Efficacy and safety of acupuncture for the treatment of non-specific acute low back pain: a randomised controlled multicentre trial

Not Applicable

Completed

• Conditions: on-specific acute low back pain; Musculoskeletal Diseases; Non-specific acute low back pain

• Registration Number: ISRCTN65814467
• Lead Sponsor: Department of Health and Consumption - Institute of Health Carlos III (Spain)

Brief Summary

1. Protocol in http://www.ncbi.nlm.nih.gov/pubmed/16630342 2. 2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22770838 (added 04/06/2019)

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-22
• Study Completion: 2008-01-30
• Last Update Posted: 2019-07-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

1. Signed informed consent form
2. New episode of non-specific acute low back pain of less than two weeks evolution, with or without irradiation (diagnosed by clinical history and physical examination). We define new as the first episode in at least the last six months.
3. Patients of working age (whether in paid employment or not), either occupationally active or absent from work because of back pain
4. No previous treatment with acupuncture (in order to minimise the possibility of patients being able to distinguish the real acupuncture treatment from the various control (placebo) modes

Exclusion Criteria

1. More than one absence from work because of back pain within a period of six months (in order to eliminate possible mercenary motives)

2. The presence of alarm signs that suggest the protrusion or prolapse of one or more intervertebral disks with concurrent neurological symptoms, infectious spondylopathy, previous surgery affecting the spine, low back pain caused by inflammatory illness, whether malign or autoimmune, congenital deformities of the spine except for slight scholiosis or lordosis, vertebral fractures, stenosis of the spinal canal, spondylolysis or spondylolisthesis

3. Contraindications for acupuncture such as extensive skin disorders, treatment with anticoagulants, or pregnancy

4. Inability to complete the questionnaires or to answer the questions of the assessor

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinically Relevant Improvement (CRI) of the lumbar complaint at three weeks after randomisation. We define CRI as a reduction of 35% or more in lumbar incapacity as reported on the Roland-Morris questionnaire

Secondary Outcome Measures

Name	Time	Method
<br> CRI at 12 and 48 weeks after randomisation and a series of result measures (pain intensity, improvement perceived by the patient, incapacity to work, quality of life [EuroQol 5D] and consumption of analgesics) used to reflect the multidimensional nature of the impact of low back pain, obtained at 3, 12 and 48 weeks after beginning the treatment.<br> Other secondary measures to be used are: a control scale of the credibility of the treatment after the first week of treatment, for groups A, B and C, the pain intensity before and immediately after each of the treatment sessions, the record of the collateral effects and adverse reactions that may appear up to week 3 (during the treatment phase), the number of new episodes of low back pain reported at weeks 12 and 48, and the number of days of enforced absence from work because of low back pain from the date of final assessment to weeks 12 and 48.<br>