Clinical trial NCT01231425: Prospective Study of Clinical Utility of Acupuncture in Back Pain
Official title: Prospective Epidemiological Study To Evaluate The Clinical Utility Of Acupuncture In The Treatment Of Back Pain (Study PUCTURE-CV)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Back Pain
Musculoskeletal Disease
Keywords: Back pain
cervicalgia
dorsalgia
lumbalgia
acupuncture
Lead sponsor: Group G-6
Sponsor class: NETWORK
First posted: 2010-11-01
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is patients who go to the Acupuncture Office diagnosed of cervical, thoracic or lumbar pain caused by musculoskeletal diseases, pretreated with pharmacological treatment, they start treatment with acupuncture as adjunctive therapy for symptoms of their disease.

Initially it was estimated that the optimal number of patients included to achieve the objectives of the study is 102 patients

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS: Visual Analogic Scale of pain
timeFrame: 10 weekly visits
Secondary outcomes:
measure: Sheehan Disability Questionnaire
timeFrame: First Visit (week 1) and Final Visit (week 10)
measure: Evaluation of the Scale Hospital Anxiety Depression (HAD)
timeFrame: First Visit (week 1) and Final Visit (week 10)
measure: Health Questionnaire EuroQol-5D
timeFrame: First Visit (week 1) and Final Visit (week 10)
measure: Assessment of sleep with the integrated scale MOS (Medical Outcomes Study)
timeFrame: First Visit (week 1) and Final Visit (week 10)
measure: McGill Pain Questionnaire
timeFrame: 10 weekly visits
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: I.H. Hospital San Jose
Study officials:
affiliation: Grupo G6
name: Valentin Martin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: