Prospective Study of Clinical Utility of Acupuncture in Back Pain

NCT01231425 | Unknown

• 1 other identifier: GE6-ACU-2010-01
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Back Pain; Musculoskeletal Disease

Keywords

Back pain; cervicalgia; dorsalgia; lumbalgia; acupuncture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Sheehan Disability Questionnaire

  First Visit (week 1) and Final Visit (week 10)

• Evaluation of the Scale Hospital Anxiety Depression (HAD)

  First Visit (week 1) and Final Visit (week 10)

• Health Questionnaire EuroQol-5D

  First Visit (week 1) and Final Visit (week 10)

• Assessment of sleep with the integrated scale MOS (Medical Outcomes Study)

  First Visit (week 1) and Final Visit (week 10)

• McGill Pain Questionnaire

  10 weekly visits

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Group G-6: lead

Study Sites (1)

I.H. Hospital San Jose

Madrid, Madrid, 20010, Spain

Location

MeSH Terms

Conditions

Back Pain; Musculoskeletal Diseases; Neck Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Valentin Martin, MD, PhD

  Grupo G6

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: November 1, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 8, 2011

Record last verified: 2011-11

Locations

ES (1)