Clinical trial NCT02374970: Transversus Abdominis Muscular Training and Chronic Low Back Pain
Official title: Effectiveness of Transversus Abdominis Muscular Training in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low back pain is not a diagnosis; it is a symptom describing the presence of pain in the lumbar vertebral or paravertebral region without any reference to the structure or cause of the process. It is one of the most widespread diseases and one of the most common reasons for visits in primary care setting.

Exercises to improve lumbar stability involving co-contraction of the transversus abdominis have proved to be effective in reducing pain and improving function. It has been stated by ultrasound images that specific stabilization exercises cause contraction of the deep abdominal muscles, but it remains unclear whether training produce thickness muscle improvement and if this improvement is related to clinical findings.

To try to resolve this issue a project of an experimental trial, double-blind (patient and evaluator) with two groups randomly assigned is presented. All participants will be recruited in an primary care center of the Catalan Health Institut and will sign informed consent. All will receive a protocolized treatment with therapeutic exercises and thermotherapy and, additionally, those assigned to the intervention group were instructed in performing lumbar stability exercises.

Pain (VAS), function (Roland-Morris Questionnaire) and the thickness of the transversus abdominis, internal and external oblique muscles (measured by ultrasound) at baseline, end of treatment protocol (12 sessions) and three months after the end of treatment will be assessed.

Results in pain, function, and its correlation with the mean changes in the thickness of transversus abdominis will be analyzed.


Eligibility criteria: Inclusion Criteria:

* 18 years old and over
* Diagnosis of chronic low back pain (over 3 months)
* Sign the informed consent form.

Exclusion Criteria:

* Non-stand supine position
* Neural Irradiation pain
* Previous surgical intervention in low back region
* Heart pathology
* Pregnancy
* Pending litigation or legal claim
* Poor language and communication skills making difficult to understand the informed consent

Primary outcomes:
measure: Change in transversus abdominis muscle thickness (Ultrasonography)
timeFrame: Baseline, 15 days after, and three months after
Secondary outcomes:
measure: Change in pain intensity (Visual analogue scale)
timeFrame: Baseline, 15 days after, and three months after
measure: Disability (Roland-Morris questionnaire)
timeFrame: Baseline, 15 days after, and three months after
measure: Change in internal oblique muscle thickness (Ultrasonography)
timeFrame: Baseline, 15 days after, and three months after
measure: Change in external oblique muscle thickness (Ultrasonography)
timeFrame: Baseline, 15 days after, and three months after
measure: Patient perception of change (Global Rating of Change scale)
timeFrame: 15 days after recruitment, and three months after
Other outcomes:
Locations:
city: Cornellà de Llobregat
country: Spain
facility: Catalan Health Institut. Sant Ildefons Rehabilitation Service
state: Barcelona
Study officials:
affiliation: Jordi Gol Institut of Research in Primary Health Care
name: Edurne Villar-Mateo
role: PRINCIPAL_INVESTIGATOR
References: