Balneotherapy and Peloid Therapy Impact Small Joint Diseases

NCT06477393 | Enrolling By Invitation DMC

• 1 other identifier: V-2
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis; Hand Osteoarthritis; Foot Osteoarthritis

Keywords

balneotherapy, peloid therapy

Outcome Measures

Primary Outcomes (14)

• Heel-Rise Test

  The Heel-Rise Test is a functional assessment used to evaluate the strength and endurance of the calf muscles, particularly the gastrocnemius and soleus muscles. During the test, the participant is asked to perform repeated heel rises while standing on one foot until they can no longer continue or until they reach a predetermined maximum number of repetitions. This test provides valuable information on muscle performance, which is critical for patients with degenerative small joints disease affecting the lower extremities. The outcome is measured by the number of heel rises completed and the quality of movement, including balance and control.

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

• Pinch grip strength

  The manometer will measure the finger compression force. This device will assess: first-second (I-II) finger grip strength, first-second-third (I-II-III) finger grip strength and grip strength. Evaluation units - kilograms (kg) Between muscle contraction measurements, a 30 s rest was applied in the bus to avoid the influence of muscle fatigue. The subjects will be evaluated with a manometer at each visit. Duration 3-5 min.

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

• Hand grip strength

  Hand grip muscle strength will be measured with a dynamometer. The dynamometer is held in the elbow-bent arm, away from the body. When evaluating with a dynamometer, the subject is seated, the shoulders are in a neutral position, the elbow is bent at an angle of 90°, the forearms are placed on the table, and the elbow deviation of the wrist is 0-15°. The device is pressed with maximum force, performing a single-hand pressing movement. The device is pressed with one hand and then with the other hand. The average of three clicks with the left and right hands is evaluated. The units of assessment are kilograms (kg). A 30 s rest will be applied between muscle contraction measurements to avoid the influence of muscle fatigue. A dynamometer will be used to assess subjects at each visit. Duration 5 min.

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

• Hand Mobility in Scleroderma, HAMIS

  Hand Mobility Test in Scleroderma (HAMIS) to assess osteoarthritis. The continuum consists of nine tasks that assess finger, thumb, and wrist mobility, with each task rated from 0 (no impairment) to 3 (cannot perform), resulting in a total possible score of 27 per hand. Standardised cylinders will assess finger flexion, finger extension and thumb adduction. The total score will be calculated as the average of the two hands (range 0-27). Finger and thumb mobility component scores will be calculated by summing the respective subscores: finger flexion, extension and abduction (range 0-9) for finger mobility, thumb adduction and pincer grasp (0-6) for thumb mobility. Duration 5-7 min.

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

• Finger-to-palm, FTP

  The finger-to-palm distance (FTP) will be measured. This measurement is important in assessing the mobility of the fingers and the possible limitation of movement due to various medical conditions such as osteoarthritis. Finger extension and flexion (maximal finger flexion and extension in all three finger joints: MKF, PIF and DIF) are measured.

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

• Modified Kapandji Index, MKI

  Based on anatomical landmarks, a Modified Kapandji (MKI) evaluation index will be performed, especially thumb opposition and finger flexion and extension movements. It allows you to assess the mobility of the fingers and thumb, giving a total score from 0 to 50, where lower scores indicate greater limitation of movement in one hand. The total score is obtained by summing the scores of the three items. Anatomical landmarks and scores are listed in Protocol Appendix No. 1. The total score will be calculated as the average of the two arms (range 0-50). Finger and thumb mobility components will be scored using the corresponding subscores: 2-5 finger flexion and extension (range 0-40) for finger mobility and thumb apposition (range 0-10) for thumb mobility. Duration 2-3 min. The test is performed at each visit.

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

• Strength of extensor and flexor muscles of the foot

  Strength of extensor and flexor muscles of the foot. The test uses a hand-held dynamometer. Strength is measured in kilograms. Force will be measured three times for each side, and the results will be averaged

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

• ROM

  The goniometer will measure the amplitudes during active movement: foot plantarflexion (bending), foot dorsiflexion (extension), and MTF dorsiflexion. The measurements will be repeated three times. The arithmetic mean is calculated after adding up all the results obtained during one measurement. The duration of the study is 5 minutes

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

• 30-second chair stand test

  The maximum number of chair stand repetitions possible in a 30 second period

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

• Stair climb test

  The time (in seconds) it takes to ascend and descend a flight of stairs

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

• 40m (4x10m) fast-paced walk test

  A fast-paced walking test that is timed over 4 x 10m (33 ft) for a total 40 m (132 ft)

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

• The single leg stance test SLS

  This exercise is performed with eyes open and hands on hips. The subject stands on one leg without assistance; time starts when the opposite foot leaves the ground. Time stops immediately when the opposite foot touches the ground and/or when the hands leave the hips. It is repeated three times with both legs, and the average is evaluated. The duration is three minutes.

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

• VAS

  Patients' pain and stiffness will be assessed using a visual analogue (VAS) scale. Pain on squeezing MTF and MCF joints. VAS every day before procedures.

  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

• biomarkers

  Cytokines (IL-6, IL-1beta, and TNF alpha) and biochemical markers of cartilage (thrombospondin-5/COMP (Human Thrombospondin-5/COMP), aggrecan (PG)) will be performed using a standardised ELISA (English enzyme-linked immunosorbent assay) methodology.

  Before and after rehabilitation program

Secondary Outcomes (7)

• Manchester-Oxford Foot Questionnaire (MOxFQ)

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

• Foot and ankle outcome score, FAOS

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

• The Quality of life questionnaire SF-36

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

• The functional index for hand osteoarthritis FIHOA

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

• Michigan Hand Outcomes Questionnaire MHQ

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

Other Outcomes (3)

• Investigator's questionnaire

  Before procedures

• x ray of joints

  Before procedures

• BMI

  Before procedures

Study Arms (2)

Control group

SHAM COMPARATOR

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.

Other: Regular rehababilitation; Other: Heat procedures

Experimental group

ACTIVE COMPARATOR

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.

Other: Regular rehababilitation; Other: Healing mud application; Other: Mineral water bath

Interventions

Regular rehababilitation 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).

Also known as: Standart pysiotherapy

Control group; Experimental group

Heat procedures 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.

Also known as: Bathing in tap water, hot packs

Control group

Healing mud application 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.

Also known as: Peloid thearapy

Experimental group

Mineral water bath 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.

Also known as: Balneotherapy

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead
• Versmė: collaborator

Study Sites (2)

AB Birštonas health resort "Versmė"

Birštonas, 59209, Lithuania

Location

The Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, 50161, Lithuania

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Baths; Balneology

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Raimondas Kubilius, Prof

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The participants can guess indirectly, and the main researcher, the laboratory investigator, will be blind to the group assignments. This single-blinded design is chosen to facilitate the implementation and adherence to the rehabilitation programs.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: 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.

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 27, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

LI (2)