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Completed

NCT Number: NCT05078008

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

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.

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Key information

Conditions

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

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Termalistur - Termas de São Pedro do Sul

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Numerical Rating Scale

    Time frame: two weeks

    Pain assessment; From "0" (minimum - better) to "10" (maximum - worse)

  2. Oswestry Disability Index, version 2.0

    Time frame: two weeks

    Functional assessment; From "0%" (minimum - better) to "100%" (maximum - worse)

  3. The Short Form-36

    Time frame: two weeks

    Quality of life assessment; From "0" (minimum - worse) to "100" (maximum - better)

  4. Center for Epidemiologic Studies Depression Scale

    Time frame: two weeks

    Depression assessment; From "0" (minimum - better) to "60" (maximum - worse)

  5. Satisfaction with life scale - 5 items version

    Time frame: two weeks

    Satisfaction with life scale assessment; From "5" (minimum - worse) to "35" (maximum - better)

  6. International Physical Activity Questionnaire - short version

    Time frame: two weeks

    Physical activity assessment; low values (worse) vs high values (better)

  7. Fatigue Assessment Scale

    Time frame: two weeks

    Fatigue assessment; From "10" (minimum - better) to "50" (maximum - worse)

  8. Dolorimeter

    Time frame: two weeks

    Pain assessment; low values (worse) vs high values (better)

Sponsors and collaborators

Lead sponsor

Termalistur - Termas de Sao Pedro do Sul, E.M., S.A.

Other

Collaborators

  • Aveiro University
  • Universidade do Porto

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2021
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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