ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Supraspinatus Tendinitis

Condition category

Condition code

Musculoskeletal

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]

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]

Pain intensity ,
The VAS pain assessment scale will be use for subjective assessment of the pain.

Timepoint [1]