Clinical trial NCT05959902: Effectiveness of Physical Therapy in Stem Cell Transplant Recipients for Knee Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Osteo Arthritis Knee
OA Knee
Keywords: Knee osteoarthritis
Mesenchymal stem cell treatment
Physiotherapy
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (change is being assessed)
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Visual analog scale (change is being assessed)
timeFrame: Baseline and 8 weeks
measure: Manual Muscle Testing (change is being assessed)
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow Institute of Physical Medicine and Rehabilitation, DUHS.
state: Sindh
city: Karachi
country: Pakistan
facility: Alkhaleej Ortho Stem Cell Clinic
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Farhan I Khan, PhD
role: STUDY_DIRECTOR
References: