Valuation of the Low Back Pain Treated With Different Types of Active Exercises in Women
ECOLUM
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable low-back-pain
Started Mar 2014
Typical duration for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 19, 2014
CompletedFirst Posted
Study publicly available on registry
April 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedDecember 5, 2014
December 1, 2014
1 year
March 19, 2014
December 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Visual Scale Analogue (VAS)
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.
Pain was measured at the beginning of the study (session 0), and changes are evaluated again at sessions 10, 20, and 1 month later.
Secondary Outcomes (1)
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.
Other Outcomes (2)
Questionnaire of Physical Activity (ClassAF)
The physical activity will be measured at the beginning of the study (session 0).
Changes in the biomarkers: Tumor Necrosis Factor (TNF-Alpha) and Interleukin 10 (IL-10)
The concentrations of these biomarkers will be measured at the beginning (session 0) and changes will be evaluated again at the end of the treatment (session 20).
Study Arms (2)
Core Stability Exercises
EXPERIMENTALCore 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).
Traditional Back School
EXPERIMENTALTraditional 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).
Interventions
The increase in intra-abdominal pressure stiffens and strengthens the relevant structural support around the spine, compacts the arthrogenic structures and in combination with abdominal contraction, it can encourage a rigid cylinder and stiffness to occur around the spine. The relevant anatomy in these type of exercises are deep muscles like transversus abdominous, multifidus or pelvic floor. The participants will have to do 10 different exercises. They will have to perform from 8 to 10 repetitions of every exercise, guided by a physical therapist. They will be recommended about making some series more at home, three days a week, when the treatment was finished.
The back school exercises are based in the traditional activity used for improve the back pain symptoms using the breathing with the stretching of the trunk muscles, the erector spinae reinforcement, the abdominal reinforcement or the postural movements. The participants will have to do 10 different exercises. They will have to perform from 8 to 10 repetitions of every exercise, guided by a physical therapist. They will be recommended about making some series more at home, three days a week, when the treatment was finished.
Used equipment: MEGASONIC 313 P4 (Carin). Application program number 15: analgesic TENS with stimulation of afferent fibers. Type of current: two-phase TNS. Width of the impulse: 70µs. Frequency of the impulse: 100Hz. Train: Not. Pause / pause activates: Not. Time of treatment: 20 minutes.
Used equipment: INFRA - 2000 (Enraf Nonius) with the following parameters: 230 V / 50-60 Hz / 1.2 A
Eligibility Criteria
You may qualify if:
- Women aged 18 to 70 years.
- Diagnosis of back pain from a trauma.
- Untreated pain (except acetaminophen).
- Informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine and Health Sciences
Reus, Tarragona, 43201, Spain
Related Publications (1)
Minobes-Molina E, Nogues MR, Giralt M, Casajuana C, de Souza DLB, Jerez-Roig J, Romeu M. Effectiveness of specific stabilization exercise compared with traditional trunk exercise in women with non-specific low back pain: a pilot randomized controlled trial. PeerJ. 2020 Nov 27;8:e10304. doi: 10.7717/peerj.10304. eCollection 2020.
PMID: 33312766DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rosa Nogués, Pharm.D.
Faculty of Medicine and Health Sciences. Rovira i Virgili University. Spain.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pharm. D.
Study Record Dates
First Submitted
March 19, 2014
First Posted
April 3, 2014
Study Start
March 1, 2014
Primary Completion
March 1, 2015
Study Completion
October 1, 2015
Last Updated
December 5, 2014
Record last verified: 2014-12