Prospective Study of Clinical Utility of Acupuncture in Back Pain (PUCTURE-CV)

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

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.

Study Overview

• Status: Unknown
• Conditions: Back Pain; Musculoskeletal Disease

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.

• Study Type: Observational
• Enrollment (Anticipated): 102

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 20010
    • I.H. Hospital San Jose

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
With usual concomitant treatment; 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; 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?

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

Collaborators and Investigators

• Sponsor: Group G-6
• Investigators: Principal Investigator: Valentin Martin, MD, PhD, Grupo G6

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: September 28, 2010
• First Submitted That Met QC Criteria: October 28, 2010
• First Posted (Estimate): November 1, 2010

Study Record Updates

• Last Update Posted (Estimate): November 8, 2011
• Last Update Submitted That Met QC Criteria: November 7, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Back pain; acupuncture; cervicalgia; dorsalgia; lumbalgia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Musculoskeletal Diseases
• Other Study ID Numbers: GE6-ACU-2010-01