Clinical trial NCT06477393: Balneotherapy and Peloid Therapy Impact Small Joint Diseases
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Osteoarthritis
Hand Osteoarthritis
Foot Osteoarthritis
Keywords: balneotherapy, peloid therapy
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Versmė
First posted: 2024-06-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study employs a parallel-group design, where participants are randomly assigned to one of two groups: an experimental group receiving the enhanced rehabilitation program with natural healing factors and a control group receiving the standard rehabilitation program. The randomisation ensures that each participant has an equal chance of being assigned to either group, minimising selection bias and ensuring comparability between the groups.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Heel-Rise Test
timeFrame: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
measure: Pinch grip strength
timeFrame: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
measure: Hand grip strength
timeFrame: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
measure: Hand Mobility in Scleroderma, HAMIS
timeFrame: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
measure: Finger-to-palm, FTP
timeFrame: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
measure: Modified Kapandji Index, MKI
timeFrame: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
measure: Strength of extensor and flexor muscles of the foot
timeFrame: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
measure: ROM
timeFrame: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
measure: 30-second chair stand test
timeFrame: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
measure: Stair climb test
timeFrame: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
measure: 40m (4x10m) fast-paced walk test
timeFrame: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
measure: The single leg stance test SLS
timeFrame: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
measure: VAS
timeFrame: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months. Additionally, the VAS will be assessed for pain and stiffness each day before the procedures at 8-9 am. morning
measure: biomarkers
timeFrame: Before and after rehabilitation program
Secondary outcomes:
measure: Manchester-Oxford Foot Questionnaire (MOxFQ)
timeFrame: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
measure: Foot and ankle outcome score, FAOS
timeFrame: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
measure: The Quality of life questionnaire SF-36
timeFrame: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
measure: The functional index for hand osteoarthritis FIHOA
timeFrame: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
measure: Michigan Hand Outcomes Questionnaire MHQ
timeFrame: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
measure: Ultrasound of hand joints
timeFrame: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
measure: Ultrasound of foot joints
timeFrame: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
Other outcomes:
measure: Investigator's questionnaire
timeFrame: Before procedures
measure: x ray of joints
timeFrame: Before procedures
measure: BMI
timeFrame: Before procedures
Locations:
city: Birštonas
country: Lithuania
facility: AB Birštonas health resort "Versmė"
city: Kaunas
country: Lithuania
facility: The Hospital of Lithuanian University of Health Sciences Kauno klinikos
Study officials:
affiliation: The Hospital of Lithuanian University of Health Sciences (LSMU) Kaunas clinics
name: Raimondas Kubilius, Prof
role: PRINCIPAL_INVESTIGATOR
References: