Valuation of the Low Back Pain Treated With Different Types of Active Exercises in Women
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Changes in Visual Scale Analogue (VAS)
Study Overview
Brief Summary
The purpose of the study is determine whether the Core Stability Exercise is more effective than the traditional Back School for low back pain (LBP) in women.
Detailed Description
The aim of this study is to check what kind of exercises are the best to treat LBP with regard to clinical improvements. The secondary objectives are: to determine which treatment is more effective in improving pain in the fewest sessions possible, to determine the involvement of inflammatory biomarkers in the development of pain and revalue the results after one month of having finishing treatment.
The project is a longitudinal, single-blind and randomized study with two treatment groups:
GROUP 1: Infrared light+ Transcutaneous Electrical Nerve Stimulation (TENS) + Core Stability Exercises.
GROUP 2: Infrared light + Transcutaneous Electrical Nerve Stimulation (TENS) + Traditional Back School.
Duration of treatment: 4 weeks. The participants will performe the exercises in 20 daily sessions (Monday to Friday) guided by a physiotherapist. Following treatment with the physiotherapist, the participants should perform the exercises at home for 4 weeks at a rate of three times per week.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women aged 18 to 70 years.
- •Diagnosis of back pain from a trauma.
- •Untreated pain (except acetaminophen).
- •Informed consent.
Exclusion Criteria
- •Algic process in the lumbar spine of infectious, neoplastic, metastasis, osteoporosis, inflammatory arthritis or fractures.
- •Cognitive impairment of any etiology.
- •Exercise intolerance for any reason.
- •Patients who have completed physical therapy in the last 3 months.
- •Patients who have received infiltration injections in the last 6 weeks.
Arms & Interventions
Core Stability Exercises
Core Stability Exercises:
20 sessions, distributed daily, from Monday to Friday. The first 5 sessions are common in all patients in the study, and involves the application of infrared light (IR) (10 minutes) and TENS (20 minutes) to treat acute pain. From session number 6 to session 20, the patients will receive IR + TENS 2 days a week, and the other 3 days IR+TENS+Core Stability Exercises (25-30 minutes).
Intervention: Core Stability Exercises (CSE) (Procedure)
Core Stability Exercises
Core Stability Exercises:
20 sessions, distributed daily, from Monday to Friday. The first 5 sessions are common in all patients in the study, and involves the application of infrared light (IR) (10 minutes) and TENS (20 minutes) to treat acute pain. From session number 6 to session 20, the patients will receive IR + TENS 2 days a week, and the other 3 days IR+TENS+Core Stability Exercises (25-30 minutes).
Intervention: TENS (Device)
Core Stability Exercises
Core Stability Exercises:
20 sessions, distributed daily, from Monday to Friday. The first 5 sessions are common in all patients in the study, and involves the application of infrared light (IR) (10 minutes) and TENS (20 minutes) to treat acute pain. From session number 6 to session 20, the patients will receive IR + TENS 2 days a week, and the other 3 days IR+TENS+Core Stability Exercises (25-30 minutes).
Intervention: Infra-red (Device)
Traditional Back School
Traditional Back School:
20 sessions, distributed daily, from Monday to Friday. The first 5 sessions are common in all patients in the study, and involves the application of infrared light (IR) (10 minutes) and TENS (20 minutes) to treat acute pain. From session number 6 to session 20, the patients will receive IR + TENS 2 days a week, and the other 3 days IR+TENS+Traditional Back School (25-30 minutes).
Intervention: Traditional Back School (Procedure)
Traditional Back School
Traditional Back School:
20 sessions, distributed daily, from Monday to Friday. The first 5 sessions are common in all patients in the study, and involves the application of infrared light (IR) (10 minutes) and TENS (20 minutes) to treat acute pain. From session number 6 to session 20, the patients will receive IR + TENS 2 days a week, and the other 3 days IR+TENS+Traditional Back School (25-30 minutes).
Intervention: TENS (Device)
Traditional Back School
Traditional Back School:
20 sessions, distributed daily, from Monday to Friday. The first 5 sessions are common in all patients in the study, and involves the application of infrared light (IR) (10 minutes) and TENS (20 minutes) to treat acute pain. From session number 6 to session 20, the patients will receive IR + TENS 2 days a week, and the other 3 days IR+TENS+Traditional Back School (25-30 minutes).
Intervention: Infra-red (Device)
Outcomes
Primary Outcomes
Changes in Visual Scale Analogue (VAS)
Time Frame: Pain was measured at the beginning of the study (session 0), and changes are evaluated again at sessions 10, 20, and 1 month later.
The VAS scale represents the pain intensity on a line of 10 cm, and one end there are the words "no pain" and the other end "the worst imaginable pain" written the distance in centimetres from the "no pain" point to the place marked by the patient represents the intensity of pain.
Secondary Outcomes
- Changes in the Roland- Morris Disability Questionnaire(Disability was measured at the beginning of the study (session 0), and changes are evaluated again at sessions 10, 20, and 1 month later.)
Investigators
M. Rosa Nogués
Pharm. D.
University Rovira i Virgili