Transversus Abdominis Muscular Training and Chronic Low Back Pain

NCT ID: NCT02374970

Last Updated: 2015-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention group

Actual Lumbar stability exercises involving co-contraction of the transversus abdominis and Protocolized Physiotherapy (therapeutic exercises and thermotherapy during 12 sessions)

Group Type EXPERIMENTAL

Lumbar stability exercises

Intervention Type 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.

Protocolized Physiotherapy

Intervention Type OTHER

Therapeutic exercises and thermotherapy during 12 daily sessions

Control group

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

Group Type ACTIVE_COMPARATOR

Protocolized Physiotherapy

Intervention Type OTHER

Therapeutic exercises and thermotherapy during 12 daily sessions

Interventions

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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.

Intervention Type OTHER

Protocolized Physiotherapy

Therapeutic exercises and thermotherapy during 12 daily sessions

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edurne Villar-Mateo

Role: PRINCIPAL_INVESTIGATOR

Jordi Gol Institut of Research in Primary Health Care

Locations

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Catalan Health Institut. Sant Ildefons Rehabilitation Service

Cornellà de Llobregat, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Edurne Villar-Mateo

Role: CONTACT

Facility Contacts

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Edurne Villar-Mateo

Role: primary

Other Identifiers

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P14/084

Identifier Type: -

Identifier Source: org_study_id

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