Knee OsteoarthritisNCT05959902
Effectiveness of Physical Therapy in Stem Cell Transplant Recipients for Knee Osteoarthritis
A study testing Forward Walking and Physiotherapy Exercises in people with Knee Osteoarthritis and Osteo Arthritis Knee, run by Dow University of Health Sciences at 2 sites in Pakistan.
Trial summary
Knee osteoarthritis has been considered as 11th highest contributor factor to nonfatal burdens in the world. It is considered one of the most common degenerative diseases of synovial joint and major cause of muscle impairment with limited functional activities. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis, Osteo Arthritis Knee, OA Knee
- What is being tested?
- Forward Walking and Physiotherapy Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesPakistan
- Study dates
- 6 Feb 2023to 6 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects of age 40 years and above.
- Male and female both will be included.
- Patients with single or both knee OA.
- Patients who had mesenchymal stem cell transplantation.
- Kellgren and Lawrence grade II, III on radiological findings.
Who cannot join
- Patients with any neurological disorder.
- Any musculoskeletal deformity (varus/valgus).
- Patients who have had any type of lower limb internal fixation.
- Patients who have had any type of lower limb arthroplasty or other knee surgery in the past.
- Patients with a history of any infectious or malignant condition.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
Dow Institute of Physical Medicine and Rehabilitation, DUHS.
Karachi, Sindh, 74200
Syed Muhammad Zaeem Hasan Zaidi, DPT, 03320319277, hxaeem@gmail.com
- Recruiting
Alkhaleej Ortho Stem Cell Clinic
Karachi, Sindh
Syed Muhammad Zaeem Hasan Zaidi, DPT, 03320319277, hxaeem@gmail.com
About this study
Official title: Effectiveness of Physical Therapy on Stem Cell Transplantation Recipients in Improving Pain, Quadriceps Muscle Strength and Functional Status of Knee Osteoarthritis: A Randomized Controlled Trial
Knee osteoarthritis has been considered as 11th highest contributor factor to nonfatal burdens in the world. It is considered one of the most common degenerative diseases of synovial joint and major cause of muscle impairment with limited functional activities. Recent efforts to investigate the possibility of stem cell therapies in the treatment of symptomatic osteoarthritis have seen an increase in interest in regenerative medicine, fueled a better understanding of the role of mesenchymal stem cells. Knee osteoarthritis is mostly managed by physical therapy, focused on managing pain, increasing the restricted range of motion and muscle strengthening. Therefore, the hypothesis is that combining both treatments will be beneficial for patients. The aim of this randomized controlled trial is to evaluate the effectiveness of physiotherapy in mesenchymal stem cell recipient in improving pain, quadriceps muscle strength and functional status of knee osteoarthritis patients.
Read the detailed description
A single blinded RCT will be conducted at Ortho Stem Cell Department, AlKhaleej Clinics. Collection of data will be started after the scientific and ethical approval from Dow University, Karachi. After screening by physician and fulfilling the inclusion and exclusion criteria, patients (n=48) will be enrolled. After briefing about the objectives and obtaining formal consent, data will be collected. Participants will be randomized and equally distributed into two groups i.e., twenty-four in control group '1' and twenty-four in treatment group '2'. The control group '1' will receive forward walking in home program after mesenchymal stem cell treatment while the treatment group '2' will be receiving quadriceps isometric exercise, straight limb raises (SLR), hip isometric adductor, knee terminal extension, semi wall squat, quadriceps drill exercises for knee osteoarthritis after mesenchymal stem cell therapy. Treatment plan will be of 8 weeks with 3 sessions in one week for 30 minutes. A physical therapist will do the assessment at baseline and at the end of treatment, other than the principal investigator to measure outcomes by using KOOS score, manual muscle testing and VAS scale. For the completion of the study 6 months are required after synopsis approval.
- Conditions
- Knee Osteoarthritis, Osteo Arthritis Knee, OA Knee
- Being tested
- Forward Walking, Physiotherapy Exercises
- Keywords
- Knee osteoarthritis, Mesenchymal stem cell treatment, Physiotherapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forward WalkingOther
During the 8-week treatment, the participants will undertake 10 minutes of forward walking, as well as a 5-minute warm-up and cool-down, three times a week on an even surface at their normal speed as a home exercise plan. During the warmup and cool down periods, the participants were advised to execute ankle toe motions, heel lift exercises, and hamstring and gastrocnemius-soleus stretches.
