Prospective Study of Clinical Utility of Acupuncture in Back Pain

Study Overview
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Brief Summary
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The purpose of this study is to evaluate prospectively the effectiveness of acupuncture as adjunctive therapy in the treatment of spinal pain is the three backbone areas: cervical, thoracic and lumbar pain, under conditions of usual clinical practice as the medical acupuncturist performed acupuncture, with and without supplementary pharmacological treatment during the first 4 weeks of follow up.

Detailed Description
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Epidemiological, observational, prospective, with two cohorts, naturalistic and non-interventionist study. The disease to be studied is Back pain (cervical, thoracic or lumbar) caused by musculoskeletal pathologies and previously treated with conventional medical treatment with or without treatment currently.

Official Title
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Prospective Epidemiological Study To Evaluate The Clinical Utility Of Acupuncture In The Treatment Of Back Pain (Study PUCTURE-CV)

Conditions
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Back Pain, Musculoskeletal Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both sexes, aged 18 and over Patients diagnosed with back pain: cervical, thoracic or lumbar. Patients who has received appropriate medical treatment for their disease: analgesics, anti-inflammatories, or other treatments, but painful and symptoms persist Patients that could receive acupuncture treatment in order to reduce the symptoms and reviewed by a medical acupuncturist Patients with sufficient cultural and educational level to complete the health questionnaires required in the study Patients who have given their written informed consent to participate in the study Exclusion Criteria: Patient with any illness and that medical opinions recommended not to participate in the study Patient can not respond to questionnaires administered during the study

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| With usual concomitant treatment<br>Two observational cohorts of patients will be evaluated: with and without concomitant analgesic/ antiinflammatory drugs. The objective is evaluate that both therapies (drugs and acupuncture) could be used as adjunctive therapy in order to maximize the analgesia that could be reached | |
| Without usual concomitant treatment<br>This group include patients that are not been treated with analgesic drugs at the beginning of the study. As an observational and naturalistic study any indicated treatment is allowed in any time | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS: Visual Analogic Scale of pain | Pain assesment will be evaluated using a Visual Analogic Scale of pain (VAS). This variable will be evaluated in all 10 visits and it will be showed its evolution (decrease) along the study | 10 weekly visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sheehan Disability Questionnaire | Sheehan Disability Questionnaire, this validated questionnaire will be administrated in Visit 1 (Basal) and Visit 10 (Final) and it will be compared if there has been statistical differences between both evaluations | First Visit (week 1) and Final Visit (week 10) | 
| Evaluation of the Scale Hospital Anxiety Depression (HAD) | Scale Hospital Anxiety Depression (HAD), this scale will be evaluated using a validated questionnaire administrated in Visit 1 (basal) and Visit 10 (Final) and it will be compared if there has been statistical differences between both evaluations | First Visit (week 1) and Final Visit (week 10) | 
| Health Questionnaire EuroQol-5D | Health Questionnaire EuroQol-5D, this validated questionnaire will be administrated in Visit 1 (Basal) and Visit 10 (Final) and it will be compared if there has been statistical differences between both evaluations | First Visit (week 1) and Final Visit (week 10) | 
| Assessment of sleep with the integrated scale MOS (Medical Outcomes Study) | Assessment of sleep with the integrated scale MOS (Medical Outcomes Study), this scale will be evaluated using a validated questionnaire administrated in Visit 1 (basal) and Visit 10 (Final) and it will be compared if there has been statistical differences between both evaluations | First Visit (week 1) and Final Visit (week 10) | 
| McGill Pain Questionnaire | A secondary evaluation of pain suffered by the patients will be evaluated using the validated McGill Pain Questionnaire. This questionnaire will be adminstrated in all 10 visits and it will be showed its evolution (decrease) along the study | 10 weekly visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Back pain, cervicalgia, dorsalgia, lumbalgia, acupuncture