Balneotherapy and Peloid Therapy Impact Small Joint Diseases (NCT06477393) | Clinical Trial Compass
By InvitationNot Applicable
Balneotherapy and Peloid Therapy Impact Small Joint Diseases
Lithuania130 participantsStarted 2024-08-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Subjects with autoimmune diseases that can affect the joints of the hands/feet (rheumatoid arthritis, systemic connective tissue diseases, seronegative spondyloarthropathies) or crystalline arthropathies.
✕
What they're measuring
1
Heel-Rise Test
Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
2
Pinch grip strength
Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
3
Hand grip strength
Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
4
Hand Mobility in Scleroderma, HAMIS
Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
5
Finger-to-palm, FTP
Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
6
Modified Kapandji Index, MKI
Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
7
Strength of extensor and flexor muscles of the foot
Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
. 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.
Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
9
30-second chair stand test
Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
10
Stair climb test
Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
11
40m (4x10m) fast-paced walk test
Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
12
The single leg stance test SLS
Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months
13
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
14
biomarkers
Timeframe: Before and after rehabilitation program