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The effectiveness of a lateral wedge insole on osteoarthritis pain, activity level and joint loading

The effectiveness of a lateral Wedge insole on osteoarthritis Pain, Activity level and joint Loading: a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10388252
Enrollment
30
Registered
2015-06-29
Start date
2015-05-01
Completion date
Unknown
Last updated
2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medial knee osteoarthritis Musculoskeletal Diseases

Interventions

Patients are randomised to two groups: lateral wedged insole group, and neutral insole group. Participants will wear those insoles for six weeks

Sponsors

University of Salford (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 40-85 2. Pain with walking. 3. Participants have been diagnosed with mild-moderate medial knee OA by GP based on the clinical and radiographic criteria 4. On AP or PA view x-ray (weight bearing, if possible) within the last 2 years of screening. Therefore, for a patient to be eligible on x-ray they must fulfil the following criteria 4.1. KL grade 2 or 3 in the tibiofemoral joint (TFJ) 4.2. The KL grade in the TFJ must be higher than the PFJ and cannot be equal 4.3. The medial joint space narrowing score must be higher that the lateral joint space narrowing score and cannot be equal 5. Medial tenderness. Absence of PF tenderness on examination. 6. They are able to walk for 100 metres non-stop - participant response. 7. Can walk without any walking aid.

Exclusion criteria

Exclusion criteria: 1. A history of high tibial osteotomy or other realignment surgery or total knee replacement on the affected side 2. Knee Arthroscopy with the last 6 months 3. Intra-articular injection into the treatment knee in the last 3 months. 4. Inflammatory arthritis including Rheumatoid Arthritis 5. Complex pain conditions such as fibromyalgia 6. Any foot and ankle problems 7. Severe coexisting medical morbidities, 8. Use, or have used, orthoses within the last 2 months. 9. BMI >35 since gait laboratory cannot perform accurate measurements. 10. Unable to walk unaided. If the participants cannot walk for 100 metres without stopping they will also be excluded, as they may be unable to complete the full testing protocol.

Design outcomes

Primary

MeasureTime frame
1. Level of physical activity 2. External knee adduction moment (EKAM) 3. Pain level Outcomes will be measured in four different specific period of time (pre- intervention, baseline, during intervention, post-intervention) to find out any change in these outcomes compare to the baseline?s findings.

Secondary

MeasureTime frame
1. Dynamic balance 2. Knee injury and Osteoarthritis Outcome Score (KOOS) other items 3. Physical Activity Score for the Elderly (PASE) 4. Aggregated Locomotor Function (ALF) score 5. 12-item Short-Form Health Survey (SF-12)

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026