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

• Sponsor: Mahidol University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00199914
• Collaborator: (none)
• Enrollment: 113
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 22.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee; Menopause	Device: Shortwave diathermy	Phase 3

Detailed Description

Osteoarthritis (OA) is the most common degenerative joint disease, resulting in significant morbidity and health care expense. It affects more than 60% of Western World adults over the age of 65 years. It causes pain and dysfunction in 20% of elderly persons. It can affect any joint containing hyaline cartilage; knee is the most commonly affected joint. There are many strategies for the treatment of knee OA but a curative method has not been found. Treatment is therefore aimed to relief symptoms and to prevent further functional deterioration. It is unclear whether any of the treatment modalities is efficacious. Shortwave diathermy (SWD) is one of deep heat widely applied to alleviate the symptoms associated with OA. The efficacy of SWD for the treatment of OA knee is still inconclusive. The outcome of treatment in previous reports varies from null to positive effect. This discrepancy is largely due to the different research methodology, the inadequate sample size, the methods used in outcome assessment, and the treatment protocols.

Comparison(s): Peri- or postmenopausal women with OA knee are randomized into two groups, receiving a course of either therapeutic SWD or sham SWD. The main outcome measured is the change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index.

Study Design

• Study Type: Interventional
• Actual Enrollment: 113 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effectiveness of Shortwave Diathermy in Knee Osteoarthritis: A Randomized Controlled Trial
• Study Start Date: Jan 1, 2004
• Actual Primary Completion Date: May 1, 2004
• Actual Study Completion Date: Jun 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Shortwave diathermy continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks	Device: Shortwave diathermy; continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Sham Comparator: control continuous sham shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks	Device: Shortwave diathermy; continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks

Outcome Measures

Primary Outcome Measures

1. The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index [3 weeks]

   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).

Secondary Outcome Measures

1. Gait Speed (Calculated From the Time Spending for 100-meter Walk) [3 weeks]

2. Global Improvement [3 weeks]

3. Patient's Satisfaction to the Treatment [3 weeks]

4. Adverse Events [3 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• peri- or postmenopausal women aged >50 years

• primary knee osteoarthritis

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok		Thailand	10700

Sponsors and Collaborators

• Mahidol University

Investigators

• Principal Investigator: Manee Rattanachaiyanont, M.D., Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Manee Rattanachaiyanont, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University
• ClinicalTrials.gov Identifier: NCT00199914
• Other Study ID Numbers: 34/2003
• First Posted: Sep 20, 2005
• Last Update Posted: Sep 18, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by Manee Rattanachaiyanont, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University: Diathermy; Short-wave therapy; Osteoarthritis; Knee
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Hyperthermia

Study Results

Participant Flow

Recruitment Details	A randomized and double blind placebo controlled equivalence trial was carried out in the out-patient clinic, Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University from January to June 2004.
Pre-assignment Detail	All patients had primary knee OA and without the following conditions: inability to walk, severe joint instability, history of previous SWD treatment, intra-articular injection within 3 months, metallic implant around knee joint, suspicious of malignancy around knee joint, significant cardiovascular disease.

Arm/Group Title	Shortwave Diathermy	Control
Arm/Group Description	continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks	continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Period Title: Overall Study
STARTED	53	60
COMPLETED	50	54
NOT COMPLETED	3	6

Baseline Characteristics

Arm/Group Title	Shortwave Diathermy	Control	Total
Arm/Group Description	continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks	continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks	Total of all reporting groups
Overall Participants	53	60	113
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.32 (7.61)	62.48 (8.47)	62.88 (8.05)
Sex: Female, Male (Count of Participants)
Female	53 100%	60 100%	113 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Thailand	53 100%	60 100%	113 100%

Outcome Measures

1. Primary Outcome

Title	The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
Description	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).
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

Statistical analyses to test the superiority were based on the intention-to-treat (ITT) population, and those chosen to demonstrate the equivalence were based on the per protocol population. The "worst -case-scenario" was applied to the dropouts in the ITT analyses.

Arm/Group Title	Shortwave Diathermy	Control
Arm/Group Description	continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks	continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Measure Participants	54	60
Mean (95% Confidence Interval) [units on a scale]	0.71	0.65

2. Secondary Outcome

Title	Gait Speed (Calculated From the Time Spending for 100-meter Walk)
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Global Improvement
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Patient's Satisfaction to the Treatment
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Adverse Events
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	3 weeks
Arm/Group Title	Shortwave Diathermy		Control
Arm/Group Description	continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks		continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
All Cause Mortality
	Shortwave Diathermy		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Shortwave Diathermy		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/54 (0%)
Other (Not Including Serious) Adverse Events
	Shortwave Diathermy		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/50 (8%)		4/54 (7.4%)
Musculoskeletal and connective tissue disorders
pain	4/50 (8%)	4	2/54 (3.7%)	2
swelling	0/50 (0%)	0	1/54 (1.9%)	1
flushing	0/50 (0%)	0	2/54 (3.7%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.