CClinicalTrials.gg
CompletedNCT03565926HPvsMT-LBPUpdated Jul 16, 2025

Effects of Hipopressive Exercises in Nonspecific Low Back Pain

An interventional study of Manual Therapy and Hypopressive exercises in Low Back Pain, sponsored by University of Valencia. Completed at 1 site in Spain. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-07-16.

Sponsored by University of Valencia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Low Back Pain

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Keywords

  • low back pain
  • manual therapy
  • hypopressive therapeutic exercises
03

In context

Low Back Pain

2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.

This study's enrollment of 64 is close to the median of 60 across 2,268 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

University of Valencia is the lead sponsor of 349 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Active comparator
    Manual Therapy

    Manual Therapy Protocol 1. Articulation technique L4-S1 2. Lumbar neuromuscular technique 3. Fascial technique of crossed hands 4. Posteroanterior mobilizations of the lumbar vertebrae

    Other: Manual Therapy

  • Experimental
    Hypopressive exercises

    Protocol of 5 Hypopressive Exercises

    Other: Hypopressive exercises

Interventions

  • OtherManual Therapy

    1. Articulation technique L4-S1 2. Lumbar neuromuscular technique 3. Fascial technique of crossed hands 4. Posteroanterior mobilizations of the lumbar vertebrae

  • OtherHypopressive exercises

    Protocol 5 Hypopressive exercises

06

What researchers measure

Primary outcomes

  1. Intensity of pain

    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.

    Time frame: 8 weeks

Secondary outcomes

  1. Low Back Pain Disability

    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: * Intensity of perceived pain * Personal care * Lift weight * Walk * Sit * Standing * Sleeping * Sex life * Social life * traveling There are 6 possible answers to each item being scored from 0 to 5, so that when completing the questionnaire, the scores of each item are added, multiplied by two, and we obtain a percentage over 100 of the degree of disability.

    Time frame: 8 weeks

  2. Algometry of spinous processes and lumbar muscles.

    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.

    Time frame: 8 weeks

  3. Lumbar flexion

    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.

    Time frame: 8 weeks

  4. Health status

    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.

    Time frame: 8 weeks

07

Study locations

1 site
  • Gemma v. Espí López
    Valencia, 46010, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03565926
Lead sponsor
University of Valencia
Responsible party
GEMMA V ESPÍ LÓPEZ, PhD (Principal Investigator, University of Valencia) — Principal investigator
First posted
Jun 21, 2018
Start date
Jul 1, 2018
Primary completion
Jul 31, 2018
Completion
Sep 15, 2018
Last update
Jul 16, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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