Low Back Pain Clinical Trial
Official title:
Effectiveness of Therapeutic Exercise Controlled Through App Adding Face-to-face Supervision Executed by Physical Therapist in the Subacute and Chronic Low Back Pain
NCT number | NCT04975568 |
Other study ID # | CI 19/514-E |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2021 |
Est. completion date | June 30, 2022 |
Verified date | April 2021 |
Source | Universidad Complutense de Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Low Back Pain (LBP) is one of the most usual illness in our society. Therapeutic Exercise (TE) has been shown the most effective and cheaper treatment in patients suffering LBP, but the lack of engagement to the therapeutic exercise programs is related with later acute LBP and chronic situations, despite symptoms slightly improve. The value of personalized therapeutic exercised programs in patients suffering LBP has been shown nowadays, improving symptomatology and quality of life. New technologies help patients to engage more in treatment, while time that health education make people "active patients". The aim of the study is to evaluate the effectiveness of a Home Therapeutic Exercise Program (HTEP) based in an app with McGill's exercised adding 6 face-to-face sessions every 15 days with a physical therapist .
Status | Completed |
Enrollment | 90 |
Est. completion date | June 30, 2022 |
Est. primary completion date | January 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - = 18 and = 65 years old. - Suffering low back pain. - In a subacute and chronic phase Exclusion Criteria: - Non signature of the informed consent - Red Flags are risk factors detected in low back pain patients' past medical history and symptomatology and are associated with a higher risk of serious disorders causing low back pain compared to patients without these characteristics. - Yellow Flags are psychosocial factors that increase the risk of developing, or perpetuating chronic pain and long-term disability (including) work-loss associated with low back pain. - Pregnancy and lactation - Serious trauma or back surgery before the study - Illness or dysfunction of balance - Visual dysfunction. - Neurological illness, dysfunction or pain. - Inability to stand up and sit without help - Inability to read, understand and complete questionnaires, read and understand a brochure, or understand and follow verbal instructions (e.g. Illiteracy, dementia or blindness) or read, understand and use an app |
Country | Name | City | State |
---|---|---|---|
Spain | Jose Javier López Marcos | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Complutense de Madrid | FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS |
Spain,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with improve intensity of Low Back pain based in Pain Intensity- Numerical Rating Scale | Intensity of low back pain (measured by Pain Intensity- Numerical Rating Scale ( PI-NRS)) at rest. It will be valued three times with 1 min between the three valuations. 1 item, minimum value 0 and maximum value 10, and 10 is the worse value and the average will be recorded. | 12 weeks treatment | |
Secondary | Number of participants with improve degree of Low Back pain disability based in Oswestry test | Low Back pain disability (measured by Oswestry test). 10 items and 10 points each item, the minimun value is 0 the maximum is 100, and 100 is the worse outcome | At baseline, 4 weeks treatment, 8 weeks treatmentment,12 weeks treatment and 2 months post-treatment | |
Secondary | Number of participants with improve degree of quality of life based in Spanish version of the Short Form Health Survey | Quality of life (measured by a previously validated Spanish version of the Short Form Health Survey (SF-12)) 12 items, the minimun value is 12 the maximum is 55, and 55 is the worse outcome | At baseline, 4 weeks treatment, 8 weeks treatmentment,12 weeks treatment and 2 months post-treatment | |
Secondary | Level of physical therapy intervention satisfaction based in Spanish version of the Patient Satisfaction Questionnaire | Satisfaction (measured by a previously validated Spanish version of the Patient Satisfaction Questionnaire (PSQ)) 13 items, the minimun value is 13 the maximum is 78, and 78 is the worse outcome | 12 weeks treatment |
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