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

NCT05078008 | Completed

• 1 other identifier: Termalistur
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Group 1 - Physiotherapy modalities

PLACEBO COMPARATOR

Procedure: Physiotherapy modalities

Group 2 - Physiotherapy modalities + Balneotherapy modalities

EXPERIMENTAL

Procedure: Physiotherapy modalities; Procedure: Balneotherapy modalities

Interventions

Physiotherapy modalities PROCEDURE

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

Group 1 - Physiotherapy modalities; Group 2 - Physiotherapy modalities + Balneotherapy modalities

Balneotherapy modalities PROCEDURE

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

Group 2 - Physiotherapy modalities + Balneotherapy modalities

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Termalistur - Termas de Sao Pedro do Sul, E.M., S.A.: lead
• Universidade do Porto: collaborator
• Aveiro University: collaborator

Study Sites (1)

Termalistur - Termas de São Pedro do Sul

São Pedro do Sul, Viseu District, 3660-692, Portugal

Location

Study Officials

• Nelson F Albuquerque

  Medical Doctor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 14, 2021
• Study Start: May 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: September 10, 2023
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)