- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07452172
Lumbar and Gluteal Motor Control in Chronic Low Back Pain
Efficacy of a Combined Lumbar Motor Control and Gluteal Strengthening Program on Pain and Function in Chronic Non-specific Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Non-specific low back pain (NSLBP) is defined as axial, non-radiating pain primarily located in the lower back, without signs of a serious underlying condition, spinal stenosis, radiculopathy, or another specific spinal cause. Its lifetime prevalence has been estimated to be as high as 84%, making it one of the most frequent reasons for medical consultation and one of the leading causes of disability worldwide. International clinical practice guidelines recommend therapeutic exercise as a first-line treatment; however, robust conclusions regarding which type of exercise provides the greatest benefit have not yet been established.
Neuromuscular control of the lumbar segment is essential both for the execution of motor tasks and for generating the forces required to stabilize the spine. NSLBP is associated with altered patterns of muscle recruitment, either as a contributing factor to pain onset or as a secondary response to pain. Specifically, altered muscle activation patterns have been observed during both static and dynamic movements, as well as in response to unexpected perturbations.
Individuals with NSLBP frequently exhibit impaired control of the deep trunk mus-cles, such as the transversus abdominis and the deep multifidus, which play a key role in maintaining spinal coordination and stability. Lumbar motor control programs aim to restore coordination, control, and functional capacity of these muscles. This is traditioally achieved by selectively training the deep trunk musculature and progressively integrating it into more complex static, dynamic, and functional tasks.
Moreover, recent studies have demonstrated a close relationship between low back pain and impaired hip motor control, particularly in the presence of reduced mobility and muscle weakness-primarily affecting the hip abductors and extensors-which leads to increased lumbar loading through compensatory mechanisms associated with altered motor patterns secondary to hip stiffness. To date, few randomized controlled trials have evaluated the effect of adding hip muscle strengthening exercises to lumbar motor control programs, and their results have been relatively heterogeneous and inconsistent. Previous studies reported no significant effects on pain or disability, most likely due to the use of unsupervised or time-limited programs, whereas others did observe improvements, although their interventions did not specifically target the transversus abdominis and deep multifidus muscles. Notably, the duration of all previously reported programs was less than 8 weeks, which is considered the minimum period required to achieve greater clinical benefits.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ruben Arroyo Fernández, PhD
- Phone Number: +34926803600
- Email: Ruben.Arroyo@uclm.es
Study Contact Backup
- Name: Rubén Arroyo Fernández, Study director
- Phone Number: +34925803600
- Email: Ruben.Arroyo@uclm.es
Study Locations
-
-
Toledo
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Talavera de la Reina, Toledo, Spain, 45600
- Hospital General Nuestra Señora del Prado
-
Contact:
- Ruben fernandez, PhD
- Phone Number: +34925803600
- Email: rubenarroyofernandez@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 65 years.
- Non-specific low back pain with an intensity greater than 3/10 on a visual analogue scale.
- Symptom duration longer than 3 months.
- Sufficient understanding of spoken and written Spanish to adequately comprehend the intervention instructions and complete the assessments.
Exclusion Criteria:
- Severe lumbar or hip trauma within the previous 6 weeks.
- Prior vertebral fracture or lumbar disc herniation.
- Fibromyalgia.
- Active oncological disease.
- Diagnosis of a severe psychiatric disorder.
- Pregnancy.
- Uncontrolled rheumatologic pathology.
- Coexisting auto-immune pathology or chronic inflammatory disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lumbar motor control + Gluteal exercises
Combined lumbar motor control program and gluteal muscle strengthening exercises
|
24 sessions over an 8-week period, at a frequency of three sessions per week (on alternating days -Monday, Wednesday, and Friday-); 60min/session.
Gluteal strengthening exercises will be performed in the same days as lumbar motor control program.
|
|
Experimental: Lumbar motor control
Lumbar motor control program alone
|
24 sessions over an 8-week period, at a frequency of three sessions per week (on alternating days -Monday, Wednesday, and Friday-); 60min/session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: Baseline; inmediately after intervention.
|
It will be measured with a visual analog scale (VAS) of 100 millimeters in length.
The subject has to indicate the level of pain he feels, being 0 the absence of pain and 100 the maximum imaginable.
|
Baseline; inmediately after intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functionality
Time Frame: Baseline; inmediately after intervention.
|
The version adapted to Spanish from the Oswestry Disability Index (ODI) will be used.
It comprises 10 items, each scored from 0 to 5 (from no limitation to maximum limitation).
The total score (0-100%) is calculated by dividing the sum of the item scores by the maximum possible score and multiplying by 100.
|
Baseline; inmediately after intervention.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Motor control in low back pain
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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