The Problem
A 74-year-old female with a history of breast cancer, hypertension, and impaired fasting glucose presents to you for blood pressure recheck. She reports a several-month history of left "great toe" pain. She denies history of trauma, gout, generalized joint pain, joint swelling, or constitutional symptoms. Pain is worse when she walks for prolonged periods and wears tight shoes. Toe pain is relieved with rest. On examination, she has lateral deviation of the first metatarsal of greater than 20 degrees with an overriding second toe. She does not have evidence of superficial skin breakdown or callous formation on either toe. She requests a referral to the foot clinic. You discuss surgical options and remind her that the recovery can take several months. She currently is caring for her husband who has parkinsonism. You recommend conservative therapies for treatment, but she presses you on the evidence for the benefit of these options. With her in your office, you do a quick literature search.
The Question
In patients with hallux valgus deformity, are conservative interventions effective for decreasing pain and deformity?
The Search
You open PubMed, enter "hallux valgus" and "conservative," and limit to "Randomized Control Trial."
The Evidence
"Surgery vs. Orthosis vs. Watchful Waiting for Hallux Valgus," (JAMA 2001;285:2474-80).
• Design and setting: Randomized clinical trial conducted at four hospitals in Finland.
• Participants: Subjects were eligible for inclusion if they had a painful bunion with the hallux valgus angle 35 degrees or less and the intermetatarsal angle of 15 degrees or less. Potential subjects were excluded if they had previous bunion surgery, hallux rigidus (stiff big toe), or hallux limitus (limited range of motion of the big toe); rheumatoid disease; functional foot orthoses; pregnancy; or were age 60 years or greater.
• Intervention: Enrolled subjects were randomized to surgery, orthotic treatment, or to a 1-year waitlisted control group. The chevron procedure was performed on the surgical group by experienced orthopedic surgeons. The procedure, which is commonly performed and well-studied, consists of a wedge-shaped cut near the neck of the metatarsal (distal osteotomy) or near the base (proximal osteotomy). The orthosis group had orthotics made by a negative case technique (that is, depression made in a soft mold). Polypropylene orthoses for both feet were fashioned and sent to the patient with usage instructions within 8 weeks. In both the orthotic treatment group and the control group, the patients were advised to contact the independent observer if their foot pain had worsened to the point where they required surgery before the end of the follow-up period.
• Outcomes: Patient outcomes measures included the duration of foot pain, foot pain intensity, ability to work, cosmetic disturbance, footwear problems, American Orthopaedic Foot and Ankle Society (AOFAS) score, health-related quality of life index, satisfaction with treatment, global assessment by patient, and costs related to foot care. The AOFAS assesses pain, function, and alignment. Data were collected at baseline, 6 months, and 12 months. Economic analyses were conducted.
• Results: A total of 209 patients were randomized (71 surgery, 69 orthotics, and 69 control). At 6 months, foot pain intensity was less in the surgical and orthosis groups than in the control group. The surgical group had the least cosmetic disturbance and footwear problems compared with the other groups. At 12 months, the intensity of pain, number of painful days, cosmetic disturbance, and footwear problems were less in the surgical group than in the orthosis and control groups. The surgical group also had the highest functional status and satisfaction with treatment, and the orthotic group had higher global improvement than the control group. Costs were lower in the orthotic group than in the surgical group. Absence from work was lowest in the orthotic group.
Our Critique
This was a well-conceived and conducted clinical trial. Follow-up was remarkable, with 99% of patients followed at 6 months and 98% at 1 year completing study assessments. Importantly, only those patients with mild-to-moderate hallux valgus deformity were included. We did not measure the degree of angulation of the toe of our patient, but we assessed her pain as "moderate." The orthotic used in this study was custom, but in a busy clinical practice it is sometimes neither practical nor cost-effective to refer for patients for such custom orthotics.
Clinical Decision
You discuss the findings with the patient. You review some inexpensive treatment options with her including a nighttime bunion regulator or toe alignment splint, a polygel toe-spreading bunion shield, and a bunion care sleeve. You plan to revisit with her in several months and consider surgical referral at that time.