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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Heel-Rise Test

Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months

Pinch grip strength

Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months

Hand grip strength

Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months

Hand Mobility in Scleroderma, HAMIS

Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months

Finger-to-palm, FTP

Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months

Modified Kapandji Index, MKI

Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months

Strength of extensor and flexor muscles of the foot

Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months

Trial details

NCT IDNCT06477393

SponsorLithuanian University of Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-06-01

View on ClinicalTrials.gov More Osteoarthritis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Heel-Rise Test

Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months

Pinch grip strength

Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months

Hand grip strength

Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months

Hand Mobility in Scleroderma, HAMIS

Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months

Finger-to-palm, FTP

Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months

Modified Kapandji Index, MKI

Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months

Strength of extensor and flexor muscles of the foot

Timeframe: Before the start of the rehabilitation program, follow up 2, 3, 6,12 months