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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03974308
Recruitment Status : Enrolling by invitation
First Posted : June 4, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Jolanta Zwolińska, 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.

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

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
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:

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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 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

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Spine osteoarthritis

Exclusion Criteria:

  • no consent to participate in the study

Information from the National Library of Medicine

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


Locations
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Poland
University of Rzeszow
Rzeszów, Poland, 35-205
Sponsors and Collaborators
University of Rzeszow
Investigators
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Principal Investigator: Jolanta Zwolińska, PhD University of Rzeszow

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Jolanta Zwolińska, Head of the Laboratory of Physical Factors, University of Rzeszow
ClinicalTrials.gov Identifier: NCT03974308     History of Changes
Other Study ID Numbers: Spa treatment
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jolanta Zwolińska, University of Rzeszow:
Balneotherapy
Health Resorts
Quality of life

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Spine
Spondylarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Spondylitis
Spinal Diseases
Bone Diseases