CompletedNot Applicable

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

Portugal30 participantsStarted 2022-05-01

Plain-language 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.

Who can participate

Age range

65 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Numerical Rating Scale

Timeframe: two weeks

Oswestry Disability Index, version 2.0

Timeframe: two weeks

The Short Form-36

Timeframe: two weeks

Center for Epidemiologic Studies Depression Scale

Timeframe: two weeks

Satisfaction with life scale - 5 items version

Timeframe: two weeks

International Physical Activity Questionnaire - short version

Timeframe: two weeks

Fatigue Assessment Scale

Timeframe: two weeks

Dolorimeter

Timeframe: two weeks

Trial details

NCT IDNCT05078008

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-01

View on ClinicalTrials.gov More Chronic Low Back Pain trials

Plain-language summary

Who can participate

Age range

65 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Numerical Rating Scale

Timeframe: two weeks

Oswestry Disability Index, version 2.0

Timeframe: two weeks

The Short Form-36

Timeframe: two weeks

Center for Epidemiologic Studies Depression Scale

Timeframe: two weeks

Satisfaction with life scale - 5 items version

Timeframe: two weeks

International Physical Activity Questionnaire - short version

Timeframe: two weeks

Fatigue Assessment Scale

Timeframe: two weeks

Dolorimeter

Timeframe: two weeks