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

NCT ID: NCT03974308

Last Updated: 2021-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-20

Study Completion Date

2020-07-30

Brief Summary

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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

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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.

Conditions

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Spine Osteoarthritis Spa Resorts

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Study group 1

Patients with spine osteoarthritis who will be treated in polish spas in Subcarpathian Region. Comprehensive physiotherapy including balneotherapy will be applied.

Group Type EXPERIMENTAL

Comprehensive physiotherapy including balneotherapy and filling questionaire

Intervention Type OTHER

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

Study group 2

Patients with spine osteoarthritis who will be treated in outpatient treatment. Comprehensive physiotherapy without balneotherapy will be applied.

Group Type ACTIVE_COMPARATOR

Comprehensive physiotherapy without balneotherapy and filling questionaire

Intervention Type OTHER

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

Control group

Patients with spine osteoarthritis who will not have applied physiotherapy nor balneotherapy.

Group Type OTHER

No intervention, only filling questionaire

Intervention Type OTHER

No physiotherapy nor balneotherapy applied but three time filling questionaire

Interventions

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Comprehensive physiotherapy including balneotherapy and filling questionaire

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

Intervention Type OTHER

Comprehensive physiotherapy without balneotherapy and filling questionaire

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

Intervention Type OTHER

No intervention, only filling questionaire

No physiotherapy nor balneotherapy applied but three time filling questionaire

Intervention Type OTHER

Other Intervention Names

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Sanatorium treatment Outpatient physiotherapy

Eligibility Criteria

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Inclusion Criteria

* Spine osteoarthritis

Exclusion Criteria

* no consent to participate in the study
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rzeszow

OTHER

Sponsor Role lead

Responsible Party

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Jolanta Zwolińska

Head of the Laboratory of Physical Factors

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jolanta Zwolińska, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rzeszow

Locations

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University of Rzeszow

Rzeszów, , Poland

Site Status

Countries

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Poland

References

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Karagulle M, Karagulle MZ. Effectiveness of balneotherapy and spa therapy for the treatment of chronic low back pain: a review on latest evidence. Clin Rheumatol. 2015 Feb;34(2):207-14. doi: 10.1007/s10067-014-2845-2. Epub 2014 Dec 23.

Reference Type BACKGROUND
PMID: 25535198 (View on PubMed)

Verhagen A, Bierma-Zeinstra S, Lambeck J, Cardoso JR, de Bie R, Boers M, de Vet HC. Balneotherapy for osteoarthritis. A cochrane review. J Rheumatol. 2008 Jun;35(6):1118-23. Epub 2008 May 1.

Reference Type BACKGROUND
PMID: 18464302 (View on PubMed)

Fortunati NA, Fioravanti A, Seri G, Cinelli S, Tenti S. May spa therapy be a valid opportunity to treat hand osteoarthritis? A review of clinical trials and mechanisms of action. Int J Biometeorol. 2016 Jan;60(1):1-8. doi: 10.1007/s00484-015-1030-x. Epub 2015 Jul 9.

Reference Type BACKGROUND
PMID: 26156832 (View on PubMed)

Mordarski S. Pain management in the elderly: transdermal fentanyl for the treatment of pain caused by osteoarthritis of the knee and hip. Biomed Res Int. 2014;2014:262961. doi: 10.1155/2014/262961. Epub 2014 Jan 5.

Reference Type RESULT
PMID: 24527441 (View on PubMed)

Li Y, Wei X, Zhou J, Wei L. The age-related changes in cartilage and osteoarthritis. Biomed Res Int. 2013;2013:916530. doi: 10.1155/2013/916530. Epub 2013 Jul 22.

Reference Type RESULT
PMID: 23971049 (View on PubMed)

Moskowitz RW. The burden of osteoarthritis: clinical and quality-of-life issues. Am J Manag Care. 2009 Sep;15(8 Suppl):S223-9.

Reference Type RESULT
PMID: 19817508 (View on PubMed)

Brown R, Tomasello L, Mitchell DA, Sebald A, Stepney S. Ternary graph as a questionnaire: a new approach to assessment of quality of life? Br J Oral Maxillofac Surg. 2017 Sep;55(7):679-684. doi: 10.1016/j.bjoms.2017.04.011. Epub 2017 May 18.

Reference Type RESULT
PMID: 28528676 (View on PubMed)

Lourenco S, Lucas R, Araujo F, Bogas M, Santos RA, Barros H. Osteoarthritis medical labelling and health-related quality of life in the general population. Health Qual Life Outcomes. 2014 Nov 30;12:146. doi: 10.1186/s12955-014-0146-8.

Reference Type RESULT
PMID: 25433808 (View on PubMed)

Bellometti S, Gallotti C, Pacileo G, Rota A, Tenconi MT. Evaluation of outcomes in SPA-treated osteoarthrosic patients. J Prev Med Hyg. 2007 Mar;48(1):1-4.

Reference Type RESULT
PMID: 17506230 (View on PubMed)

Dandinoglu T, Dandin O, Ergin T, Tihan D, Akpak YK, Aydin OU, Teomete U. Can balneotherapy improve the bowel motility in chronically constipated middle-aged and elderly patients? Int J Biometeorol. 2017 Jun;61(6):1139-1148. doi: 10.1007/s00484-016-1295-8. Epub 2016 Dec 23.

Reference Type RESULT
PMID: 28011998 (View on PubMed)

Zwolinska J, Gasior M. Effects of complex spa therapy in patients with osteoarthritis of the spine receiving treatments in health resorts in south-eastern Poland. Sci Rep. 2022 Aug 29;12(1):14663. doi: 10.1038/s41598-022-18046-6.

Reference Type DERIVED
PMID: 36038633 (View on PubMed)

Other Identifiers

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Spa treatment

Identifier Type: -

Identifier Source: org_study_id

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