Low Back PainHPvsMT-LBPNCT03565926
Effects of Hipopressive Exercises in Nonspecific Low Back Pain
A study testing Manual Therapy and Hypopressive exercises in people with Low Back Pain, run by University of Valencia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Manual Therapy and Hypopressive exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2018to 15 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Serious injuries in the 3 months prior to the study
- Root pain
- Any breach of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Hipopressive Exercises Versus Manual Therapy in Subjects With Nonspecific Low Back Pain
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.
Read more
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.
- Conditions
- Low Back Pain
- Being tested
- Manual Therapy, Hypopressive exercises
- Keywords
- low back pain, manual therapy, hypopressive therapeutic exercises
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyOther
- Articulation technique L4-S1
- Lumbar neuromuscular technique
- Fascial technique of crossed hands
- Posteroanterior mobilizations of the lumbar vertebrae
Hypopressive exercisesOther
Protocol 5 Hypopressive exercises
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy | Active comparator | 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 Receives: Other: Manual Therapy |
| Hypopressive exercises | Experimental | Protocol of 5 Hypopressive Exercises Receives: Other: Hypopressive exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (4)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start1 Jul 2018
- Primary completion31 Jul 2018
- Study completion15 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565926
- Sponsor's protocol ID
- ID0019
- Acronym
- HPvsMT-LBP
- Status last verified
- Jul 2025
- First submitted
- 30 May 2018
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hipopressive Exercises Versus Manual Therapy in Subjects With Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT03565926
- Acronym / sponsor ID
- HPvsMT-LBP / ID0019
- Conditions
- Low Back Pain
- Keywords
- low back pain, manual therapy, hypopressive therapeutic exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy | Active comparator | Other: Manual TherapyManual Therapy Protocol 1. Articulation technique L4-S1 2. Lumbar neuromuscular technique 3. Fascial technique of crossed hands 4. Posteroanterior mobilizations of the lumbar vertebrae |
| Hypopressive exercises | Experimental | Other: Hypopressive exercisesProtocol of 5 Hypopressive Exercises |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Acute low back pain
- Lumbalgia operated surgically
- Low back pain after traumatism
- Episodes of sciatica
- Contraindication to any of the treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Therapy1. Articulation technique L4-S1 2. Lumbar neuromuscular technique 3. Fascial technique of crossed hands 4. Posteroanterior mobilizations of the lumbar vertebrae | Other | Manual Therapy |
| Hypopressive exercisesProtocol 5 Hypopressive exercises | Other | Hypopressive exercises |
Primary outcome
Intensity of 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.
4 secondary outcomes
Low Back Pain Disability
Time frame: 8 weeks
Algometry of spinous processes and lumbar muscles.
Time frame: 8 weeks
Lumbar flexion
Time frame: 8 weeks
Health status
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy and Hypopressive exercises in people with Low Back Pain, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of pain (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.