None listed
Conditions
Brief summary
Greater trochanteric pain syndrome (GTPS), also referred to as gluteal tendinopathy, is a painful, debilitating disorder of the hip. Symptoms arise primarily from pathology of one or more of the soft tissues located over its lateral aspect, including the gluteal muscles, tendons and bursae. People with GTPS frequently demonstrate lower physical activity levels, lower workforce participation, and lower quality of life. Walking is the most common aggravating activity, with over 50% of those with GTPS experiencing symptoms after just a few minutes. Fatigue of the gluteal muscles/tendons is considered to be the primary cause of pain during walking. Foot orthoses are contoured shoe inserts worn in everyday footwear that have been shown to improve pain in people with foot and knee symptoms. Therapeutic effects of foot orthoses are hypothesised to occur through either biomechanical, neuromuscular or load attenuation mechanisms. Pilot data acquired by our team from healthy adults demonstrates that unmodified ‘off-the-shelf’ foot orthoses reduce gluteal muscle activity during gait by up to 37%. Therefore, it is plausible that foot orthoses, by reducing gluteal muscle activity, may have positive effects on pain in people with GTPS. The primary aims of this study are to: (i) evaluate changes in pain and function after 12 weeks of foot orthoses use, and (ii) identify clinical predictors of foot orthoses efficacy in individuals with GTPS. The secondary aim is to undertake a process evaluation, through qualitative interviews, to determine barriers and enablers of foot orthoses use in this patient population.
Interventions
The objectives of this study are to (i) determine whether a 12-week trial of foot orthoses intervention can improve symptoms in participants with a clinical diagnosis of greater trochanteric pain syndrome and (ii) identify clinical predictors of foot orthoses efficacy in this patient population.
Participants will be fitted with prefabricated contoured shoe inserts (foot orthoses) from a commercially available range (Vasyli International, Labrador, Australia). The inserts are manufactured from e
The objectives of this study are to (i) determine whether a 12-week trial of foot orthoses intervention can improve symptoms in participants with a clinical diagnosis of greater trochanteric pain syndrome and (ii) identify clinical predictors of foot orthoses efficacy in this patient population. Participants will be fitted with prefabricated contoured shoe inserts (foot orthoses) from a commercially available range (Vasyli International, Labrador, Australia). The inserts are manufactured from ethylene-vinyl acetate (EVA) and are available in low, medium and high density, with inbuilt arch support and varus wedging. Participants will be provided with two pairs of contoured inserts, fitted to their usual footwear. They will also receive a pair of contoured sandals from the Vionics shoe range (Vionics International, San Francisco, USA). A physiotherapist who has been trained in prescription of the foot orthoses will fit the contoured inserts to each participant using a previously developed prescription algorithm that emphasises comfort. Comfort is maximised through selecting the most suitable density and can be enhanced through the addition of forefoot, rear foot or heel wedges, and gentle heat moulding if required. Participants will be advised to gradually increase their wear time over the first 1-2 weeks to accommodate to the inserts. They will be advised to start off wearing them for 1 hour per day, and to increase this by one hour per day over the following two weeks, until they can tolerate them for a whole day. After this, they will be encouraged to wear the inserts as often as possible for the remaining 12-week intervention period. They will also be advised that for the first two weeks, they should only use the shoe inserts for sport if they are comfortable to walk in, and don’t cause them any discomfort during sport. They will be advised to slowly increase the wear time for sport until they are used to them and are encouraged to try them over a number of practice sessions first. To maximise wear time, they will also be encouraged to wear the Vionic sandals during times that they do not normally wear enclosed footwear. Participants will be given written instructions regarding their use of the inserts and sandals. The orthoses intervention will be delivered face-to-face at the La Trobe University Biomechanics Laboratory at Visit 1. One week after fitting the shoe inserts, the participant will be contacted via telephone by the same physiotherapist who prescribed the intervention to ensure that the participant is tolerating the inserts and troubleshoot any issues that they are having with the inserts if required. If any issues cannot be resolved via the telephone consult, they will be asked to return to the Laboratory for further evaluation. Participants will be provided with a logbook to document adherence to the intervention and any adverse events over the 12-week intervention period.
Sponsors
La Trobe University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(i) aged 18 years or older; (ii) symptoms for at least 3 months; (iii) primary pain located over the lateral hip; (iv) average pain intensity over the previous week of 3 or more on an 11-point numerical rating scale; and (v) GTPS diagnosis confirmed via clinical assessment: (a) pain reproduced on palpation of the greater trochanter; (b) pain reproduced on the Flexion, Abduction and External Rotation (FABER) test; (c) pain on one of the following: single leg stance test, resisted hip abduction, external de-rotation test.
Exclusion criteria
(i) Signs of intra-articular hip pathology; (ii) previous hip surgery on the symptomatic side; (iii) low back or other lower limb injury requiring management by a medical professional, or time off sport, work or leisure over the last three months; (iv) any neurological disorders; (v) any form of systemic arthritis; (vi) currently regularly wearing contoured shoe inserts; (vii) any foot disorder precluding wearing of shoe inserts; (viii) corticosteroid injection into hip region within previous 3 months; (x) currently undergoing treatment including physiotherapy, osteopathy or chiropractic; (ix) low-English speaking proficiency such that unable to comprehend study assessment requirements.
Outcome results
None listed