Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000285651
Ethics application status
Approved
Date submitted
10/03/2014
Date registered
18/03/2014
Date last updated
3/07/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing a sham dry needle for the cervical spine in healthy adults: a randomised controlled trial.
Scientific title
Can healthy adults (aged 18-65) identify whether a sham or true needle has been applied in the cervical spine?
Secondary ID [1] 284226 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tension-type headache 291339 0
Cervicogenic headache 291340 0
Condition category
Condition code
Physical Medicine / Rehabilitation 291700 291700 0 0
Physiotherapy
Musculoskeletal 291701 291701 0 0
Other muscular and skeletal disorders
Neurological 291762 291762 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two parts to this trial. Both parts will follow the exact same methods protocol, however the populations studied will be slightly different. Part 1 will look at a healthy adult population (i.e. no headache diagnosis) with a no previous needling exposure (acupuncture or dry needling). Part 2 will look at a healthy adult population, and who have had needling previously. Each part will recruit 50 participants.

Participants will be randomly allocated to either receive a single dry needling needle or a sham needle (toothpick) in the back of their neck.

Dry needling will be applied by a qualified physiotherapist. A single-use sterile needle (50mm long with 0.25-0.30mm gauge) will be inserted superficially only (5-10mm) into a muscle in the back of the neck. The needle will remain in position for 10-15 seconds and needle will not be manipulated within this time.

Participants will then be asked whether they think they had the needle or the sham needle.

The total appointment time for each participant will be around 10 minutes. Participants need only present for the study on this one occasion.
Intervention code [1] 288932 0
Treatment: Other
Comparator / control treatment
Placebo: the sham needling will follow the exact same protocol as the true needling however the toothpick will not pierce the skin (instead the therapist will hold the toothpick in place to mimic a needle).

The sham needle will involve a toothpick within a plastic guide tube.
Control group
Placebo

Outcomes
Primary outcome [1] 291638 0
Whether participants can identify if they had the needle or the sham needle. This will be assessed by asking the question: "Do you think you had the needle or the sham?".
Timepoint [1] 291638 0
Straight after the needle or sham needle has been applied.
Secondary outcome [1] 307211 0
Qualitative information about why the participant thought they had the needle or sham needle, and a description of what they felt. Two questions will be asked to obtain this information. Question 1: "You thought you had the needle/sham. Why do you think you had the needle/sham?". Question 2: "Can you briefly describe what you felt?".
Timepoint [1] 307211 0
Straight after the needle or sham needle has been applied.

Eligibility
Key inclusion criteria
Inclusion Criteria (part 1):
Healthy adults (no headaches)
No previous exposure to needling therapy
Aged 18-65 years
Males & Females
Sufficient English to understand the purpose of the trial, give informed consent and to complete outcome measures

Inclusion Criteria (part 2):
Healthy adults (no headaches)
Previous needling therapy exposure
Aged 18-65 years
Males & Females
Sufficient English to understand the purpose of the trial, give informed consent and to complete outcome measures
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria (part 1):
History of haemorrhagic disease, blood-borne disease, diabetes mellitus, unstable epilepsy, peripheral neuropathy
Immunologically compromised (acute immune disorders, malignancy, chemotherapy, radiation therapy, organ transplant recipient, predisposition to infections)
Incompetent heart valve or valve replacements, recent cardiac surgery, acute cardiac arrhythmias, CCF, pacemaker, unstable angina
Infections, oedema
Pregnancy
Schizophrenia
Manic depression
Unstable diabetes
Extreme fatigue
Joint replacement in the last 6 months
Metal allergies
Medications that may be affected by autonomic reaction (blood pressure, diabetes medications)
Anticoagulant medication
Any previous needling therapy anywhere on the body
Body art in the area to be needled (tattoos, piercings)
Areas of altered sensation (e.g. due to scar, or past history of neck problems that might have affected sensation
Fear of needles

