Effects of Hipopressive Exercises in Nonspecific Low Back Pain (HPvsMT-LBP)
Effects of Hipopressive Exercises Versus Manual Therapy in Subjects With Nonspecific Low Back Pain
Introduction Non-specific low back pain is very prevalent in our society. Different effective physiotherapy treatments have been performed in the reduction of pain and improvement of quality of life, however there are few studies that exist on the effectiveness of these treatments in protocol format based on manual therapy. On the other hand, there are no studies that implement a protocol of therapeutic exercises called abdominal hypopressives.
The aim of the study is to study the effect of a manual therapy protocol on non-specific low back pain and the implementation of hypopressive exercises in different areas such as disability, pain, flexibility and quality of life.
Material and methods
Participants The sample will consist of subjects with non-specific low back pain. Inclusion criteria
-Participants with nonspecific lumbar pain of at least 4 pain crises a month with recurrent low back pain.
Exclusion criteria
- Light acute.
- Lumbalgia after trauma.
- Presenting sciatica or musculoskeletal disorders or injuries within three months prior to the study.
- Contraindication of one of the two treatments.
- Participate in this period of no functional recovery program or physiotherapy treatment.
Study design A randomized clinical trial will be conducted. The sample will be divided into 2 groups: Group 1 will receive a manual therapy protocol that has previously shown its effectiveness in non-specific low back pain being 1 session a week, while group 2 will receive a protocol of hypopressive therapeutic exercises.
Evaluations
At the beginning of the study, a clinical interview will be carried out and, in addition, 3 evaluations will be carried out: at the beginning, at the end of the treatment and one follow-up per month. The investigators will use the following evaluation tools:
- Pain, through the Visual Analog Scale.
- Oswestry Low Back Pain Disability Scale.
- SF-36 quality of life scale.
- Visual Analog Scale.
- Algometry of spinous processes and lumbar muscles.
- Lumbar flexion with inclinometer and fingers test - floor.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Valencia, Spain, 46010
- Gemma v. Espí López
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Man between 18 and 40 years old
- Recurrent episodes of low back pain at least 4 times a month
- At least 3 months of evolution
- Non-specific low back pain
- Not having undergone surgery
Exclusion Criteria:
- Acute low back pain
- Lumbalgia operated surgically
- Low back pain after traumatism
- Episodes of sciatica
- Contraindication to any of the treatments
- Attend, during the study period, rehabilitation programs
- Serious injuries in the 3 months prior to the study
- Root pain
- Any breach of the inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Manual Therapy
Manual Therapy Protocol
|
|
|
Experimental: Hypopressive exercises
Protocol of 5 Hypopressive Exercises
|
Protocol 5 Hypopressive exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intensity of pain
Time Frame: 8 weeks
|
Visual Analog Scale.
The participants are asked to mark the intensity of pain from 1 to 10, with 1 being almost non-existent and 10 being the worst pain imaginable.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Low Back Pain Disability
Time Frame: 8 weeks
|
Oswestry Low Back Pain Disability Scale. Oswestry Low Back Pain Scale: The questionnaire consists of 10 questions in which he assesses the impact of the patient's back pain on daily life activities:
|
8 weeks
|
|
Algometry of spinous processes and lumbar muscles.
Time Frame: 8 weeks
|
The evaluation of muscle pain was performed by algometry.
The algometer evaluates the perceptual sensitivity of the pain through the pressure threshold looking for the stimulation of the nociceptors with a minimum pressure necessary to trigger discomfort at a certain point and the tolerance of the patient.
The evaluator locates the point and places the pointer of the perpendicular algometer increasing the pressure force with a constant speed of 1Kg / cm² / s in a uniform and continuous way until the perception of the sensitive point, the patient informs the evaluator, he stops exerting pressure and take the corresponding record, so that the evaluator can not see the results.
Between measurements, an interval of 30 seconds is left.
|
8 weeks
|
|
Lumbar flexion
Time Frame: 8 weeks
|
Lumbar flexibility.
It was measured with the Sit-and-reach (SR) test.
It has been used to assess the overall flexibility on the finger-floor distance method.
The test is conducted with a box designed for this purpose which has a vertical scale with a range of 50 cm (25 cm negative and 25cm positive).
The subject remains standing on it, leaving the arms and trunk relaxed, then flexes the trunk forward and maintains its maximum flexion for 3 seconds.
The evaluator is placed next to the scale and records the furthest measurement touched by the fingertips of both hands.
If each hand reaches a different measurement, then the shortest one is registered.
This is repeated 3 times and the most favourable measurement is registered.
|
8 weeks
|
|
Health status
Time Frame: 8 weeks
|
SF-36 is a health questionnaire, both physical and metal.
It contains 36 items comprising 8 health status sub-scales.
It includes different dimensions (Bodily Pain, Perceptions, Mental Health, Physical Function, Role-physical, Role-emotional, Social Function, and Vitality).
Positive and negative health statuses are assessed.
To evaluate each dimension, the items are transformed on a scale from 0 to 100.
The result is obtained by summation of all the questions, in which 0 is the worst and 100 the best result and state of health.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- ID0019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.