Effectiveness of Spa Treatment, Outpatient Physiotherapy and no Physiotherapy in Spine Osteoarthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Spa Treatment in Patients With Spine Osteoarthritis in Comparison With Outpatient Physiotherapy and no Physiotherapy

Conditions
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Spine Osteoarthritis, Spa Resorts

Intervention / Treatment
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* Other: Comprehensive physiotherapy including balneotherapy and filling questionaire
* Other: Comprehensive physiotherapy without balneotherapy and filling questionaire
* Other: No intervention, only filling questionaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spine osteoarthritis Exclusion Criteria: no consent to participate in the study

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group 1<br>Patients with spine osteoarthritis who will be treated in polish spas in Subcarpathian Region. Comprehensive physiotherapy including balneotherapy will be applied. | Other: Comprehensive physiotherapy including balneotherapy and filling questionaire<br>* Three-week stay in a sanatorium with comprehensive physiotherapy including balneotherapy and three time filling questionaire.<br>* Other names: Sanatorium treatment;|
| Active Comparator: Study group 2<br>Patients with spine osteoarthritis who will be treated in outpatient treatment. Comprehensive physiotherapy without balneotherapy will be applied. | Other: Comprehensive physiotherapy without balneotherapy and filling questionaire<br>* Two-week outpatient treatment with comprehensive physiotherapy without balneotherapy and three time filling questionaire<br>* Other names: Outpatient physiotherapy;|
| Other: Control group<br>Patients with spine osteoarthritis who will not have applied physiotherapy nor balneotherapy. | Other: No intervention, only filling questionaire<br>* No physiotherapy nor balneotherapy applied but three time filling questionaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline HAQ value at month and six months after therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline Laitinen value at month and six months after therapy | 
| 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. | Change from baseline VAS value at month and six months after therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Balneotherapy, Health Resorts, Quality of life