Balneotherapy in Hand Osteoarthritis

NCT06702514 | Not Yet Recruiting

• 1 other identifier: SABALNEO
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

There are a limited number of studies in the literature on the effectiveness of balneotherapy in hand osteoarthritis. The aim of this study was to evaluate the effects of balneotherapy on pain, manual skills, functionality and quality of life in patients with hand osteoarthritis who have undergone balneotherapy.

Conditions

Hand Osteoarthritis

Outcome Measures

Primary Outcomes (5)

• Visual Pain Scale (VAS)

  VAS which is easy to understand, apply and interpret, and provides valid and reliable data in a short time, is the most commonly used method in clinics. With a 100 mm visual linear scale, the patient is told that there is no pain at point 0, and that the most severe pain they have ever felt at point 100, and the patient is asked to put a mark on the point corresponding to their pain.

  Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)

• Palm-to-finger distance

  Palm-to-finger distance Used to assess hand joint mobility. Obtained by measuring the distance (in millimeters) between the fingertip of the second to fifth finger and the distal palmar crease while making a full fist and adding the distances (higher scores indicate greater limitations).

  Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)

• The Australian / Canadian Osteoarthritis Hand Index (AUSCAN)

  It was developed specifically for use in hand osteoarthritis. It is recommended for use in clinical studies by OMERACT (Outcome Measures in Rheumatology Clinical Trials Group). It evaluates hand functions, pain and stiffness in patients with hand osteoarthritis. It consists of three subscales: Hand pain (5 items), hand stiffness (1 item), hand function (9 items). A 5-point Likert scale (0=none, 4=severe) LK 3.0 is used. Its validity and reliability have been demonstrated in osteoarthritis.

  Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)

• Hand Osteoarthritis Functional Index

  It is a 10-question questionnaire. Answers are scored on a 4-point scale: 0 = Possible without difficulty; 1 = Possible with some difficulty; 2 = Possible with great difficulty; 3 = Impossible. The total score for the questionnaire ranges from 0 to 30. A higher score indicates a more severe functional limitation. Validity and reliability in Turkish have been demonstrated.

  Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)

• Jamar Dynamometer

  Measurements will be made by sitting with the shoulder adducted and neutrally rotated, adjacent to the body, elbow 90 degrees flexed, wrist 0-30 degrees dorsiflexed and 0-15 degrees ulnar deviation, thumb up. Measurements will be repeated three times with 5-second intervals on the affected hand and the average of the three measurements will be recorded in kilograms. Finger grip strength will be assessed with the 'Jamar digital pinchmeter'. Patients will be placed in a sitting position with the wrist 90° flexed and the forearm in a neutral position. Measurements will be made bilaterally in three different positions as lateral, palmar and fingertip grips. Patients will be asked to squeeze with maximum force and each measurement will be taken three times and the average will be recorded in kg.

  Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)

Secondary Outcomes (4)

• Nine Hole Pag Test

  Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)

• Jebsen Taylor Hand Function Test

  Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)

• Health Assessment Questionnaire (HAQ)

  Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)

• SF-36 Quality of Life Scale

  Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)

Study Arms (2)

Balneotherapy Group

EXPERIMENTAL

This group will receive 20 minutes of paraffin and 20 minutes of balneotherapy on both hands, five times a week for 4 weeks, for a total of 20 sessions, using one session per day. In addition, a daily exercise program (15 minutes of joint range of motion, 15 minutes of strengthening exercises) will be given once a day, accompanied by a physiotherapist.

Other: Exercise; Other: Paraffin; Other: Balneotherapy

Control Group

ACTIVE COMPARATOR

The control group was planned to receive 20 minutes of paraffin treatment on both hands, five times a week for 4 weeks, one session per day for a total of 20 sessions. In addition, a daily exercise program (15 minutes of joint range of motion, 15 minutes of strengthening exercises) will be given once a day, accompanied by a physiotherapist.

Other: Exercise; Other: Paraffin

Interventions

Exercise OTHER

After their treatment, both groups will be given a daily exercise program (15 minutes of range of motion, 15 minutes of strengthening exercises) once a day, accompanied by a physiotherapist.

Balneotherapy Group; Control Group

Paraffin OTHER

It was planned to apply paraffin treatment to both hands for 20 minutes, five times a week for 4 weeks, using one session per day for a total of 20 sessions.

Balneotherapy Group; Control Group

Balneotherapy OTHER

The balneotherapy group will receive 20 minutes of paraffin and 20 minutes of balneotherapy on both hands, five times a week for 4 weeks, one session per day for a total of 20 sessions. The spa treatment will be given in the form of a 20-minute full body bath in the pool in each session. The spa water temperature will be 38-40 degrees Celsius.

Balneotherapy Group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 50-75
• Hand osteoarthritis diagnosed according to ACR criteria

You may not qualify if:

• Non-cooperative patients
• Trauma or surgery to the hand region in the last 6 months
• Infection
• Infection, loss of sensation, metal implant in the treatment area
• Injection to the hand joints in the last 3 months
• Physical therapy and rehabilitation to the hand region in the last 3 months
• Balneotherapy in the last 3 months
• Inflammatory rheumatic diseases
• NSAI use
• Planning pregnancy during pregnancy or treatment
• Malignancy
• Presence of a neurological disease
• Hand-wrist entrapment neuropathy
• Loss of muscle strength or sensation in the hand
• Uncontrolled cardiopulmonary disease

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

MeSH Terms

Interventions

Exercise; Paraffin; Balneology

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Hydrocarbons; Organic Chemicals; Therapeutics

Central Study Contacts

SEVDA ADAR, Ass. Prof.

CONTACT

+90 532 594 07 25; drsevdaadar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof.

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 25, 2024
• Study Start: December 15, 2024
• Primary Completion: November 15, 2025
• Study Completion: December 15, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share