Knee Osteoarthritis
Conditions
Keywords
mud-pack therapy, osteoarthritis of the knee, hot-pack therapy, non-inferiority study
Brief summary
In this double-blind, randomized, follow-up study investigators evaluated and compared the effects of Tiszasüly and Kolop mud-pack therapy on pain, function and quality of life in patients with knee osteoarthritis. 30 patients were treated with Tiszasüly hot mud-pack (Group 1), 30 patients with Kolop hot mud-pack (Group 2) for 10 working days. Knee pain, function a nd qualitiy of life were measured at baseline, at the end of treatment and 3 months later.
Detailed description
The aim of this non-inferiority study was to evaluate and compare the effects of Tiszasüly and Kolop mud-pack therapy on pain, function and quality of life in patients with knee osteoarthritis. Methods: In this double-blind, randomized, follow-up study 60 patients with knee osteoarthritis were treated with either Tiszasüly hot mud-pack (Group 1), or with Kolop hot mud-pack (Group 2) on 10 occasions for 2 weeks (10 working days). 100 mm Visual Analogue Scale (VAS) for knee pain, Western Ontario and McMaster Universities Arthritis Index (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS), Lequesne Index for physical function and EuroQoL-5D for quality-of-life measure were recorded at baseline, at the end of treatment (Week 2) and 3 months later (Week 12).
Interventions
OTHERTiszasüly hot mud-pack therapy
Patients received Tiszasüly hot mud-packs (42 Celsius degree) for 30 minutes on 10 occasions for 2 weeks (10 working days) on the painful knee.
OTHERKolop mud-pack
Patients received Kolop hot mud-packs (42 Celsius degree) for 30 minutes on 10 occasions for 2 weeks (10 working days) on the painful knee.
Sponsors
Petz Aladar County Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients over 18 years of age with knee osteoarthritis (radiologically Kellgren-Laurence II-III. stage) * resting VAS pain is \> 50 mm
Exclusion criteria
* infection * fever * tumour * neurologic disorders with numbness and tingling sensation in the lower extremeties * skin disease aroud the knee * untreated hypertension * heart failure (NYHA II-IV. stage) * inflammatory rheumatic diseases * knee arthroplasty * steroid or hialuronic acid injection into the knee joint within 3 months * physiotherapy of the knee within 3 months * inflammatory knee osteoarthitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in severity of pain at rest | Week 0 and Week 2 | change from baseline severity of pain at rest recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain. |
| change in function | Week 0 and Week 2 | change from baseline physical function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 2. It is comprised of 24 items divided into three subscales: Pain (5 items), stiffness (2 items), and physical function (17 items). All the items are scored on a 100mm visual analogue scale. Values are summed up for a combined WOMAC score. The lower score represents better outcome. |
| change in quality of life | Week 0 and Week 2 | change from baseline qualiity of life measured by EuroQoL-5D. It has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), where patients are asked to rate their health problems at five levels (no problems, slight problems, moderate problems, severe problems, extreme problems). It also includes a self-rating of health status on a visual analogue scale (EQ VAS) ranging from 0 to 100 (where 0 means the worst and 100 means the best health status). |
Countries
Hungary
Outcome results
None listed