Clinical trial NCT05078008: The Role of Balneotherapy in Older Adults With Chronic Low Back Pain
Official title: The Role of Balneotherapy in Older Adults With Chronic Low Back Pain: a Biopsychosocial Approach at São Pedro do Sul Thermal Baths
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low Back Pain
Older Adults
Health Resort Medicine
Quality of Life
Keywords: Balneotherapy
Chronic Low Back Pain
Older adults
Health Resort Medicine
Quality of Life
Thermography
Crenotherapy
Balneology
Lead sponsor: Termalistur - Termas de Sao Pedro do Sul, E.M., S.A.
Sponsor class: OTHER
Collaborators: name: Universidade do Porto
name: Aveiro University
First posted: 2021-10-14
Enrollment: 130
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Numerical Rating Scale
timeFrame: two weeks
measure: Oswestry Disability Index, version 2.0
timeFrame: two weeks
measure: The Short Form-36
timeFrame: two weeks
measure: Center for Epidemiologic Studies Depression Scale
timeFrame: two weeks
measure: Satisfaction with life scale - 5 items version
timeFrame: two weeks
measure: International Physical Activity Questionnaire - short version
timeFrame: two weeks
measure: Fatigue Assessment Scale
timeFrame: two weeks
measure: Dolorimeter
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: São Pedro do Sul
country: Portugal
facility: Termalistur - Termas de São Pedro do Sul
state: Viseu
Study officials:
affiliation: Medical Doctor
name: Nelson F Albuquerque
role: PRINCIPAL_INVESTIGATOR
References: