Quality-of-life and Pain After Spa Treatment in Elderly With Osteoarthritis

December 29, 2017 updated by: Jolanta Zwolińska, University of Rzeszow

Short and Long-term Follow-up of Quality-of-life and Pain After Spa Treatment in Elderly With Osteoarthritis

The aim of the study was to evaluate the short- and long-term effects of spa therapy on quality of life and pain in patients aged 65 years and older with osteoarthritis.

70 patients with osteoarthritis referred to spa treatment in south-eastern Poland were enrolled in the study. Spa treatment lasted 3 weeks.

All the patients benefited from spa therapy.

VAS pain scale, the Laitinen scale and WHOQOL-BREF questionnaire were used to assess the condition of the patients. The examinations were performed three times: at the beginning of the spa treatment, after three months and one year after the first examinations.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

In an interventional study design, there have been examined patients aged over 65 years with the diagnosis of osteoarthritis who were prescribed a first spa therapy course in spa resorts in south-eastern Poland, between April 2016 and July 2016.

Patients were assessed by an experienced physicians on the first day of the spa therapy (study 1), after three months (study 2) and one year (study 3) after the completion of the spa therapy.

All patients who had been enrolled to the study, were asked to fill out the appropriate questionnaires (on the first day of the spa therapy). The investigators ensured that questionnaires were properly completed, under the supervision of researcher previously trained for their application. Second (study 2) and third (study 3) stages of the study were performed after three months, and one year after the first study, respectively (participants were interviewed by telephone survey).

Interventions Spa treatment was applied during a session lasting 120 to 150 minutes a day. Spa treatment lasted 3 weeks, including treatments from Monday to Friday (15 days of treatment). As a part of comprehensive spa treatment, all the patients benefited from kinesiotherapy, physical agent modalities (electrotherapy, phototherapy), massage and balneotherapy (peloid therapy, hydrotherapy with mineral waters, crenotherapy).

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age over 65
  • diagnosis of osteoarthritis,
  • completion of 3 weeks of spa treatment
  • patient's consent to participate in the study

Exclusion Criteria:

  • failure to complete 3-weeks spa treatment,
  • significant random events during follow-up
  • diagnosed other diseases during follow-up,
  • other forms of therapy implemented during follow-up,
  • refusal to participate in II or III stage of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spa therapy
Spa treatment was applied during a session lasting 120 to 150 minutes a day. Spa treatment lasted 3 weeks, including treatments from Monday to Friday (15 days of treatment). As a part of comprehensive spa treatment, all the patients benefited from kinesiotherapy, physical agent modalities (electrotherapy, phototherapy), massage and balneotherapy (peloid therapy, hydrotherapy with mineral waters, crenotherapy).
Spa treatment was applied during a session lasting 120 to 150 minutes a day. Spa treatment lasted 3 weeks, including treatments from Monday to Friday (15 days of treatment). As a part of comprehensive spa treatment, all the patients benefited from kinesiotherapy, physical agent modalities (electrotherapy, phototherapy), massage and balneotherapy (peloid therapy, hydrotherapy with mineral waters, crenotherapy).
Other Names:
  • balneotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the quality of life
Time Frame: at baseline, 3 and 12 months
Comparison of the WHOQOL-BREF questionnaire mean between baseline, 3 and 12 months. Quantitative evaluation of the primary outcome.
at baseline, 3 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain perception (VAS)
Time Frame: at baseline, 3 and 12 months
Evolution of VAS (Visual Analogic Scale) between baseline, 3 and 12 months.
at baseline, 3 and 12 months
Change in: pain intensity, frequency of pain, frequency of using painkillers and mobility
Time Frame: at baseline, 3 and 12 months
Evolution of the Modified Laitinen Pain Questionnaire between baseline, 3 and 12 months.
at baseline, 3 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jolanta Zwolińska, Dr, Medical Faculty, University of Rzeszów

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

August 30, 2017

Study Registration Dates

First Submitted

December 1, 2017

First Submitted That Met QC Criteria

December 29, 2017

First Posted (Actual)

January 3, 2018

Study Record Updates

Last Update Posted (Actual)

January 3, 2018

Last Update Submitted That Met QC Criteria

December 29, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • Spa-osteoarthritis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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