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

NCT ID: NCT03826511

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-02-28

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).

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Tiszasüly mud-pack

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.

Group Type ACTIVE_COMPARATOR

Tiszasüly hot mud-pack therapy

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Kolop mud-pack

Intervention Type OTHER

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.

Interventions

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Tiszasüly 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.

Intervention Type OTHER

Kolop 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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Petz Aladar County Teaching Hospital

OTHER

Sponsor Role lead

Responsible Party

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Márta Király

chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Petz Aladár County Teaching Hospital

Győr, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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PetzCTH

Identifier Type: -

Identifier Source: org_study_id

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