NCT03388801

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
Last Updated

January 3, 2018

Status Verified

December 1, 2017

Enrollment Period

3 months

First QC Date

December 1, 2017

Last Update Submit

December 29, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in the quality of life

    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 Outcomes (2)

  • Change in pain perception (VAS)

    at baseline, 3 and 12 months

  • Change in: pain intensity, frequency of pain, frequency of using painkillers and mobility

    at baseline, 3 and 12 months

Study Arms (1)

Spa therapy

EXPERIMENTAL

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: Spa therapy

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).

Also known as: balneotherapy
Spa therapy

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Zwolinska J, Weres A, Wyszynska J. One-Year Follow-Up of Spa Treatment in Older Patients with Osteoarthritis: A Prospective, Single Group Study. Biomed Res Int. 2018 Jul 2;2018:7492106. doi: 10.1155/2018/7492106. eCollection 2018.

MeSH Terms

Conditions

Osteoarthritis

Interventions

Balneology

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Jolanta Zwolińska, Dr

    Medical Faculty, University of Rzeszów

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 1, 2017

First Posted

January 3, 2018

Study Start

April 1, 2016

Primary Completion

July 1, 2016

Study Completion

August 30, 2017

Last Updated

January 3, 2018

Record last verified: 2017-12