The Effects of Tiszasüly and Kolop Mud-pack Therapy in Knee Osteoarthritis

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Effects of Tiszasüly and Kolop Mud-pack Therapy in Knee Osteoarthritis: Randomized Non-inferiority Controlled Pilot Study

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Tiszasüly hot mud-pack therapy
* Other: Kolop mud-pack


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tiszasüly mud-pack<br>Patients in the Tiszasüly mud-pack group got hot mud-packs for 30 minutes on 10 occasions for 2 weeks (10 working days) on the painful knee. | Other: Tiszasüly hot mud-pack therapy<br>* 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.<br>|
| Active Comparator: Kolop mud-pack<br>Patients in the Kolop mud-pack group got hot mud-packs for 30 minutes on 10 occasions for 2 weeks (10 working days) on the painful knee. | Other: Kolop mud-pack<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in severity of pain at rest | 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. | Week 0 and Week 2 | 
| change in severity of pain at rest | 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. | Week 0 and Week 12 | 
| change in function | 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. | Week 0 and Week 2 | 
| change in function | change from baseline Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 12. 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. | Week 0 and Week 12 | 
| change in function | change from baseline physical function measuredf by Lequesne Index, which is a 10-question survey. It has five questions pertaining to pain or discomfort, 1 question dealing with maximum distance walked, and four questions about activities of daily living. | Week 0 and Week 2 | 
| change in function | change from baseline physical function measured by Lequesne Index, which is a 10-question survey. It has five questions pertaining to pain or discomfort, 1 question dealing with maximum distance walked, and four questions about activities of daily living. | Week 0 and Week 12 | 
| change in function | change from baselilne physical function measured by Knee Injury and Osteoarthritis Outcome Score (KOOS). It is an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in knee osteoarthritis. It has five separately scored subscales: pain, other symptoms, function in daily living (ADL), function in sport and recreation (Sport/Rec), and knee-related quality of life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Week 0 and Week 2 | 
| change in function | change from baselilne physical function measured by Knee Injury and Osteoarthritis Outcome Score (KOOS). It is an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in knee osteoarthritis. It has five separately scored subscales: pain, other symptoms, function in daily living (ADL), function in sport and recreation (Sport/Rec), and knee-related quality of life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Week 0 and Week 12 | 
| change in quality of life | 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). | Week 0 and Week 2 | 
| change in quality of life | 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). | Week 0 and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mud-pack therapy, osteoarthritis of the knee, hot-pack therapy, non-inferiority study