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

February 15, 2021 updated by: Jolanta Zwolińska, University of Rzeszow

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Rzeszów, Poland, 35-205
        • University of Rzeszów

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Spine osteoarthritis

Exclusion Criteria:

  • no consent to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Outpatient physiotherapy
Other: Control group
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

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline LISAT-9 value at month and six months after therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rzeszow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2019

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

July 30, 2020

Study Registration Dates

First Submitted

May 11, 2018

First Submitted That Met QC Criteria

June 3, 2019

First Posted (Actual)

June 4, 2019

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Spa treatment

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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