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Trial registered on ANZCTR


Registration number
ACTRN12613001333707
Ethics application status
Not yet submitted
Date submitted
2/12/2013
Date registered
5/12/2013
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Is dry needling an effective physiotherapy management strategy for adults with cervicogenic or tension-type headache?
Scientific title
Does giving adults (aged 18-65) with a clinical diagnosis of cervicogenic or tension-type headache a dry needling and standard physiotherapy intervention have an effect on their headache pain severity? (No comparator - single group study).
Secondary ID [1] 283675 0
Nil
Universal Trial Number (UTN)
U1111-1150-9082
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tension-type headache 290628 0
Cervicogenic headache 290629 0
Condition category
Condition code
Physical Medicine / Rehabilitation 291018 291018 0 0
Physiotherapy
Musculoskeletal 291031 291031 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The addition of dry needling to standard physiotherapy treatment (such as massage, stretches, manipulation/mobilisation and exercises).

Dry needling will be applied by a qualified physiotherapist. Single-use sterile needles (50mm long with 0.25-0.30mm gauge) will be inserted superficially only (5-10mm) into myofascial trigger points around the head, neck and back. Needles will remain in position for 10-15 minutes and needles may be manipulated within this time. Approximately 8-15 needles will be inserted at each appointment.

The standard physiotherapy treatment type, dosage and duration will be applied as indicated at the discretion of the treating student physiotherapist, within evidence based guidelines.

The total appointment time for each participant will be approximately half an hour. Participants will attend appointments 1-2 times per week at first, and appointments will become less frequent at the treating physiotherapist's discretion, until they decide treatment is no longer needed. Each participant will receive a minimum of 2 weeks treatment and a maximum of 8 weeks treatment.
Intervention code [1] 288375 0
Treatment: Other
Comparator / control treatment
No comparator will be used in this study as it will adopt a pre-post test design (single group trial), therefore there is only 1 study arm - i.e. all participants will receive the same intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291007 0
Headache pain severity as measured by the Visual Analogue Scale (VAS). The VAS is a 10cm line with 0 marked at one end and 10 at the other. The participant will be asked to indicate their current perceived level of headache pain on this line, 0 being no pain and 10 being the worst pain imaginable. This will then be measured in millimetres.
Timepoint [1] 291007 0
Participants will be asked to indicate their headache pain severity on the VAS before and after each treatment. They will also fill out a VAS every morning and evening as part of the Daily Headache Diary (see secondary outcome measures), as well as at 1 week and 1 month follow-up (after treatments have finished).
Primary outcome [2] 291008 0
Feasibility of running a clinical trail using this treatment modality (dry needling) for headaches. This will be measured by, for example; adherence rates to management, availability of eligible participants, willingness of participants to be recruited, participants' subjective experience.

This will allow determination of a sample size estimate, the availability of eligible participants, the willingness for subjects to be recruited, and adherence rates to management, enabling evaluation of the feasibility of a future successful, cost-effective large-scale efficacy trial
Timepoint [2] 291008 0
Throughout the trial
Secondary outcome [1] 305814 0
Headache-related disability as measured by the Neck Disability Index (NDI).
Timepoint [1] 305814 0
Participants will be asked to fill out a NDI prior to their first treatment, at approximately mid-intervention (approximately 3 weeks) and at 1 week and 1 month follow-up.
Secondary outcome [2] 305817 0
Headache frequency as measured by a Daily Headache Diary, which will include whether headache was experienced that day, and if so, the time of onset, how long it lasted and the severity of that headache's pain on a VAS.
Timepoint [2] 305817 0
Participants will be asked to begin filling out the Daily Headache Diary on the day of their first treatment, and this must be filled out each morning and evening of every day throughout that participant's intervention period. They will be asked to continue to fill it out for one month after their last treatment.

Eligibility
Key inclusion criteria
Clinical diagnosis of cervicogenic or tension-type headache using the International Classification of Headache Disorders-II
Adult males and females
Sufficient English to understand the purpose of the trial, give informed consent and complete outcome measures

Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prophylaxis treatment in the last 6 months

Standard dry needling exclusions including:
History of haemorrhagic disease, blood-borne disease, diabetes mellitus, unstable epilepsy, peripheral neuropathy
Immunologically compromised (acute immune disorders, cancer)
Incompetent heart valve or valve replacements, recent cardiac surgery, acute cardiac arrhythmias, congestive cardiac failure
Infections, oedema
Pregnancy
Metal allergies
Medications that may be affected by autonomic reaction (blood pressure, diabetes medications)
Anticoagulant medication

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size will be based on the moderate effect size as calculated by a systematic review, 'Acupuncture and dry-needling for low back pain' (Furlan et al. 2005), using the primary outcome measure, the Visual Analogue Scale (VAS) for pain. The sample size estimate is 24 in order to detect a moderate effect size (f=0.3), with a power of 0.8 in a two-sided test, at significance level p<0.05. Thirty adults will be recruited based on pragmatics of recruitment and the number necessary to examine feasibility, and to attenuate potential drop out.

Part of this study's aim is to determine the feasibility of running an efficacy trial for dry needling and headaches, as well as the feasibility of running student oriented research in the University of South Australia's Student Physiotherapy Clinic. In-keeping with this statement, the feasibility of the recruitment process is part of the determination of feasibility of running a future efficacy RCT for this modality. Therefore, if 30 subjects are not recruited in this time, data will still be analysed and recruitment difficulties will be documented so that future trails can consider this prior to commencement.

To evaluate the feasibility of this trial, descriptive statistics will be used to determine whether an RCT is a feasible means to investigate dry needling for headache. For example, we will look at the availability of eligible participants and adherence rates of subjects to the protocol. We will also include their comments, for example on how they found the process. Feasibility analysis for a future cost-effective large-scale RCT will include an analysis of sample group means for all 3 outcome measures at mid-intervention and one-week follow-up, using a repeated measure ANOVA. To analyse the effectiveness of dry needling for headaches, data collected will be analysed using a repeated measure ANOVA for sample group means at four time points.


Reference:
Furlan, AD, Van Tulder, MW, Cherkin, D, Tsukayama, H, Lao, L, Koes, BW & Berman, BM 2011, Acupuncture and dry-needling for low back pain, Cochrane Database of Systematic Reviews, art. no. CD001351, DOI: 10.1002/14651858.CD001351.pub2.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Decided to change methodological approach
Date of first participant enrolment
Anticipated
15/12/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 288360 0
University
Name [1] 288360 0
The University of South Australia
Country [1] 288360 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] 287067 0
None
Name [1] 287067 0
Address [1] 287067 0
Country [1] 287067 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290241 0
The University of South Australia Human Research Ethics Committee (HREC)
Ethics committee address [1] 290241 0
Magill Campus, St. Bernards Road, Magill, South Australia, 5072
Ethics committee country [1] 290241 0
Australia
Date submitted for ethics approval [1] 290241 0
06/12/2013
Approval date [1] 290241 0
Ethics approval number [1] 290241 0

Summary
Brief summary
This study's purpose is to generate preliminary data on the efficacy of the addition of dry needling to standard physiotherapy management in the treatment of headaches, as well as to determine the feasibility of running an efficacy trial for this condition.

This will involve the collection of a small set of data on the efficacy of dry needling for headaches, and to determine the feasibility of running a trial collecting this data. This will allow determination of a sample size estimate, the availability of eligible participants, the willingness for subjects to be recruited, and adherence rates to management, enabling evaluation of the feasibility of a future successful, cost-effective large-scale efficacy trial.

We hypothesise that:
1. An efficacy trial is a feasible means to study the impact of dry needling on cervicogenic and tension-type headache
2. Standard physiotherapy plus dry needling changes the severity, frequency and disability of cervicogenic and tension-type headache pain in adults
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44658 0
Miss Felicity Braithwaite
Address 44658 0
University of South Australia City East Campus, Corner North Terrace and Frome Road, Adelaide, SA, 5001
Country 44658 0
Australia
Phone 44658 0
+61883887683
Fax 44658 0
Email 44658 0
[email protected]
Contact person for public queries
Name 44659 0
Dr Julie Walters
Address 44659 0
University of South Australia City East Campus, Corner North Terrace and Frome Road, Adelaide, SA, 5001
Country 44659 0
Australia
Phone 44659 0
+61883022541
Fax 44659 0
Email 44659 0
[email protected]
Contact person for scientific queries
Name 44660 0
Dr Julie Walters
Address 44660 0
University of South Australia City East Campus, Corner North Terrace and Frome Road, Adelaide, SA, 5001
Country 44660 0
Australia
Phone 44660 0
+61883022541
Fax 44660 0
Email 44660 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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