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Effects of Diaphragmatic Manual Therapy in Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
manual therapy with diaphragmatic treatment
Placebo treatment
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring diaphragm, osteopathic treatment, myofascial release

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • low back pain for more than 3 months

Exclusion Criteria:

  • vertebra fracture
  • systemic disease
  • spinal surgery
  • degenerative articular disease
  • acute soft tissue inflammation
  • radiculopathy
  • structural spine deformities
  • pregnancy
  • mental disease
  • dermatologic disease
  • rejection to manual contact

Sites / Locations

  • University CEU UCH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

diaphragmatic treatment

Placebo

Arm Description

Subjects in this arm receive different manual techniques for the low back pain and diaphragmatic treatment.

Subjects in this arm receive different manual techniques for the low back pain and a sham diaphragmatic treatment.

Outcomes

Primary Outcome Measures

Pain
Short form McGill Pain Questionnaire
Disability
Oswestry Disability Index

Secondary Outcome Measures

Fear Avoidance Beliefs Questionnaire
FABQ
Hospital Anxiety and Depression Scale
Pain Catastropizing Scale
Satisfaction with treatment Questionnaire

Full Information

First Posted
December 22, 2014
Last Updated
August 7, 2017
Sponsor
Cardenal Herrera University
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1. Study Identification

Unique Protocol Identification Number
NCT02343185
Brief Title
Effects of Diaphragmatic Manual Therapy in Chronic Low Back Pain
Official Title
Effects of Diaphragmatic Manual Therapy in Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a double-blind randomized clinical trial with two arms which aims to study the effects of diaphragmatic treatment in patients with nonspecific low back pain. Low back pain has a great importance in today's society, and it is therefore important to develop an effective treatment for this condition. People with chronic nonspecific low back pain, can present respiratory disorders and get anxiety states, affecting mainly the diaphragm muscle. Therefore, given its direct anatomic relationship, the diaphragm may be part of the development of chronic low back pain. Although clinical practice guidelines for chronic low back pain have been developed, it hasn't been explored before a physiotherapy treatment especially aimed at a diaphragmatic treatment. A double-blind randomized clinical trial with two arms will be used for this purpose, 64 patients with nonspecific low back pain referred from different hospitals of Castellón will be randomized into two groups: Diaphragmatic intervention with osteopathic manual therapy treatment (D). Diaphragmatic intervention with placebo treatment group (P). An osteopathic manual therapy protocol for the treatment of back pain including techniques for the diaphragm muscle will be applied to the patients in group D, in a total of 5 sessions. For patients in group P, the same protocol will be performed on the diaphragm but with placebo treatment techniques. The study focuses on the analysis of the following variables: scores on the questionnaires: Pain: McGill Pain Questionnaire and VAS (Visual Analogical Scale ). Fear Avoidance: (FABQ) Disability: Oswestry Disability Index and Roland-Morris Anxiety: HADS: (Hospital Anxiety and Depression Scale) Catastropizing: PCS (Pain Catastropizing Scale) Satisfaction with treatment (Escala de Satisfacción con el tratamiento) The results of these pre-intervention and post-intervention variables will be compared between the two groups in the first session, in the fourth session and in the first and third month after the first intervention. The VAS score will also be assessed in the second and third session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
diaphragm, osteopathic treatment, myofascial release

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
diaphragmatic treatment
Arm Type
Experimental
Arm Description
Subjects in this arm receive different manual techniques for the low back pain and diaphragmatic treatment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects in this arm receive different manual techniques for the low back pain and a sham diaphragmatic treatment.
Intervention Type
Other
Intervention Name(s)
manual therapy with diaphragmatic treatment
Intervention Description
Subjects receive five sesions of manual therapy for low back pain combined with diaphragmatic treatment.
Intervention Type
Other
Intervention Name(s)
Placebo treatment
Intervention Description
Subjects receive five sesions of manual therapy for low back pain combined with a sham diaphragmatic treatment.
Primary Outcome Measure Information:
Title
Pain
Description
Short form McGill Pain Questionnaire
Time Frame
4 weeks
Title
Disability
Description
Oswestry Disability Index
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Fear Avoidance Beliefs Questionnaire
Description
FABQ
Time Frame
4 weeks
Title
Hospital Anxiety and Depression Scale
Time Frame
4 weeks
Title
Pain Catastropizing Scale
Time Frame
4 weeks
Title
Satisfaction with treatment Questionnaire
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: low back pain for more than 3 months Exclusion Criteria: vertebra fracture systemic disease spinal surgery degenerative articular disease acute soft tissue inflammation radiculopathy structural spine deformities pregnancy mental disease dermatologic disease rejection to manual contact
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Francisco Lisón, PhD
Organizational Affiliation
University CEU UCH
Official's Role
Study Director
Facility Information:
Facility Name
University CEU UCH
City
Moncada
State/Province
Valencia
ZIP/Postal Code
46113
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
12779297
Citation
Assendelft WJ, Morton SC, Yu EI, Suttorp MJ, Shekelle PG. Spinal manipulative therapy for low back pain. A meta-analysis of effectiveness relative to other therapies. Ann Intern Med. 2003 Jun 3;138(11):871-81. doi: 10.7326/0003-4819-138-11-200306030-00008.
Results Reference
background
PubMed Identifier
8455963
Citation
Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.
Results Reference
background
PubMed Identifier
12850660
Citation
Herrero MJ, Blanch J, Peri JM, De Pablo J, Pintor L, Bulbena A. A validation study of the hospital anxiety and depression scale (HADS) in a Spanish population. Gen Hosp Psychiatry. 2003 Jul-Aug;25(4):277-83. doi: 10.1016/s0163-8343(03)00043-4.
Results Reference
background
PubMed Identifier
10547405
Citation
Andersson GB, Lucente T, Davis AM, Kappler RE, Lipton JA, Leurgans S. A comparison of osteopathic spinal manipulation with standard care for patients with low back pain. N Engl J Med. 1999 Nov 4;341(19):1426-31. doi: 10.1056/NEJM199911043411903.
Results Reference
background
PubMed Identifier
16550448
Citation
Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.
Results Reference
background
PubMed Identifier
29787734
Citation
Marti-Salvador M, Hidalgo-Moreno L, Domenech-Fernandez J, Lison JF, Arguisuelas MD. Osteopathic Manipulative Treatment Including Specific Diaphragm Techniques Improves Pain and Disability in Chronic Nonspecific Low Back Pain: A Randomized Trial. Arch Phys Med Rehabil. 2018 Sep;99(9):1720-1729. doi: 10.1016/j.apmr.2018.04.022. Epub 2018 May 19.
Results Reference
derived

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Effects of Diaphragmatic Manual Therapy in Chronic Low Back Pain

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