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

January 31, 2019 updated by: Márta Király, Petz Aladar County Teaching Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Győr, Hungary, 9025
        • Petz Aladar County Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Other: 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.
ACTIVE_COMPARATOR: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in severity of pain at rest
Time Frame: 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.
Week 0 and Week 2
change in severity of pain at rest
Time Frame: 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.
Week 0 and Week 12
change in function
Time Frame: Week 0 and Week 12
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
Time Frame: 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.
Week 0 and Week 2
change in function
Time Frame: Week 0 and Week 2
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
Time Frame: Week 0 and Week 12
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
Time Frame: Week 0 and Week 2
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
Time Frame: 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.
Week 0 and Week 12
change in quality of life
Time Frame: 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).
Week 0 and Week 2
change in quality of life
Time Frame: 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).
Week 0 and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Petz Aladar County Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2016

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

February 1, 2018

Study Registration Dates

First Submitted

January 30, 2019

First Submitted That Met QC Criteria

January 31, 2019

First Posted (ACTUAL)

February 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PetzCTH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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