, duration of symptoms, baseline number of medi-
cations, and the change in ‘function’ domain scores over time.
Discussion
This study shows that, in a primary care setting, the addition
of customized foot orthotics to the treatment of fibromyalgia
improves clinical outcomes, as measured by the FIQR. The
change in the FIQR score is almost wholly attributable to
changes in the ‘function’ domain. The changes in the total
FIQR are not dramatic, and this is not surprising. The FIQR
addresses a broad range of symptoms not likely to be affect-
ed by orthotics use (e.g., memory concentration difficulties,
depression, anxiety, sensitivity to noise). However, examining
the ‘function’ scale of the FIQR clearly indicates a significant
difference between groups, as this is where interventions such
as orthotics would be most expected to have an impact. The
observed changes are at least as great as those observed in
trials of drug interventions in fibromyalgia [10].
There are a number of limitations to this study. First, this
was not a randomized, controlled study. There could be a
number of factors that affected the observed outcomes,
including subject characteristics not measured, producing a
selection bias. The author, although involved in the care of
the subjects, did not have contact with any of them in the
interval between baseline and follow-up, and the measures
are unlikely to have been influenced by the author. It is
possible that the primary care physicians and treating exer-
cise therapist learned of the subject’s use of orthotics, and
this may have influenced how they treated the subjects, thus
affecting outcomes. It is also possible that there was a
selection bias due to practitioner style and treatments be-
tween the two groups because the subjects were from two
clinics. At the same time, the author was involved in the
clinical care in all subjects, as was the very same exercise
therapist. Thus, treatment approaches were highly standard-
ized and very similar in both clinics. Finally, it is not
possible to create a placebo control for foot orthotics. Much
of the response could have been due to placebo effect. At the
same time, placebo effect could be a factor in both exercise
therapy and medication use. All of these therapies, in clin-
ical practice, are subject to placebo or therapist effect. Given
the innocuous nature of orthotics, however, compared to
medications, and the ease with which they may be provided,
their use in clinical practice warrants further, structured
evaluation. Further studies will be required, with larger
subject numbers, in a variety of clinical populations. As
well, economic data should be gathered in future studies to
quantify cost-effectiveness.

Table 2 Follow-up FIQR

scores in the Orthotics group and Group Change (decrease) in FIQR from Change (decrease) in ‘function’ domain score
Control group at 8 weeks baseline (mean ± SD, range) from baseline (score out of 90 maximum)

Control (n030) 4.3±4.4, −2 to 13 8.1±4.3, 2 to 15

Orthotics (n033) 9.9±5.9, 0 to 23 (p<0.001) 19.6±9.4, 1 to 39 (p<0.001)
Clin Rheumatol (2012) 31:1041–1045
Disclosures None.
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