Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000426785
Ethics application status
Approved
Date submitted
8/04/2013
Date registered
16/04/2013
Date last updated
16/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Myofascial trigger point dry needling combined with a stretching exercise regimen in the management of plantar fasciitis: A pilot randomized controlled trial
Scientific title
A pilot randomised controlled trial using the Weight bearing Lunge test and Foot Health Status Questionaires to compare the effectiveness of Myofascial trigger point dry needling combined with a stretching exercise regimen against a stretching exercise regimen alone in the management of plantar fasciitis.
Secondary ID [1] 282274 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plantar Fasciitis. 288808 0
Condition category
Condition code
Physical Medicine / Rehabilitation 289166 289166 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Myofascial Trigger Point (MTrPs) is defined as hypersensitive palpable nodules in a taut band of a skeletal muscle that are painful on compression, contraction, or stretching of the muscle. Myofascial Trigger Point Dry Needling will be administered by two fully trained research students.Myofascial Trigger Point Dry needling will only be administered once only during the initial visit. The duration of the Myofascial Trigger Point Dry needling session is 20 minutes during the initial visit. All participants will be instructed on a stretching exercise regimen for a period of two weeks. This includes stretching exercises for both the calf muscles and the plantar fascia. The frequency for each muscle specific stretching exercise will be two times per day, using intermittent stretching of 20 seconds, followed by 20 seconds rest for a total of three minutes for each stretch. Hence, the gastrocnemius, soleus and the plantar fascia will each be stretched for six minutes total per day. A stretching exercise logbook will be given to each participant for their compliance towards the stretching regimen to be recorded.
Intervention code [1] 286904 0
Treatment: Other
Comparator / control treatment
Stretching exercise regimen of the calf muscles and plantar fascia only. The frequency for each muscle specific stretching exercise will be two times per day, using intermittent stretching of 20 seconds, followed by 20 seconds rest for a total of three minutes for each stretch. Patient will then be follow-up 2 weeks after initial visit.
Control group
Active

Outcomes
Primary outcome [1] 289273 0
All the questions in Foot Health Status Questionnaire
Timepoint [1] 289273 0
1 - Before treatment
2 - Immediately after treatment
3 - 2 week follow up
Secondary outcome [1] 302141 0
Weight bearing lunge test:
Distance of the Hallux from the wall to the nearest 0.1cm.

Angle of the tibial relative to the vertical to the nearest 0.1.
Timepoint [1] 302141 0
1 - Before treatment
2 - Immediately after treatment
3 - 2 week follow up

Eligibility
Key inclusion criteria
- Male or female who are above the age of 18 years old.
- Have a correctly diagnosed unilateral plantar fasciitis condition.
- At least one identifiable MTrPs within the calf muscle complex.
- Foot Posture Index between -8 to +8.
- Without previous foot and ankle surgery or fractures for at least two years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Currently in a trial evaluating other treatments for their plantar fasciitis.
- Currently treating their plantar fasciitis or intend to treat their condition by other means during the study period.
- Unable to give informed consent.
- A known hypersensitivity to metal.
- A history of injection therapy in the heel in the previous treatment.
- A history of surgery to plantar fascia.
- History of plantar heel pain secondary to connective tissue disease.
- Previous adverse effects from dry needling.
- Needle phobic participants.
- At risk of impaired healing (e.g. Diabetes, Peripheral vascular disease, Keloid scarring).
- Immune-compromised participants with risk of infection and impaired healing.
- History of inflammatory, osseous, metabolic, vascular, musculoskeletal or neurological disorders and abnormalities.
- Pregnant during the study period.
- Current medications which may affect wound healing. Eg. Anticoagulants (warfarin, heparin) or immunosuppressant drugs (systemic steroids).
- Presence of Osseous Equinus.
- If the subject is suffering from any medical condition, of which the attending person deem it inappropriate for the participant to partake in the study.

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)
Participants will be recruited from between March to August 2013 and obtained through the following:
-Subjects who phone or present to the UWA Podiatry Clinic for appointment.

This study will be highlighted to patients with heel pain by the UWA clinic receptionist. Patients who are interested will be told to contact Reza Naraghi via email address supplied. He will give a brief explanation of the study and inform the subject of the inclusion/exclusion criteria. They will then book an appointment to participate in this study through the UWA Podiatry Clinic. Additional information about this study can be obtained from the posters pasted around the clinic.

-People who have become aware of the study through marketing strategies, such as the university e-mail system and poster advertisements.

Subjects enquiring about this study through marketing strategies will contact Reza Naraghi via the email address supplied. He will give a brief explanation of the study and inform the subject of the inclusion/exclusion criteria. If the Subject is interested in participating, they will be asked to phone and book an appointment at the University of Western Australia (UWA) Podiatry Clinic for further assessment. All communications with participants thereafter will be made through the UWA Podiatry Clinic.

Method of allocation concealment used in this trial will be like this:
-Using a computer to do a block randomization, utilizing an online randomization tool 'Research Randomizer' http://www.randomizer.org .This method involved creating a table using two number sets. The randomizer ensured each group appeared an equal number of times whilst randomly allocating participants to each group.

-Upon recruitment of a subject, the allocation of the subject into either the treatment group or the control group will be based on the block randomization that has been done.

The chief investigator who determines the eligibility of the participant is unaware of the allocation. This has been predetermined by the block randomization that has been done by one of the research student.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once consent has been secured, all eligible participants will be randomly allocated to either the treatment group or the control group using the randomization programme provided by www.randomization.org
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A retrospective sample size calculation was performed using the power.exe online programme on the basis of the post-test standard deviation (3.4); 2 group sample; a = 0.05; using 80% power and a clinical effect of 5° increase in ankle ROM.

SPSS (Statistical Package for the Social Sciences) will be used to analyse data collected from the WBLT. It appears to be the easiest and most widely used statistical technique in performing quantitative research in health sciences. Variables (Independent and dependent) will be added to the program to generate a descriptive statistics of the data collected. Furthermore, independent t-test can be calculated using SPSS to determine if there is any outcome difference between treatment group and control group.

Foot Health Status Questionnaire

FHSQ data analysis software © (Version 1.03) will be used to analyse all the participants’ answers. A graph of the averages of the four main outcomes will be generated. This program will also provide averages for other categories such as physical activity, social capacity and vigour. By comparing the data between the two groups, we can determine if dry needling helps to improve the quality of life of the participants. Uncompleted questionnaires will be excluded.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/04/2013
Actual
Date of last participant enrolment
Anticipated
31/10/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 6663 0
6009 - Crawley

Funding & Sponsors
Funding source category [1] 287043 0
University
Name [1] 287043 0
University of Western Australia
Country [1] 287043 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Reza Naraghi
Address
M422
35 Stirling Highway
Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 285818 0
University
Name [1] 285818 0
University of Western Australia
Address [1] 285818 0
M422
35 Stirling Highway
Crawley WA 6009
Country [1] 285818 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289075 0
University of Western Australia, Human Research Ethics Committee.
Ethics committee address [1] 289075 0
Administration Building M459
North Wing
35 Stirling Highway
Crawley, Perth
Western Australia
Ethics committee country [1] 289075 0
Australia
Date submitted for ethics approval [1] 289075 0
14/11/2012
Approval date [1] 289075 0
13/12/2012
Ethics approval number [1] 289075 0
RA/4/1/5725

Summary
Brief summary
Stretching exercises are commonly prescribed by healthcare professionals in treating musculoskeletal conditions of the foot. This comparison study aims to find out how dry needling can affect the effectiveness of stretching exercises in treating heel pain. The treatment of dry needling plus a stretching exercise program will be compared against a stretching exercise program only in this study. Participant satisfaction and the degree of calf muscle relaxation will be compared between the two treatment groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39110 0
A/Prof Reza Naraghi
Address 39110 0
M422
35 Stirling Highway
Crawley WA 6009
Country 39110 0
Australia
Phone 39110 0
+61 (08) 6488 4526
Fax 39110 0
Email 39110 0
[email protected]
Contact person for public queries
Name 39111 0
A/Prof Reza Naraghi
Address 39111 0
M422
35 Stirling Highway
Crawley WA 6009
Country 39111 0
Australia
Phone 39111 0
+61 (08) 6488 4526
Fax 39111 0
Email 39111 0
[email protected]
Contact person for scientific queries
Name 39112 0
A/Prof Reza Naraghi
Address 39112 0
M422
35 Stirling Highway
Crawley WA 6009
Country 39112 0
Australia
Phone 39112 0
+61 (08) 6488 4526
Fax 39112 0
Email 39112 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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