Overview

This trial is active, not recruiting.

Condition low back pain
Treatments manual therapy with diaphragmatic treatment, placebo treatment
Sponsor Cardenal Herrera University
Start date January 2014
End date January 2015
Trial size 64 participants
Trial identifier NCT02343185, CEU-UCH-125

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Subjects in this arm receive different manual techniques for the low back pain and diaphragmatic treatment.
manual therapy with diaphragmatic treatment
Subjects receive five sesions of manual therapy for low back pain combined with diaphragmatic treatment.
(Placebo Comparator)
Subjects in this arm receive different manual techniques for the low back pain and a sham diaphragmatic treatment.
placebo treatment
Subjects receive five sesions of manual therapy for low back pain combined with a sham diaphragmatic treatment.

Primary Outcomes

Measure
Pain
time frame: 4 weeks
Disability
time frame: 4 weeks

Secondary Outcomes

Measure
Fear Avoidance Beliefs Questionnaire
time frame: 4 weeks
Hospital Anxiety and Depression Scale
time frame: 4 weeks
Pain Catastropizing Scale
time frame: 4 weeks
Satisfaction with treatment Questionnaire
time frame: 4 weeks

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Effects of Diaphragmatic Manual Therapy in Chronic Low Back Pain
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Cardenal Herrera University.