Clinical trial NCT03565926: Effects of Hipopressive Exercises in Nonspecific Low Back Pain
Official title: Effects of Hipopressive Exercises Versus Manual Therapy in Subjects with Nonspecific Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
manual therapy
hypopressive therapeutic exercises
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Intensity of pain
timeFrame: 8 weeks
Secondary outcomes:
measure: Low Back Pain Disability
timeFrame: 8 weeks
measure: Algometry of spinous processes and lumbar muscles.
timeFrame: 8 weeks
measure: Lumbar flexion
timeFrame: 8 weeks
measure: Health status
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Gemma v. Espí López
Study officials:
References: