Clinical trial NCT02343185: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: diaphragm
osteopathic treatment
myofascial release
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2015-01-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain
timeFrame: 4 weeks
measure: Disability
timeFrame: 4 weeks
Secondary outcomes:
measure: Fear Avoidance Beliefs Questionnaire
timeFrame: 4 weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: 4 weeks
measure: Pain Catastropizing Scale
timeFrame: 4 weeks
measure: Satisfaction with treatment Questionnaire
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Moncada
country: Spain
facility: University CEU UCH
state: Valencia
Study officials:
affiliation: University CEU UCH
name: Juan Francisco Lisón, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.