Transversus Abdominis Muscular Training and Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

Effectiveness of Transversus Abdominis Muscular Training in Patients With Chronic Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02374970
• Other study ID #: P14/084
• Status: Recruiting
• Phase: N/A
• First received: February 19, 2015
• Last updated: February 27, 2015
• Start date: February 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2015
• Source: Jordi Gol i Gurina Foundation
• Contact: Edurne Villar-Mateo
• Email: edurne.villar.mateo[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Catalan Heatlh Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Lumbar stability exercises
Four individualized learning sessions will be held during the same period of protocolized physiotherapy. Biofeedback training using the ultrasound machine will be performed in the first session, in order to show the specific contraction of the abdominal muscles with the stability exercises. The other three learning sessions will be performed without feedback, for the patient learn the exercises to make at home during the follow-up period.
• Protocolized Physiotherapy
Therapeutic exercises and thermotherapy during 12 daily sessions

Locations

Country	Name	City	State
Spain	Catalan Health Institut. Sant Ildefons Rehabilitation Service	Cornellà de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in transversus abdominis muscle thickness (Ultrasonography)		Baseline, 15 days after, and three months after	Yes
Secondary	Change in pain intensity (Visual analogue scale)		Baseline, 15 days after, and three months after	Yes
Secondary	Disability (Roland-Morris questionnaire)		Baseline, 15 days after, and three months after	Yes
Secondary	Change in internal oblique muscle thickness (Ultrasonography)		Baseline, 15 days after, and three months after	Yes
Secondary	Change in external oblique muscle thickness (Ultrasonography)		Baseline, 15 days after, and three months after	Yes
Secondary	Patient perception of change (Global Rating of Change scale)		15 days after recruitment, and three months after	Yes