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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Other: Kolop mud-pack; Other: Tiszasüly hot mud-pack therapy

• Registration Number: NCT03826511
• Lead Sponsor: Petz Aladar County Teaching Hospital

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).

Study Timeline

• Study Start: 2016-08
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2019-01
• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-31
• Last Update Submitted: 2019-01-31
• Study First Posted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kolop mud-pack	Kolop mud-pack	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.
Tiszasüly mud-pack	Tiszasüly hot mud-pack therapy	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.

Primary Outcome Measures

Name	Time	Method
change in severity of pain at rest	Week 0 and Week 12	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 12	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.
change in quality of life	Week 0 and Week 12	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).

Trial Locations

Locations (1)

Petz Aladár County Teaching Hospital; 🇭🇺 Győr, Hungary