Physiotherapy ExercisesOther
Isometric quadriceps exercise. Straight leg raising (SLR) exercise. Isometric hip adduction exercise.
Terminal knee extension exercise:
Semi-wall squat exercise. Quadriceps drill exercise.
| Study group | Role | What they receive |
|---|---|---|
| Forward Walking | Active comparator | This study ARM will receive following treatment in home program after mesenchymal stem cell treatment.
• Forward Walking Receives: Other: Forward Walking |
| Physiotherapy | Experimental | This study ARM will be receiving following physiotherapy exercises for knee osteoarthritis after mesenchymal stem cell therapy.
* Isometric quadriceps exercise
* Straight leg raising (SLR) exercise
* Isometric hip adduction exercise
* Terminal knee extension exercise
* Semi wall squat exercise
* Quadriceps drill exercise Receives: Other: Physiotherapy Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score (change is being assessed)
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a self reported specific joint measure developed to assess a broad spectrum of patients with knee injuries and OA, for pain and other symptoms, function in daily life, function in sports and recreation, and quality of knee-related life, being easy to use, evaluating the short- and long-term health problems related to the knee joint.
The Knee injury and Osteoarthritis Outcome Score contains 42 items covering five subscales: pain, other symptoms, activities of daily living, sports/recreation, and quality of life. A patient's maximum score is 100, which indicates that they have no knee concerns. The lowest possible score is 0, which indicates serious knee issues.
Measured: Baseline and 8 weeks
Secondary outcomes (2)
Visual analog scale (change is being assessed)
It measures the subjective of pain ranges from 10-cm lines with defined cut off scores. The correlation between vertical and horizontal orientations of the VAS is 0.99 . Aggregate score ranges for this screening tool starting with 0-10. Scores between 0-4 means mild pain. Scores between 4-7 indicates moderate pain. Scores between 7-10 means severe pain. pain severity will be assessed at rest and during stairs ascending and descending
Measured: Baseline and 8 weeks
Manual Muscle Testing (change is being assessed)
It is used to assess weakness and is capable of distinguishing actual weakness from imbalance or insufficient endurance. Muscle strength testing is used to assess a complaint of weakness, which commonly occurs when a suspected neurologic condition or muscle weakness is present. The Oxford Scale is the most widely used way of determining muscle strength (AKA Medical Research Council Manual Muscle Testing scale). This method entails putting important muscles in the upper and lower limbs to the test against the examiner's resistance and assessing the patient's strength on a scale of 0 to 5.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start6 Feb 2023
- Primary completion6 Nov 2023 (estimated)
- Study completion6 Dec 2023 (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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Muhammad Zaeem Hasan Zaidi, Dow University of Health Sciences
- Investigators
- Farhan I Khan, PhD, Study director, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959902
- Sponsor's protocol ID
- 2777
- Status last verified
- Jul 2023
- First submitted
- 16 Jul 2023
- Last updated
- 27 Jul 2023
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physical Therapy on Stem Cell Transplantation Recipients in Improving Pain, Quadriceps Muscle Strength and Functional Status of Knee Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05959902
- Acronym / sponsor ID
- 2777
- Conditions
- Knee Osteoarthritis, Osteo Arthritis Knee, OA Knee
- Keywords
- Knee osteoarthritis, Mesenchymal stem cell treatment, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 6 Nov 2023 (estimated)
- Study completion
- 6 Dec 2023 (estimated)
- First posted
- 25 Jul 2023 (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.
Knee osteoarthritis has been considered as 11th highest contributor factor to nonfatal burdens in the world. It is considered one of the most common degenerative diseases of synovial joint and major cause of muscle impairment with limited functional activities. Recent efforts to investigate the possibility of stem cell therapies in the treatment of symptomatic osteoarthritis have seen an increase in interest in regenerative medicine, fueled a better understanding of the role of mesenchymal stem cells. Knee osteoarthritis is mostly managed by physical therapy, focused on managing pain, increasing the restricted range of motion and muscle strengthening. Therefore, the hypothesis is that combining both treatments will be beneficial for patients. The aim of this randomized controlled trial is to evaluate the effectiveness of physiotherapy in mesenchymal stem cell recipient in improving pain, quadriceps muscle strength and functional status of knee osteoarthritis patients.
