Overview

This trial is active, not recruiting.

Conditions back pain, musculoskeletal disease
Sponsor Group G-6
Start date July 2010
End date June 2012
Trial size 102 participants
Trial identifier NCT01231425, GE6-ACU-2010-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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
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

Primary Outcomes

Measure
VAS: Visual Analogic Scale of pain
time frame: 10 weekly visits

Secondary Outcomes

Measure
Sheehan Disability Questionnaire
time frame: First Visit (week 1) and Final Visit (week 10)
Evaluation of the Scale Hospital Anxiety Depression (HAD)
time frame: First Visit (week 1) and Final Visit (week 10)
Health Questionnaire EuroQol-5D
time frame: First Visit (week 1) and Final Visit (week 10)
Assessment of sleep with the integrated scale MOS (Medical Outcomes Study)
time frame: First Visit (week 1) and Final Visit (week 10)
McGill Pain Questionnaire
time frame: 10 weekly visits

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Prospective Epidemiological Study To Evaluate The Clinical Utility Of Acupuncture In The Treatment Of Back Pain (Study PUCTURE-CV)
Principal investigator Valentin Martin, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by Group G-6.