Chronic Low Back PainNCT05078008
The Role of Balneotherapy in Older Adults With Chronic Low Back Pain
A study testing Physiotherapy modalities and Balneotherapy modalities in people with Chronic Low Back Pain and Older Adults, run by Termalistur - Termas de Sao Pedro do Sul, E.M., S.A. at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Chronic Low Back Pain, Older Adults, Health Resort Medicine
- What is being tested?
- Physiotherapy modalities and Balneotherapy modalities
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 1 May 2022to 10 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Termalistur - Termas de São Pedro do Sul
São Pedro do Sul, Viseu District, 3660-692
About this study
Official title: 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.
- Being tested
- Physiotherapy modalities, Balneotherapy modalities
- Keywords
- Balneotherapy, Chronic Low Back Pain, Older adults, Health Resort Medicine, Quality of Life, Thermography, Crenotherapy, Balneology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy modalitiesProcedure or surgery
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 modalitiesProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Physiotherapy modalities | Placebo comparator | Not described Receives: Procedure: Physiotherapy modalities |
| Group 2 - Physiotherapy modalities + Balneotherapy modalities | Experimental | Not described Receives: Procedure: Physiotherapy modalities; Procedure: Balneotherapy modalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale
Pain assessment; From "0" (minimum - better) to "10" (maximum - worse)
Measured: two weeks
Oswestry Disability Index, version 2.0
Functional assessment; From "0%" (minimum - better) to "100%" (maximum - worse)
Measured: two weeks
The Short Form-36
Quality of life assessment; From "0" (minimum - worse) to "100" (maximum - better)
Measured: two weeks
Center for Epidemiologic Studies Depression Scale
Depression assessment; From "0" (minimum - better) to "60" (maximum - worse)
Measured: two weeks
Satisfaction with life scale - 5 items version
Satisfaction with life scale assessment; From "5" (minimum - worse) to "35" (maximum - better)
Measured: two weeks
International Physical Activity Questionnaire - short version
Physical activity assessment; low values (worse) vs high values (better)
Measured: two weeks
Fatigue Assessment Scale
Fatigue assessment; From "10" (minimum - better) to "50" (maximum - worse)
Measured: two weeks
Dolorimeter
Pain assessment; low values (worse) vs high values (better)
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start1 May 2022
- Primary completion1 Feb 2023
- Study completion10 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Termalistur - Termas de Sao Pedro do Sul, E.M., S.A.
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Porto, Aveiro University
- Responsible party
- Sponsor
- Investigators
- Nelson F Albuquerque, Principal investigator, Medical Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078008
- Sponsor's protocol ID
- Termalistur
- Status last verified
- Jun 2025
- First submitted
- 30 Sep 2021
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Balneotherapy in Older Adults With Chronic Low Back Pain: a Biopsychosocial Approach at São Pedro do Sul Thermal Baths
- ClinicalTrials.gov ID
- NCT05078008
- Acronym / sponsor ID
- Termalistur
- Keywords
- Balneotherapy, Chronic Low Back Pain, Older adults, Health Resort Medicine, Quality of Life, Thermography, Crenotherapy, Balneology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Termalistur - Termas de Sao Pedro do Sul, E.M., S.A.University, hospital or other
- Collaborators
- Universidade do Porto, Aveiro University
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 10 Sep 2023 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Physiotherapy modalities | Placebo comparator | Procedure: Physiotherapy modalities |
| Group 2 - Physiotherapy modalities + Balneotherapy modalities | Experimental | Procedure: Physiotherapy modalities, Procedure: Balneotherapy modalities |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy modalitiesparafango 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 or surgery | Group 1 - Physiotherapy modalities, Group 2 - Physiotherapy modalities + Balneotherapy modalities |
| Balneotherapy modalitiesImmersion 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 | Procedure or surgery | Group 2 - Physiotherapy modalities + Balneotherapy modalities |
Primary outcome
Numerical Rating Scale
Time frame: two weeks
Pain assessment; From "0" (minimum - better) to "10" (maximum - worse)
Oswestry Disability Index, version 2.0
Time frame: two weeks
Functional assessment; From "0%" (minimum - better) to "100%" (maximum - worse)
The Short Form-36
Time frame: two weeks
Quality of life assessment; From "0" (minimum - worse) to "100" (maximum - better)
Center for Epidemiologic Studies Depression Scale
Time frame: two weeks
Depression assessment; From "0" (minimum - better) to "60" (maximum - worse)
Satisfaction with life scale - 5 items version
Time frame: two weeks
Satisfaction with life scale assessment; From "5" (minimum - worse) to "35" (maximum - better)
International Physical Activity Questionnaire - short version
Time frame: two weeks
Physical activity assessment; low values (worse) vs high values (better)
Fatigue Assessment Scale
Time frame: two weeks
Fatigue assessment; From "10" (minimum - better) to "50" (maximum - worse)
Dolorimeter
Time frame: two weeks
Pain assessment; low values (worse) vs high values (better)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelson F Albuquerque principal investigator
Medical Doctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy modalities and Balneotherapy modalities in people with Chronic Low Back Pain and Older Adults, run by Termalistur - Termas de Sao Pedro do Sul, E.M., S.A. at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (time frame: two weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.