Effects of Diaphragmatic Manual Therapy in Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

Effects of Diaphragmatic Manual Therapy in Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02343185
• Other study ID #: CEU-UCH-125
• Status: Completed
• Phase: N/A
• First received: December 22, 2014
• Last updated: August 7, 2017
• Start date: January 2014
• Est. completion date: June 2016

Study information

• Verified date: August 2017
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
Spain	University CEU UCH	Moncada	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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:S192-300. — View 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. — View 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. Review. — View 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. — View 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):157-68. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Short form McGill Pain Questionnaire	4 weeks
Primary	Disability	Oswestry Disability Index	4 weeks
Secondary	Fear Avoidance Beliefs Questionnaire	FABQ	4 weeks
Secondary	Hospital Anxiety and Depression Scale		4 weeks
Secondary	Pain Catastropizing Scale		4 weeks
Secondary	Satisfaction with treatment Questionnaire		4 weeks