Balneotherapy in Hand Osteoarthritis

Effectiveness of Balneotherapy in the Treatment of Hand Osteoarthritis: a Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hand Osteoarthritis
• Intervention / Treatment: Other: Exercise; Other: Paraffin; Other: Balneotherapy

Detailed Description

Hand osteoarthritis (OA) is a chronic and disabling disease that can cause pain and functional limitations. The estimated radiological prevalence of hand OA is approximately 54-67% in the adult population aged 55 years and older. This prevalence is expected to increase as the number of elderly people increases. Current guidelines strongly recommend exercise as a nonpharmacological approach to the treatment of hand osteoarthritis, while thermal treatments and paraffin therapy are conditionally recommended.

Balneotherapy is defined as a natural mineral water bath and is one of the most widely used nonpharmacological complementary treatments for different rheumatic diseases in many European countries, Turkey, Israel and Japan. In the last decade, related advances have made it possible to understand the therapeutic effects of balneotherapy in some musculoskeletal disorders.

The effectiveness is achieved through a combination of mechanical, thermal and chemical effects. Warm stimuli increase the pain threshold and provide analgesia in nerve endings. The EULAR task force's recommendation for hand OA, which suggests local heat application (e.g. paraffin wax, hot pack) as a useful treatment, also draws attention to the effect of heat. Spa treatment triggers a series of neuroendocrine reactions and particularly induces the release of adrenocorticotropic hormone (ACTH), cortisol, prolactin and growth hormone (GH).

Thermomineral water baths have a small effect on pain, a moderate effect on symptoms related to other musculoskeletal diseases and up to 3 months of pain relief; it is considered to be more beneficial than tap water or no treatment for the improvement of symptoms related to musculoskeletal diseases. Even a single balneotherapy procedure can provide pain relief.

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SEVDA ADAR, Ass. Prof.; Phone Number: +90 532 594 07 25; Email: drsevdaadar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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
• Open wound
• Orthopedic condition that would prevent entering the spa

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Balneotherapy Group; 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; 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.; Other: Paraffin; 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.; Other: Balneotherapy; 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.
Active Comparator: Control Group; 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; 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.; Other: Paraffin; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nine Hole Pag Test	This test measures manual dexterity based on performance (seconds). A wooden board with nine holes on it, 9 short wooden sticks and a box in which the wooden sticks can be placed are placed in front of the patient. The patient is asked to place the wooden sticks in the box into the holes on the board as quickly as possible using the hand to be evaluated, then is asked to put the sticks back into the box one by one. The test completion time is determined by a stopwatch	Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)
Jebsen Taylor Hand Function Test	Test items are turning cards, picking up small objects and throwing them into a tin can, stacking backgammon tiles, writing, jumping 5 light tin cans across, jumping 5 heavy tin cans across, collecting 5 dried kidney beans using a dessert spoon The test materials include detailed instructions for use in the test manual. In order to ensure a standard arrangement of the objects used, a scaled board and a stopwatch are included in the test materials to measure the time the activities are performed. Before the test is administered, the person is shown how to do it. Explaining that the test is performed against time is necessary for the patient's motivation. The patient starts with the start command and the stopwatch is stopped when the activity is completed.	Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)
Health Assessment Questionnaire (HAQ)	HAQ was developed for the assessment of patients with rheumatic diseases. It consists of 20 questions related to eight activities (items); dressing, getting up, eating, walking, hygiene, grasping and activities of daily living are questioned. HAQ reflects the functional status of patients and this questionnaire has been shown to correlate with disease activity markers. Each item or question is rated on a scale of 0 to 3, with 0 (normal/no difficulty), 1 (some difficulty), 2 (much difficulty), and 3 (unable to do). The 8 category scores are averaged, which represent an overall score from 0 (no disability) to 3 (completely disabled). Scores 0-1 indicates mild to moderate disability, 1-2 indicates moderate to severe disability, and 2-3 indicates severe to very severe disability.	Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)
SF-36 Quality of Life Scale	SF-36 is a generic quality of life scale. It is evaluated between 0-100 points. It was created to evaluate health status. It contains a total of 36 items. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.There is a Turkish validity and reliability study.	Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)

Collaborators and Investigators

• Sponsor: Afyonkarahisar Health Sciences University

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2024
• Primary Completion (Estimated): November 15, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Estimated): November 25, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: SABALNEO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No