Balneotherapy and Peloid Therapy Impact Small Joint Diseases

Официальное название

The Inclusion of Natural Healing Factors in Complex Regular Rehabilitation of Patients with Degenerative Small Joints Disease: Impact on Changes in Functional Status, Quality of Life, and Socio-economic Significance in Reducing Temporary Incapacity for Work and Disability, Improving Participation

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Regular rehababilitation
  Subjects of the experimental and control groups will receive routine procedures applied in the resort sanatorium: physiotherapy (28-32), occupational therapy (12-18), dry hydromassage (7-8), psychotherapy or audiovisual relaxation (3-4), social worker's visit ( 1-2), physiotherapy (magnetotherapy, ultrasound therapy (8-9).
• Другое Heat procedures
  The bath is filled with 200 litres of warm tap water at 36-38°C. The participant lies in the prepared bath, ensuring the chest area remains uncovered. While in the bath, the participant performs gentle movements. The procedure lasts 12-15 minutes. Air is pumped into the water to increase the oxygen saturation in the bath environment. A prepared gel pack will be placed in another bag and heated to 50-55°C. The heated pack will be delivered to the treatment area using pumps. For applications, the
• Другое Healing mud application
  Therapeutic mud applications: peat brought from the quarry is sifted, ground, and mixed with natural mineralisation of 20-22g/l with mineral water in a ratio of at least 4:1 until the consistency of thick sour cream. The prepared peat mud is heated to 50-55 degrees. The heated mud is fed to the place where the procedures are performed with the help of pumps. Mud mass at 40-42 degrees is used for applications. A mud temperature range of 38-43 degrees is possible. Before the procedure, it is reco
• Другое Mineral water bath
  The pearl bath is prepared by a physical method. The bath is filled with 200 l of warm 36-38 C mineral water, the subject lies in the prepared bath, leaving the heart area open, while lying in the bath he performs light movements. The duration of the procedure is 12-15 minutes. Air is blown into the water, which increases oxygen saturation in the bath environment. Before the procedure, it is recommended not to eat, go to the toilet, take a warm shower. After the procedure, the subject takes a wa

Первичные конечные точки

• Heel-Rise Test [Срок оценки: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months]
• Pinch grip strength [Срок оценки: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months]
• Hand grip strength [Срок оценки: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months]
• Hand Mobility in Scleroderma, HAMIS [Срок оценки: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months]
• Finger-to-palm, FTP [Срок оценки: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months]
• Modified Kapandji Index, MKI [Срок оценки: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months]
• Strength of extensor and flexor muscles of the foot [Срок оценки: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months]
• ROM [Срок оценки: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months]
• 30-second chair stand test [Срок оценки: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months]
• Stair climb test [Срок оценки: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months]

Вторичные конечные точки (7)

• Manchester-Oxford Foot Questionnaire (MOxFQ) [Срок оценки: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months]
• Foot and ankle outcome score, FAOS [Срок оценки: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months]
• The Quality of life questionnaire SF-36 [Срок оценки: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months]
• The functional index for hand osteoarthritis FIHOA [Срок оценки: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months]
• Michigan Hand Outcomes Questionnaire MHQ [Срок оценки: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months]
• Ultrasound of hand joints [Срок оценки: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months]
• Ultrasound of foot joints [Срок оценки: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months]

Критерии участия

• Inclusion Criteria:1. Adult (> 18 years).
• 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.
• 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).
• Rehabilitation procedures, except physical exercises performed at home, will not be applied for at least 2 months.
• Subjects can sign the patient's informed consent form.

Критерии исключения

• Subjects with autoimmune diseases that can affect the joints of the hands/feet (rheumatoid arthritis, systemic connective tissue diseases, seronegative spondyloarthropathies) or crystalline arthropathies.
• 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.
• Subjects who have suffered serious injuries in the last 6 months or who have undergone surgical interventions on the joints of the hands/feet.
• The functional tests provided in the study cannot be performed due to advanced OA or other diseases.
• Subjects with skin lesions or sensitivity to the intended procedures.
• Diagnosed with oncological diseases or being investigated for oncological diseases.
• Diseases or conditions for which mud or mineral water baths are contraindicated
• Constantly taking pain relievers for other conditions unless the dose is stable for ≥ 1 month.
• Taking Sy-SADOA symptomatic slow-acting OA drugs unless the dose is stable for ≥ 3 months.
• Pregnancy or planned pregnancy.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Литва · 2 центра

• AB Birštonas health resort "Versmė" — Birštonas
• The Hospital of Lithuanian University of Health Sciences Kauno klinikos — Kaunas

Идентификаторы

NCT: NCT06477393 · V-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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