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Clinical Trials/NCT04384185
NCT04384185
Completed
Not Applicable

Effectiveness of a Therapeutic Exercise Protocol Combined With Manual Therapy Techniques on the Diaphragm Muscle in Patients With Low Back Pain

University of Alcala1 site in 1 country42 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain, Mechanical
Sponsor
University of Alcala
Enrollment
42
Locations
1
Primary Endpoint
Low-back pain
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

MAIN OBJECTIVE: to assess whether an exercise protocol on the lumbar musculature by adding manual therapy techniques on the diaphragm muscle has the same or greater effect on chronic non-specific lumbar pain than an isolated exercise protocol.

SECONDARY OBJECTIVES: to evaluate the effectiveness of a lumbar exercise protocol in chronic non-specific low back pain in isolation; To evaluate the effectiveness of both therapies in improving joint range in patients with chronic non-specific low back pain and, finally, to assess catastrophism and the avoidance of lumbar mobility when carrying out loaded movements.

HYPOTHESIS: that a lumbar exercise protocol combined with manual therapy treatment on the diaphragm is equal or more effective on pain in patients with chronic nonspecific low back pain than treatment with the same lumbar exercise protocol in isolation.

Detailed Description

METHODOLOGY: A prospective randomized clinical trial with two types of intervention (lumbar exercise protocol and manual diaphragm therapy) will be carried out. The variables to be measured are pain, disability, mobility and kinesiophobia. It will be performed in two groups of 21 people who are of legal age, who have low back pain of more than 3 months duration and which is of non-specific origin. The patients will be randomized and divided into two groups A (control) and B (experimental). Group A will undergo an exercise protocol. Group B will undergo the same protocol plus manual therapy techniques on diaphragm muscle. Study participants will have treatment twice a week for 8 weeks, the first information session and the second measurement-evaluation session in the first week of treatment. In the following 3 weeks the session will last 40 minutes for both groups. In the 4th week the established measurements will be carried out again.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
April 15, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Alcala
Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Daniel Pecos Martín

PhD. Daniel Pecos Martín

University of Alcala

Eligibility Criteria

Inclusion Criteria

  • Legal age
  • Non-specific Low-Back pain
  • Pain more 3 months

Exclusion Criteria

  • subjects with lumbar herniation.
  • Spine canal stenosis
  • Subjects with neurological disease.
  • Lumbar surgery

Outcomes

Primary Outcomes

Low-back pain

Time Frame: Change from Baseline disability at 3 months

The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient with lowback pain.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and ten the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale.

Secondary Outcomes

  • Lumbar range of motion(Change from Baseline disability at 3 months)
  • Disability with Oswestry Disability Index(Change from Baseline disability at 3 months)
  • Kinesiophobia(Change from Baseline disability at 3 months)

Study Sites (1)

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