A Crossover Study on the Blinding Effect of a New Pragmatic Placebo Needle

December 23, 2017 updated by: Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Effect of Blinding With a New Pragmatic Placebo Needle: a Crossover Study

Placebo needle is a useful tool to assess the efficacy of acupuncture. Investigators have applied a new kind of placebo needle in large scale acupuncture clinical trials, which named as pragmatic placebo needle. Compared with other placebo needles used in acupuncture trials, this pragmatic placebo needle shows several advantages: the outlook closer to traditional acupuncture needles, no restriction to needle depth of true needle, simple to manipulate and more economical. However, its blinding effect is not yet validated. The primary objective of this trial is to validate the blinding effect of the new pragmatic placebo needle; the secondary objective is to explore factors influencing the blinding effect of the placebo needles.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

blinding refers to subject blinding

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-74 years old;
  • with a basic capacity of listening, speaking, reading and writing in Chinese;
  • volunteer to join this research and sign the informed consent.

Exclusion Criteria:

  • with acute or chronic pain;
  • taking analgesics or drugs inducing abnormal sensation;
  • with diseases of sensory disturbance or sensory loss;
  • with alcohol or drug abuse history;
  • serious cardiovascular, cerebral, hepatic, renal, hematopoietic, hemorrhagic or psychiatric diseases;
  • diabetes mellitus or dermatological disease;
  • women in pregnancy or lactation period;
  • cardiac pacemaker carrier, metal allergy or severe needle phobia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: real needle- placebo needle
Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.
Device: real needle- placebo needle
All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles.
Experimental: placebo needle - real needle
Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.
Device: placebo needle - real needle
All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle.
Time Frame: in the third acupuncture session in each period

The primary outcome was the proportion of volunteers'perception of needle penetration between the placebo needle and the real needle in the third acupuncture session in each period.

LI4, on the dorsum of the hand, between the first and second metacarpal bones, approximately in the center of the second metacarpal bone; RN12, on the upper abdomen,4 cun above the umbilicus,on the anterior midline; BL36, on the back of the thigh,on the midpoint of the inferior gluteal crease; BL25, on the loin, 1.5 cun lateral to the lower border of the spinous process of the fourth lumbar vertebra.
in the third acupuncture session in each period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Southampton Needle Sensation Questionnaire-Type of Needle Sensation
Time Frame: in the third acupuncture session in each period
This questionnaire is used to collect the types and degree of needle sensation experienced by participants. Information is collected after the third acupuncture session in each period. The difference between two kinds of needles is to be analyzed.
in the third acupuncture session in each period
Southampton Needle Sensation Questionnaire-Degree of Needle Sensation
Time Frame: in the third acupuncture session in each period

The degree of needle sensation between the placebo needle and the real needle were compared.

The data of degree of needle sensation of the placebo needle included rows 1-4,i.e,, rows of "placebo needle:no", "placebo needle: mild", "placebo needle: moderate" and "placebo needle: severe".

The data of degree of needle sensation of the real needle included rows 5-8, i.e., rows of "real needle: no", 'real needle: mild", "real needle: moderate", and "real needle: severe".
in the third acupuncture session in each period
Degree of Acupuncture Pain
Time Frame: in the third acupuncture session in each period

The pain of acupuncture is assessed using visual analogue scale (VAS), where 0 means no pain, and 10 means the imaginable severest pain. The VAS value of each period is used to compare the difference of acupuncture pain between the placebo needle and the real needle.

A lower value represented a better outcome, which indicated that needles used induced less pain.
in the third acupuncture session in each period
Acceptability of the Acupuncture Needle
Time Frame: in the third acupuncture session in each period

After the third acupuncture of each period, participants are asked to show their acceptance toward the needles with a 5-point scale: very difficult to accept, a little difficult to accept, acceptable, easy to accept, very easy to accept.

The needle acceptability between the placebo needle and real needle are compared.

Data of the acceptability of the placebo needle included rows 1-5, i.e., rows of "placebo needle: very difficult to accept", "placebo needle: a little difficult to accept", "placebo needle: acceptable", "placebo needle: easy to accept" and "placebo needle: very easy to accept".

Data of the acceptability of the real needle included rows 6-10, i.e., rows of "real needle: very difficult to accept", "real needle: a little difficult to accept", "real needle: acceptable", "real needle: easy to accept" and "real needle: very easy to accept".
in the third acupuncture session in each period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012BAI24B01-0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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