Center-based Physical Therapy and Home-based Physical Therapy After Platelet Rich Plasm Injection

NCT05033977 | Completed

• 1 other identifier: GO 2021/049
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) of the knee is a chronic disease characterized by pain, reduced range of motion, instability and effusion in the joint. Moreover, no study has investigated the effect of Platelet-rich Plasma (PRP) in comparison with that of a placebo injection in the same patient with bilateral knee OA. The purpose of this study was to compare the effectiveness of supervised physiotherapy and home exercises after PRP injection in patients with knee OA. The investigator hypothesized that the supervised physiotherapy program would be more effective in decreasing pain and improving muscle strength, physical function, and quality of life than home exercises following PRP injection in patients with knee OA. A total of 30 patients with complete follow-up to 6 weeks post-intervention; 17 patients randomized to the supervised exercise group and 13 patients randomized to the home exercise group. Subjects were recruited from who had radiographic evidence (Kellgren-Lawrence Grade II-III) of knee OA and ranged from 45 to 70 years of age. Measurements including pain during rest and activity, muscle strength assessment, self-estimated functions of the affected knee and functional performance tests for lower extremity strength were performed.

Conditions

Knee Osteoarthritis

Keywords

Knee; Osteoarthritis; Exercise; Platelet rich plasma; muscle strength

Outcome Measures

Primary Outcomes (2)

• Visuel analogue scale

  Visual Analog Scale was used to assess the subjects' pain during rest and activity. A 10 cm line was driven and subjects was wanted to mark the point (0; no pain, 10; worst imaginable pain) as representing the pain during rest and activity

  6 weeks

• Muscle Strenght

  Quadriceps, hamstring muscles and the hip stability isometric test (HipSIT) strength were measured with a hand-held digital dynamometer. Each subject was verbally informed before the test in order to ensure correct movement and subjects were asked to perform submaximal contraction against the evaluator's hand before testing. ''Break test'' technique was performed for the strength measurement.

  6 weeks

Secondary Outcomes (5)

• Physical Function

  6 weeks

• Knee Function

  6 weeks

• Weight

  6 weeks

• Height

  6 weeks

• Body mass index (BMI)

  6 weeks

Study Arms (2)

Center-based Exercise

EXPERIMENTAL

patients did exercises with a physical therapist in a clinic 3 days and 45 minute in a week for 6 weeks. The exercise programe included strenghtening and streching exercises. Strenghtening exercises for lower extremity and streching exercises for hamstrings.

Other: Exercise (center-based)

Home-based exercise

EXPERIMENTAL

Patients did exercises at home every day and 3 times per day. The exercise programe included strenghtening and streching exercises. Strenghtening exercises for lower extremity and streching exercises for hamstrings.

Other: Exercise (home-based)

Interventions

Exercise (center-based) OTHER

Exercise therapy with a physical therapist in a clinic.

Center-based Exercise

Exercise (home-based) OTHER

Patients did exercises at home every day and 3 times per day.

Home-based exercise

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with knee osteoarthritis
• Patients with PRP injections

You may not qualify if:

• have any neurologic disease
• have any oncologic disease
• have any other intraarticular injection last 6 months

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Samanpazari, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hande Güney Deniz, Assoc.,Prof

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc, Prof.

Model Details: supervised exercise group home exercise group

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: September 5, 2021
• Study Start: July 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: April 1, 2020
• Last Updated: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)