The Role of Balneotherapy in Older Adults With Chronic Low Back Pain

Quality of Life Clinical Trial

Official title:

The Role of Balneotherapy in Older Adults With Chronic Low Back Pain: a Biopsychosocial Approach at São Pedro do Sul Thermal Baths

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05078008
• Other study ID #: Termalistur
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 5, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: October 2021
• Source: Termalistur - Termas de Sao Pedro do Sul, E.M., S.A.
• Contact: Liliana Ferreira
• Phone: 232720300
• Email: lilianaferreira[@]termas-spsul.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The effectiveness of balneotherapy in relieving chronic low back pain has been scientifically proven. This project aims to study in what extent a Balneotherapy program in São Pedro do Sul Thermal Baths influences chronic low back pain of individuals aged 65 and above, and in what order of magnitude it happens, on which domains (functional, psychological, biophysical and socioeconomic) and it's repercussions. For that, the investigators intended to carry out a project subdivided into two tasks. The first, and the most complex, with a holistic approach, will be carried out by a randomized controlled study (RCT) with focus on the various biopsychosocial domains of patients with chronic lumbar pain. Concerning the second task, another RCT will be carried out aiming for statistically significant changes in the lumbar thermographic maps before and after treatment, as well as the theoretical framework of all the findings.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: July 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patient aged 65 and over
• Low back pain with or without irradiation to the lower limbs with more than 3 months of evolution
• Imaging exam of the lumbar spine that excludes neoplastic pathology or severe structural misalignments
• Availability to carry out a 14-day treatment plan

Exclusion Criteria:

• Can't read and write
• History of fracture, surgery, infection or neoplasm in the spine
• Scoliosis with a cobb angle >20
• Lower limb muscle strength or vesico-sphincter changes
• Fever, history of recent violent trauma, unexplained weight loss, night sweats, or persistent night pain
• Others: unstable angina pectoris, poorly controlled hypertension, cardiac decompensation, respiratory failure, endocrine disorder, acute febrile condition, skin infections, fecal or urinary incontinence and psychosis or decompensated neurosis

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain
• Older Adults
• Quality of Life

Intervention

Procedure:
• Physiotherapy modalities
parafango in the lumbar region 20min/day; High frequency Transcutaneous Electrical Nerve Stimulation (TENS), 100 Hz, 0,04-0,2mseg, 20 min/day; lumbar flexibility self-exercise plan
• Balneotherapy modalities
Immersion in a thermal pool with 15 minutes of automatic hydromassage and 15 minutes of spine flexibility exercises; thermal steam treatment to spinal column; hydromassage bath with Vichy thermal water

Locations

Country	Name	City	State
Portugal	Termalistur - Termas de São Pedro do Sul	São Pedro do Sul	Viseu

Sponsors (3)

Lead Sponsor	Collaborator
Termalistur - Termas de Sao Pedro do Sul, E.M., S.A.	Aveiro University, Universidade do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rating Scale	Pain assessment; From "0" (minimum - better) to "10" (maximum - worse)	two weeks
Primary	Oswestry Disability Index, version 2.0	Functional assessment; From "0%" (minimum - better) to "100%" (maximum - worse)	two weeks
Primary	The Short Form-36	Quality of life assessment; From "0" (minimum - worse) to "100" (maximum - better)	two weeks
Primary	Center for Epidemiologic Studies Depression Scale	Depression assessment; From "0" (minimum - better) to "60" (maximum - worse)	two weeks
Primary	Satisfaction with life scale - 5 items version	Satisfaction with life scale assessment; From "5" (minimum - worse) to "35" (maximum - better)	two weeks
Primary	International Physical Activity Questionnaire - short version	Physical activity assessment; low values (worse) vs high values (better)	two weeks
Primary	Fatigue Assessment Scale	Fatigue assessment; From "10" (minimum - better) to "50" (maximum - worse)	two weeks
Primary	Dolorimeter	Pain assessment; low values (worse) vs high values (better)	two weeks