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CompletedNCT03388801Updated Jan 3, 2018

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

An interventional study of Spa therapy in Osteoarthritis, Quality of Life and Elderly, sponsored by University of Rzeszow. Completed. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2018-01-03.

Sponsored by University of Rzeszow · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Osteoarthritis
  • Quality of Life
  • Elderly
  • Balneology

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03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • 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).

    Other: Spa therapy

Interventions

  • OtherSpa 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).

    Also known as: balneotherapy

05

What researchers measure

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.

    Time frame: at baseline, 3 and 12 months

Secondary outcomes

  1. Change in pain perception (VAS)

    Evolution of VAS (Visual Analogic Scale) between baseline, 3 and 12 months.

    Time frame: at baseline, 3 and 12 months

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

    Evolution of the Modified Laitinen Pain Questionnaire between baseline, 3 and 12 months.

    Time frame: at baseline, 3 and 12 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 30065943 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03388801
Lead sponsor
University of Rzeszow
Responsible party
Jolanta Zwolińska (Principal Investigator, University of Rzeszow) — Principal investigator
First posted
Jan 3, 2018
Start date
Apr 1, 2016
Primary completion
Jul 1, 2016
Completion
Aug 30, 2017
Last update
Jan 3, 2018

Study contacts

Jolanta Zwolińska, Dr
principal investigator · Medical Faculty, University of Rzeszów

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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