Text Size

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

September 28, 2010
November 7, 2011
July 2010
June 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01231425 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Prospective Study of Clinical Utility of Acupuncture in Back Pain
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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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
  • Back Pain
  • Musculoskeletal Disease
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
102
October 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01231425
GE6-ACU-2010-01
No
Group G-6
Group G-6
Not Provided
Principal Investigator: Valentin Martin, MD, PhD Grupo G6
Group G-6
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP