Podiatry Intervention Versus Usual General Practitioner Care for Symptomatic Radiographic Osteoarthritis of the First Metatarsophalangeal Joint: A Randomized Clinical Feasibility Study.

OBJECTIVE: To determine the feasibility of a clinical trial comparing a podiatry intervention to usual general practitioner (GP) care for people with first metatarsophalangeal (MTP) joint osteoarthritis (OA). METHODS: A 2-arm, participant- and assessor-blinded, randomized feasibility study was conducted over 12 weeks. Participants were age >40 years and had pain and radiographic OA in the first MTP joint. Participants in the podiatry group had 3 visits and received foot orthoses, exercise, manual therapy, and advice. Participants in the GP group had 1 visit and received medication advice/prescription and the same advice as the podiatry group. Primary outcomes were measures of feasibility (recruitment, attendance, and retention rates; percentage of prescribed exercise sessions completed; orthoses wear hours/day; treatment fidelity). Secondary outcomes included self-reported pain, function, satisfaction, adherence, adverse events, and dropouts. RESULTS: A total of 236 people were screened, and 30 (13%) were included. All except 1 participant in the podiatry group attended the required clinical visits, and retention rates were 93% (podiatry group) and 80% (GP group). Participants completed 66% of the exercise sessions and wore orthoses for an average of 6.3 hours/day. Adherence to medication use was 5.3 on an 11-point numeric rating scale. Both treatment approaches improved pain and function by clinically important differences at 12 weeks. CONCLUSION: A clinical trial comparing a podiatry intervention to usual GP care for people with first MTP joint OA is feasible. Given the improvements in pain and function observed, a larger appropriately powered clinical trial is warranted to evaluate the superiority of one treatment approach over the other.

Manual and manipulative therapy compared to night splint for symptomatic hallux abducto valgus: an exploratory randomised clinical trial.

CONTEXT: Hallux abducto valgus (HAV) is a frequent cause of great toe pain and disability, yet common treatments are only supported by mixed or equivocal research findings. Surgery often only provides modest improvement and post-surgery complications may significantly hamper outcomes, implying the need for trials testing conservative treatment, such as manual and manipulative therapy, particularly in cases where surgery may be contraindicated or premature. The purpose of this exploratory trial was to test an innovative protocol of manual and manipulative therapy (MMT) and compare it to standard care of a night splint(s) for symptomatic mild to moderate HAV, with a view gather insight into the effectiveness of MMT and inform the design of a definitive trial. DESIGN: Parallel-group randomised trial set in an out-patient teaching clinic. PARTICIPANTS: A convenience sample of 75 patients was assessed for eligibility, with 30 participants (15 per group) being consented and randomly allocated to either the control group (standard care with a night splint) or the experimental group (MMT). INTERVENTION: Participants in the control group used a night splint(s) and those in the experimental group (MMT) received a structured protocol of MMT, with the participants in the experimental group receiving 4 treatments over a 2-week period. OUTCOME MEASURES: Visual analogue scale (HAV-related pain), foot function index (HAV-related disability) and hallux dorsiflexion (goniometry). RESULTS: There were no participant dropouts and no data was missing. There were no statistical (p<0.05) or clinically meaningful differences (MCID<20%) between the two groups based on outcome measure scores. However, the outcome measure scores in the control group (night splint) regressed between the 1-week follow-up and 1-month follow-up, while the scores in the experimental group (MMT) were sustained up to the 1-month follow-up. The within-group data analysis produced statistically and clinically significant changes from baseline to the 1-week flow-up across all outcome measures. Post hoc power analysis and sample size calculations suggest that the average between group power of this trial was approximately 60% (ES = 0.33) and that a definitive trial would require a minimum of 102 participants per group (N = 204) to achieve satisfactory power of ≥80%. CONCLUSIONS: The trend in results of this trial suggest that an innovative structured protocol of manual and manipulative therapy (experimental group) is equivalent to standard care of a night splint(s) (control group) for symptomatic mild to moderate HAV in the short term. The protocol of MMT maintains its treatment effect from 1-week to 1-month follow-up without further treatment, while patients receiving standard care seem to regress when not using the night splint. Insights from this study support further testing of MMT for symptomatic mild to moderate HAV, particularly where surgery is premature or where surgical outcomes may be equivocal, and serve to inform the design of a future definitive trial.

The influence of two different types of foot orthoses on first metatarsophalangeal joint kinematics during gait in a single subject.

OBJECTIVE: To quantify the effect of two distinct foot orthotic designs on in vivo multisegment foot and leg motion; in particular, the first metatarsal and first metatarsophalangeal (MTP) joint during gait. METHODS: A 23-year-old man had an excessively pronated foot structure as measured during a clinical orthopedic examination. The Optotrak Motion Analysis System was used to collect three-dimensional position and orientation data from four modeled rigid body segments (hallux, first metatarsal, calcaneus, and tibia) during the stance phase of walking. The subject walked at a self-selected comfortable walking speed, and a minimum of five trials were collected under three different test conditions: no orthosis, semirigid orthosis with a varus post, and a semirigid orthosis with a varus post and a large medial flange. Data were normalized to the stance period, and descriptive statistics were calculated for dependent variables. RESULTS: Both orthotic interventions equally modified first MTP joint motion when compared with the no orthotic condition. First MTP joint dorsiflexion was decreased (>2 SD) with the orthosis during terminal stance phase. This decrease was associated with a concomitant increase in first metatarsal plantar flexion. CONCLUSION: A custom-made semirigid orthosis posted medially and made from a neutral position off-weight-bearing plaster cast can alter motion in the forefoot during the propulsive period by increasing first metatarsal plantar flexion and decreasing excessive first MTP joint dorsiflexion.