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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Procedure: Physiotherapy modalities
* Procedure: Balneotherapy modalities


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1 - Physiotherapy modalities<br> | Procedure: Physiotherapy modalities<br>* 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<br>|
| Experimental: Group 2 - Physiotherapy modalities + Balneotherapy modalities<br> | Procedure: Physiotherapy modalities<br>* 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<br>Procedure: Balneotherapy modalities<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Balneotherapy, Chronic Low Back Pain, Older adults, Health Resort Medicine, Quality of Life, Thermography, Crenotherapy, Balneology