The Effects of Tiszasüly and Kolop Mud-pack Therapy in Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Tiszasüly hot mud-pack therapy
Kolop mud-pack
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring mud-pack therapy, osteoarthritis of the knee, hot-pack therapy, non-inferiority study
Eligibility Criteria
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
Sites / Locations
- Petz Aladár County Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Tiszasüly mud-pack
Kolop mud-pack
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03826511
First Posted
January 30, 2019
Last Updated
January 31, 2019
Sponsor
Petz Aladar County Teaching Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03826511
Brief Title
The Effects of Tiszasüly and Kolop Mud-pack Therapy in Knee Osteoarthritis
Official Title
The Effects of Tiszasüly and Kolop Mud-pack Therapy in Knee Osteoarthritis: Randomized Non-inferiority Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Petz Aladar County Teaching Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
mud-pack therapy, osteoarthritis of the knee, hot-pack therapy, non-inferiority study
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tiszasüly mud-pack
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Kolop mud-pack
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Tiszasüly hot mud-pack therapy
Intervention Description
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
Intervention Name(s)
Kolop mud-pack
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in severity of pain at rest
Description
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.
Time Frame
Week 0 and Week 2
Title
change in severity of pain at rest
Description
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.
Time Frame
Week 0 and Week 12
Title
change in function
Description
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.
Time Frame
Week 0 and Week 2
Title
change in function
Description
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.
Time Frame
Week 0 and Week 12
Title
change in function
Description
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.
Time Frame
Week 0 and Week 2
Title
change in function
Description
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.
Time Frame
Week 0 and Week 12
Title
change in function
Description
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.
Time Frame
Week 0 and Week 2
Title
change in function
Description
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.
Time Frame
Week 0 and Week 12
Title
change in quality of life
Description
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).
Time Frame
Week 0 and Week 2
Title
change in quality of life
Description
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).
Time Frame
Week 0 and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Petz Aladár County Teaching Hospital
City
Győr
ZIP/Postal Code
9025
Country
Hungary
12. IPD Sharing Statement
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The Effects of Tiszasüly and Kolop Mud-pack Therapy in Knee Osteoarthritis
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