Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000161325
Ethics application status
Approved
Date submitted
5/01/2017
Date registered
30/01/2017
Date last updated
29/01/2019
Date data sharing statement initially provided
29/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Biomechanical and clinical effects of customized foot orthoses and biomechanical taping in patients with plantar heel pain
Scientific title
Biomechanical and clinical effects of customized foot orthoses and biomechanical taping in patients with plantar heel pain
Secondary ID [1] 290831 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plantar heel pain 301506 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301216 301216 0 0
Physiotherapy
Musculoskeletal 301217 301217 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients in this study will receive the individualized biomechanical taping applied to both feet by an experienced physical therapist. The biomechanical taping consisted of 2 components, arch taping and calcaneal taping. The physical therapist apply 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 follows the similar pattern, from the lateral aspect of the fifth metatarsal head and runs medially around the medial longitudinal arch to end on the navicular tuberosity, with overlap of approximately one third of the tape. Calcaneal taping will be applied when the physical therapist found the presence of calcaneal valgus exceeding 5 degrees. Application of the tape in this study will be 3.8-cm-wide Leuko Sports Tape (Beiersdorf Australasia Ltd, North Ryde, Sydney, Australia). Patients will be advised to maintain usual activity within the limits of symptoms and removed the tape after 3 days.

After 1 week, all participants will be randomized into either the intervention group (n=30) or the control group (n=30), and each group will not be aware of the existence of the other one. Intervention group will receive customized foot orthoses (Vasyli International), which were fitted to their shoes with comfort as a primary goal, and home exercise instructions by an experienced physical therapist. These orthoses are customisable to some degree to optimise comfort through heat moulding and by adding wedge or heel raises. All patients in the intervention group will wear the foot orthoses for 3 months. The control group will only receive home exercises instructions by the same experienced physical therapist. Home exercises include calf muscles stretching and plantar fascia stretching, Each stretching will be performed 30 seconds for one repetition, 20 repetitions per day for the 3 month intervention period. After 1 week, 1 month and 3 months, all patients will return back for follow-ups and assessment by another physical therapist. There is no specific frequency/duration for which the shoes with fitted orthoses are to worn for the intervention group, but the frequency and duration were recorded. At each follow-up, we will encourage the intervention group to wear the foot orthoses as much time as possible and record the duration of wearing. We will encourage the control group to record the exercise diary every day. The format of instructions will be paper-based. Two different physical therapists will be an assessor and a treatment provider respectively. Before the end of the study, the assessor will be not aware of the group of each patient..
Intervention code [1] 296753 0
Rehabilitation
Intervention code [2] 296754 0
Treatment: Other
Intervention code [3] 296936 0
Treatment: Devices
Comparator / control treatment
The control group will only receive home exercises instructions by an experienced physical therapist, including calf stretching and plantar fascia stretching. We will instruct patients in the control group to perform each exercise 10 times a set, 3 sets per day. After 1 week, 1 month and 3 months, all patients returned back for follow-ups and assessment by another physical therapist. We will encourage the control group to record the exercise diary every day. Two different physical therapists will be an assessor and a treatment provider respectively. Before the end of the study, the assessor will be not aware of the group of each patient.
Control group
Active

