Clinical trial NCT03974308: 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
Overall status: COMPLETED
Phase: NA
Conditions: Spine Osteoarthritis
Spa Resorts
Keywords: Balneotherapy
Health Resorts
Quality of life
Lead sponsor: University of Rzeszow
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of the level of pain, life satisfaction and level of disability in people with degenerative spine disease which:

1. use the spa treatment
2. use complex physiotherapy in the place of residence
3. don't use physiotherapy, ad hoc pharmacotherapy
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* Spine osteoarthritis

Exclusion Criteria:

* no consent to participate in the study

Primary outcomes:
measure: Health Assesment Questionaire (HAQ)
timeFrame: Change from baseline HAQ value at month and six months after therapy
Secondary outcomes:
measure: Laitinen Pain Indicator Questionnaire
timeFrame: Change from baseline Laitinen value at month and six months after therapy
measure: Visual Analogue Scale (VAS)
timeFrame: Change from baseline VAS value at month and six months after therapy
Other outcomes:
measure: Life Satisfaction Questionnaire (LISAT-9)
timeFrame: Change from baseline LISAT-9 value at month and six months after therapy
Locations:
city: Rzeszów
country: Poland
facility: University of Rzeszow
Study officials:
affiliation: University of Rzeszow
name: Jolanta Zwolińska, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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