Placebo Development and Validation for Healing Water

Balneology Clinical Trial

Official title:

Introducing a New and Validated Placebo Development Method to Healing Water Based Rehabilitation Research

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04290143
• Other study ID #: OTKA_131531_PLACEBO
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: February 7, 2020

Study information

• Verified date: February 2020
• Source: University of Pecs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water.

Description:

Introduction: The beneficial health effects of healing waters have been reported by numerous studies. However, the lack of proper placebo substance makes the "medication-like" investigation of healing waters difficult. The investigators aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water.

Methods: Both medical water and tap water will be colored. The temperature and the pH of the tap water will be adjusted to the temperature pH of the healing water. The patients will be divided into two groups, colored healing water and placebo group. A single 20 minutes-long treatment will be performed in bath tubs. Considering the healing waters odor, the treatment will be given in the same room. Patients will be asked to tell whether they are treated with colored healing water or placebo or could not tell. Questions will be asked before the treatment, 10 minutes after the beginning of the treatment, immediately after the end of the treatment and after shower. The study will be performed in a double blind setup. Patients will be scored, one point for each correct answer.

Target patient number:174

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: February 7, 2020
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• willingness to participate in the study

• age between 18-80 years

Exclusion Criteria:

• patients physically unable to enter or exit the bath tub

• autoimmune diseases

• any kind of malignity

• acute inflammation

• infection

• acute coronary syndrome or recent surgical interventions (6 month before enrollment)

Related Conditions & MeSH terms

• Balneology

Intervention

Other:
• Colored healing water
Patients will be treated with colored healing water for 20 minutes.
• Placebo treatment (colored tap water)
Patients will be treated with colored tap water for 20 minutes.

Locations

Country	Name	City	State
Hungary	Harkány Thermal Rehabilitation Centre	Harkány	Baranya
Hungary	Katalin Dr Szendi	Pécs	Baranya

Sponsors (3)

Lead Sponsor	Collaborator
University of Pecs	Harkány Spa Hospital, Harkány, Hungary, National Research, Development and Innovation Office, Budapest, Hungary

Country where clinical trial is conducted

Hungary, 

References & Publications (6)

Bender T, Bálint G, Prohászka Z, Géher P, Tefner IK. Evidence-based hydro- and balneotherapy in Hungary--a systematic review and meta-analysis. Int J Biometeorol. 2014 Apr;58(3):311-23. doi: 10.1007/s00484-013-0667-6. Epub 2013 May 16. Review. — View Citation

Hanzel A, Berényi K, Horváth K, Szendi K, Németh B, Varga C. Evidence for the therapeutic effect of the organic content in Szigetvár thermal water on osteoarthritis: a double-blind, randomized, controlled clinical trial. Int J Biometeorol. 2019 Apr;63(4):449-458. doi: 10.1007/s00484-019-01676-3. Epub 2019 Feb 7. — View Citation

Hanzel A, Horvát K, Molics B, Berényi K, Németh B, Szendi K, Varga C. Clinical improvement of patients with osteoarthritis using thermal mineral water at Szigetvár Spa-results of a randomised double-blind controlled study. Int J Biometeorol. 2018 Feb;62(2):253-259. doi: 10.1007/s00484-017-1446-6. Epub 2017 Sep 27. — View Citation

Matsumoto S. Evaluation of the Role of Balneotherapy in Rehabilitation Medicine. J Nippon Med Sch. 2018;85(4):196-203. doi: 10.1272/jnms.JNMS.2018_85-30. Review. — View Citation

Morer C, Roques CF, Françon A, Forestier R, Maraver F. The role of mineral elements and other chemical compounds used in balneology: data from double-blind randomized clinical trials. Int J Biometeorol. 2017 Dec;61(12):2159-2173. doi: 10.1007/s00484-017-1421-2. Epub 2017 Aug 28. Review. — View Citation

Szucs L, Ratko I, Lesko T, Szoor I, Genti G, Balint G. Double-blind trial on the effectiveness of the Puspokladany thermal water on arthrosis of the knee-joints. J R Soc Health. 1989 Feb;109(1):7-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who responded 'placebo,' to question 1	The measurement is performed by a questionnaire filled in accordingly by an investigator	prior to treatment
Primary	Number of participants who responded 'colored healing water' to question 1	The measurement is performed by a questionnaire filled in accordingly by an investigator	prior to treatment
Primary	Number of participants who responded ' could not tell' to question 1	The measurement is performed by a questionnaire filled in accordingly by an investigator	prior to treatment
Primary	Number of participants who responded 'placebo,' to question 2	The measurement is performed by a questionnaire filled in accordingly by an investigator	10 minutes after the beginning of treatment
Primary	Number of participants who responded 'colored healing water' to question 2	The measurement is performed by a questionnaire filled in accordingly by an investigator	10 minutes after the beginning of treatment
Primary	Number of participants who responded ' could not tell' to question 2	The measurement is performed by a questionnaire filled in accordingly by an investigator	10 minutes after the beginning of treatment
Primary	Number of participants who responded 'placebo,' to question 3	The measurement is performed by a questionnaire filled in accordingly by an investigator	Immediately after the end of the treatment
Primary	Number of participants who responded 'colored healing water' to question 3	The measurement is performed by a questionnaire filled in accordingly by an investigator	Immediately after the end of the treatment
Primary	Number of participants who responded ' could not tell' to question 3	The measurement is performed by a questionnaire filled in accordingly by an investigator	Immediately after the end of the treatment
Primary	Number of participants who responded 'placebo,' to question 4	The measurement is performed by a questionnaire filled in accordingly by an investigator	After taking a sower (within 15 minutes after the end of the treatment)
Primary	Number of participants who responded 'colored healing water' to question 4	The measurement is performed by a questionnaire filled in accordingly by an investigator	After taking a sower (within 15 minutes after the end of the treatment)
Primary	Number of participants who responded ' could not tell' to question 4	The measurement is performed by a questionnaire filled in accordingly by an investigator	After taking a sower (within 15 minutes after the end of the treatment)