Low Back PainNCT02374970
Transversus Abdominis Muscular Training and Chronic Low Back Pain
A study testing Lumbar stability exercises and Protocolized Physiotherapy in people with Low Back Pain, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Lumbar stability exercises and Protocolized Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and over
- Diagnosis of chronic low back pain (over 3 months)
- Sign the informed consent form.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Edurne Villar-Mateo contact
Spain1 site, 1 recruiting
- Recruiting
Catalan Health Institut. Sant Ildefons Rehabilitation Service
Cornellà de Llobregat, Barcelona, 08940
Edurne Villar-Mateo, edurne.villar.mateo@gmail.com
About this study
Official title: 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.
Read more
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
- Being tested
- Lumbar stability exercises, Protocolized Physiotherapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar stability exercisesOther
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 PhysiotherapyOther
Therapeutic exercises and thermotherapy during 12 daily sessions
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Actual Lumbar stability exercises involving co-contraction of the transversus abdominis and Protocolized Physiotherapy (therapeutic exercises and thermotherapy during 12 sessions) Receives: Other: Lumbar stability exercises; Other: Protocolized Physiotherapy |
| Control group | Active comparator | Protocolized Physiotherapy treatment: therapeutic exercises and thermotherapy during 12 sessions. Receives: Other: Protocolized Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in transversus abdominis muscle thickness (Ultrasonography)
Measured: Baseline, 15 days after, and three months after
Secondary outcomes (5)
Change in pain intensity (Visual analogue scale)
Measured: Baseline, 15 days after, and three months after
Disability (Roland-Morris questionnaire)
Measured: Baseline, 15 days after, and three months after
Change in internal oblique muscle thickness (Ultrasonography)
Measured: Baseline, 15 days after, and three months after
Change in external oblique muscle thickness (Ultrasonography)
Measured: Baseline, 15 days after, and three months after
Patient perception of change (Global Rating of Change scale)
Measured: 15 days after recruitment, and three months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edurne Villar-Mateo, Principal investigator, Jordi Gol Institut of Research in Primary Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374970
- Sponsor's protocol ID
- P14/084
- Status last verified
- Feb 2015
- First submitted
- 19 Feb 2015
- Last updated
- 2 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transversus Abdominis Muscular Training in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02374970
- Acronym / sponsor ID
- P14/084
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Lumbar stability exercises, Other: Protocolized PhysiotherapyActual Lumbar stability exercises involving co-contraction of the transversus abdominis and Protocolized Physiotherapy (therapeutic exercises and thermotherapy during 12 sessions) |
| Control group | Active comparator | Other: Protocolized PhysiotherapyProtocolized Physiotherapy treatment: therapeutic exercises and thermotherapy during 12 sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old and over
- Diagnosis of chronic low back pain (over 3 months)
- Sign the informed consent form.
Key exclusion criteria (7 listed)
- Non-stand supine position
- Neural Irradiation pain
- Previous surgical intervention in low back region
- Heart pathology
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar stability exercisesFour 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 | Intervention group |
| Protocolized PhysiotherapyTherapeutic exercises and thermotherapy during 12 daily sessions | Other | Control group, Intervention group |
Primary outcome
Change in transversus abdominis muscle thickness (Ultrasonography)
Time frame: Baseline, 15 days after, and three months after
5 secondary outcomes
Change in pain intensity (Visual analogue scale)
Time frame: Baseline, 15 days after, and three months after
Disability (Roland-Morris questionnaire)
Time frame: Baseline, 15 days after, and three months after
Change in internal oblique muscle thickness (Ultrasonography)
Time frame: Baseline, 15 days after, and three months after
Change in external oblique muscle thickness (Ultrasonography)
Time frame: Baseline, 15 days after, and three months after
Patient perception of change (Global Rating of Change scale)
Time frame: 15 days after recruitment, and three months after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edurne Villar-Mateo contact
Edurne Villar-Mateo principal investigator
Jordi Gol Institut of Research in Primary Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar stability exercises and Protocolized Physiotherapy in people with Low Back Pain, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edurne Villar-Mateo (edurne.villar.mateo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in transversus abdominis muscle thickness (Ultrasonography) (time frame: Baseline, 15 days after, and three months after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2015.