Balneotherapy in Hand Osteoarthritis

Official title

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

Overview

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

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.

Interventions

• 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.

Primary outcome measures

• Visual Pain Scale (VAS) [Time frame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)]
• Palm-to-finger distance [Time frame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)]
• The Australian / Canadian Osteoarthritis Hand Index (AUSCAN) [Time frame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)]
• Hand Osteoarthritis Functional Index [Time frame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)]
• Jamar Dynamometer [Time frame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)]

Secondary outcome measures (4)

• Nine Hole Pag Test [Time frame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)]
• Jebsen Taylor Hand Function Test [Time frame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)]
• Health Assessment Questionnaire (HAQ) [Time frame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)]
• SF-36 Quality of Life Scale [Time frame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06702514 · SABALNEO

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