Knee OsteoarthritisNCT06664632
Effectiveness of Knee Sync Partner and Strengthening Exercises Versus Strengthening Exercises in Knee Osteoarthritis.RCT
A study testing Exp in people with Knee Osteoarthritis, run by Superior University at 1 site in Pakistan.
Trial summary
This study explores the effectiveness of a novel treatment approach for knee osteoarthritis (OA) by comparing the combined use of a new device, "Knee Sync Partner," which provides electrical knee traction with stimulation and strengthening exercises, to traditional strengthening exercises alone. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Exp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having pain in knee for more than 3 months in most days of week
- age between 40 and 70 years
- patient who filled Kellgren-Lawrence radiographic criteria
Who cannot join
- joint injection in the previous three months.
- The exclusion criteria were patients who had inflammatory arthritis
- osteoarthritis of the hips.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
Lahore, Punjab Province
About this study
Official title: Effectiveness of Knee Sync Partner and Strengthening Exercises Versus Strengthening Exercises in Knee Osteoarthritis. A Randomized Controlled Trial.
This study explores the effectiveness of a novel treatment approach for knee osteoarthritis (OA) by comparing the combined use of a new device, "Knee Sync Partner," which provides electrical knee traction with stimulation and strengthening exercises, to traditional strengthening exercises alone. Knee osteoarthritis is a leading cause of chronic pain and disability worldwide, significantly impacting the quality of life for many individuals, especially with the growing elderly population.
Read the detailed description
While strengthening exercises are a well-established treatment for improving joint stability and mobility in knee OA patients, the potential benefits of integrating electrical stimulation and traction therapy remain underexplored. This research addresses the gap by conducting a randomized controlled trial to assess whether this combined approach leads to superior outcomes in terms of pain relief, functional improvement, and joint health. The findings could provide valuable insights into more effective, non-invasive management strategies for knee OA, expanding therapeutic options in physical therapy.
- Conditions
- Knee Osteoarthritis
- Being tested
- Exp, control
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExpBehavioural
Participants in this group will receive treatment using the Knee Sync Partner, a novel portable device designed to provide electrical traction and stimulation specifically for the knee joint.
controlled mechanical traction to the knee joint to reduce joint contact pressure, enhance synovial fluid flow, and increase joint space. This is expected to alleviate pain and improve mobility.
controlDiagnostic test
This will include a combination of isometric and isotonic exercises aimed at strengthening the knee musculature, enhancing joint stability, and reducing pain. The exercise regimen will focus on major muscle groups supporting the knee, such as the quadriceps, hamstrings, and calf muscles.
| Study group | Role | What they receive |
|---|---|---|
| Exp Group | Experimental | Not described Receives: Behavioral: Exp |
| Control Group | Active comparator | Not described Receives: Diagnostic Test: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC Scale
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Nov 2023
- Primary completion1 Jun 2024
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664632
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/745
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Knee Sync Partner and Strengthening Exercises Versus Strengthening Exercises in Knee Osteoarthritis. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06664632
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/745
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study explores the effectiveness of a novel treatment approach for knee osteoarthritis (OA) by comparing the combined use of a new device, "Knee Sync Partner," which provides electrical knee traction with stimulation and strengthening exercises, to traditional strengthening exercises alone. Knee osteoarthritis is a leading cause of chronic pain and disability worldwide, significantly impacting the quality of life for many individuals, especially with the growing elderly population.
Detailed description
While strengthening exercises are a well-established treatment for improving joint stability and mobility in knee OA patients, the potential benefits of integrating electrical stimulation and traction therapy remain underexplored. This research addresses the gap by conducting a randomized controlled trial to assess whether this combined approach leads to superior outcomes in terms of pain relief, functional improvement, and joint health. The findings could provide valuable insights into more effective, non-invasive management strategies for knee OA, expanding therapeutic options in physical therapy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exp Group | Experimental | Behavioral: Exp |
| Control Group | Active comparator | Diagnostic Test: control |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- having pain in knee for more than 3 months in most days of week
- age between 40 and 70 years
- patient who filled Kellgren-Lawrence radiographic criteria
Key exclusion criteria (3 listed)
- joint injection in the previous three months.
- The exclusion criteria were patients who had inflammatory arthritis
- osteoarthritis of the hips.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExpParticipants in this group will receive treatment using the Knee Sync Partner, a novel portable device designed to provide electrical traction and stimulation specifically for the knee joint. controlled mechanical traction to the knee joint to reduce joint contact pressure, enhance synovial fluid flow, and increase joint space. This is expected to alleviate pain and improve mobility. | Behavioural | Exp Group |
| controlThis will include a combination of isometric and isotonic exercises aimed at strengthening the knee musculature, enhancing joint stability, and reducing pain. The exercise regimen will focus on major muscle groups supporting the knee, such as the quadriceps, hamstrings, and calf muscles. | Diagnostic test | Control Group |
Primary outcome
WOMAC Scale
Time frame: 12 Months
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Individual participant dataSharing planned: No
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exp in people with Knee Osteoarthritis, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC Scale (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.