- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03388801
Quality-of-life and Pain After Spa Treatment in Elderly With Osteoarthritis
Short and Long-term Follow-up of 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.
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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).
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
at baseline, 3 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
at baseline, 3 and 12 months
|
|
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.
|
at baseline, 3 and 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jolanta Zwolińska, Dr, Medical Faculty, University of Rzeszów
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Spa-osteoarthritis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
Ziekenhuis Oost-LimburgRecruitingQuality of Life | Postoperative Quality of Recovery | Health-Related Quality-of-LifeBelgium
-
Istituto Ortopedico RizzoliUniversity of BolognaCompletedImprove Quality of LifeItaly
-
Children's National Research InstituteCompletedProfessional Quality of LifeUnited States
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
Linkoeping UniversityRecruiting
-
South Valley UniversityActive, not recruitingDeterminants of Health-related Quality of Life for Patients After Renal Lithotripsy: PNL Versus RIRSHealth Related Quality of LifeEgypt
-
University of South CarolinaNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingHealth Related Quality of LifeUnited States
-
PharmanexSprim Advanced Life SciencesCompletedHealth-related Quality of LifeUnited States
Clinical Trials on Spa therapy
-
Thermes de BaregesUniversity Grenoble Alps; FloralisRecruiting
-
Le Syndicat Intercommunal pour le Thermalisme et...University Grenoble Alps; Floralis; thermes de NEYRACCompletedChronic Venous InsufficiencyFrance
-
University Hospital, Clermont-FerrandCompleted
-
Association Francaise pour la Recherche ThermaleUnknown
-
Centre Hospitalier Universitaire de NīmesTerminatedPulmonary Disease, Chronic ObstructiveFrance
-
University of BordeauxCompletedKnee OsteoarthritisFrance
-
Association Francaise pour la Recherche ThermaleCompleted
-
Abant Izzet Baysal UniversityCompleted
-
Association Francaise pour la Recherche ThermaleUniversity Hospital, Clermont-FerrandCompletedMusculoskeletal DisordersFrance
-
Azienda Ospedaliera Universitaria SeneseCompleted