NCT01017445

Brief Summary

This study aims to compare the efficacy between Boonme stick exercise and quadriceps strengthening exercise in knee osteoarthritis.Patients diagnosed as knee osteoarthritis using Altman criteria will be randomized into 2 groups using simple random technique. Patients will be instructed and trained for both quadriceps or Boonme stick exercise by one-trained physical therapist. All patients will be treated with behavioral modification, NSAIDs and analgesic drugs and regularly follow-up . Assessment included visual analogue scale, exercise compliance, WOMAC and patient satisfaction were done by an assessor in a blinded fashion.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at below P25 for phase_3 knee-osteoarthritis

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_3 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

5.2 years

First QC Date

November 17, 2009

Last Update Submit

May 12, 2012

Conditions

Knee Osteoarthritis

Keywords

osteoarthritis, exercise

Outcome Measures

Primary Outcomes (1)

  • vas score

    1,2 years

Secondary Outcomes (2)

  • WOMAC

    1,2 yrs

  • number of analgesic used

    1,2 years

Study Arms (1)

Quadricep strengthening exercise

EXPERIMENTAL

Quadricep strengthening exercise

Other: Boonme stick exercise

Interventions

Boonme stick exerciseOTHER

individual exercise daily

Quadricep strengthening exercise

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • knee osteoarthritis using Altman criteria

You may not qualify if:

  • problem of communication ability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Boonsin Tangtrakulwanich, MD.,Ph.D

    Faculty of Medicine, Prince of Songkla University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Orthopaedic surgery

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 20, 2009

Study Start

October 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

TH(1)