Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607848323274 Date of Registration: 29/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Long-Term Efficacy of Combined Low-Intensity Pulsed Ultrasound and Stationary Cycling on Clinical and Psychological Outcomes in Radiographic Knee Osteoarthritis: A Randomized Controlled Trial Protocol
Official scientific title Long-Term Efficacy of Combined Low-Intensity Pulsed Ultrasound and Stationary Cycling on Clinical and Psychological Outcomes in Radiographic Knee Osteoarthritis: A Randomized Controlled Trial Protocol
Brief summary describing the background and objectives of the trial Knee osteoarthritis (KOA) is a progressive, degenerative joint pathology characterized by persistent mechanical pain, structural joint degradation, and secondary psychological sequelae, including anxiety and depressive symptoms. While non-pharmacological modalities such as low-intensity pulsed ultrasound (LIPUS) and mechanical joint-unloading exercises (stationary cycling) have demonstrated isolated clinical utility, empirical evidence validating their combined long-term efficacy and longitudinal sustainability remains unestablished. This protocol outlines a randomized controlled trial designed to evaluate the immediate and 24-week cumulative clinical and psychological outcomes of a combined LIPUS and stationary cycling intervention in patients presenting with moderate-to-severe radiographic KOA.1. Evaluation of Early-Stage Clinical Trajectory (T1 - Week 6)To track and compare early-stage physiological adaptations, localized pain mitigation (via VAS), and joint function improvement (via WOMAC) midway through the intervention protocol between the combined LIPUS/cycling cohort and the control cohort.2. Determination of Peak Therapeutic Efficacy (T2 - Week 12)To identify and measure the immediate post-intervention therapeutic maximums across both physical joint indices (VAS pain scores, WOMAC functional profiles, and knee Range of Motion) and psychological markers (HADS anxiety/depression scores and SF-36 health-related quality of life domains).3. Assessment of Longitudinal Therapeutic Retention (T3 - Week 24)To evaluate the durability, multi-dimensional sustainability, and potential "wash-out" effects of the combined intervention three months (12 weeks) after the complete cessation of supervised clinical care.4. Analysis of Clinical Responsiveness (MCID Proportions)To calculate and compare the exact proportion of participants in both arms who successfully hit the threshold for a Minimal Clinically Important Difference (MCID) in pain reduction
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ULTRACYCLE
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 25/06/2026
Actual trial start date 15/07/2026
Anticipated date of last follow up 16/12/2026
Actual Last follow-up date 15/01/2027
Anticipated target sample size (number of participants) 58
Actual target sample size (number of participants) 58
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ULTRACYCLE Active LIPUS therapy will be administered to the periarticular margins of the target joint line for 15 minutes immediately before each cycling bout. The device parameters will be configured to a 1.5MHz ultrasound frequency, functioning in a pulsed wave mode of 1:4 (20% duty cycle), yielding a spatial-average temporal-average (SATA) intensity of (0.03 W/cm^2 or 30{ mW/cm}^2). 12Weeksthen 24 weeks, follow up Intervention Name: Combined Low-Intensity Pulsed Ultrasound (LIPUS) and Stationary Cycling Regimen.Type of Intervention: Combination Strategy (Device / Active Rehabilitation Exercise).Description of Protocol: Participants assigned to this cohort will receive a multi-modal rehabilitation program delivered in a sequential, single-session format, three times per week for a total duration of 12 weeks.Low-Intensity Pulsed Ultrasound (LIPUS): Patients will undergo targeted LIPUS administration to the affected bilateral knee joint structures using a clinically calibrated therapeutic ultrasound unit. The parameters will be locked at a frequency of 1.0 MHz, a pulse repetition rate of 100 Hz operating at a 20% duty cycle, and a spatial-average temporal-average (SATA) intensity of 0.1 W/cm^2. The total application time is 20 minutes per knee joint, using a standard water-soluble coupling gel and a slow, continuous circular transducer stroke technique over the medial and lateral joint lines.Stationary Cycling Exercise: Immediately following the LIPUS application, participants will complete a closed-kinetic-chain aerobic exercise session on a stationary upright bicycle ergometer. The seat height will be personalized to ensure a comfortable 5^circ to 10^{\circ} knee flexion angle at the lowest point of the pedal revolution to minimize patellofemoral joint loading. The session configuration includes a 5-minute warm-up at minimal resistance, 30 minutes of continuous cycling at a target workload corresponding to 50% to 60% of their age-predicted maximum heart rate ({HR}_{\max}), and a 5-minute passive cool-down period. 29
