Balneotherapy in Hand Osteoarthritis

NCT ID: NCT06702514

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2025-12-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hand Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise

Intervention Type 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.

Paraffin

Intervention Type 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

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type 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.

Paraffin

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Afyonkarahisar Health Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Sevda Adar

Ass. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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SEVDA ADAR, Ass. Prof.

Role: CONTACT

+90 532 594 07 25

Other Identifiers

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SABALNEO

Identifier Type: -

Identifier Source: org_study_id

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