Efficacy Study of Shortwave Diathermy for the Treatment of Patients With Knee Osteoarthritis

NCT00199914 | Completed Phase 3 Results

• 1 other identifier: 34/2003
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether shortwave diathermy is effective in reducing knee pain and increasing function of the patients with knee osteoarthritis.

Conditions

Osteoarthritis, Knee; Menopause

Keywords

Diathermy; Short-wave therapy; Osteoarthritis; Knee

Outcome Measures

Primary Outcomes (1)

• The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index

  The WOMAC index is a multidimensional, self-administered health status evaluation instrument for patients with OA of the hip and knee. It is composed of 24 items that are grouped into three dimensions, including pain (5 items), stiffness (2 items), and function (17 items). The response can be in a form of visual analog or five-point Likert scale \[11, 23\]. In this study, the response is on a 10-cm horizontal line with numeric description from 0 to 10. The score of each dimension is an average of the component item scores. The WOMAC total score is determined by averaging the scores of all dimensions. The total score ranges from 0 (best outcome possible) to 10 (worst outcome possible).

  3 weeks

Secondary Outcomes (4)

• Gait Speed (Calculated From the Time Spending for 100-meter Walk)

  3 weeks

• Global Improvement

  3 weeks

• Patient's Satisfaction to the Treatment

  3 weeks

• Adverse Events

  3 weeks

Study Arms (2)

Shortwave diathermy

EXPERIMENTAL

continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks

Device: Shortwave diathermy

control

SHAM COMPARATOR

continuous sham shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks

Device: Shortwave diathermy

Interventions

Shortwave diathermy DEVICE

continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks

Shortwave diathermy; control

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• peri- or postmenopausal women aged \>50 years
• primary knee osteoarthritis

You may not qualify if:

• inability to walk
• severe joint instability
• history of previous shortwave diathermy
• intra-articular injection within 3 months
• metallic implant around knee joint
• suspicious of malignancy around knee joint
• significant cardiovascular disease
• inability to understand how to score the symptoms

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Related Publications (1)

• Rattanachaiyanont M, Kuptniratsaikul V. No additional benefit of shortwave diathermy over exercise program for knee osteoarthritis in peri-/post-menopausal women: an equivalence trial. Osteoarthritis Cartilage. 2008 Jul;16(7):823-8. doi: 10.1016/j.joca.2007.10.013. Epub 2008 Feb 21.

  PMID: 18178111 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Fever; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The present study has limitations in generalizability. The study population was peri-/post-menopausal Thai women whose lifestyle might be different from that of other ethnic groups. The relatively short duration of treatment might not be sufficient to show the benefit of short-wave diathermy (SWD) treatment. Only one SWD machine with a unique output power was used in order to homogenize the provided treatment. All of these conditions would make the results in-applicable to different situations.

Results Point of Contact

• Title: Manee Rattanachaiyanont
• Organization: Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

manee.rat@mahidol.ac.th

+66-2419-4657

Study Officials

• Manee Rattanachaiyanont, M.D.

  Mahidol University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital

Model Details: The treatment group received short-wave diathermy (SWD) plus exercise whereas the control group received exercise alone.

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2004
• Primary Completion: May 1, 2004
• Study Completion: June 1, 2004
• Last Updated: October 14, 2022
• Results First Posted: November 8, 2013

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)