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

Spine Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03974308
• Other study ID #: Spa treatment
• Status: Completed
• Phase: N/A
• Start date: April 20, 2019
• Est. completion date: July 30, 2020

Study information

• Verified date: February 2021
• Source: University of Rzeszow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Spine osteoarthritis

Exclusion Criteria:

• no consent to participate in the study

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Spine
• Spa Resorts
• Spine Osteoarthritis
• Spondylarthritis

Intervention

Other:
• Comprehensive physiotherapy including balneotherapy and filling questionaire
Three-week stay in a sanatorium with comprehensive physiotherapy including balneotherapy and three time filling questionaire.
• Comprehensive physiotherapy without balneotherapy and filling questionaire
Two-week outpatient treatment with comprehensive physiotherapy without balneotherapy and three time filling questionaire
• No intervention, only filling questionaire
No physiotherapy nor balneotherapy applied but three time filling questionaire

Locations

Country	Name	City	State
Poland	University of Rzeszow	Rzeszów

Sponsors (1)

Lead Sponsor	Collaborator
University of Rzeszow

Country where clinical trial is conducted

Poland, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Karagülle M, Karagülle 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. Review. — View Citation

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. Review. — View Citation

Lourenço S, Lucas R, Araújo 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. — View Citation

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. — View Citation

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

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Life Satisfaction Questionnaire (LISAT-9)	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.	Change from baseline LISAT-9 value at month and six months after therapy
Primary	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	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.	Change from baseline Laitinen value at month and six months after therapy
Secondary	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.	Change from baseline VAS value at month and six months after therapy