Effectiveness of Spa Treatment, Outpatient Physiotherapy and no Physiotherapy in Spine Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT03974308|
Recruitment Status : Enrolling by invitation
First Posted : June 4, 2019
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spine Osteoarthritis Spa Resorts||Other: Comprehensive physiotherapy including balneotherapy and filling questionaire Other: Comprehensive physiotherapy without balneotherapy and filling questionaire Other: No intervention, only filling questionaire||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Comparison of the level of pain, life satisfaction and level of disability in people with degenerative spine disease which:
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Effectiveness of Spa Treatment in Patients With Spine Osteoarthritis in Comparison With Outpatient Physiotherapy and no Physiotherapy|
|Actual Study Start Date :||February 5, 2018|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Study group 1
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
Three-week stay in a sanatorium with comprehensive physiotherapy including balneotherapy and three time filling questionaire.
Other Name: Sanatorium treatment
Active Comparator: Study group 2
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
Two-week outpatient treatment with comprehensive physiotherapy without balneotherapy and three time filling questionaire
Other Name: Outpatient physiotherapy
Patients with spine osteoarthritis who will not have applied physiotherapy nor balneotherapy.
Other: No intervention, only filling questionaire
No physiotherapy nor balneotherapy applied but three time filling questionaire
- Health Assesment Questionaire (HAQ) [ Time Frame: Change from baseline HAQ value at month and six months after therapy ]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.
- Laitinen Pain Indicator Questionnaire [ Time Frame: Change from baseline Laitinen value at month and six months after therapy ]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) [ Time Frame: Change from baseline VAS value at month and six months after therapy ]pain severity rating scale. only one value. Minimium value is 0, maximum value is 10. the best is 0, the worst is 10.
- Life Satisfaction Questionnaire (LISAT-9) [ Time Frame: Change from baseline LISAT-9 value at month and six months after therapy ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974308
|University of Rzeszow|
|Rzeszów, Poland, 35-205|
|Principal Investigator:||Jolanta Zwolińska, PhD||University of Rzeszow|