Prospective Study of Clinical Utility of Acupuncture in Back Pain

Back Pain Clinical Trial

— PUCTURE-CV  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01231425
• Other study ID #: GE6-ACU-2010-01
• Status: Active, not recruiting
• Phase: N/A
• First received: September 28, 2010
• Last updated: November 7, 2011
• Start date: July 2010
• Est. completion date: October 2012

Study information

• Verified date: November 2011
• Source: Group G-6
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: October 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Musculoskeletal Disease
• Musculoskeletal Diseases

Locations

Country	Name	City	State
Spain	I.H. Hospital San Jose	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Group G-6

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	No