Effectiveness of Balneotherapy in the Treatment of Hand Osteoarthritis: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Primary Endpoint
- Visual Pain Scale (VAS)
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
Visual Pain Scale (VAS)
Time Frame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)
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.
Palm-to-finger distance
Time Frame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)
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).
The Australian / Canadian Osteoarthritis Hand Index (AUSCAN)
Time Frame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)
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.
Hand Osteoarthritis Functional Index
Time Frame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)
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.
Jamar Dynamometer
Time Frame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)
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.
Secondary Outcomes
- Jebsen Taylor Hand Function Test(Before treatment (T0), after treatment (4. week) (T1), 8. week (T2))
- Nine Hole Pag 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))
Investigators
Sevda Adar
Ass. Prof.
Afyonkarahisar Health Sciences University