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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05078008
Enrollment
30
Registered
2021-10-14
Start date
2022-05-01
Completion date
2023-09-10
Last updated
2025-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain, Health Resort Medicine, Older Adults, Quality of Life

Keywords

Balneotherapy, Chronic Low Back Pain, Older adults, Health Resort Medicine, Quality of Life, Thermography, Crenotherapy, Balneology

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.

Interventions

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

PROCEDUREBalneotherapy 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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Numerical Rating Scaletwo weeksPain assessment; From 0 (minimum - better) to 10 (maximum - worse)
Oswestry Disability Index, version 2.0two weeksFunctional assessment; From 0% (minimum - better) to 100% (maximum - worse)
The Short Form-36two weeksQuality of life assessment; From 0 (minimum - worse) to 100 (maximum - better)
Center for Epidemiologic Studies Depression Scaletwo weeksDepression assessment; From 0 (minimum - better) to 60 (maximum - worse)
Satisfaction with life scale - 5 items versiontwo weeksSatisfaction with life scale assessment; From 5 (minimum - worse) to 35 (maximum - better)
International Physical Activity Questionnaire - short versiontwo weeksPhysical activity assessment; low values (worse) vs high values (better)
Fatigue Assessment Scaletwo weeksFatigue assessment; From 10 (minimum - better) to 50 (maximum - worse)
Dolorimetertwo weeksPain assessment; low values (worse) vs high values (better)

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026