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

Primary Purpose

Chronic Low Back Pain, Older Adults, Health Resort Medicine

Status

Unknown status

Phase

Not Applicable

Locations

Portugal

Study Type

Interventional

Intervention

Physiotherapy modalities

Balneotherapy modalities

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Balneotherapy, Chronic Low Back Pain, Older adults, Health Resort Medicine, Quality of Life, Thermography, Crenotherapy, Balneology

Eligibility Criteria

65 Years - 100 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Termalistur - Termas de São Pedro do Sul

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Group 1 - Physiotherapy modalities

Group 2 - Physiotherapy modalities + Balneotherapy modalities

Arm Description

Outcomes

Primary Outcome Measures

Numerical Rating Scale

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

Oswestry Disability Index, version 2.0

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

The Short Form-36

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

Center for Epidemiologic Studies Depression Scale

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

Satisfaction with life scale - 5 items version

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

International Physical Activity Questionnaire - short version

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

Fatigue Assessment Scale

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

Dolorimeter

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05078008

First Posted

September 30, 2021

Last Updated

October 13, 2021

Sponsor

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

Collaborators

Universidade do Porto, Aveiro University

1. Study Identification

Unique Protocol Identification Number

NCT05078008

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 5, 2021 (Anticipated)

Primary Completion Date

May 31, 2022 (Anticipated)

Study Completion Date

July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

Collaborators

Universidade do Porto, Aveiro University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1 - Physiotherapy modalities

Arm Type

Placebo Comparator

Arm Title

Group 2 - Physiotherapy modalities + Balneotherapy modalities

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Physiotherapy modalities

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Balneotherapy modalities

Intervention Description

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 Outcome Measure Information:

Title

Numerical Rating Scale

Description

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

Time Frame

two weeks

Title

Oswestry Disability Index, version 2.0

Description

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

Time Frame

two weeks

Title

The Short Form-36

Description

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

Time Frame

two weeks

Title

Center for Epidemiologic Studies Depression Scale

Description

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

Time Frame

two weeks

Title

Satisfaction with life scale - 5 items version

Description

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

Time Frame

two weeks

Title

International Physical Activity Questionnaire - short version

Description

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

Time Frame

two weeks

Title

Fatigue Assessment Scale

Description

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

Time Frame

two weeks

Title

Dolorimeter

Description

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

Time Frame

two weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liliana Ferreira

Phone

232720300

Ext

+351

lilianaferreira@termas-spsul.com

First Name & Middle Initial & Last Name or Official Title & Degree

Victor Leal

jleal@termas-spsul.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nelson F Albuquerque

Organizational Affiliation

Medical Doctor

Official's Role

Principal Investigator

Facility Information:

Facility Name

Termalistur - Termas de São Pedro do Sul

City

São Pedro do Sul

State/Province

Viseu

ZIP/Postal Code

3660-692

Country

Portugal

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nelson F Albuquerque, MD

Phone

967935536

Ext

+351

nfal.albuquerque@gmail.com

First Name & Middle Initial & Last Name & Degree

Nelson Albuquerque

First Name & Middle Initial & Last Name & Degree

Liliana Ferreira

First Name & Middle Initial & Last Name & Degree

Laetitia Teixeira

First Name & Middle Initial & Last Name & Degree

Pedro Cantista

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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