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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Group G-6
ClinicalTrials.gov Identifier:
NCT01231425
First received: September 28, 2010
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition
Back Pain
Musculoskeletal Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Epidemiological Study To Evaluate The Clinical Utility Of Acupuncture In The Treatment Of Back Pain (Study PUCTURE-CV)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Group G-6:

Primary Outcome Measures:
  • VAS: Visual Analogic Scale of pain [ Time Frame: 10 weekly visits ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Sheehan Disability Questionnaire [ Time Frame: First Visit (week 1) and Final Visit (week 10) ] [ Designated as safety issue: No ]
    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

  • Evaluation of the Scale Hospital Anxiety Depression (HAD) [ Time Frame: First Visit (week 1) and Final Visit (week 10) ] [ Designated as safety issue: No ]
    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

  • Health Questionnaire EuroQol-5D [ Time Frame: First Visit (week 1) and Final Visit (week 10) ] [ Designated as safety issue: No ]
    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

  • Assessment of sleep with the integrated scale MOS (Medical Outcomes Study) [ Time Frame: First Visit (week 1) and Final Visit (week 10) ] [ Designated as safety issue: No ]
    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

  • McGill Pain Questionnaire [ Time Frame: 10 weekly visits ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 102
Study Start Date: July 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231425

Locations
Spain
I.H. Hospital San Jose
Madrid, Spain, 20010
Sponsors and Collaborators
Group G-6
Investigators
Principal Investigator: Valentin Martin, MD, PhD Grupo G6
  More Information

No publications provided

Responsible Party: Group G-6
ClinicalTrials.gov Identifier: NCT01231425     History of Changes
Other Study ID Numbers: GE6-ACU-2010-01
Study First Received: September 28, 2010
Last Updated: November 7, 2011
Health Authority: Spain: Ministry of Health

Keywords provided by Group G-6:
Back pain
cervicalgia
dorsalgia
lumbalgia
acupuncture

Additional relevant MeSH terms:
Back Pain
Musculoskeletal Diseases
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013