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Completed

NCT Number: NCT03388801

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spa therapy

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Rzeszow

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jan 3, 2018
Registry last updated
Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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