Trial Outcomes & Findings for Efficacy Study of Shortwave Diathermy for the Treatment of Patients With Knee Osteoarthritis (NCT NCT00199914)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

113 participants

Primary outcome timeframe

3 weeks

Results posted on

2022-10-14

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Shortwave Diathermy continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks	Control continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Overall Study STARTED	53	60
Overall Study COMPLETED	50	54
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Shortwave Diathermy n=53 Participants continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks	Control n=60 Participants continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks	Total n=113 Participants Total of all reporting groups
Age, Continuous	63.32 years STANDARD_DEVIATION 7.61 • n=93 Participants	62.48 years STANDARD_DEVIATION 8.47 • n=4 Participants	62.88 years STANDARD_DEVIATION 8.05 • n=27 Participants
Sex: Female, Male Female	53 Participants n=93 Participants	60 Participants n=4 Participants	113 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Thailand	53 participants n=93 Participants	60 participants n=4 Participants	113 participants n=27 Participants

PRIMARY outcome

Timeframe: 3 weeks

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Shortwave Diathermy n=54 Participants continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks	Control n=60 Participants continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index	0.71 units on a scale Interval 0.42 to 0.99	0.65 units on a scale Interval 0.37 to 0.92

SECONDARY outcome

Timeframe: 3 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 weeks

Outcome measures

Outcome data not reported

Adverse Events

Shortwave Diathermy

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Shortwave Diathermy n=50 participants at risk continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks	Control n=54 participants at risk continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Musculoskeletal and connective tissue disorders pain	8.0% 4/50 • Number of events 4 • 3 weeks	3.7% 2/54 • Number of events 2 • 3 weeks
Musculoskeletal and connective tissue disorders swelling	0.00% 0/50 • 3 weeks	1.9% 1/54 • Number of events 1 • 3 weeks
Musculoskeletal and connective tissue disorders flushing	0.00% 0/50 • 3 weeks	3.7% 2/54 • Number of events 2 • 3 weeks

Additional Information

Manee Rattanachaiyanont

Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

Phone: +66-2419-4657

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place