Control Group SHAMRACYCLE (3 sessions per week for 12 weeks) treatment duration (20 minutes per knee), (3 sets of 10 repetitions) Control Intervention Group (Control Arm)Intervention Name: Sham Low-Intensity Pulsed Ultrasound and Standard Care Progression.Type of Intervention: Sham/Placebo Control and Conventional Physical Therapy.Description of Protocol: Participants randomized into the control cohort will attend the clinical facility at an identical frequency (3 sessions per week for 12 weeks) to preserve the double-blind architecture of the trial.Sham Low-Intensity Pulsed Ultrasound: Patients will be positioned identically to the experimental group and treated using a physically indistinguishable, modified ultrasound machine. The treatment duration (20 minutes per knee), coupling gel application, and circular applicator motions over the knee joint structures will replicate the active protocol exactly. However, the machine’s internal transducer circuitry has been disconnected by an external engineer. The device console will illuminate and display active timers, but it will emit zero acoustic or biophysical wave energy (0.0 W/cm^2).Standard Physical Therapy / Education: Following the sham application, instead of structured bicycle ergometry, control participants will undergo a conventional lower-limb management protocol consisting of static quadriceps sets, straight leg raises (3 sets of 10 repetitions), and localized hot pack applications (15 minutes). This will be paired with standard osteoarthritic self-management counseling and activity-modification education. 29 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. 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. Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/05/2026 Gombe State Hospital Management Board Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Buba Shongo Adjacent Former Civil Defence Corps Gombe, Gombe State. Gombe 760211 Nigeria
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/06/2026 FTH HREC TR.25.447
Ethics Committee Address
Street address City Postal code Country
ASHAKA ROAD P.M.B, 0037 Gombe 760211 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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." Pre-T0 , during T1 Week 6 , T2, Week 12 Post 24weeks
Secondary Outcome 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." Pre T0, DuringT1, T2, Post T3.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
state specialist hospital state Gombe Department of Physiotherapy, State Specialist Hospital Gombe Gombe 760211 Nigeria
Federal Medical Centre Gombe Gombe State Federal Medical Centre Gombe Gombe State, Gombe 760211 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Suleiman Mohammed Federal University of Health Sciences Azare Bauchi state along Maiduguri Road Bauchi Nigeria Azare 760211 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Suleiman Mohammed Gombe State tumfure akko LGA Gombe 760211 Nigeria self
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator SULEIMAN MOHAMMED suleiman.mohammed@fuhsa.edu.ng +2348060608463 Department of Physiotherapy, Federal University of Health Science Azare-Bauchi State
City Postal code Country Position/Affiliation
Bauchi 751101 Nigeria Lecturer
Role Name Email Phone Street address
Public Enquiries Farida Samaila fgsumaila.pth@buk.edu.ng +2348036164228 Department of Physiothrrspy, Bayero University Kano, Kano Nigeria
City Postal code Country Position/Affiliation
Kano 700231 Nigeria associate prof
Role Name Email Phone Street address
Scientific Enquiries Bashir Kaka bkaka@buk.edu.ng +2348028460237 Kano
City Postal code Country Position/Affiliation
Kano 700231 Nigeria PROF
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes "Upon completion of the ULTRACYCLE Trial, the investigators are committed to promoting scientific transparency and data reuse. De-identified, anonymized individual participant data (IPD) that underlie the results reported in the final publication (including primary physical joint parameters [VAS, WOMAC, ROM] and secondary psychological profiles [HADS, SF-36]) will be made available to qualified medical researchers. To protect participant confidentiality in line with institutional ethical guidelines, data will only be shared with researchers who provide a methodologically sound, peer-reviewed study proposal. The primary objective of the requesting analysis must align with secondary data analysis or meta-analytic syntheses regarding knee osteoarthritis rehabilitation interventions." Study Protocol "The de-identified dataset, along with the study protocol and statistical analysis plan, will be accessible beginning 12 months following the publication of the primary manuscript and will remain available for a closed window of 36 months." "Requests for data access should be directed via email to the corresponding author (Suleiman.mohammed@fuhsa.edu.ng). Approved requests will receive access to a secure, password-protected cloud-based data repository or an encrypted data package. Users must sign a formal Data Use Agreement (DUA) ensuring that data will not be repurposed for commercial gains or used to attempt participant re-identification."
