Transversus Abdominis Muscular Training and Chronic Low Back Pain

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

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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Lumbar stability exercises; Other: Protocolized Physiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edurne Villar-Mateo; Email: edurne.villar.mateo@gmail.com

Study Locations

• Spain
  • Barcelona
    • Cornellà de Llobregat, Barcelona, Spain, 08940
      • Recruiting
      • Catalan Health Institut. Sant Ildefons Rehabilitation Service
      • Contact: Edurne Villar-Mateo; Email: edurne.villar.mateo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Actual Lumbar stability exercises involving co-contraction of the transversus abdominis and Protocolized Physiotherapy (therapeutic exercises and thermotherapy during 12 sessions)	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.; Other: Protocolized Physiotherapy; Therapeutic exercises and thermotherapy during 12 daily sessions
Active Comparator: Control group; Protocolized Physiotherapy treatment: therapeutic exercises and thermotherapy during 12 sessions.	Other: Protocolized Physiotherapy; Therapeutic exercises and thermotherapy during 12 daily sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in transversus abdominis muscle thickness (Ultrasonography)	Baseline, 15 days after, and three months after

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in pain intensity (Visual analogue scale)	Baseline, 15 days after, and three months after
Disability (Roland-Morris questionnaire)	Baseline, 15 days after, and three months after
Change in internal oblique muscle thickness (Ultrasonography)	Baseline, 15 days after, and three months after
Change in external oblique muscle thickness (Ultrasonography)	Baseline, 15 days after, and three months after
Patient perception of change (Global Rating of Change scale)	15 days after recruitment, and three months after

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Investigators: Principal Investigator: Edurne Villar-Mateo, Jordi Gol Institut of Research in Primary Health Care

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): February 1, 2016

Study Registration Dates

• First Submitted: February 19, 2015
• First Submitted That Met QC Criteria: February 27, 2015
• First Posted (Estimate): March 2, 2015

Study Record Updates

• Last Update Posted (Estimate): March 2, 2015
• Last Update Submitted That Met QC Criteria: February 27, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: P14/084