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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual Therapy
Hypopressive exercises
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, manual therapy, hypopressive therapeutic exercises

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gemma v. Espí López

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Manual Therapy

Hypopressive exercises

Arm Description

Manual Therapy Protocol Articulation technique L4-S1 Lumbar neuromuscular technique Fascial technique of crossed hands Posteroanterior mobilizations of the lumbar vertebrae

Protocol of 5 Hypopressive Exercises

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Global Impression of Change
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).
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.

Full Information

First Posted
May 30, 2018
Last Updated
August 16, 2018
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT03565926
Brief Title
Effects of Hipopressive Exercises in Nonspecific Low Back Pain
Acronym
HPvsMT-LBP
Official Title
Effects of Hipopressive Exercises Versus Manual Therapy in Subjects With Nonspecific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
August 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, manual therapy, hypopressive therapeutic exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Therapy
Arm Type
Active Comparator
Arm Description
Manual Therapy Protocol Articulation technique L4-S1 Lumbar neuromuscular technique Fascial technique of crossed hands Posteroanterior mobilizations of the lumbar vertebrae
Arm Title
Hypopressive exercises
Arm Type
Experimental
Arm Description
Protocol of 5 Hypopressive Exercises
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
Articulation technique L4-S1 Lumbar neuromuscular technique Fascial technique of crossed hands Posteroanterior mobilizations of the lumbar vertebrae
Intervention Type
Other
Intervention Name(s)
Hypopressive exercises
Intervention Description
Protocol 5 Hypopressive exercises
Primary Outcome Measure Information:
Title
Intensity of pain
Description
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 Outcome Measure Information:
Title
Low Back Pain Disability
Description
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
Title
Algometry of spinous processes and lumbar muscles.
Description
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
Title
Lumbar flexion
Description
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
Title
Global Impression of Change
Description
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).
Time Frame
8 weeks
Title
Health status
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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 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
Facility Information:
Facility Name
Gemma v. Espí López
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

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Effects of Hipopressive Exercises in Nonspecific Low Back Pain

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