Treatment forGolfer's Toe - Crespine Gel

interaction, and nearly unlimited frequency of use.
Whether intra-articular FIA use in a smaller joint, such
as the first MTB provides efficary and a low side-effect
proflle similar to the knee is unknor,r,.n.
Study Design
The protocol and written informed consent for
studies involving human subjects were approved by
the Universityof Westem Ontario ReviewBoard.
The study was a single-center, single-arm, openlabel
trial with an B-week treatment phase. Within 12
months, orthopedic and primary care physicians referred
patients who had pain in the first MTP joint
(unilateral only) and disability (described as reduced
golfing activity without an acute injury event) for at
least 3 months. In addition, all patients had radiogaphic
evidence of osteoarthritis of the first MTP joint
(ie, grade 1 to 3 hallu rigidus using the Regnauld classification
ofjoint-space narrowing and osteophy'te formation).
The subjects provided informed consent, had
not taken NSAIDs for 2 weeks prior to entry, had not
received intra-articular corticosteroid injection in the
first MTP joint within the previous 3 months, did not
have other lower- extremity musculoskeletal disability
or pain, and had pain exceeding 45 Irrn on a 100-mm
visual analogue scale (VAS) immediately following
tiptoe walking for 10 m.
After screening and enrollment, patients completed
assessments and received a 1.0-mL intra-articular
injecton of FIA (Suplasyn, Bioniche Life Sciences Inc,
Belleville, Ontario; 20 mgl2 mL) in the first MTP joint.
An experienced physician delivered the injections
using a27-gauge needle. The toe was semiflexed and
held in gentle traction without topical or local anesthesia
during injection. One dose was administered each
week (t 2 days) for B consecutive weeks in an unblinded
fashion. Patients returned at 9 and 16 weeks and then
self-selected a follow-up visit when theywould request
a second series of injections based on retum of s1'rnptoms
that interfered with their golf activity.
Assessments
Clinical assessments were performed prior to injection
at baseline, at each of seven subsequent weekly
treatment visits, at 16 weeks, and at the second series
visit (28 to 76 weeks after the eighth injection). Adverse
events were recorded at each srudv visit and classified
using standard World Health O rgarrizatio n terminolo gy
and coding. The primary efficacy measures rvere fust
MTP joint pain after 5 minutes of seated rest and following
completion of 10 m of tiptoe rvalking (assessed
byVAS), range of plantar flexion and dorsiflexion of the
first MTP joint (measured from the metatarsal to the
proximal phalanx with a goniometer), and global
patient satisfaction (GPS)(measured on a S-point categorical
scale, with I representing completeh'unsatisfied
and 5 completely satisfied).
In addition to FIA injection therapv patients were
permitted to use standard nonpharmacologic therapies,
including rest, ice, compression, and elevation,
(RICE) and orthoses, aspirin for cardiovascular disease
prophylaxis up to 325 mg/day, and general analgesia
using acetaminophen up to 1 g/dart NSAIDs were not
allowed during HA treatment but were allowed at
patient discretion during the follow-up posttreatment.
Use of altemate treatment modalities was recorded at
16 weeks and at follow-up visits.
Statistical Analysis
Changes in pain scores were evaluated using analysis
of variance (ANOVA) for repeated measures. GPS
was evaluated to determine the proportion of treatment
responders at each treatment and at follow-up
visits. Frequenry of adverse events over the treatment
period and during follow-up were also recorded. level
of statistical significance was accepted at P