Detailed description
A single blinded RCT will be conducted at Ortho Stem Cell Department, AlKhaleej Clinics. Collection of data will be started after the scientific and ethical approval from Dow University, Karachi. After screening by physician and fulfilling the inclusion and exclusion criteria, patients (n=48) will be enrolled. After briefing about the objectives and obtaining formal consent, data will be collected. Participants will be randomized and equally distributed into two groups i.e., twenty-four in control group '1' and twenty-four in treatment group '2'. The control group '1' will receive forward walking in home program after mesenchymal stem cell treatment while the treatment group '2' will be receiving quadriceps isometric exercise, straight limb raises (SLR), hip isometric adductor, knee terminal extension, semi wall squat, quadriceps drill exercises for knee osteoarthritis after mesenchymal stem cell therapy. Treatment plan will be of 8 weeks with 3 sessions in one week for 30 minutes. A physical therapist will do the assessment at baseline and at the end of treatment, other than the principal investigator to measure outcomes by using KOOS score, manual muscle testing and VAS scale. For the completion of the study 6 months are required after synopsis approval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forward Walking | Active comparator | Other: Forward WalkingThis study ARM will receive following treatment in home program after mesenchymal stem cell treatment. • Forward Walking |
| Physiotherapy | Experimental | Other: Physiotherapy ExercisesThis study ARM will be receiving following physiotherapy exercises for knee osteoarthritis after mesenchymal stem cell therapy. * Isometric quadriceps exercise * Straight leg raising (SLR) exercise * Isometric hip adduction exercise * Terminal knee extension exercise * Semi wall squat exercise * Quadriceps drill exercise |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects of age 40 years and above.
- Male and female both will be included.
- Patients with single or both knee OA.
- Patients who had mesenchymal stem cell transplantation.
- Kellgren and Lawrence grade II, III on radiological findings.
Key exclusion criteria (5 listed)
- Patients with any neurological disorder.
- Any musculoskeletal deformity (varus/valgus).
- Patients who have had any type of lower limb internal fixation.
- Patients who have had any type of lower limb arthroplasty or other knee surgery in the past.
- Patients with a history of any infectious or malignant condition.
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 |
|---|---|---|
| Forward WalkingDuring the 8-week treatment, the participants will undertake 10 minutes of forward walking, as well as a 5-minute warm-up and cool-down, three times a week on an even surface at their normal speed as a home exercise plan. During the warmup and cool down periods, the participants were advised to execute ankle toe motions, heel lift exercises, and hamstring and gastrocnemius-soleus stretches. | Other | Forward Walking |
| Physiotherapy ExercisesIsometric quadriceps exercise. Straight leg raising (SLR) exercise. Isometric hip adduction exercise. Terminal knee extension exercise: Semi-wall squat exercise. Quadriceps drill exercise. | Other | Physiotherapy |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score (change is being assessed)
Time frame: Baseline and 8 weeks
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a self reported specific joint measure developed to assess a broad spectrum of patients with knee injuries and OA, for pain and other symptoms, function in daily life, function in sports and recreation, and quality of knee-related life, being easy to use, evaluating the short- and long-term health problems related to the knee joint. The Knee injury and Osteoarthritis Outcome Score contains 42 items covering five subscales: pain, other symptoms, activities of daily living, sports/recreation, and quality of life. A patient's maximum score is 100, which indicates that they have no knee concerns. The lowest possible score is 0, which indicates serious knee issues.
2 secondary outcomes
Visual analog scale (change is being assessed)
Time frame: Baseline and 8 weeks
Manual Muscle Testing (change is being assessed)
Time frame: Baseline and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Farhan I Khan, PhD study director
Dow University of Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forward Walking and Physiotherapy Exercises in people with Knee Osteoarthritis and Osteo Arthritis Knee, run by Dow University of Health Sciences at 2 sites 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Syed Muhammad Zaeem Hasan Zaidi, DPT (03320319277, hxaeem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score (change is being assessed) (time frame: Baseline and 8 weeks). 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 27 Jul 2023.