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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Chronic Low Back Pain; Older Adults; Health Resort Medicine
• Intervention / Treatment: Procedure: Physiotherapy modalities; Procedure: Balneotherapy modalities

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Viseu
    • São Pedro do Sul, Viseu, Portugal, 3660-692
      • Termalistur - Termas de São Pedro do Sul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 1 - Physiotherapy modalities	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
Experimental: Group 2 - Physiotherapy modalities + Balneotherapy modalities	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; Procedure: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Termalistur - Termas de Sao Pedro do Sul, E.M., S.A.
• Collaborators: Universidade do Porto; Aveiro University
• Investigators: Principal Investigator: Nelson F Albuquerque, Medical Doctor

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): September 10, 2023

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Life; Older adults; Chronic Low Back Pain; Thermography; Balneotherapy; Health Resort Medicine; Crenotherapy; Balneology
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Termalistur

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No