Effects of Hipopressive Exercises in Nonspecific Low Back Pain (HPvsMT-LBP)
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|ClinicalTrials.gov Identifier: NCT03565926|
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : July 10, 2018
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.
- 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.
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Active Comparator: Manual Therapy
Manual Therapy Protocol
Other: Manual Therapy
Experimental: Hypopressive exercises
Protocol of 5 Hypopressive Exercises
Other: Hypopressive exercises
Protocol 5 Hypopressive exercises
- 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.
- 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
- 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. [ 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.
- 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.
- 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).
- 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.
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
|Contact: Gemma V Espí-Lópezfirstname.lastname@example.org|
|Contact: Gemma V Espí-López|
|Gemma v. Espí López||Recruiting|
|Valencia, Spain, 46010|
|Contact: Gemma V Espí-López, Ph, Dr|