Effects of Short Wave Diathermy Added on Dextrose Prolotherapy Injections in Osteoarthritis of the Knee
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ege University
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Visual Analogous Scale(for the intensity of pain)(VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Short wave diathermy group
Patients were randomized into 2 groups depending on their patient number, with odd numbers being recruited to SWD group, and even numbers to sham SWD group.
Prolotherapy solutions were injected using 25 gauge needle, with solutions being 6 ml 25 % dextrose (3 ml 20% dextrose + 3 ml 30% dextrose) for intraarticular, and 20 ml 15% dextrose (10 ml 0,9% NaCl + 10 ml 30% dextrose) for periarticular.
SWD group took short wave diathermy with specifications of 400 watt power output, 27.12 MHz frequency, 11.06m wave length, using condensators and electrodes of 12 cm diameter parallel to the knee for 20 minutes(Enraf-Nonius, Curapuls 970 Short wave diathermy device). Both groups took injections in the beginning of the therapy, 3rd week and 6th week, a total of 3 times. SWD or sham SWD therapy was given right after the injections, also for a total of 3 times.
Intervention: Short wave diathermy (Device)
Short wave diathermy group
Patients were randomized into 2 groups depending on their patient number, with odd numbers being recruited to SWD group, and even numbers to sham SWD group.
Prolotherapy solutions were injected using 25 gauge needle, with solutions being 6 ml 25 % dextrose (3 ml 20% dextrose + 3 ml 30% dextrose) for intraarticular, and 20 ml 15% dextrose (10 ml 0,9% NaCl + 10 ml 30% dextrose) for periarticular.
SWD group took short wave diathermy with specifications of 400 watt power output, 27.12 MHz frequency, 11.06m wave length, using condensators and electrodes of 12 cm diameter parallel to the knee for 20 minutes(Enraf-Nonius, Curapuls 970 Short wave diathermy device). Both groups took injections in the beginning of the therapy, 3rd week and 6th week, a total of 3 times. SWD or sham SWD therapy was given right after the injections, also for a total of 3 times.
Intervention: Prolotherapy (Other)
Sham diathermy group
Patients were randomized into 2 groups depending on their patient number, with odd numbers being recruited to SWD group, and even numbers to sham SWD group.
Prolotherapy solutions were injected using 25 gauge needle, with solutions being 6 ml 25 % dextrose (3 ml 20% dextrose + 3 ml 30% dextrose) for intraarticular, and 20 ml 15% dextrose (10 ml 0,9% NaCl + 10 ml 30% dextrose) for periarticular.
Sham SWD group took 20 minutes of SWD therapy with device not working(Enraf-Nonius, Curapuls 970 Short wave diathermy device).
Intervention: Prolotherapy (Other)
Outcomes
Primary Outcomes
Visual Analogous Scale(for the intensity of pain)(VAS)
Time Frame: 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 Outcomes
- Western Ontorio and McMaster Universities Osteoarthritis Index (WOMAC)(3 months)
- Short Form-36 (SF-36)(3 months)
Investigators
Hale Karapolat
Professor in Physical Medicine and Rehabilitation Department
Ege University