Randomised controlled study in the primary healthcare sector to investigate the effectiveness and safety of auriculotherapy for the treatment of uncomplicated chronic rachialgia
| ISRCTN | ISRCTN01897462 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01897462 |
| Secondary identifying numbers | 07/90058-0046/2007 |
- Submission date
- 29/05/2008
- Registration date
- 05/06/2008
- Last edited
- 28/02/2014
- 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 of protocol
Not provided at time of registration
Contact information
Dr Jorge Vas
Scientific
Scientific
Pain Treatment Unit
Primary Healthcare Centre
Segovia s/n
Dos Hermanas
41700
Spain
| jorgef.vas.sspa@juntadeandalucia.es |
Study information
| Study design | Randomised controlled multicentre prospective study, with two parallel arms. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | |
| Study objectives | The auriculotherapy using implants with vaccaria seeds is more effective than placebo, with respect to the pain intensity, experienced by patients with uncomplicated chronic rachialgia. |
| Ethics approval(s) | Andalusian Government Committee for Clinical Trials. Date of approval: 07/12/2007 (ref: acta 10/07) |
| Health condition(s) or problem(s) studied | Uncomplicated chronic musculoskeletal rachialgia (neck, mid-back or lower back) |
| Intervention | True auriculotherapy using pressure with vaccaria seeds (TAP): Application of auricular implants with vaccaria seeds (vaccaria segetalis Garcke, known in China as Wang bu liu xing) as an individualised form of sensory stimulation, affixed to the auricular pavilion by means of flesh-coloured sticking plaster. Selection of the auricular points will be made in accordance with the pain characteristics and the sensitivity of the auricular zones, examined using a 250 gr pressure detector. The patients will be requested to squeeze the implant with their finger 10 times, 3 times a day. A new implant will be inserted every week for 8 weeks. Placebo auriculotherapy (PAP): The same protocol will be followed, under the same conditions as for TAP, but with the application of sticking plaster over inactive black plastic discs, with a diameter of 1.5 mm, simulating the appearance of the auricular implants used in the TAP. Any adverse reactions or side effects that may occur will be recorded in the corresponding data logbook, stating details of the reaction, and date of occurrence. The same amount of time should be dedicated to the patients in each of the two groups, as well as for the pre and post-session evaluations. The patients in both groups will be called 8 times for treatment (once a week) for the auricular implants to be inserted (Total duration of interventions: 8 weeks). |
| Intervention type | Other |
| Primary outcome measure | Changes in pain intensity, measured on the 100 mm visual analogue scale (VAS), at 9 weeks after beginning treatment |
| Secondary outcome measures | 1. Changes in pain intensity, measured on the 100 mm VAS, at 6 months after beginning treatment 2. Changes in the McGill Pain Questionnaire (MPQ), at the end of treatment and after 6 months 3. Satisfaction on the improvement perceived by the patient, measured at 9 weeks 4. Changes in health-related quality of life, according to the Spanish version of the 12-item Short Form health survey, version 2, at the end of treatment and after 6 months 5. Changes in the results of the Lattinen test and in the consumption of analgesics and NSAIDs (whether or not prescribed by the GP), at the time of randomisation, after each treatment session, at the end of treatment and after 6 months |
| Overall study start date | 01/05/2008 |
| Completion date | 20/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | 1. Both males and females, aged at least 18 years 2. Uncomplicated chronic muscular-skeletal rachialgia (neck, mid-back or lower back), diagnosed by clinical background and physical examination 3. Have not previously received treatment with auricular implants |
| Key exclusion criteria | 1. Protrusion or prolapse of one or more intervertebral discs with concurrent neurological symptoms 2. Infectious spondylopathy 3. Previous surgery of the spinal column 4. Rachialgia caused by inflammatory disease, malign or autoimmmune 5. Congenital deformities of the spinal column, except mild degrees of scoliosis or lordosis 6. Vertebral fractures 7. Spinal stenosis 8. Spondylolysis or spondylolystesis 9. Skin complaints in the auricular pavilion or allergy to sticking plaster 10. Pregnancy 11. Lawsuits brought by reason of rachialgia 12. Incapacity to fill in the questionnaires or respond to the evaluator's questions |
| Date of first enrolment | 01/05/2008 |
| Date of final enrolment | 20/12/2009 |
Locations
Countries of recruitment
- Spain
Study participating centre
Pain Treatment Unit
Dos Hermanas
41700
Spain
41700
Spain
Sponsor information
Carlos III Health Institute (Spain)
Research organisation
Research organisation
C/ Sinesio Delgado, 6
Madrid
28029
Spain
| Website | http://www.isciii.es/htdocs/en/index.jsp |
|---|---|
"ROR" |
https://ror.org/00ca2c886 |
Funders
Funder type
Research organisation
Healthcare Research Fund of the Carlos III Health Institute (Project no. PI0790058) (Spain)
No information available
Andalusian Regional Ministry of Health (Project no. 0046/2007)
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 | 06/07/2008 | Yes | No | |
| Results article | results | 01/06/2014 | Yes | No |
