AzTrials
AzTrials

Spine OsteoarthritisNCT03974308

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

A study testing Comprehensive physiotherapy including balneotherapy and filling questionaire and Comprehensive physiotherapy without balneotherapy and filling questionaire in people with Spine Osteoarthritis and Spa Resorts, run by University of Rzeszow at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Spine Osteoarthritis, Spa Resorts
What is being tested?
Comprehensive physiotherapy including balneotherapy and filling questionaire and Comprehensive physiotherapy without balneotherapy and filling questionaire
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 sitePoland
Study dates
20 Apr 2019to 30 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Spine osteoarthritis

Who cannot join

  • no consent to participate in the study

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • University of Rzeszow

    Rzeszów, 35-205

Other trials in Poland

About this study

Official title: 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.

Read the 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.

Being tested
Comprehensive physiotherapy including balneotherapy and filling questionaire, Comprehensive physiotherapy without balneotherapy and filling questionaire, No intervention, only filling questionaire
Keywords
Balneotherapy, Health Resorts, Quality of life
Medical subject headings
Osteoarthritis, Spine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comprehensive physiotherapy including balneotherapy and filling questionaireOther

    Also called Sanatorium treatment

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

  • Comprehensive physiotherapy without balneotherapy and filling questionaireOther

    Also called Outpatient physiotherapy

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

  • No intervention, only filling questionaireOther

    No physiotherapy nor balneotherapy applied but three time filling questionaire

Study groups in NCT03974308
Study groupRoleWhat they receive
Study group 1ExperimentalPatients with spine osteoarthritis who will be treated in polish spas in Subcarpathian Region. Comprehensive physiotherapy including balneotherapy will be applied.
Receives: Other: Comprehensive physiotherapy including balneotherapy and filling questionaire
Study group 2Active comparatorPatients with spine osteoarthritis who will be treated in outpatient treatment. Comprehensive physiotherapy without balneotherapy will be applied.
Receives: Other: Comprehensive physiotherapy without balneotherapy and filling questionaire
Control groupOtherPatients with spine osteoarthritis who will not have applied physiotherapy nor balneotherapy.
Receives: Other: No intervention, only filling questionaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health Assesment Questionaire (HAQ)

    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.

    Measured: Change from baseline HAQ value at month and six months after therapy

Secondary outcomes (2)

  1. Laitinen Pain Indicator Questionnaire

    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.

    Measured: Change from baseline Laitinen value at month and six months after therapy

  2. Visual Analogue Scale (VAS)

    pain severity rating scale. only one value. Minimium value is 0, maximum value is 10. the best is 0, the worst is 10.

    Measured: Change from baseline VAS value at month and six months after therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2019
  2. Study start20 Apr 2019
  3. Primary completion30 Jun 2020
  4. Study completion30 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03974308
Sponsor's protocol ID
Spa treatment
Status last verified
Feb 2021
First submitted
11 May 2018
Last updated
16 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25535198

  • 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.

    PubMed 18464302

  • 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.

    PubMed 26156832

  • 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.

    PubMed 24527441

  • 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.

    PubMed 23971049

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

    PubMed 19817508

  • 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.

    PubMed 28528676

  • 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.

    PubMed 25433808

  • 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.

    PubMed 17506230

  • 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.

    PubMed 28011998

  • 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.

    PubMed 36038633

Questions about this trial

What is this clinical trial studying?

A study testing Comprehensive physiotherapy including balneotherapy and filling questionaire and Comprehensive physiotherapy without balneotherapy and filling questionaire in people with Spine Osteoarthritis and Spa Resorts, run by University of Rzeszow at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health Assesment Questionaire (HAQ) (time frame: Change from baseline HAQ value at month and six months after therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03974308, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.

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