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NCT Number: NCT02343185

Effects of Diaphragmatic Manual Therapy in Chronic Low Back Pain

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University CEU UCH

Moncada, Valencia, 46113, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

manual therapy with diaphragmatic treatment

Other

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

Placebo treatment

Other

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

Primary outcomes

  1. Pain

    Time frame: 4 weeks

    Short form McGill Pain Questionnaire

  2. Disability

    Time frame: 4 weeks

    Oswestry Disability Index

Secondary outcomes

  1. Fear Avoidance Beliefs Questionnaire

    Time frame: 4 weeks

    FABQ

  2. Hospital Anxiety and Depression Scale

    Time frame: 4 weeks

  3. Pain Catastropizing Scale

    Time frame: 4 weeks

  4. Satisfaction with treatment Questionnaire

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 21, 2015
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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