Efficacy and safety of acupuncture for the treatment of non-specific acute low back pain: a randomised controlled multicentre trial
| ISRCTN | ISRCTN65814467 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65814467 |
| Secondary identifying numbers | PI051191 |
- Submission date
- 21/02/2006
- Registration date
- 22/02/2006
- Last edited
- 04/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Jorge Vas
Scientific
Scientific
Unidad de Tratamiento del Dolor
Centro de Salud Dos Hermanas A
Segovia s/n
Dos Hermanas (Sevilla)
41700
Spain
| jvas@acmas.com |
Study information
| Study design | Randomised, four-branch, multicentre, prospective study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Efficacy and safety of acupuncture for the treatment of non-specific acute low back pain: a randomised controlled multicentre trial |
| Study acronym | Acute-LBP & Acupuncture |
| Study hypothesis | Acupuncture is capable of reducing pain and incapacity among patients suffering non-specific acute low back pain better than sham acupuncture (applied at non-specific points), placebo acupuncture and conventional treatment. Moreover, the application of this technique reduces the duration of absence from work caused by non-specific acute low back pain, while at the same time moderating the consumption of medicines used as conventional therapy and reducing the iatrogeny caused by such medicines without provoking any significant iatrogeny of its own. |
| Ethics approval(s) | The ethical validity of this study has been analysed by the Andalusian Regional Committee for Clinical Trials, after approval by the Research Committee at each of the healthcare clinics concerned, date 29/06/2005 |
| Condition | Non-specific acute low back pain |
| Intervention | 1. Semi-standardised real acupuncture (group A) 2. Sham acupuncture (acupuncture at non-specific points) (group B) 3. Placebo acupuncture (group C) 4. Conventional treatment (group D) |
| Intervention type | Other |
| Primary outcome measure | 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 | 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. 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. |
| Overall study start date | 20/02/2006 |
| Overall study end date | 30/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 340 |
| Total final enrolment | 275 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 20/02/2006 |
| Recruitment end date | 30/01/2008 |
Locations
Countries of recruitment
- Spain
Study participating centre
Unidad de Tratamiento del Dolor
Dos Hermanas (Sevilla)
41700
Spain
41700
Spain
Sponsor information
Department of Health and Consumption - Institute of Health Carlos III (Spain)
Government
Government
Sinesio Delgado, 6
Madrid
28029
Spain
| Phone | +34 (0)918222522 |
|---|---|
| proyectos@isciii.es | |
"ROR" |
https://ror.org/00ca2c886 |
Funders
Funder type
Government
Institute of Heath Carlos III, Ministry of Health and Consumption (Instituto de Salud Carlos III, Instituto de Salud y Consumo) (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 21/04/2006 | Yes | No | |
| Results article | results | 01/09/2012 | 04/06/2019 | Yes | No |
Editorial Notes
04/06/2019: Total final enrolment and publication reference were added.
