Anterior knee pain Musculoskeletal Diseases Anterior knee pain
Conditions
Interventions
The participants will be randomly allocated to the following two arms:
1. Arm 1: Orthaheel® regular. This is a 3/4 length insole with arch shape. It is inserted into shoes and worn daily for 12 month
Sponsors
SSL International (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female participants between the ages of 18 and 65 years old 2. Participants with self-reported anterior knee pain (pain at the front of the knee) with a minimum of 4 weeks duration 3. Participants with self-reported anterior knee pain who score at least 40 mm on a 100 mm visual analogue scale (VAS) for pain 4. Participants with self-reported anterior knee pain in the 2 days prior to recruitment 5. Participants who agree to wear the insoles provided for at least 4 hours each day and complete diary cards and postal questionnaire as required 6. Participants who give written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients must not report any acute injury to the knee at the onset of their anterior knee pain 2. Patients must not report posterior or medial/lateral knee pain or any secondary pain elsewhere in lower limb joints since the onset of anterior knee pain 3. Patients must not have any significant diagnosed musculo-skeletal disease, such as rheumatoid arthritis, diabetes or osteoarthritis of the knee or deterioration dysfunction of associated structures of the knee e.g., cartilage or any other condition associated with sensory and motor dysfunction 4. Patients must not have received or self administered treatment for the knee pain in the previous 4 weeks 5. Patients who are pregnant or breast-feeding 6. Patients who have received or self-administered treatment for the knee pain in the previous 4 weeks 7. Patients who have received corticosteroid injection therapy in the knee in the previous 3 months 8. Patients that were previously in this study 9. Patients that were in another study within the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Knee pain 2. Knee function The outcomes above will be measured using the following at 4 weeks: a. VAS (scores 0-10) b. The Kujala Anterior knee pain questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Use of insoles (in time) 2. Knee pain at 3, 6 and 12 months (see primary outcome measures for methods of measurement) 3. Knee function at 3, 6 and 12 months (see primary outcome measures for methods of measurement) | — |
Countries
United Kingdom
Outcome results
None listed