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

Not Applicable

Completed

• Conditions: Spine Osteoarthritis; Spa Resorts
• Interventions: Other: No intervention, only filling questionaire; Other: Comprehensive physiotherapy including balneotherapy and filling questionaire; Other: Comprehensive physiotherapy without balneotherapy and filling questionaire

• Registration Number: NCT03974308
• Lead Sponsor: University of Rzeszow

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.

Study Timeline

• Study First Submitted: 2018-05-11
• Study Start: 2019-04-20
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-04
• Primary Completion: 2020-06-30
• Study Completion: 2020-07-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Spine osteoarthritis

Exclusion Criteria

• no consent to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	No intervention, only filling questionaire	Patients with spine osteoarthritis who will not have applied physiotherapy nor balneotherapy.
Study group 1	Comprehensive physiotherapy including balneotherapy and filling questionaire	Patients with spine osteoarthritis who will be treated in polish spas in Subcarpathian Region. Comprehensive physiotherapy including balneotherapy will be applied.
Study group 2	Comprehensive physiotherapy without balneotherapy and filling questionaire	Patients with spine osteoarthritis who will be treated in outpatient treatment. Comprehensive physiotherapy without balneotherapy will be applied.

Primary Outcome Measures

Name	Time	Method
Health Assesment Questionaire (HAQ)	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.

Secondary Outcome Measures

Name	Time	Method
Laitinen Pain Indicator Questionnaire	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)	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.

Trial Locations

Locations (1)

University of Rzeszow; 🇵🇱 Rzeszów, Poland