Effects of Short Wave Diathermy Added on Dextrose Prolotherapy Injections in Osteoarthritis of the Knee

Not Applicable

Completed

• Conditions: Knee Osteoarthritis

• Registration Number: NCT03931811
• Lead Sponsor: Ege University

Brief Summary

Goal: To show the effects of short wave diathermy added on prolotherapy injections in osteoarthritis of the knee on pain, physical functioning and quality of life.

Material and Methods: 63 patients with osteoarthritis of the knee with Kellgren-Lawrence (K-L) class 2 or 3 were included in the study. Patients were randomized to two grous, first being dextrose prolotherapy+ short wave diathermy(SWD), and second being dextrose prolotherapy with sham SWD. Patients were injected with dextrose prolotherapy solutions in the beginning, 3rd and 6th week of the study, for a total of 3 times, and took 20 minutes of SWD after injection(true or sham). Western Ontorio and McMaster Universities Osteoarthritis Index (WOMAC), Visual Analogous Scale for pain(VAS) and Short Form Health Survey (SF-36)were applied before, after(6th week) and at the 3rd month of treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-04
• Primary Completion: 2018-04-04
• Study Completion: 2018-04-04
• Status Verified: 2019-04
• Study First Submitted: 2019-04-26
• Study First Submitted QC: 2019-04-26
• Study First Posted: 2019-04-30
• Last Update Submitted: 2019-04-30
• Last Update Posted: 2019-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Inclusion criteria were being between 45 and 75 years old, knee pain of 3 months or longer duration, and having OA of the knee compatible with Kellgren-Lawrance class 2 or 3

Exclusion Criteria

• Patients using analgesics other than acetaminophen, having pregnancy, diabetes mellitus, infectious or inflammatory arthritis, hemophilia, knee prosthesis, history of knee injections in last 3 months or anticoagulant use, allergy to ingredients of the solutions, having cardiac pacemaker or other device, or metallic implants were exluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analogous Scale(for the intensity of pain)(VAS)	3 months	VAS was used to assess the resting pain intensity of the subjects. Patients were asked to show their intensity of pain on a 10 cm long line, with 0 end being no pain, and 10 cm end being highest amount of pain possible. The distance between the mark and the 0 end was measured and the result was recorded as milimeters.

Secondary Outcome Measures

Name	Time	Method
Western Ontorio and McMaster Universities Osteoarthritis Index (WOMAC)	3 months	WOMAC is an index for the assessment of osteoarthritis consisting of 24 questions, with subscales being pain(5 questions), stiffness(2 questions) and physical functioning(17 questions). Turkish version of the test is expressed as a likert type scale, ranging from 0 to 4, with greater numbers expressing higher severity. The greater scores are associated with more severe disease
Short Form-36 (SF-36)	3 months	SF-36 is an index for the evaluation of quality of life in a broad range of patients. It consists of 8 domains: Physical function, bodily pain, role-physical, general health, vitality, social function, role-emotional, and mental health. Each domain is expressed separately, rather than a total score. All of the domains are given from 0 to 100 points, with greater values being associated with a better quality of life.

Trial Locations

Locations (1)

Ege university school of medicine; 🇹🇷 Izmir, Turkey