None listed
Conditions
Brief summary
This trial will compare two commonly used treatments for patellofemoral pain, foot orthoses and hip strengthening exercises. There is evidence to support both approaches, and often debate revolves around counter-posing perspectives as to which may be more effective to use, yet the two treatment approaches have not directly compared before. Previous foot orthoses trials have reported benefits on patient rated outcomes from use of foot orthoses over a flat shoe insert or adopting a wait-and-see approach in the treatment of patellofemoral pain. Recent trials implementing hip strengthening exercises have demonstrated reduced pain and improved ability to climb stairs after strength exercises for the hip, in people with patellofemoral pain. In the FOHX trial, participants will be randomly allocated into either wearing foot orthoses or performing hip muscle strengthening exercises. The clinical trial will compare the outcome of the two treatments, and also identify the baseline profile (physical measures and patient perceptions) that are associated with the greatest response to foot orthoses or hip strengthening exercises.
Interventions
Prefabricated foot orthoses. Orthoses will be adjusted to optimise participant comfort at the orthosis-foot interface, as well as to improve knee pain during physical tasks. Participants will use the orthoses during waking hours for 12 weeks. The orthoses will be fitted, reviewed and if required revised by a physiotherapist. In the first 6 weeks the participant will attend a physiotherapist clinic, 2 times a week for the first week and once a week for the remaining weeks with no sessions in the
Prefabricated foot orthoses. Orthoses will be adjusted to optimise participant comfort at the orthosis-foot interface, as well as to improve knee pain during physical tasks. Participants will use the orthoses during waking hours for 12 weeks. The orthoses will be fitted, reviewed and if required revised by a physiotherapist. In the first 6 weeks the participant will attend a physiotherapist clinic, 2 times a week for the first week and once a week for the remaining weeks with no sessions in the 5th week. These sessions will usually last approximately 30 minutes and no more than 45 minutes. We aim to improve adherence to wearing these devices by (a) having the patient attend regular sessions with a physiotherapist over the first 6 weeks of the trial, (b) have the physiotherapist record in case file the level of adherence and any issues in this regard and strategies used in addressing these, and (c) patient recording in a diary over the last 6 weeks their level of wear of the devices as well as at exit by means of a questionnaire.
Sponsors
Professor Bill Vicenzino
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Patellofemoral pain of non-traumatic origin and greater than six weeks duration 2. Patellofemoral pain that is provoked by at least two of the following activities: squatting, jogging or running, hopping, jumping, stair ascending or descending. 3. Patellofemoral pain over the previous week equal to or greater than 3 out of 10 on a numerical pain rating scale. 4. Pain on palpation about the patella.
Exclusion criteria
1. Concomitant injury or pathology of other knee structures (e.g. ligament, tendon or cartilage) 2. A history of knee surgery, patellofemoral dislocation or subluxation, Osgood-Schlatter’s disease, Sinding-Larsen-Johanssen Syndrome 3. A positive patella apprehension test or evidence of swelling at the knee 4. A foot condition that may preclude the use of foot orthoses 5. Pain at the hip, pelvis or low back 6. Physiotherapy treatment of patellofemoral pain that included foot orthoses or hip exercises in the last 12 months 6. Current use of anti-inflammatory or corticosteroid medication.
Outcome results
None listed