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NCT Number: NCT03974308

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

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.

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Key information

Conditions

Spine Osteoarthritis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Spine Rheumatic Diseases Spa Resorts Spinal Diseases Spondylarthritis Spondylitis

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rzeszow

Rzeszów, 35-205, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Spine osteoarthritis

Exclusion criteria

  • no consent to participate in the study

Treatment and study plan

Comprehensive physiotherapy including balneotherapy and filling questionaire

Other

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

Other names: Sanatorium treatment

Comprehensive physiotherapy without balneotherapy and filling questionaire

Other

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

Other names: Outpatient physiotherapy

No intervention, only filling questionaire

Other

No physiotherapy nor balneotherapy applied but three time filling questionaire

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Rzeszow

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 4, 2019
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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