Developing a new treatment for knee osteoarthritis using feedback from muscle measurements

Not Applicable

Completed

• Conditions: Knee osteoarthritis; Musculoskeletal Diseases; Gonarthrosis [arthrosis of knee]

• Registration Number: ISRCTN51913166
• Lead Sponsor: niversity of Salford

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34103040/ (added 13/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-24
• Study Completion: 2020-10-02
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Knee OA participants will be included if they have a clinical diagnosis of knee OA, using the American College of Rheumatology (ACR) criteria. This is given as clinical presentation of pain in the knee and at least three of the following:
1. Age 40-80 years (note those under 50 must have a confirmed radiological diagnosis of knee OA)
2. Stiffness < 30 minutes per day
3. Crepitus
4. Bony tenderness
5. Bony enlargement
6. Palpable warmth

Full inclusion criteria are given below:
1. Age range of 18-80 (upper age limit to exclude people who may have limited mobility)
2. Ability to stand and walk independently
3. Speak and understand English to read the information sheet and sign consent form
4. Ability to walk without any assistive for at least 100 m (this is 100 m is not representative of the real demand of the testing, but we want to be sure participants will not get fatigued during the testing)
5. Clinical diagnosis of knee OA according to American College of Rheumatology (ACR) [37], see above, only for subjects with knee OA
6. Pain for at least 6 months' duration only for subjects with knee OA
7. Pain or difficulty in rising from sitting and/or climbing stairs, only for subjects with knee OA

Exclusion Criteria

1. Complex pain conditions such as diabetic neuropathic pain, fibromyalgia
2. Dementia or other major cognitive impairment
3. Have had previous surgery to the lower limb
4. BMI >35 since it is not possible to obtain EMG muscle measurements on individuals with excess adipose tissue
5. Lower limb arthroplasty
6. Any systemic inflammatory disorders, such as rheumatoid arthritis
7. Any balance disorders which may increase the risk of a fall

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain measured using the knee injury and osteoarthritis outcome score (KOOS) at baseline and immediately after the end of the intervention (typically 6 sessions over 12 weeks)

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures