Balneotherapy and Peloid Therapy Impact Small Joint Diseases

Lithuanian University of Health Sciences

Status: Invitation-only

Conditions: Osteoarthritis; Hand Osteoarthritis; Foot Osteoarthritis

Treatments: Other: Heat procedures; Other: Mineral water bath; Other: Regular rehababilitation; Other: Healing mud application

Study type: Interventional

Funder types: Other

Identifiers

NCT06477393

V-2

Details and patient eligibility

About

This clinical trial investigates the effects of natural healing factors (mineral water and mud procedures) in combination with regular rehabilitation of patients with degenerative small joint disease. The study aims to assess the impact on functional status, quality of life, and socio-economic factors, including the reduction of temporary incapacity for work and disability and the improvement of patient participation. Participants will undergo a regular rehabilitation program incorporating these natural healing factors, measuring outcomes through various health metrics.

Full description

This interventional clinical trial is designed to evaluate the efficacy of incorporating natural healing factors into the standard rehabilitation regimen for patients suffering from degenerative small joint disease. The study will involve a well-defined cohort of participants diagnosed with this condition, randomly assigned to either the experimental group, which will receive the combination of mineral water and mud procedures with a regular rehabilitation program, or the control group, which will receive the standard regular rehabilitation.

The primary objective is to determine patients' functional status and quality of life changes, measured through validated health questionnaires and functional tests specific to small joints. Secondary objectives include analysing the socio-economic impact, reducing temporary incapacity for work and disability rates and improving patient participation in daily activities and employment.

The data collection process will be rigorous, involving a comprehensive mix of qualitative and quantitative methods. Participants will be required to complete health surveys and functional status tests and provide socioeconomic data at multiple points throughout the study. The rehabilitation program will include physiotherapy, occupational therapy, and the application of natural healing factors such as balneotherapy and peloid therapy.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion Criteria:1. Adult (> 18 years).
2. Subjects will be diagnosed with symptomatic (duration greater than 3 months) osteoarthritis of the hands and/or feet and meet the validated classification or diagnostic criteria for hand and/or foot OA published by EULAR/ACR (Altman et al., 1990; Zhang et al. et al., 2009). Hand and/or foot joint pain at baseline will be at least 40 mm on a 100 mm visual analogue scale (VAS) (0 = no pain; 10 = worst pain) without pain medication.
3. Participants will be assessed for radiographic changes characteristic of osteoarthritis. This assessment will be based on the Kellgren-Lawrence (K-L) grading system, which is a widely used method for classifying the severity of osteoarthritis. The system is based on stages, with a minimum requirement of osteoarthritis in more than one joint and at least two stages of severity (Kellgren JH, 1957).
4. Rehabilitation procedures, except physical exercises performed at home, will not be applied for at least 2 months.
5. Subjects can sign the patient's informed consent form.

Exclusion Criteria:

1. Subjects with autoimmune diseases that can affect the joints of the hands/feet (rheumatoid arthritis, systemic connective tissue diseases, seronegative spondyloarthropathies) or crystalline arthropathies.
2. Diagnosed with thoracic outlet syndrome, carpal tunnel syndrome, Guyon's canal syndrome, cubital tunnel syndrome, diabetic neuropathy or cheiroarthropathy, palmar tenosynovitis, fibromyalgia and pain syndrome.
3. Subjects who have suffered serious injuries in the last 6 months or who have undergone surgical interventions on the joints of the hands/feet.
4. The functional tests provided in the study cannot be performed due to advanced OA or other diseases.
5. Subjects with skin lesions or sensitivity to the intended procedures.
6. Diagnosed with oncological diseases or being investigated for oncological diseases.
7. Diseases or conditions for which mud or mineral water baths are contraindicated
8. Constantly taking pain relievers for other conditions unless the dose is stable for ≥ 1 month.
9. Taking Sy-SADOA symptomatic slow-acting OA drugs unless the dose is stable for ≥ 3 months.
10. Pregnancy or planned pregnancy.
11. Intra-articular (IA) injection of corticosteroids (joints of hands and feet) within the last 1 month or IA injection of hyaluronic acid within 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Control group

Sham Comparator group

Description:

The control group will receive "placebo" type procedures in addition to the usual medical rehabilitation procedures, i.e., heat treatments, so routine health care will not be lost. The typical procedures are assigned in accordance with the order of the Minister of Health of the Republic of Lithuania "On the approval of descriptions of general and special requirements for the provision of medical rehabilitation and anti-recidivism sanatorium treatment services" valid version dated 06.14.2023). In-resort sanatoriums, the mud and mineral water procedures are additionally paid services, which the sanatorium will provide free of charge for scientific development.

Treatment:

Other: Regular rehababilitation

Other: Heat procedures

Experimental group

Active Comparator group

Description:

Standard rehabilitation procedures will be applied (following the order of the Minister of Health of the Republic of Lithuania) supplemented by balneotherapy/peloid therapy. Rehabilitation procedures will be performed in the Lithuanian resort Birstonas sanatorium "Versme." The standard rehabilitation procedures will be the same as those in the control group.

Treatment:

Other: Healing mud application

Other: Regular rehababilitation

Other: Mineral water bath