Musculoskeletal Diseases
Conditions
Interventions
ULTRACYCLE
SHAMRACYCLE
Sponsors
Suleiman Mohammed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible candidates must meet all of the following parameters prior to enrollment: 1. Radiographic Diagnosis: Confirmed radiographic diagnosis of primary knee osteoarthritis according to the diagnostic criteria of the American College of Rheumatology (ACR), displaying a Kellgren-Lawrence (K-L) classification grade of 2 (moderate osteoarthritis) or 3 (severe osteoarthritis). 2. Clinical Pain Profile: Persistent, mechanical or non-specific joint pain lasting for a minimum of 3 to 6 months prior to study intake, with a self-reported baseline resting pain score of =4/10 on a 100mm visual analog scale (VAS). 3. Age Demographic: Adults aged between 30 and 75 years, matching the peak demographic distribution for primary degenerative articular pathologies. 4. Pharmacological Stability: If taking oral analgesics or non-steroidal anti-inflammatory drugs (NSAIDs), the dosage must be strictly unchanged for at least 4 weeks prior to baseline testing and contractually maintained throughout the study. 5. Cognitive Sufficiency: Intact cognitive status, validated by clinical interview, adequate to execute informed consent and independently complete the multi-page patient-reported outcome questionnaires.
Exclusion criteria
Exclusion criteria: Candidates presenting with any of the following factors will be excluded: 1. Recent Articular Injections: Any intra-articular corticosteroid, platelet-rich plasma (PRP), or hyaluronic acid (viscosupplementation) injections administered to the target knee joint within the preceding 3 months. 2. Surgical Interventions: A surgical history involving total knee arthroplasty (TKA), high tibial osteotomy (HTO), or significant ligamentous/meniscal reconstruction on the index joint. 3. LIPUS Contraindications: Localized cutaneous malignancy over the joint line, physical sensory loss around the knee area, underlying deep vein thrombosis, or active cardiac pacemakers/implantable cardioverter-defibrillators (ICDs). 4. Cycling Contraindications: Decompensated cardiovascular pathology (e.g., unstable angina, New York Heart Association [NYHA] Class III or IV heart failure) or neurological conditions (e.g., hemiparetic stroke, advanced Parkinson's disease) that prevent safe operation of a stationary cycle. 5. Inflammatory Comorbidities: Secondary joint diseases including Rheumatoid Arthritis, crystalline arthropathies (Gout), or active infectious Septic Arthritis. 6. Inability to Complete Longitudinal Follow-Up: Immediate plans to relocate out of the study geographic area or medical conditions presenting a high risk of baseline dropout prior to the 24-week terminal evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time Frame: Pre Baseline (Day 0), During Week 6, Week 12 (Primary Endpoint), and post Week 24. Description: "Assessments will be conducted at baseline prior to randomization, mid-intervention at 6 weeks, immediately post-intervention at 12 weeks to capture peak efficacy, and at 24 weeks to assess the long-term sustainability or wash-out effects of the intervention." | — |
Secondary
| Measure | Time frame |
|---|---|
| For Secondary Outcomes (HADS Mental Health and Knee ROM): Time Frame: Pre Baseline (Day 0), During Week 6, Week 12, and Post Week 24. Description: "Psychological profiles (HADS total score) and localized physical metrics (goniometric knee range of motion in degrees) will be recorded at baseline, 6 weeks, 12 weeks, and 24 weeks post-randomization." | — |
Countries
Nigeria
Contacts
Public ContactFarida Samaila
associate prof
Outcome results
None listed