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 22/07/2026 base on reviewer comment 50 58
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation concealment 22/07/2026 proper RCT Allocation was determined by the holder of the sequence who is situated off site Sealed opaque envelopes
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 22/07/2026 i have tick all Middle Aged: 45 Year(s)-64 Year(s) Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s), Aged: 65 Year(s)-79 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 22/07/2026 To avoid using the same name Control Group, ULTRACYCLE, (3 sessions per week for 12 weeks) , treatment duration (20 minutes per knee), (3 sets of 10 repetitions), Control Intervention Group (Control Arm)Intervention Name: Sham Low-Intensity Pulsed Ultrasound and Standard Care Progression.Type of Intervention: Sham/Placebo Control and Conventional Physical Therapy.Description of Protocol: Participants randomized into the control cohort will attend the clinical facility at an identical frequency (3 sessions per week for 12 weeks) to preserve the double-blind architecture of the trial.Sham Low-Intensity Pulsed Ultrasound: Patients will be positioned identically to the experimental group and treated using a physically indistinguishable, modified ultrasound machine. The treatment duration (20 minutes per knee), coupling gel application, and circular applicator motions over the knee joint structures will replicate the active protocol exactly. However, the machine’s internal transducer circuitry has been disconnected by an external engineer. The device console will illuminate and display active timers, but it will emit zero acoustic or biophysical wave energy (0.0 W/cm^2).Standard Physical Therapy / Education: Following the sham application, instead of structured bicycle ergometry, control participants will undergo a conventional lower-limb management protocol consisting of static quadriceps sets, straight leg raises (3 sets of 10 repetitions), and localized hot pack applications (15 minutes). This will be paired with standard osteoarthritic self-management counseling and activity-modification education., 29, Active-Treatment of Control Group Control Group, SHAMRACYCLE, (3 sessions per week for 12 weeks) , treatment duration (20 minutes per knee), (3 sets of 10 repetitions), Control Intervention Group (Control Arm)Intervention Name: Sham Low-Intensity Pulsed Ultrasound and Standard Care Progression.Type of Intervention: Sham/Placebo Control and Conventional Physical Therapy.Description of Protocol: Participants randomized into the control cohort will attend the clinical facility at an identical frequency (3 sessions per week for 12 weeks) to preserve the double-blind architecture of the trial.Sham Low-Intensity Pulsed Ultrasound: Patients will be positioned identically to the experimental group and treated using a physically indistinguishable, modified ultrasound machine. The treatment duration (20 minutes per knee), coupling gel application, and circular applicator motions over the knee joint structures will replicate the active protocol exactly. However, the machine’s internal transducer circuitry has been disconnected by an external engineer. The device console will illuminate and display active timers, but it will emit zero acoustic or biophysical wave energy (0.0 W/cm^2).Standard Physical Therapy / Education: Following the sham application, instead of structured bicycle ergometry, control participants will undergo a conventional lower-limb management protocol consisting of static quadriceps sets, straight leg raises (3 sets of 10 repetitions), and localized hot pack applications (15 minutes). This will be paired with standard osteoarthritic self-management counseling and activity-modification education., 29, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 22/07/2026 base on reviewer Primary Outcome, Time Frame: Baseline (Day 0), Week 6, Week 12 (Primary Endpoint), and 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.", T , T1 Week 6 , T2, Week 12 Primary Outcome, 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.", Pre-T0 , during T1 Week 6 , T2, Week 12 Post 24weeks
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 22/07/2026 base on reviewer comment Secondary Outcome, For Secondary Outcomes (HADS Mental Health and Knee ROM): Time Frame: Baseline (Day 0), Week 6, Week 12, and 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.", T0, T1, T2, T3. Secondary Outcome, 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.", Pre T0, DuringT1, T2, Post T3.
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 01/07/2026 IS ADDITION General Hospital Kaltungo , Department of Physiotherapy, General Hospital Kaltungo Gombe, Gombe, 760211, Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 04/07/2026 multi centre TRUE, FTH HREC TR.25.447, ASHAKA ROAD P.M.B, 0037, Gombe, 760211, Nigeria, , 24 Jun 2026, +20500880234, cmd@fthgombe.gov.ng, 41518_39965_4737.pdf