Condition category
Musculoskeletal Diseases
Date applied
22/02/2011
Date assigned
10/03/2011
Last edited
30/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Nobuari Takakura

ORCID ID

Contact details

2-9-1 Ariake
Koto-ku
Tokyo
135-0063
Japan

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

http://www.jsps.go.jp/

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

  1. 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.

Additional files

Editorial Notes