NCT07568691

Brief Summary

Background: Osteoarthritis (OA) is a joint disease commonly found in the knee. Therapeutic exercise has been known as the most common therapy to treat OA, however, therapy only focuses on reducing symptoms, not on treatment of the disease which help reduce cost and improve long term quality of life. Objective: This randomized controlled trial aim was to compare the effectiveness of Stochastic Resonance Therapy-Whole Body Vibration (SRT-WBV) vs. Balance Board (BB) training on knee pain, knee function and quality of life in obese patients with osteoarthritis. Design: Randomized controlled trial. Methods: Forty-four subjects diagnosed with Grade I-II Osteoarthritis Kellgren Lawrence and Grade I obesity were included, randomized to two treatment groups, the SRT-WBV (n=22) or BB (n=22) to complete a series of exercises over eight weeks. Evaluation using the following clinical outcomes: Visual Analog Scale (VAS), Timed Up and Go test (TUG), Single leg stance (SLS) test, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Short Form 12 Health Survey Questions (SF-12).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 21, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

OsteoarthritisKnee PainStochastic Resonance Therapy-Whole Body VibrationBalance BoardTherapeutic Exercise

Outcome Measures

Primary Outcomes (4)

  • Knee function (WOMAC Total Score)

    Knee function was assessed using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) questionnaire where pain score, stiffness, and physical function were evaluated on a scale of 0-4, with higher scores indicating worse pain, stiffness, and functional limitations. The questionnaire contains 24 items and the WOMAC Osteoarthritis Index scores were then derived from the sum of the scores for the three subscales It was administered at the beginning and completion of the intervention, as well as every 4 weeks during the intervention.

    8 weeks

  • Timed Up and Go Test (Balance)

    Balance and mobility will be assessed using the Timed Up and Go Test. The time (in seconds) taken to stand up from a chair, walk 3 meters, turn, return, and sit down will be recorded.

    8 weeks

  • Straight Leg Raise Test

    Balance/flexibility will be assessed using the Straight Leg Raise test. The maximum angle (in degrees) achieved during leg elevation will be recorded.

    8 weeks

  • Knee Pain (VAS Score)

    Knee pain will be measured using the Visual Analog Scale ranging from 0 to 10, with higher scores indicating greater pain. Participants will rate their pain at rest while seated.

    8 weeks

Secondary Outcomes (1)

  • Quality of Life (SF-12 Score)

    8 weeks

Study Arms (2)

Stochastic Resonance Therapy-Whole Body Vibration

ACTIVE COMPARATOR

Subjects assigned to the SRT-WBV group were required to stand on the footboard of the SRT-WBV (SR Therapiesysteme GmbH \& Co. Lifescience KG, Berlin) device with shoulder width stance, and knees bent at 30 degrees, facing forward. The trim settings progressed from weak (45 seconds with 8 repetitions), to mild (55 seconds with 8 repetitions), average (60 seconds with 6 repetitions), and strong (60 seconds with 6 repetitions), with intensity increased at two-week intervals. Each repetition was separated by a resting period that had the same duration as the trim settings (weak: 45 seconds, mild: 55 seconds, average and strong: 60 seconds).

Device: Stochastic Resonance Therapy-Whole Body Vibration

Balance Board

ACTIVE COMPARATOR

Subjects were required to stand on the balance board with knees bent at 30 degrees and both hands placed on the chest with eyes opened. The balance board intervention used different durations as its intensity, such as 7.5 minutes, 10 minutes, 12.5 minutes, and 15 minutes continuously without resting period. The intensity of exercise was progressively increased every 2 weeks until completion of the program.

Device: Balance Board

Interventions

A total of 16 therapeutic exercise sessions were conducted during the intervention where 2 sessions were conducted every week, separated by at least one day. Specifically, subjects assigned to either group, with each session began with standardized warm-up exercises lasting approximately 5-10 minutes, followed by specific therapeutic exercises such as SRT-WBV and Balance Board.

Also known as: SRT-WBV
Stochastic Resonance Therapy-Whole Body Vibration

The balance board intervention used different durations as its intensity, such as 7.5 minutes, 10 minutes, 12.5 minutes, and 15 minutes continuously without resting period. The intensity of exercise was progressively increased every 2 weeks until completion of the program.

Balance Board

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old patient
  • VAS score ranged from 4 - 6
  • Diagnosed with knee OA KL Grade I - II based on American College of Rheumatology Classification
  • Grade I obesity
  • Understand Bahasa Indonesia

You may not qualify if:

  • Used assistive devices or can't walk
  • Diagnosed with other medical conditions or mentally unstable
  • Diagnosed with advanced stage of osteoporosis
  • Had history of knee surgery
  • Were currently taking analgesic or anti-inflammatory medications
  • Pregnant
  • Unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitas Indonesia, Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Osteoarthritis, KneeObesityOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tirza Z Tamin, MD

    Indonesia University

    PRINCIPAL INVESTIGATOR

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

April 21, 2026

First Posted

May 6, 2026

Study Start

March 1, 2023

Primary Completion

September 30, 2023

Study Completion

October 15, 2023

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations