None listed
Conditions
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).
Interventions
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 needl
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.
Sponsors
The University of South Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
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
Outcome results
None listed