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Trial registered on ANZCTR


Registration number
ACTRN12610000611022
Ethics application status
Approved
Date submitted
22/07/2010
Date registered
28/07/2010
Date last updated
19/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of dry needling for plantar heel pain (plantar fasciitis): a randomised controlled trial
Scientific title
Effectiveness of dry needling for plantar heel pain (plantar fasciitis): a randomised controlled trial
Secondary ID [1] 252262 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plantar heel pain (plantar fasciitis) 257779 0
Condition category
Condition code
Musculoskeletal 257951 257951 0 0
Other muscular and skeletal disorders
Alternative and Complementary Medicine 257952 257952 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment involves dry needling of myofascial trigger points (MTrPs) using an acupuncture needle. Treatment will be conducted once per week for a total of 6 weeks. Each session will last for approximately 30 minutes.
Intervention code [1] 256849 0
Treatment: Devices
Intervention code [2] 256893 0
Treatment: Other
Comparator / control treatment
"Sham" dry needling using an acupuncture needle that is indistinguishable from the "real" needle. The sham needle will be manipulated using the same technique as for the real intervention group, however it will not penetrate the skin.
Control group
Placebo

Outcomes
Primary outcome [1] 258822 0
Pain subscale of the Foot Health Status Questionnaire
Timepoint [1] 258822 0
Baseline, then 2, 4, and 6 weeks post randomisation
Secondary outcome [1] 264918 0
Foot function subscale of the Foot Health Status Questionnaire
Timepoint [1] 264918 0
Baseline, then 2, 4, 6 and 12 weeks post randomisation
Secondary outcome [2] 264919 0
Level of depression, anxiety and stress measured using the Depression, Anxiety and Stress scale - short version (DASS-21)
Timepoint [2] 264919 0
Baseline, then 6 and 12 weeks post randomisation
Secondary outcome [3] 264920 0
Health-related quality of life will be assessed using the Short Form-36 version 2 (SF-36)
Timepoint [3] 264920 0
Baseline, then 6 and 12 weeks post randomisation
Secondary outcome [4] 264921 0
Frequency and severity of adverse events.

During each consultation, the chief investigator will use a questionnaire to record the type of adverse event (bleeding, haematoma, infection, unacceptable pain, aggravation of symptoms, feeling faint, drowsiness and/or sweating) and the severity of adverse event (mild, moderate or severe).

In addition, participants will be issued a diary so they can record any adverse event (as described above) experienced since the last visit. The participant will be asked to rate the perceived degree of severity (mild, moderate and severe) for each type of adverse event. An open response type format will also be available for participant responses. All adverse events will be managed by the investigators in this project. A detailed description will be made of adverse events that result in withdrawal of participants from the trial.
Timepoint [4] 264921 0
1, 2, 3, 4, 5, 6 weeks post randomisation by the chief investigator
1, 2, 3, 4, 5, 6 weeks post randomisation by the participant

Eligibility
Key inclusion criteria
Age greater than 18 years;

Clinical diagnosis of plantar heel pain in accordance with the Clinical Guidelines linked to the International Classification of Function, Disability, and Health from the Orthopaedic Section of the American Physical Therapy Association;

History of plantar heel pain for greater than one month;

First step pain during the previous week rated at least 20mm on a 100mm visual analogue scale;

A willingness to not receive or implement any form of physical therapy (e.g. foot orthoses, night splints, foot taping, massage therapy and/or footwear modifications) for the duration of the trial;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participant refusal to be needled;

The presence of coagulopathy or the use of anti-coagulants (except for acetylsalicylic acid at dosages up to 325mg/day);
Woman who are pregnant;

History of significant peripheral vascular disease;

Dermatological disease within the dry needling area that might impair the dry needling treatment;

Dry needling or acupuncture treatment in the past 12 months;

History of plantar heel pain secondary to connective tissue disease;

The presence of a chronic medical condition that might preclude participation in the study such as: malignancy; systemic inflammatory disorders (e.g., rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis; septic arthritis); neurological abnormalities; sciatica; and/or chronic pain;

A history of surgery to the plantar fascia;

A history of a corticosteroid injection in the heel in the previous three months;

Participant included in any other trial or study in the previous three months;

A known hypersensitivity to metals.

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)
The allocation will be concealed in a password protected computer file. Concealment of the allocation sequence will be ensured as each participant’s allocation will be contained in a sealed envelope. Envelopes will be made opaque by using a sheet of aluminium foil inside the envelope. In addition, a system using carbon paper will be employed so the details (name of participant and date of recruitment) are transferred from the outside of the envelopes to the paper inside the envelope containing the allocation prior to opening the seal.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple random sampling procedure using a computer program (Microsoft Excel) will be used to generate an allocation sequence that will be used to allocate participants to either the real or sham intervention groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be performed using the SPSS (SPSS Corp, Chicago III, USA) software. If the participant has bilateral symptoms, data from the most painful side will be recorded and analysed. Data analysis will follow the intention-to-treat principle using all randomised participants and missing data will be handled using a modified group mean substitution method. This method involves substituting the missing data value with the mean baseline score plus the difference between the mean baseline and mean follow-up score for that particular group. Standard tests to assess continuous data for normal distribution will be used and transformation carried out if required.

Demographic and anthropometric characteristics (gender, age, mass, height, body mass index, sporting activities, foot posture using the FPI will be determined for each treatment group. Summary statistics will also be calculated for duration of symptoms and side affected (left, right or both).

Outcomes measured at 2, 4, 6 and 12 weeks will be analysed. A linear regression approach to ANCOVA will be used to assess for differences in continuous outcomes between the two groups. Appropriate non-parametric statistical tests will be used for outcomes that are nominal and ordinal scaled. The p-value will be set at 0.05.

Eighty participants (i.e. 40 per group) with plantar heel pain (who satisfy the inclusion and exclusion criteria) will be recruited. An initial prospective sample size calculation estimated that 76 participants will provide 80% power to detect a minimally important difference of 13 points in the pain domain of the FHSQ with a standard deviation of 20 points and an alpha set at 0.05. This sample size will also be sufficient to detect a minimally important difference of 19mm for the other primary outcome measure, ‘first-step’ pain measured on a visual analogue scale.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/10/2010
Actual
8/02/2011
Date of last participant enrolment
Anticipated
Actual
7/10/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257310 0
Charities/Societies/Foundations
Name [1] 257310 0
Australian Podiatry Council
Country [1] 257310 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Drive, Bundooora, Victoria, 3086
Country
Australia
Secondary sponsor category [1] 256555 0
University
Name [1] 256555 0
Musculoskeletal Research Centre at La Trobe University
Address [1] 256555 0
Kingsbury Drive, Bundooora, Victoria, 3086
Country [1] 256555 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259337 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 259337 0
Ethics committee country [1] 259337 0
Australia
Date submitted for ethics approval [1] 259337 0
Approval date [1] 259337 0
25/06/2010
Ethics approval number [1] 259337 0
1/10/0015

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3 3 0 0
/AnzctrAttachments/335736-Cotchett et al. (2011). Effectiveness of trigger point dry needling for PHP. Protocol for a randomised controlled trial..pdf

Contacts
Principal investigator
Name 31414 0
Mr Matthew Cotchett
Address 31414 0
La Trobe University
PO Box 199
Bendigo, Victoria, 3552
Country 31414 0
Australia
Phone 31414 0
+61 3 54447213
Fax 31414 0
Email 31414 0
[email protected]
Contact person for public queries
Name 14661 0
Matthew Cotchett
Address 14661 0
La Trobe University
PO Box 199
Bendigo, Victoria, 3552
Country 14661 0
Australia
Phone 14661 0
+61 3 54447213
Fax 14661 0
Email 14661 0
[email protected]
Contact person for scientific queries
Name 5589 0
Matthew Cotchett
Address 5589 0
La Trobe University
PO Box 199
Bendigo, Victoria, 3552
Country 5589 0
Australia
Phone 5589 0
+61 3 54447213
Fax 5589 0
Email 5589 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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