Effect of acupuncture treatment on stiff neck
| ISRCTN | ISRCTN76896018 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76896018 |
| Secondary identifying numbers | RCT |
- Submission date
- 22/02/2011
- Registration date
- 10/03/2011
- Last edited
- 27/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
There have been no reported randomized placebo-controlled trials investigating the effectiveness of acupuncture under double-blind conditions using practitioner-patient blinded needles. The aim of this study is to verify the effectiveness of acupuncture for functional neck/shoulder stiffness.
Who can participate?
Patients aged over 18 with stiff neck not from organic disease.
What does the study involve?
Before treatment, patients will be asked about the intensity of their stiff neck. Patients will be randomly allocated to receive one of the following four acupuncture treatments:
1. Treatment with penetrating needles
2. Treatment with skin-touch placebo needles (the needle tip presses against the skin)
3. Treatment with no-touch placebo needles (the needle tip does not reach the skin)
4. Treatment without any needle applications (control group)
Immediately after and 24 hours after treatment, the patients are asked about the intensity of their stiff neck. Also, the acupuncturists and patients are asked to record whether the treatment is 'no-touch control', 'skin-touch placebo', 'penetrating', or 'unidentifiable'.
What are the possible benefits and risks of participating?
Participants will contribute to developing acupuncture and moxibustion studies. Although rare, there is the possibility of needle pain, unpleasantness, bleeding and hematoma with acupuncture.
Where is the study run from?
Tokyo Ariake University of Medical and Health Sciences (Japan).
When is the study starting and how long is it expected to run for?
The study started in June 2010 and will run until March 2015.
Who is funding the study?
Grants-in-Aid for Scientific Research (B) (Japan).
Who is the main contact?
Prof Nobuari Takakura
Contact information
Scientific
2-9-1 Ariake, Koto-ku
Tokyo
135-0063
Japan
Study information
| Study design | Randomised double-blind placebo-controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effect of acupuncture treatment on stiff neck: a randomised, double-blind, placebo-controlled trial |
| Study objectives | Differences exist in therapeutic effect on stiff neck between treatments with the penetrating, skin-touch placebo, no-touch control needle and a control group without any needles. The aim of the study is to assess whether verum penetrating needle treatment has specific effect over placebo needle treatment on stiff neck. On 23/07/2014 the following changes were made to the trial record: 1. The overall trial start date was changed from 24/01/2011 to 09/06/2010. 2. The overall trial end date was changed from 31/03/2013 to 31/03/2015. |
| Ethics approval(s) | Ethics Committee of Tokyo Ariake University of Medical and Health Sciences, 08/07/2010 |
| Health condition(s) or problem(s) studied | Musculoskeletal discomfort |
| Intervention | Treatments using the double-blind needle: 1. The no-touch needle which the needle tip does not reach the skin 2. Skin-touch placebo needle which the needle tip presses against the skin 3. Verum penetrating needle 4. Treatment without any needle applications (control group) Before treatment, patients are asked about the intensity of their stiff neck on a visual analogue scale. In this trial, each of five acupuncturists applies acupuncture treatment to 60 patients. For each treatment, the acupuncturist applies four needles to four acupoints on the neck and shoulder in the patients. Immediately after and 24 hours after treatment, the patients are asked about the intensity of their stiff neck on a visual analogue scale. Also, acupuncturists (practitioners) and patients are asked to record whether the treatment is 'no-touch control', 'skin-touch placebo', 'penetrating', or 'unidentifiable'. The same methods are applied to the control group without any needles and relating questions are asked. |
| Intervention type | Other |
| Primary outcome measure | Improvement in stiff neck: before, immediately and 24 hours after needle application, the patients are asked about the intensity of their stiff neck on a Visual Analogue Scale (VAS) ranging from 0 (no stiff neck) to 100 (the most intense stiff neck imaginable) |
| Secondary outcome measures | Effect of patient and practitioner blinding using the double-blind needle: after completion of treatment, the practitioners and patients are asked to record whether they think the treatment is 'penetrating', 'skin-touch', 'no-touch' or 'utterly unidentifiable' |
| Overall study start date | 09/06/2010 |
| Completion date | 31/03/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| Total final enrolment | 400 |
| Key inclusion criteria | 1. Patients with stiff neck not from organic disease 2. Age range: over 18 years, both male and female |
| Key exclusion criteria | Patients who have: 1. Cervical spondylosis 2. Cervical disc herniation 3. Cervico-omo-brachial syndrome 4. Thoracic outlet syndrome 5. Liver, gallbladder or heart disease 6. High blood pressure 7. Cerebral vascular disease 8. Neurological disease 9. Under any pharmacological treatment 10. Patients who will receive any cure for stiff neck or acupuncture treatment within 24 hours after treatment in this study |
| Date of first enrolment | 24/01/2011 |
| Date of final enrolment | 31/08/2014 |
Locations
Countries of recruitment
- Japan
Study participating centre
135-0063
Japan
Sponsor information
Government
8 Ichiban-cho, Chiyoda-ku
Tokyo
102-8472
Japan
| Website | http://www.jsps.go.jp/ |
|---|---|
"ROR" |
https://ror.org/00hhkn466 |
Funders
Funder type
Government
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 | 16/07/2014 | Yes | No | |
| Results article | 09/12/2023 | 27/12/2023 | Yes | No |
Editorial Notes
27/12/2023: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
25/06/2020: No publications found.
