Balneotherapy and Peloid Therapy Impact Small Joint Diseases

NCT ID: NCT06477393

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2029-06-01

Brief Summary

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.

Detailed 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.

Conditions

Osteoarthritis; Hand Osteoarthritis; Foot Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

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.

Group Type: SHAM_COMPARATOR

Regular rehababilitation

Intervention Type: OTHER

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).

Heat procedures

Intervention Type: OTHER

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 gel pack is used at 40-42°C. Temperature of the gel pack can range between 38-43°C.

Experimental group

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.

Group Type: ACTIVE_COMPARATOR

Regular rehababilitation

Intervention Type: OTHER

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).

Healing mud application

Intervention Type: OTHER

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 recommended not to eat, go to the toilet, or take a warm shower. A polyethene film is laid on a special heated couch, and a 2-4 cm thick layer of mud is poured into the area of the hands and feet, covered with a blanket. After the procedure, the subject takes a warm, lukewarm shower, wipes himself with a soft towel, and rests. Peloids are not reused.

Mineral water bath

Intervention Type: OTHER

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 warm, lukewarm shower, wipes himself with a soft towel and rests. Mineral waters are not reused.

Interventions

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).

Intervention Type: OTHER

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 gel pack is used at 40-42°C. Temperature of the gel pack can range between 38-43°C.

Intervention Type: OTHER

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 recommended not to eat, go to the toilet, or take a warm shower. A polyethene film is laid on a special heated couch, and a 2-4 cm thick layer of mud is poured into the area of the hands and feet, covered with a blanket. After the procedure, the subject takes a warm, lukewarm shower, wipes himself with a soft towel, and rests. Peloids are not reused.

Intervention Type: OTHER

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 warm, lukewarm shower, wipes himself with a soft towel and rests. Mineral waters are not reused.

Intervention Type: OTHER

Other Intervention Names

Standart pysiotherapy; Bathing in tap water, hot packs; Peloid thearapy; Balneotherapy

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Versmė

UNKNOWN

Sponsor Role: collaborator

Lithuanian University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Ona Montvydaite-Kreivaitiene

PhD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raimondas Kubilius, Prof

Role: PRINCIPAL_INVESTIGATOR

The Hospital of Lithuanian University of Health Sciences (LSMU) Kaunas clinics

Locations

AB Birštonas health resort "Versmė"

Birštonas, , Lithuania

The Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, , Lithuania

Countries

Lithuania

Other Identifiers

V-2

Identifier Type: -

Identifier Source: org_study_id