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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03931811
Enrollment
63
Registered
2019-04-30
Start date
2017-04-04
Completion date
2018-04-04
Last updated
2019-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis, Prolotherapy, Hypertonic dextrose solution injections, Short-wave diathermy

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.

Interventions

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).

OTHERProlotherapy

Prolotherapy solutions were injected to the knee by a blinded physician in the group, 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. Injection points wwere defined as medial collateral ligaments, adhesion points of quadriceps tendon, adhesion points of patellar tendon, tuberositas tibia, pes anserinus, lateral collateral ligaments, coronal ligaments, medial and lateral tibia plateaus. Patients were blinded to their treatment groups

Sponsors

Ege University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogous Scale(for the intensity of pain)(VAS)3 monthsVAS 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

MeasureTime frameDescription
Western Ontorio and McMaster Universities Osteoarthritis Index (WOMAC)3 monthsWOMAC 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 monthsSF-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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026