Testing a sham dry needle for the cervical spine in healthy adults: a randomised controlled trial.

Completed

• Conditions: Tension-type headache; Cervicogenic headache; Physical Medicine / Rehabilitation - Physiotherapy; Musculoskeletal - Other muscular and skeletal disorders; Neurological - Studies of the normal brain and nervous system

• Registration Number: ACTRN12614000285651
• Lead Sponsor: The University of South Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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?.[Straight after the needle or sham needle has been applied.]

Secondary Outcome Measures

Name	Time	Method
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?. [Straight after the needle or sham needle has been applied.]