Clinical trial of insoles for pain at the front of the knee

Not Applicable

Completed

• Conditions: Anterior knee pain; Musculoskeletal Diseases

• Registration Number: ISRCTN84641129
• Lead Sponsor: SSL International (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-31
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified