Hand OsteoarthritisNCT06702514
Balneotherapy in Hand Osteoarthritis
A study testing Exercise, Paraffin and Balneotherapy in people with Hand Osteoarthritis, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- Exercise, Paraffin and Balneotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2024to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 50-75
- Hand osteoarthritis diagnosed according to ACR criteria
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University Health Application and Research Center Physical Medicine and Rehabilitation Clinic
Afyonkarahisar
About this study
Official title: 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.
Read the 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.
- Conditions
- Hand Osteoarthritis
- Being tested
- Exercise, Paraffin, Balneotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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.
ParaffinOther
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.
BalneotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercise; Other: Paraffin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)
Secondary outcomes (4)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start15 Dec 2024
- Primary completion15 Oct 2026
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Adar, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702514
- Sponsor's protocol ID
- SABALNEO
- Status last verified
- Jul 2026
- First submitted
- 19 Nov 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Balneotherapy in the Treatment of Hand Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06702514
- Acronym / sponsor ID
- SABALNEO
- Conditions
- Hand Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 15 Oct 2026 (actual)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balneotherapy Group | Experimental | Other: Exercise, Other: Paraffin, Other: BalneotherapyThis 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. |
| Control Group | Active comparator | Other: Exercise, Other: ParaffinThe 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between the ages of 50-75
- Hand osteoarthritis diagnosed according to ACR criteria
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAfter 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 | Balneotherapy Group, Control Group |
| ParaffinIt 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 Group, Control Group |
| BalneotherapyThe 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. | Other | Balneotherapy Group |
Primary outcome
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.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Paraffin and Balneotherapy in people with Hand Osteoarthritis, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Pain Scale (VAS) (time frame: Before treatment (T0), after treatment (4. week) (T1), 8. week (T2)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.