None listed
Conditions
Brief summary
The primary objective of this study is to evaluate the feasibility of conducting a trial comparing the efficacy of a multifaceted, non-surgical intervention (including self-management advice, footwear, foot orthoses and foot exercises) versus usual care (self-management advice) for reducing pain associated with hallux valgus (also known as 'bunions') in women aged 40 years and over. Feasibility will be assessed using measures of demand, acceptability, adherence, adverse events and drop-out rate. The secondary objective is to obtain statistical parameters to inform the main trial sample size calculation and providing signal of efficacy to justify the future main trial.
Interventions
The overall duration of the intervention is 12 weeks.
(i) Self-management package: this study-specific pamphlet is based on UK National Health Service recommendations and includes advice to wear wide shoes with a low heel and soft sole, apply cold-packs and silicone gel bunion pads, and use of paracetamol. The silicone gel bunion pads and cold packs will be provided. The self-management package is delivered in a single 10-15 session with a podiatrist. Adherence to the self-management package wi
The overall duration of the intervention is 12 weeks. (i) Self-management package: this study-specific pamphlet is based on UK National Health Service recommendations and includes advice to wear wide shoes with a low heel and soft sole, apply cold-packs and silicone gel bunion pads, and use of paracetamol. The silicone gel bunion pads and cold packs will be provided. The self-management package is delivered in a single 10-15 session with a podiatrist. Adherence to the self-management package will be assessed via structured questionnaire at the 4, 8 and 12 week follow-up periods. (ii) Footwear: high quality, off-the-shelf footwear (Anodyne Sport Jogger) with a sufficiently wide toe-box to alleviate pressure on the hallux. The shoes will be correctly fitted by a research podiatrist, and participants will be asked to wear them as often as possible. (iii) Foot orthoses: prefabricated Formthotics(TM) (Foot Science International, Christchurch, New Zealand). These orthoses are ¾ length and are constructed from 140 kg/m3 single-density, closed-cell polyethylene foam. Participants will be asked to wear these with their footwear as often as possible. Adherence to the footwear/orthoses intervention will be documented using 4-weekly diaries and objectively assessed over 12 weeks using a small (9×13×4.5 mm) temperature sensor embedded in the shoe (Orthotimer, Balingen, Germany). Time, date, and temperature measurements are stored every 15 minutes. (iv) Foot exercises: participants will be provided with a booklet, smart-phone app (Physitrack®) and webpage which demonstrates a home-based version of the progressive resistance foot exercise program. The set of 9 exercises are performed three times per week for the 12 weeks. Each session takes approximately 30 minutes to complete. Most of the exercises are performed in a seated position using resistance rubber bands (TheraBand®, Akron, OH, USA) wrapped around the toes and/or foot. The exercises target the muscles responsible for ankle dorsiflexion, ankle inversion/eversion, hallux and lesser toe flexion and hallux abduction, and are progressed by either increasing the number of times the exercises are performed (repetitions) or by increasing the level of resistance provided by the bands (light to extra heavy). Participants will be contacted by videoconference every 2 weeks to address any questions they have and to ensure that the exercises are being performed correctly. Adherence to the exercise program will be documented using 4-weekly diaries and the Physitrack® smart-phone app.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
To be eligible for inclusion, participants must: (i) be aged >=40 years; (ii) be female; (iii) have pain in the toe joint/s (i.e. first metatarsophalangeal or interphalangeal) for at least 12 weeks; (iv) have pain in the toe joint/s (i.e. first metatarsophalangeal or interphalangeal) rated at least 3 out of 10 on a numerical rating scale; (v) be able to walk household distances (more than 50 m) without the aid of a walker, crutches or cane; (vi) be capable of understanding the English language in verbal and written form, and; (vii) have at least moderate hallux valgus on one or both feet, defined as a score of 2 or more on the validated Manchester scale, a tool containing four standardised photographs of varying degrees of hallux valgus deformity.
Exclusion criteria
Participants will not be eligible for inclusion if they have: (i) had surgical treatment for hallux valgus on either foot; (ii) had a lower limb or partial foot amputation; (iii) have an inflammatory rheumatological condition such as gout, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthropathy or connective tissue disease, (iv) have a neurological disease which interferes with walking (e.g. Parkinson’s disease); (v) have worn arch-contouring foot orthoses in the past 12 weeks (although flat insoles will be permitted); (vi) have been performing foot exercises (stretching, mobilisation or strengthening) in the past 12 weeks, or; (vii) have an injury of lower limb(s) or back that may interfere with reaching their feet.
Outcome results
None listed