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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03388801
• Other study ID #: Spa-osteoarthritis
• Status: Completed
• Phase: N/A
• First received: December 1, 2017
• Last updated: December 29, 2017
• Start date: April 1, 2016
• Est. completion date: August 30, 2017

Study information

• Verified date: December 2017
• Source: University of Rzeszow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 30, 2017
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Balneology
• Elderly
• Osteoarthritis
• Quality of Life

Intervention

Other:
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Rzeszow

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in pain perception (VAS)	Evolution of VAS (Visual Analogic Scale) between baseline, 3 and 12 months.	at baseline, 3 and 12 months
Secondary	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.	at baseline, 3 and 12 months