ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Hipopressive Exercises in Nonspecific Low Back Pain (HPvsMT-LBP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03565926
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia

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.
  • Perception of change after treatment.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Manual Therapy Other: Hypopressive exercises Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Hipopressive Exercises Versus Manual Therapy in Subjects With Nonspecific Low Back Pain
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : August 15, 2018

Resource links provided by the National Library of Medicine


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

Experimental: Hypopressive exercises
Protocol of 5 Hypopressive Exercises
Other: Hypopressive exercises
Protocol 5 Hypopressive exercises




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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:

    • 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.

  2. 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.

  3. 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.

  4. Global Impression of Change [ Time Frame: 8 weeks ]
    Patient Global Impression of Change Scale, published by Hurst H. and Bolton J. Evaluates the sensation of change after the treatment received. It contains 7 affirmations (1 = I have improved a lot, 2 = I have improved a lot, 3 = I have improved a little, 4 = I am the same, 5 = I have worsened a little, 6 = I have worsened a lot, 7 = I have worsened a lot), together with an analog scale on the degree of change (0 = much better, 5 = no change, 10 = much worse).

  5. Quality of life [ 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 weeks 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565926


Contacts
Contact: Gemma V Espí-López 34963983853 gemma.espi@uv.es
Contact: Gemma V Espí-López

Locations
Spain
Gemma v. Espí López Recruiting
Valencia, Spain, 46010
Contact: Gemma V Espí-López, Ph, Dr         
Sponsors and Collaborators
University of Valencia

Responsible Party: GEMMA V ESPÍ LÓPEZ, PhD, Principal Investigator, University of Valencia
ClinicalTrials.gov Identifier: NCT03565926     History of Changes
Other Study ID Numbers: ID0019
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia:
low back pain
manual therapy
hypopressive therapeutic exercises

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms