Clinical trial NCT03826511: 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
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: mud-pack therapy
osteoarthritis of the knee
hot-pack therapy
non-inferiority study
Lead sponsor: Petz Aladar County Teaching Hospital
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: change in severity of pain at rest
timeFrame: Week 0 and Week 2
measure: change in severity of pain at rest
timeFrame: Week 0 and Week 12
measure: change in function
timeFrame: Week 0 and Week 2
measure: change in function
timeFrame: Week 0 and Week 12
measure: change in function
timeFrame: Week 0 and Week 2
measure: change in function
timeFrame: Week 0 and Week 12
measure: change in function
timeFrame: Week 0 and Week 2
measure: change in function
timeFrame: Week 0 and Week 12
measure: change in quality of life
timeFrame: Week 0 and Week 2
measure: change in quality of life
timeFrame: Week 0 and Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Győr
country: Hungary
facility: Petz Aladár County Teaching Hospital
Study officials:
References: