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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03974308
Enrollment
300
Registered
2019-06-04
Start date
2019-04-20
Completion date
2020-07-30
Last updated
2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spa Resorts, Spine Osteoarthritis

Keywords

Balneotherapy, Health Resorts, Quality of life

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.

Interventions

OTHERComprehensive physiotherapy including balneotherapy and filling questionaire

Three-week stay in a sanatorium with comprehensive physiotherapy including balneotherapy and three time filling questionaire.

OTHERComprehensive physiotherapy without balneotherapy and filling questionaire

Two-week outpatient treatment with comprehensive physiotherapy without balneotherapy and three time filling questionaire

OTHERNo intervention, only filling questionaire

No physiotherapy nor balneotherapy applied but three time filling questionaire

Sponsors

University of Rzeszow
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Spine osteoarthritis

Exclusion criteria

* no consent to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Health Assesment Questionaire (HAQ)Change from baseline HAQ value at month and six months after therapySubjective 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

MeasureTime frameDescription
Laitinen Pain Indicator QuestionnaireChange from baseline Laitinen value at month and six months after therapypain 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)Change from baseline VAS value at month and six months after therapypain severity rating scale. only one value. Minimium value is 0, maximum value is 10. the best is 0, the worst is 10.

Other

MeasureTime frameDescription
Life Satisfaction Questionnaire (LISAT-9)Change from baseline LISAT-9 value at month and six months after therapySubjective 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.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026