NCT03565926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2018

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

1 month

First QC Date

May 30, 2018

Last Update Submit

July 10, 2025

Conditions

Keywords

low back painmanual therapyhypopressive therapeutic exercises

Outcome Measures

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.

    8 weeks

Secondary Outcomes (4)

  • Low Back Pain Disability

    8 weeks

  • Algometry of spinous processes and lumbar muscles.

    8 weeks

  • Lumbar flexion

    8 weeks

  • Health status

    8 weeks

Study Arms (2)

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

Other: Manual Therapy

Hypopressive exercises

EXPERIMENTAL

Protocol of 5 Hypopressive Exercises

Other: Hypopressive exercises

Interventions

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

Manual Therapy

Protocol 5 Hypopressive exercises

Hypopressive exercises

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gemma v. Espí López

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 30, 2018

First Posted

June 21, 2018

Study Start

July 1, 2018

Primary Completion

July 31, 2018

Study Completion

September 15, 2018

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations