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Trial registered on ANZCTR


Registration number
ACTRN12617000119392
Ethics application status
Approved
Date submitted
15/11/2016
Date registered
23/01/2017
Date last updated
23/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Customized Foot orthoses and Biomechanical Taping on Patients with Plantar Heel Pain
Scientific title
Effects of Customized Foot orthoses and Biomechanical Taping on Patients with Plantar Heel Pain
Secondary ID [1] 283820 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plantar heel pain 300305 0
Condition category
Condition code
Physical Medicine / Rehabilitation 300172 300172 0 0
Physiotherapy
Musculoskeletal 301215 301215 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients in this study received the individualized biomechanical taping applied to both feet by the physical therapist. The biomechanical taping consisted of 2 components, arch taping and calcaneal taping. The physical therapist applied 2-4 straps of tape over the longitudinal arch according to navicular drop test to reach the optimal goal that the distance of the navicular drop was less than 10 mm or reduced 50 % after taping. Each piece of tape followed the similar pattern, from the lateral aspect of the fifth metatarsal head and ran medially around the medial longitudinal arch to end on the navicular tuberosity, with overlap of approximately one third of the tape. Calcaneal taping was applied when the physical therapist found the presence of calcaneal valgus exceeding 5 degrees. Application of the tape in this study was 3.8-cm-wide Leuko Sports Tape (Beiersdorf Australasia Ltd, North Ryde, Sydney, Australia). Patients were advised to maintain usual activity within the limits of symptoms and removed the tape after 3 days by himself or herself.
At 1 week after the first visit, a experienced physical therapist gave all patients customizied foot orthoses (Vasyli International), which were fitted to their shoes with comfort as a primary goal. These orthoses are customisable to some degree to optimise comfort through heat moulding and by adding wedge or heel raises. After wearing for 1 week, 1 month, 3 months and 6 months, all patients returned back for follow-ups. There is no specific frequency/duration for which the shoes with fitted orthoses are to worn, but the frequency and duration were recorded. At each follow-up, we encouraged patients to wear the foot orthoses as much time as possible.


Intervention code [1] 296394 0
Rehabilitation
Intervention code [2] 296752 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300183 0
Pain intensity was assessed by numeric rating scale (NRS)
Timepoint [1] 300183 0
after 1 week of taping; after 1 week, 1 month, 3 months and 6 months of wearing foot orthoses
Primary outcome [2] 300628 0
Foot function was assessed by the patient-specific functional scale (PSFS) and Foot Function Index (FFI)
Timepoint [2] 300628 0
after 1 week of taping; after 1 week, 1 month, 3 months and 6 months of wearing foot orthoses
Secondary outcome [1] 329266 0
kinematics of rearfoot, assessed by Vicon motion capture analysis system (Oxford Metrics, Oxford, England).
Timepoint [1] 329266 0
after 1 week of taping; after 1 week, 1 month, 3 months and 6 months of wearing foot orthoses
Secondary outcome [2] 330439 0
kinetics of ankle external moment, assessed by Vicon motion capture analysis system (Oxford Metrics, Oxford, England) and AMTI force plate (AMTI, Newton, MA, USA).
Timepoint [2] 330439 0
after 1 week of taping; after 1 week, 1 month, 3 months and 6 months of wearing foot orthoses
Secondary outcome [3] 330440 0
plantar pressure distribution was assessed by the The F-Scan Trademark in-shoe plantar pressure system (Tekscan, Inc., South Boston, MA, USA).
Timepoint [3] 330440 0
after 1 week of taping; after 1 week, 1 month, 3 months and 6 months of wearing foot orthoses
Secondary outcome [4] 330441 0
kinematics of forefoot, assessed by Vicon motion capture analysis system (Oxford Metrics, Oxford, England).
Timepoint [4] 330441 0
after 1 week of taping; after 1 week, 1 month, 3 months and 6 months of wearing foot orthoses
Secondary outcome [5] 330442 0
kinematics of ankle joint, assessed by Vicon motion capture analysis system (Oxford Metrics, Oxford, England).
Timepoint [5] 330442 0
after 1 week of taping; after 1 week, 1 month, 3 months and 6 months of wearing foot orthoses
Secondary outcome [6] 330443 0
kinematics of knee joint, assessed by Vicon motion capture analysis system (Oxford Metrics, Oxford, England).
Timepoint [6] 330443 0
after 1 week of taping; after 1 week, 1 month, 3 months and 6 months of wearing foot orthoses
Secondary outcome [7] 330444 0
kinematics of hip joint, assessed by Vicon motion capture analysis system (Oxford Metrics, Oxford, England).
Timepoint [7] 330444 0
after 1 week of taping; after 1 week, 1 month, 3 months and 6 months of wearing foot orthoses
Secondary outcome [8] 330445 0
kinematics of pelvis, assessed by Vicon motion capture analysis system (Oxford Metrics, Oxford, England).
Timepoint [8] 330445 0
after 1 week of taping; after 1 week, 1 month, 3 months and 6 months of wearing foot orthoses
Secondary outcome [9] 330446 0
kinetics of knee external moment, assessed by Vicon motion capture analysis system (Oxford Metrics, Oxford, England) and AMTI force plate (AMTI, Newton, MA, USA).
Timepoint [9] 330446 0
after 1 week of taping; after 1 week, 1 month, 3 months and 6 months of wearing foot orthoses
Secondary outcome [10] 330447 0
kinetics of hip external moment, assessed by Vicon motion capture analysis system (Oxford Metrics, Oxford, England) and AMTI force plate (AMTI, Newton, MA, USA).
Timepoint [10] 330447 0
after 1 week of taping; after 1 week, 1 month, 3 months and 6 months of wearing foot orthoses

Eligibility
Key inclusion criteria
Inclusion criteria included (1) patients aged between 20 and 80 years, (2) a symptom duration of greater than 4 weeks, (3) symptom over the heel or plantar fascia region, and (4) pain over the previous week of at least 3 point on a 11-point (0-10) numeric rating scale (NRS).
Minimum age
20 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded if they had neurological symptoms, a trauma history of lower extremity in the past 6 months, a history of lower extremity surgery in the past 6 months, or receiving other treatment in the past 1 month.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8389 0
Taiwan, Province Of China
State/province [1] 8389 0

Funding & Sponsors
Funding source category [1] 294965 0
Government body
Name [1] 294965 0
Ministry of Education, Aim for the Top University Plan.
Address [1] 294965 0
No.5, Zhongshan S. Rd., Zhongzheng Dist., Taipei City 10051, Taiwan (R.O.C.)
Country [1] 294965 0
Taiwan, Province Of China
Primary sponsor type
University
Name
National Yang-ming University
Address
No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country
Taiwan, Province Of China
Secondary sponsor category [1] 293794 0
None
Name [1] 293794 0
Address [1] 293794 0
Country [1] 293794 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296333 0
Institutional Review Board, Taipei Veterans General Hospital
Ethics committee address [1] 296333 0
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan 11217, R.O.C.
Ethics committee country [1] 296333 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 296333 0
20/12/2012
Approval date [1] 296333 0
18/01/2013
Ethics approval number [1] 296333 0
2013-01-026B

Summary
Brief summary
The aim of this study was to develop a clinical prediction rule to identify patients with plantar heel pain likely to benefit from biomechanical taping and customized foot orthoses.
The study hypothesis is that there are clinical prediction rules to identify patients with plantar heel pain who are likely to benefit from biomechanical taping and customized foot orthoses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45190 0
A/Prof Tzyy-Jiuan Wang
Address 45190 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University. No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country 45190 0
Taiwan, Province Of China
Phone 45190 0
+886 2 28267000 #7091
Fax 45190 0
Email 45190 0
tjwang@ym.edu.tw
Contact person for public queries
Name 45191 0
Mr Fu-Lien Wu
Address 45191 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University. No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country 45191 0
Taiwan, Province Of China
Phone 45191 0
+886 2 28267000 #5865
Fax 45191 0
Email 45191 0
qazwsx783@msn.com
Contact person for scientific queries
Name 45192 0
Mr Fu-Lien Wu
Address 45192 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University. No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country 45192 0
Taiwan, Province Of China
Phone 45192 0
+886 2 28267000 #5865
Fax 45192 0
Email 45192 0
qazwsx783@msn.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary