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

NCT03974308 | Completed

• 1 other identifier: Spa treatment
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Osteoarthritis; Spa Resorts

Keywords

Balneotherapy; Health Resorts; Quality of life

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

• Laitinen Pain Indicator Questionnaire

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

• Visual Analogue Scale (VAS)

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

Other Outcomes (1)

• Life Satisfaction Questionnaire (LISAT-9)

  Change from baseline LISAT-9 value at month and six months after therapy

Study Arms (3)

Study group 1

EXPERIMENTAL

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

Study group 2

ACTIVE COMPARATOR

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

Control group

OTHER

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

Other: No intervention, only filling questionaire

Interventions

Comprehensive physiotherapy including balneotherapy and filling questionaire OTHER

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

Also known as: Sanatorium treatment

Study group 1

Comprehensive physiotherapy without balneotherapy and filling questionaire OTHER

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

Also known as: Outpatient physiotherapy

Study group 2

No intervention, only filling questionaire OTHER

No physiotherapy nor balneotherapy applied but three time filling questionaire

Control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Spine osteoarthritis

You may not qualify if:

• no consent to participate in the study

Sponsors & Collaborators

• University of Rzeszow: lead

Study Sites (1)

University of Rzeszow

Rzeszów, 35-205, Poland

Location

Related Publications (11)

• 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.

  PMID: 25535198 BACKGROUND

• 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.

  PMID: 18464302 BACKGROUND

• 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.

  PMID: 26156832 BACKGROUND

• 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.

  PMID: 24527441 RESULT

• 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.

  PMID: 23971049 RESULT

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

  PMID: 19817508 RESULT

• 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.

  PMID: 28528676 RESULT

• 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.

  PMID: 25433808 RESULT

• 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.

  PMID: 17506230 RESULT

• 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.

  PMID: 28011998 RESULT

• 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.

  PMID: 36038633 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Spine

Interventions

Balneology

Condition Hierarchy (Ancestors)

Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jolanta Zwolińska, PhD

  University of Rzeszow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Laboratory of Physical Factors

Model Details: 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

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: June 4, 2019
• Study Start: April 20, 2019
• Primary Completion: June 30, 2020
• Study Completion: July 30, 2020
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

PL (1)