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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000045112
Ethics application status
Approved
Date submitted
31/12/2018
Date registered
14/01/2019
Date last updated
26/03/2019
Date data sharing statement initially provided
14/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Balneotherapy on Treatment of Subacute Suraspinatus Tendinitis
Scientific title
The Effect of Balneotherapy on Treatment of Subacute Suraspinatus Tendinitis
Secondary ID [1] 296956 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Supraspinatus Tendinitis 310919 0
Condition category
Condition code
Musculoskeletal 309580 309580 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of 90 patients aged 20-65 years who were admitted to physical therapy and rehabilitation clinic with the diagnosis of subacute supraspinatus tendinitis will be included in this study.
Each study groups will be treated by exercises and physical therapy agents, only the study group will be treated by phisical therapy agents, exercises and additionally balneotherapy.
Balneotherapy, calcium sulphate and bicarbonate, carbon dioxide, fluoride, thermal (natural temperature average 45 C) and mineral (total mineral up to 2 g / L) will be applied with natural thermomineral healing water. The application will be carried out every day according to the patient's endurance, in the form of full bath, the first day is 10 minutes to 20-25 minutes in the following days.
Patients to be included in the study will be evaluated before treatment, 15 sessions after treatment.
The evaluation criteria will be taken by the VAS scoring system with pain (rest, movement, sleep) and quick dash test which is functional assessment of the shoulder, and the overall quality of life scale (SF-36).
In addition, for the purpose of functional evaluation; Evaluation of hand grip strength with jamar hand dynamometry, active joint range of motion of the shoulder with goniometer will be evaluated, the results will be recorded.
The comparison of these results with baseline and post-treatment results and whether they are associated with SF-36, VAS, Quick Dash scoring will be analyzed.
Intervention code [1] 313229 0
Diagnosis / Prognosis
Comparator / control treatment
Update
Each study groups will be treated by exercises and physical therapy agents :
-Transcutaneus Electrical Nerve Stimulation (TENS) ;.the painful shoulder will be applied in conventional mode for 20 minutes. In this model, high frequency, short pulse duration and low amplitude stimulant are given.
The frequency is 50-100 Hz, the pulse duration is 200 msec and the amplitude density is
without contraction, excessive feeling of discomfort and slight tingling intensity of 1-100 mA will be between.
To obtain the best effect, the electrodes will be placed under and above the painful area.
-HotPack;
For 30 minutes.
Silica gel is used to heat and use pillows.
These pillows will be heated by standing in water tanks with a temperature of 71-79 C °.
When applied to the towel wrapped around the painful shoulder will be put on.
Utrasound application; with 1,5 w/cm² for 5 minutes).
Exercises: Codman's Pendulum Exercises and active range of motion exercises with shoulder wheel.
Exercises will be applied to the painful shoulder as the investigator observes and directs.
30 minutes after each treatment session is planned to be implemented.
Only the study group will be treated by physical therapy agents, exercises and additionally whole body balneotherapy for 30 minutes every day.
Treatment sessions will be administered for 3 weeks except weekends
Control group
Active

Outcomes
Primary outcome [1] 318535 0
Pain intensity , The VAS pain assessment scale will be use for subjective assessment of the pain.
Timepoint [1] 318535 0
Patients to be included in the study will be evaluated before treatment, 21 sessions after treatment and 3 months after diagnosis.
Primary outcome [2] 318536 0
Quality of life Short Form 36 (SF-36) will be use to assess quality of life of the patients.
Timepoint [2] 318536 0
Patients to be included in the study will be evaluated before treatment, 21 sessions after treatment and 3 months after diagnosis.
Primary outcome [3] 318537 0
Functional assessment of the shoulder Quick Dash test will be use to functional assessment of the shoulder
Timepoint [3] 318537 0
Patients to be included in the study will be evaluated before treatment, 21 sessions after treatment and 3 months after diagnosis.
Secondary outcome [1] 365302 0
Evaluation of hand grip strength with jamar hand dynamometry,
Timepoint [1] 365302 0
Patients to be included in the study will be evaluated before treatment, 21 sessions after treatment and 3 months after diagnosis.
Secondary outcome [2] 365303 0
Evaluation of the range of motion of the shoulder with goniometer
Timepoint [2] 365303 0
Patients to be included in the study will be evaluated before treatment, 21 sessions after treatment and 3 months after diagnosis.

Eligibility
Key inclusion criteria
Patients who were admitted to the physical therapy and rehabilitation clinic with the complaint of shoulder pain and diagnosed as supraspinatus tendinitis ;
-Pain intensity (VAS 4 and above) to be moderate or severe
-Complete passive range of motion
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neurological deficit,
Rheumatologic, oncological or infectious disease,
Severe psychiatric disorder,
Severe cardiovascular and pulmonary disease,
Coagulopathy,
Having received the balneotherapy and physical therapy program in the last 1 year,
Shoulder surgery,
Rotator cuf rupture, osteonecrosis, cuff arthropathy, septic arthritis, adhesive capsulitis,
Regional diseases (sevikal radiculopathy, brachial neuritis, complex regional pain syndrome, malignancy),
Internal organ-induced shoulder pain,
Trauma and fracture,
Acromioclavicular joint pathology,
Patient discontinuation of treatment,
Removal from treatment due to patient mismatch.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
For all analyzes, SPSS 22.0 (IBM Corp. Released 2013. IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY: IBM Corp.) will be used. Numerical variables with mean ± standard deviation, median (minimum-maximum) values; categorical variables will be given by frequency and percentage. The Shapiro-Wilk Normality Test will be used to determine whether the numerical variables satisfy the normality assumption. Paired t-test or Wilcoxon Assay for the comparison of pre-treatment values for treatment groups; Two samples t Test or Mann-Whitney U Test will be used to compare the differences between the treatment groups before and after treatment. The McNemar Test will be used to analyze the post-treatment change of categorically dependent variables, and the chi-square test will be used to compare categorical variable rates before and after treatment between treatment groups. In the analyzes p <0.05 will be taken as statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/03/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/05/2019
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 21152 0
Turkey
State/province [1] 21152 0
Kirsehir

Funding & Sponsors
Funding source category [1] 301524 0
University
Name [1] 301524 0
Ahi Evran University Faculty of Medicine
Country [1] 301524 0
Turkey
Primary sponsor type
University
Name
Ahi Evran University Faculty of Medicine
Address
Bagbasi Mah. Sehit Sahir Kurutluoglu Cad. No:100
Country
Turkey
Secondary sponsor category [1] 301300 0
None
Name [1] 301300 0
Address [1] 301300 0
Country [1] 301300 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302266 0
Ahi Evran University Faculty of Medicine Clinical Research Ethics Committee
Ethics committee address [1] 302266 0
Ethics committee country [1] 302266 0
Turkey
Date submitted for ethics approval [1] 302266 0
12/02/2018
Approval date [1] 302266 0
01/03/2018
Ethics approval number [1] 302266 0
1

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89630 0
Dr Cihan Koc
Address 89630 0
Ahi Evran University Faculty of Medicine Department of Physical Medicine and Rehabilitation Bagbasi Mah. Sehit Sahir Kurutluoglu Cad. No: 100
Country 89630 0
Turkey
Phone 89630 0
+905418455733
Fax 89630 0
Email 89630 0
[email protected]
Contact person for public queries
Name 89631 0
Cihan Koc
Address 89631 0
Ahi Evran University Faculty of Medicine Department of Physical Medicine and Rehabilitation Bagbasi Mah. Sehit Sahir Kurutluoglu Cad. No: 100
Country 89631 0
Turkey
Phone 89631 0
+905418455733
Fax 89631 0
Email 89631 0
[email protected]
Contact person for scientific queries
Name 89632 0
Cihan Koc
Address 89632 0
Ahi Evran University Faculty of Medicine Department of Physical Medicine and Rehabilitation Bagbasi Mah. Sehit Sahir Kurutluoglu Cad. No: 100
Country 89632 0
Turkey
Phone 89632 0
+905418455733
Fax 89632 0
Email 89632 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone who wants to access

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• Any purpose

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication and no end date determined

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Unrestricted access via web address

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.