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

Petz Aladar County Teaching Hospital

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Other: Kolop mud-pack; Other: Tiszasüly hot mud-pack therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03826511

PetzCTH

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Tiszasüly mud-pack

Active Comparator group

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.

Treatment:

Other: Tiszasüly hot mud-pack therapy

Kolop mud-pack

Active Comparator group

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.

Treatment:

Other: Kolop mud-pack