Effectiveness of Physical Therapy in Stem Cell Transplant Recipients for Knee Osteoarthritis

NCT05959902 | Unknown DMC

• 1 other identifier: 2777
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Osteoarthritis; Osteo Arthritis Knee; OA Knee

Keywords

Knee osteoarthritis; Mesenchymal stem cell treatment; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 8 weeks

Secondary Outcomes (2)

• Visual analog scale (change is being assessed)

  Baseline and 8 weeks

• Manual Muscle Testing (change is being assessed)

  Baseline and 8 weeks

Study Arms (2)

Forward Walking

ACTIVE COMPARATOR

This study ARM will receive following treatment in home program after mesenchymal stem cell treatment. • Forward Walking

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

Other: Physiotherapy Exercises

Interventions

Forward Walking OTHER

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.

Forward Walking

Physiotherapy Exercises OTHER

Isometric quadriceps exercise. Straight leg raising (SLR) exercise. Isometric hip adduction exercise. Terminal knee extension exercise: Semi-wall squat exercise. Quadriceps drill exercise.

Physiotherapy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (2)

Dow Institute of Physical Medicine and Rehabilitation, DUHS.

Karachi, Sindh, 74200, Pakistan

RECRUITING

Alkhaleej Ortho Stem Cell Clinic

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Farhan I Khan, PhD

  Dow University of Health Sciences

  STUDY DIRECTOR

Central Study Contacts

Syed Muhammad Zaeem Hasan Zaidi, DPT

CONTACT

03320319277; hxaeem@gmail.com

Farhan I Khan, PhD

CONTACT

03332209704; farhan.ishaque@duhs.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: July 25, 2023
• Study Start: February 6, 2023
• Primary Completion: November 6, 2023
• Study Completion: December 6, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)