Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RCT
Study information
Scientific title
Effect of acupuncture treatment on stiff neck: a randomised, double-blind, placebo-controlled trial
Acronym
Study hypothesis
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
Ethics Committee of Tokyo Ariake University of Medical and Health Sciences, 08/07/2010
Study design
Randomised double-blind placebo-controlled single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
09/06/2010
Overall trial end date
31/03/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with stiff neck not from organic disease
2. Age range: over 18 years, both male and female
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant 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
Recruitment start date
24/01/2011
Recruitment end date
31/08/2014
Locations
Countries of recruitment
Japan
Trial participating centre
2-9-1 Ariake, Koto-ku
Tokyo
135-0063
Japan
Sponsor information
Organisation
Japan Society for the Promotion of Science (Japan)
Sponsor details
8 Ichiban-cho
Chiyoda-ku
Tokyo
102-8472
Japan
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Grants-in-Aid for Scientific Research (B) (Japan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25027157
Publication citations
-
Protocol
Takakura N, Takayama M, Kawase A, Kaptchuk TJ, Kong J, Yajima H, Design of a randomised acupuncture trial on functional neck/shoulder stiffness with two placebo controls., BMC Complement Altern Med, 2014, 14, 246, doi: 10.1186/1472-6882-14-246.