NCT02343185

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.

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 Jan 2014

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

2.4 years

First QC Date

December 22, 2014

Last Update Submit

August 7, 2017

Conditions

Low Back Pain

Keywords

diaphragmosteopathic treatmentmyofascial release

Outcome Measures

Primary Outcomes (2)

  • Pain

    Short form McGill Pain Questionnaire

    4 weeks

  • Disability

    Oswestry Disability Index

    4 weeks

Secondary Outcomes (4)

  • Fear Avoidance Beliefs Questionnaire

    4 weeks

  • Hospital Anxiety and Depression Scale

    4 weeks

  • Pain Catastropizing Scale

    4 weeks

  • Satisfaction with treatment Questionnaire

    4 weeks

Study Arms (2)

diaphragmatic treatment

EXPERIMENTAL

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

Other: manual therapy with diaphragmatic treatment

Placebo

PLACEBO COMPARATOR

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

Other: Placebo treatment

Interventions

manual therapy with diaphragmatic treatmentOTHER

Subjects receive five sesions of manual therapy for low back pain combined with diaphragmatic treatment.

diaphragmatic treatment
Placebo treatmentOTHER

Subjects receive five sesions of manual therapy for low back pain combined with a sham diaphragmatic treatment.

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • low back pain for more than 3 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University CEU UCH

Moncada, Valencia, 46113, Spain

Location

Related Publications (6)

  • 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.

    PMID: 12779297BACKGROUND

  • 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.

    PMID: 8455963BACKGROUND

  • 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.

    PMID: 12850660BACKGROUND

  • 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.

    PMID: 10547405BACKGROUND

  • 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.

    PMID: 16550448BACKGROUND

  • 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.

    PMID: 29787734DERIVED

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 Officials

  • Juan Francisco Lisón, PhD

    University CEU UCH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 22, 2014

First Posted

January 21, 2015

Study Start

January 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 8, 2017

Record last verified: 2017-08

Locations

ES(1)