Effects of Diaphragmatic Manual Therapy in Chronic Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Diaphragmatic Manual Therapy in Chronic Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: manual therapy with diaphragmatic treatment
* Other: Placebo treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diaphragmatic treatment<br>Subjects in this arm receive different manual techniques for the low back pain and diaphragmatic treatment. | Other: manual therapy with diaphragmatic treatment<br>* Subjects receive five sesions of manual therapy for low back pain combined with diaphragmatic treatment.<br>|
| Placebo Comparator: Placebo<br>Subjects in this arm receive different manual techniques for the low back pain and a sham diaphragmatic treatment. | Other: Placebo treatment<br>* Subjects receive five sesions of manual therapy for low back pain combined with a sham diaphragmatic treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Short form McGill Pain Questionnaire | 4 weeks | 
| Disability | Oswestry Disability Index | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear Avoidance Beliefs Questionnaire | FABQ | 4 weeks | 
| Hospital Anxiety and Depression Scale |  | 4 weeks | 
| Pain Catastropizing Scale |  | 4 weeks | 
| Satisfaction with treatment Questionnaire |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diaphragm, osteopathic treatment, myofascial release