Investigating the Effectiveness of Vibration Therapy on Sarcopenia in Osteoarthritis Knee Patients

NCT03880344 | Unknown

• 1 other identifier: CUHK_2018.403
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) is one of the commonest chronic degenerative conditions affecting our aging population. It limits joint movement and causing disability in elderlies due to discordant symptoms such as pain and stiffness. The prevalence of radiologic knee osteoarthritis increases in proportion to age, reaching an astounding 64.1% for patients whom are over 60 years of age. In addition the prevalence of symptomatic knee OA has been shown to be around 10% in people who are 60 years and older.

Conditions

Knee Arthropathy; Osteoarthritis, Knee; Knee Osteoarthritis

Keywords

vibration therapy; Knee Osteoarthritis; Knee Arthropathy

Outcome Measures

Primary Outcomes (5)

• Knee Flexion/Extension Strength

  Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee flexion/extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee flexion/extension movement are measured by the dynamometer attached at the malleoli level with a strap. The measurements (0 to 30 cm) will be taken at maximum force for three times.

  Baseline Assessment

• Knee Flexion/Extension Strength

  Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee flexion/extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee flexion/extension movement are measured by the dynamometer attached at the malleoli level with a strap. The measurements (0 to 30 cm) will be taken at maximum force for three times.

  Pre-Operative Assessment

• Knee Flexion/Extension Strength

  Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee flexion/extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee flexion/extension movement are measured by the dynamometer attached at the malleoli level with a strap. The measurements (0 to 30 cm) will be taken at maximum force for three times.

  Post-Operative 6 weeks

• Knee Flexion/Extension Strength

  Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee flexion/extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee flexion/extension movement are measured by the dynamometer attached at the malleoli level with a strap. The measurements (0 to 30 cm) will be taken at maximum force for three times.

  Post-Operative 6 months

• Knee Flexion/Extension Strength

  Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee flexion/extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee flexion/extension movement are measured by the dynamometer attached at the malleoli level with a strap. The measurements (0 to 30 cm) will be taken at maximum force for three times.

  Post-Operative 12 months

Secondary Outcomes (33)

• Whole body lean muscle mass

  Baseline Assessment

• Whole body lean muscle mass

  Pre-Operative Assessment

• Whole body lean muscle mass

  Post-Operative 6 months

• Muscle Biopsy

  Intra-Operatively

• Knee Functions measure by the Knee Society Score

  Baseline Assessment

Study Arms (2)

Vibration Therapy + Normal Out-Patient Physiotherapy

EXPERIMENTAL

Patients' randomized to this group will receive vibration therapy as a pre-operative rehabilitation programme 3 times a week for 3 months. Regular out-patient department physiotherapy will also be given. They will be assessed 6 weeks and 6 months post operatively.

Device: Vibration Therapy; Combination Product: Physiotherapy

Normal Out-Patient Department Physiotherapy

ACTIVE COMPARATOR

Patients randomized to this group will receive regular out-patient department physiotherapy postoperatively for 6 months. They will be assessed 6 weeks and 6 months post operatively.

Combination Product: Physiotherapy

Interventions

Vibration Therapy DEVICE

Vibration therapy as a pre-operative rehabilitation programme 3 times a week for 3 months + Normal Regular out-patient department physiotherapy

Vibration Therapy + Normal Out-Patient Physiotherapy

Physiotherapy COMBINATION_PRODUCT

Physiotherapy as post-operative rehabilitation programme for 6 months.

Normal Out-Patient Department Physiotherapy; Vibration Therapy + Normal Out-Patient Physiotherapy

Eligibility Criteria

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

You may qualify if:

• Male and female patients aged over 45 with end stage knee OA
• Patient has been scheduled for TKR
• Able to comply with the assessments and has given oral and written consent

You may not qualify if:

• Patients with connective tissue disorders or myositis condition
• Previous cases of alcoholism or drug abuse
• Pregnancy or breast feeding

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Orthopaedics & Traumatology

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professional Consultant

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 19, 2019
• Study Start: January 31, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

HK (1)