Exclusion Criteria (part 2):
History of haemorrhagic disease, blood-borne disease, diabetes mellitus, unstable epilepsy, peripheral neuropathy
Immunologically compromised (acute immune disorders, malignancy, chemotherapy, radiation therapy, organ transplant recipient, predisposition to infections)
Incompetent heart valve or valve replacements, recent cardiac surgery, acute cardiac arrhythmias, CCF, pacemaker, unstable angina
Infections, oedema
Pregnancy
Schizophrenia
Manic depression
Unstable diabetes
Extreme fatigue
Joint replacement in the last 6 months
Metal allergies
Medications that may be affected by autonomic reaction (blood pressure, diabetes medications)
Anticoagulant medication
Body art in the area to be needled (tattoos, piercings)
Areas of altered sensation (e.g. due to scar, or past history of neck problems that might have affected sensation)
Fear of needles

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed within sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into true dry needling or sham needling groups using a computer generated sequence of random numbers (simple block randomisation to ensure equal group numbers).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculations were based on data from a study investigating acupuncture versus sham acupuncture (toothpick). They found that after the intervention:

4/25 participants who had the sham, identified that they'd had the sham.
2/25 participants who had the needle, identified that they'd had the sham.

Sample sizes were calculated for using this data, for within and between study comparisons (i.e. the amount of subjects required to compare Parts 1 and 2 of this study, plus a previous pilot study, was calculated by a statistician). The sample size is 50 in each part of the study (100 total; 25 in each group) calculated with a power of 0.8 at significance level p<0.05.

Data will be entered using Microsoft Excel. Descriptive statistics will be used to analyse the data, including proportions. Qualitative data analysis will be used to synthesise the data obtained from the two open ended questions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2014
Actual
23/01/2014
Date of last participant enrolment
Anticipated
Actual
29/09/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 288852 0
University
Name [1] 288852 0
The University of South Australia
Country [1] 288852 0
Australia
Primary sponsor type
University
Name
The University of South Australia
Address
City East Campus, Corner Frome Road and North Terrace, Adelaide, South Australia, 5001
Country
Australia
Secondary sponsor category [1] 287544 0
None
Name [1] 287544 0
Address [1] 287544 0
Country [1] 287544 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290687 0
The University of South Australia Human Research Ethics Committee (HREC)
Ethics committee address [1] 290687 0
Magill Campus, St. Bernards Road, Magill, South Australia, 5072
Ethics committee country [1] 290687 0
Australia
Date submitted for ethics approval [1] 290687 0
24/09/2013
Approval date [1] 290687 0
09/01/2014
Ethics approval number [1] 290687 0

Summary
Brief summary
The aim of this project is to validate a sham dry needling protocol in the cervical spine for healthy adults, for future applications to headache. To build on results to be established from a small pilot study investigating the efficacy of a sham protocol in healthy needling-naive subjects, two randomised controlled trials are proposed to strengthen the methodology of the future research. This will be achieved through determining whether a toothpick is an effective sham to use as a placebo treatment for dry needling in healthy subjects, and to investigate the influence, if any, of previous exposure to needling therapy.

There is no consensus in the existing literature regarding an appropriate sham to acupuncture or dry needling. Historically, needles have been inserted either away from the area of pain or acupuncture point or inserted superficially (a shorter distance than that hypothesised to be required for therapeutic benefit). More recent studies suggest that both of these approaches trigger a physiological response that may confound the treatment effect of the dry needling itself. Other studies investigating more conservative sham approaches for acupuncture have focused on areas away from the neck, which, due to variation in tactile acuity may not be transferable, and no studies have investigated sham protocols specifically for dry needling (as compared to acupuncture).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46802 0
Miss Felicity Braithwaite
Address 46802 0
Affiliated with the University of South Australia at this address: University of South Australia City East Campus, Corner North Terrace and Frome Road, Adelaide, SA, 5001
Country 46802 0
Australia
Phone 46802 0
+6183887683
Fax 46802 0
Email 46802 0
[email protected]
Contact person for public queries
Name 46803 0
Dr Julie Walters
Address 46803 0
University of South Australia City East Campus, Corner North Terrace and Frome Road, Adelaide, SA, 5001
Country 46803 0
Australia
Phone 46803 0
+61883022541
Fax 46803 0
Email 46803 0
[email protected]
Contact person for scientific queries
Name 46804 0
Dr Julie Walters
Address 46804 0
University of South Australia City East Campus, Corner North Terrace and Frome Road, Adelaide, SA, 5001
Country 46804 0
Australia
Phone 46804 0
+61883022541
Fax 46804 0
Email 46804 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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