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Completed

NCT Number: NCT03931811

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege university school of medicine

Izmir, 35100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Short Wave Diathermy

Device

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).

Prolotherapy

Other

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

Other names: Hypertonic dextrose injections

Primary outcomes

  1. 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

  1. Western Ontorio and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 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

  2. Short Form-36 (SF-36)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 30, 2019
Registry last updated
May 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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