Prospective Study of Clinical Utility of Acupuncture in Back Pain

Group G-6102 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

102

Conditions

Back Pain Musculoskeletal Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

I.H. Hospital San Jose

Madrid, Madrid, Spain

Outcomes

Primary Outcomes

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

Time frame: 10 weekly visits

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: First Visit (week 1) and Final Visit (week 10)

Data from ClinicalTrials.gov

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