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Transversus Abdominis Muscular Training and Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lumbar stability exercises
Protocolized Physiotherapy
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Catalan Health Institut. Sant Ildefons Rehabilitation ServiceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in transversus abdominis muscle thickness (Ultrasonography)

Secondary Outcome Measures

Change in pain intensity (Visual analogue scale)
Disability (Roland-Morris questionnaire)
Change in internal oblique muscle thickness (Ultrasonography)
Change in external oblique muscle thickness (Ultrasonography)
Patient perception of change (Global Rating of Change scale)

Full Information

First Posted
February 19, 2015
Last Updated
February 27, 2015
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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1. Study Identification

Unique Protocol Identification Number
NCT02374970
Brief Title
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

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Actual Lumbar stability exercises involving co-contraction of the transversus abdominis and Protocolized Physiotherapy (therapeutic exercises and thermotherapy during 12 sessions)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Protocolized Physiotherapy treatment: therapeutic exercises and thermotherapy during 12 sessions.
Intervention Type
Other
Intervention Name(s)
Lumbar stability exercises
Intervention Description
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
Intervention Name(s)
Protocolized Physiotherapy
Intervention Description
Therapeutic exercises and thermotherapy during 12 daily sessions
Primary Outcome Measure Information:
Title
Change in transversus abdominis muscle thickness (Ultrasonography)
Time Frame
Baseline, 15 days after, and three months after
Secondary Outcome Measure Information:
Title
Change in pain intensity (Visual analogue scale)
Time Frame
Baseline, 15 days after, and three months after
Title
Disability (Roland-Morris questionnaire)
Time Frame
Baseline, 15 days after, and three months after
Title
Change in internal oblique muscle thickness (Ultrasonography)
Time Frame
Baseline, 15 days after, and three months after
Title
Change in external oblique muscle thickness (Ultrasonography)
Time Frame
Baseline, 15 days after, and three months after
Title
Patient perception of change (Global Rating of Change scale)
Time Frame
15 days after recruitment, and three months after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edurne Villar-Mateo
Email
edurne.villar.mateo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edurne Villar-Mateo
Organizational Affiliation
Jordi Gol Institut of Research in Primary Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catalan Health Institut. Sant Ildefons Rehabilitation Service
City
Cornellà de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08940
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edurne Villar-Mateo
Email
edurne.villar.mateo@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Transversus Abdominis Muscular Training and Chronic Low Back Pain

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