Transversus Abdominis Muscular Training and Chronic Low Back Pain

NCT02374970 | Unknown

• 1 other identifier: P14/084
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Change in transversus abdominis muscle thickness (Ultrasonography)

  Baseline, 15 days after, and three months after

Secondary Outcomes (5)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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; Other: Protocolized Physiotherapy

Control group

ACTIVE COMPARATOR

Protocolized Physiotherapy treatment: therapeutic exercises and thermotherapy during 12 sessions.

Other: Protocolized Physiotherapy

Interventions

Lumbar stability exercises OTHER

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.

Intervention group

Protocolized Physiotherapy OTHER

Therapeutic exercises and thermotherapy during 12 daily sessions

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Study Sites (1)

Catalan Health Institut. Sant Ildefons Rehabilitation Service

Cornellà de Llobregat, Barcelona, 08940, Spain

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Edurne Villar-Mateo

  Jordi Gol Institut of Research in Primary Health Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edurne Villar-Mateo

CONTACT

edurne.villar.mateo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: March 2, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 2, 2015

Record last verified: 2015-02

Locations

ES (1)