Effectiveness of Spa Treatment, Outpatient Physiotherapy and no Physiotherapy in Spine Osteoarthritis
Primary Purpose
Spine Osteoarthritis, Spa Resorts
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Comprehensive physiotherapy including balneotherapy and filling questionaire
Comprehensive physiotherapy without balneotherapy and filling questionaire
No intervention, only filling questionaire
Sponsored by
About this trial
This is an interventional health services research trial for Spine Osteoarthritis focused on measuring Balneotherapy, Health Resorts, Quality of life
Eligibility Criteria
Inclusion Criteria:
- Spine osteoarthritis
Exclusion Criteria:
- no consent to participate in the study
Sites / Locations
- University of Rzeszow
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Study group 1
Study group 2
Control group
Arm Description
Patients with spine osteoarthritis who will be treated in polish spas in Subcarpathian Region. Comprehensive physiotherapy including balneotherapy will be applied.
Patients with spine osteoarthritis who will be treated in outpatient treatment. Comprehensive physiotherapy without balneotherapy will be applied.
Patients with spine osteoarthritis who will not have applied physiotherapy nor balneotherapy.
Outcomes
Primary Outcome Measures
Health Assesment Questionaire (HAQ)
Subjective assesment of level of disability. Value of each of 8 subsections: minimum value 0, maximum value 3. total score is averaged. the best total score is 0, the worst is 3.
Secondary Outcome Measures
Laitinen Pain Indicator Questionnaire
pain severity rating scale. Each subsection is considered separately and total score is considered summed. In each of 4 subsections minimum value is 0, maximum value is 4. the best score is 0, the worst is 4.
Visual Analogue Scale (VAS)
pain severity rating scale. only one value. Minimium value is 0, maximum value is 10. the best is 0, the worst is 10.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03974308
Brief Title
Effectiveness of Spa Treatment, Outpatient Physiotherapy and no Physiotherapy in Spine Osteoarthritis
Official Title
Effectiveness of Spa Treatment in Patients With Spine Osteoarthritis in Comparison With Outpatient Physiotherapy and no Physiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 20, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rzeszow
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In the first study group will participate patients with spine osteoarthritis who will be treated in polish spas in Subcarpathian Region. Complex physiotherapy including balneotherapy will be applied in study group participants. In the second study group will participate patients with spine osteoarthritis who will be treated in outpatient treatment. Complex physiotherapy without balneotherapy will be applied in second study group participants. In the control group will participate patients with spine osteoarthritis who will not have applied physiotherapy nor balneotherapy during observation. In all patients will be evaluated quality of life, level of pain intensity and health assessment.
Detailed Description
The following questionnaires will be used: original socio-demographic data questionnaire, the VAS (visual analogue scale) pain severity rating scale, the modified Laitinen pain questionnaire, the Life Satisfaction Questionnaire LISAT-9 and the HAQ: Health Assesment Questionnaire.
Questionnaires will be completed: before the beginning of therapy, one month and six months after the end of therapy.
Questionnaires in control group will be completed: in the beginning of observation and in the same time intervals as in study groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Osteoarthritis, Spa Resorts
Keywords
Balneotherapy, Health Resorts, Quality of life
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparison of the level of pain, life satisfaction and level of disability in people with degenerative spine disease which:
use the spa treatment
use complex physiotherapy in the place of residence
don't use physiotherapy, ad hoc pharmacotherapy
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group 1
Arm Type
Experimental
Arm Description
Patients with spine osteoarthritis who will be treated in polish spas in Subcarpathian Region. Comprehensive physiotherapy including balneotherapy will be applied.
Arm Title
Study group 2
Arm Type
Active Comparator
Arm Description
Patients with spine osteoarthritis who will be treated in outpatient treatment. Comprehensive physiotherapy without balneotherapy will be applied.
Arm Title
Control group
Arm Type
Other
Arm Description
Patients with spine osteoarthritis who will not have applied physiotherapy nor balneotherapy.
Intervention Type
Other
Intervention Name(s)
Comprehensive physiotherapy including balneotherapy and filling questionaire
Other Intervention Name(s)
Sanatorium treatment
Intervention Description
Three-week stay in a sanatorium with comprehensive physiotherapy including balneotherapy and three time filling questionaire.
Intervention Type
Other
Intervention Name(s)
Comprehensive physiotherapy without balneotherapy and filling questionaire
Other Intervention Name(s)
Outpatient physiotherapy
Intervention Description
Two-week outpatient treatment with comprehensive physiotherapy without balneotherapy and three time filling questionaire
Intervention Type
Other
Intervention Name(s)
No intervention, only filling questionaire
Intervention Description
No physiotherapy nor balneotherapy applied but three time filling questionaire
Primary Outcome Measure Information:
Title
Health Assesment Questionaire (HAQ)
Description
Subjective assesment of level of disability. Value of each of 8 subsections: minimum value 0, maximum value 3. total score is averaged. the best total score is 0, the worst is 3.
Time Frame
Change from baseline HAQ value at month and six months after therapy
Secondary Outcome Measure Information:
Title
Laitinen Pain Indicator Questionnaire
Description
pain severity rating scale. Each subsection is considered separately and total score is considered summed. In each of 4 subsections minimum value is 0, maximum value is 4. the best score is 0, the worst is 4.
Time Frame
Change from baseline Laitinen value at month and six months after therapy
Title
Visual Analogue Scale (VAS)
Description
pain severity rating scale. only one value. Minimium value is 0, maximum value is 10. the best is 0, the worst is 10.
Time Frame
Change from baseline VAS value at month and six months after therapy
Other Pre-specified Outcome Measures:
Title
Life Satisfaction Questionnaire (LISAT-9)
Description
Subjective assesment of life satisfaction. Each of 9 subsections is considered separately and in total. Minimum value in each subsection is 1, maximum value is 6. Total score is averaged. The best value is 6, the worst is 1.
Time Frame
Change from baseline LISAT-9 value at month and six months after therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Spine osteoarthritis
Exclusion Criteria:
no consent to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jolanta Zwolińska, PhD
Organizational Affiliation
University of Rzeszow
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rzeszow
City
Rzeszów
ZIP/Postal Code
35-205
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25535198
Citation
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Results Reference
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PubMed Identifier
18464302
Citation
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Results Reference
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PubMed Identifier
26156832
Citation
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Results Reference
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PubMed Identifier
24527441
Citation
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Results Reference
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PubMed Identifier
23971049
Citation
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Results Reference
result
PubMed Identifier
19817508
Citation
Moskowitz RW. The burden of osteoarthritis: clinical and quality-of-life issues. Am J Manag Care. 2009 Sep;15(8 Suppl):S223-9.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
Lourenco S, Lucas R, Araujo F, Bogas M, Santos RA, Barros H. Osteoarthritis medical labelling and health-related quality of life in the general population. Health Qual Life Outcomes. 2014 Nov 30;12:146. doi: 10.1186/s12955-014-0146-8.
Results Reference
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Citation
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Results Reference
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Citation
Dandinoglu T, Dandin O, Ergin T, Tihan D, Akpak YK, Aydin OU, Teomete U. Can balneotherapy improve the bowel motility in chronically constipated middle-aged and elderly patients? Int J Biometeorol. 2017 Jun;61(6):1139-1148. doi: 10.1007/s00484-016-1295-8. Epub 2016 Dec 23.
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Citation
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Results Reference
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Effectiveness of Spa Treatment, Outpatient Physiotherapy and no Physiotherapy in Spine Osteoarthritis
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