Clinical trial NCT03388801: Quality-of-life and Pain After Spa Treatment in Elderly With Osteoarthritis
Official title: Short and Long-term Follow-up of Quality-of-life and Pain After Spa Treatment in Elderly With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Quality of Life
Elderly
Balneology
Lead sponsor: University of Rzeszow
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in the quality of life
timeFrame: at baseline, 3 and 12 months
Secondary outcomes:
measure: Change in pain perception (VAS)
timeFrame: at baseline, 3 and 12 months
measure: Change in: pain intensity, frequency of pain, frequency of using painkillers and mobility
timeFrame: at baseline, 3 and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Medical Faculty, University of Rzeszów
name: Jolanta Zwolińska, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.