Outcomes
Primary outcome [1] 300643 0
Pain intensity will be assessed by numeric rating scale (NRS)
Timepoint [1] 300643 0
after 1 week of taping; after 1 week, 1 month and 3 months of wearing foot orthoses
Primary outcome [2] 300644 0
Foot function will be assessed by the patient-specific functional scale (PSFS) and Foot Function Index (FFI)
Timepoint [2] 300644 0
after 1 week of taping; after 1 week, 1 month and 3 months of wearing foot orthoses
Secondary outcome [1] 330488 0
kinematics of rearfoot, assessed by Vicon motion capture analysis system (Oxford Metrics, Oxford, England).
Timepoint [1] 330488 0
after 1 week of taping; after 1 week, 1 month and 3 months of wearing foot orthoses
Secondary outcome [2] 330489 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] 330489 0
after 1 week of taping; after 1 week, 1 month and 3 months of wearing foot orthoses
Secondary outcome [3] 330490 0
plantar pressure distribution will be assessed by the The F-Scan Trademark in-shoe plantar pressure system (Tekscan, Inc., South Boston, MA, USA).
Timepoint [3] 330490 0
after 1 week of taping; after 1 week, 1 month and 3 months of wearing foot orthoses
Secondary outcome [4] 330491 0
kinematics of forefoot, assessed by Vicon motion capture analysis system (Oxford Metrics, Oxford, England).
Timepoint [4] 330491 0
after 1 week of taping; after 1 week, 1 month and 3 months of wearing foot orthoses
Secondary outcome [5] 330492 0
kinematics of ankle joint, assessed by Vicon motion capture analysis system (Oxford Metrics, Oxford, England).
Timepoint [5] 330492 0
after 1 week of taping; after 1 week, 1 month and 3 months of wearing foot orthoses
Secondary outcome [6] 330493 0
kinematics of knee joint, assessed by Vicon motion capture analysis system (Oxford Metrics, Oxford, England).
Timepoint [6] 330493 0
after 1 week of taping; after 1 week, 1 month and 3 months of wearing foot orthoses
Secondary outcome [7] 330494 0
kinematics of hip joint, assessed by Vicon motion capture analysis system (Oxford Metrics, Oxford, England).
Timepoint [7] 330494 0
after 1 week of taping; after 1 week, 1 month and 3 months of wearing foot orthoses
Secondary outcome [8] 330495 0
kinematics of pelvis, assessed by Vicon motion capture analysis system (Oxford Metrics, Oxford, England).
Timepoint [8] 330495 0
after 1 week of taping; after 1 week, 1 month and 3 months of wearing foot orthoses
Secondary outcome [9] 330496 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] 330496 0
after 1 week of taping; after 1 week, 1 month and 3 months of wearing foot orthoses
Secondary outcome [10] 330497 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] 330497 0
after 1 week of taping; after 1 week, 1 month and 3 months of wearing foot orthoses
Secondary outcome [11] 330498 0
Muscle activity of tibialis anterior will be assessed by surface electromyography (sEMG)
Timepoint [11] 330498 0
after 1 week of taping; after 1 week, 1 month and 3 months of wearing foot orthoses
Secondary outcome [12] 330499 0
Muscle activity of soleus will be assessed by surface electromyography (sEMG)
Timepoint [12] 330499 0
after 1 week of taping; after 1 week, 1 month and 3 months of wearing foot orthoses
Secondary outcome [13] 330500 0
Muscle activity of peroneal longus will be assessed by surface electromyography (sEMG)
Timepoint [13] 330500 0
after 1 week of taping; after 1 week, 1 month and 3 months of wearing foot orthoses
Secondary outcome [14] 330501 0
Muscle activity of gluteus medius will be assessed by surface electromyography (sEMG)
Timepoint [14] 330501 0
after 1 week of taping; after 1 week, 1 month and 3 months of wearing foot orthoses

Eligibility
Key inclusion criteria
Inclusion criteria includ (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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be 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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to display the demographic and basic physical examination data. We will compare baseline variables between groups with independent t-tests or Mann–Whitney U tests for continuous data and chi-square tests for categorical data. We will examine the clinical and biomechanical effects from the customized foot orthoses with a 3-way repeated-measures multivariate analysis of variance (ANOVA) with groups (intervention or control) and status on the clinical prediction rule (positive or negative) and time (baseline, 2nd week, 3rd week, 6th week, 14th week). Significant level will be set as 0.05. If the 3-way interaction occurs, independent t tests will be used as post hoc tests with Bonferroni adjustment.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2017
Actual
23/10/2017
Date of last participant enrolment
Anticipated
30/11/2019
Actual
Date of last data collection
Anticipated
29/02/2020
Actual
Sample size
Target
60
Accrual to date
26
Final
Recruitment outside Australia
Country [1] 8548 0
Taiwan, Province Of China
State/province [1] 8548 0

Funding & Sponsors
Funding source category [1] 295271 0
Government body
Name [1] 295271 0
Ministry of Education, Aim for the Top University Plan.
Country [1] 295271 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] 294095 0
None
Name [1] 294095 0
Address [1] 294095 0
Country [1] 294095 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296606 0
Institutional Review Board (IRB) of National Yang-Ming University
Ethics committee address [1] 296606 0
No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Ethics committee country [1] 296606 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 296606 0
09/11/2016
Approval date [1] 296606 0
26/12/2016
Ethics approval number [1] 296606 0
YM105094F

Summary
Brief summary
The purpose of this study is to evaluate the biomechanical and clinical effects of customized foot orthoses in patients with plantar heel pain.
The study hypothesis is that customized foot orthoses will be more effective in patients with plantar heel pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45130 0
A/Prof Tzyy-Jiuan Wang
Address 45130 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University. No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country 45130 0
Taiwan, Province Of China
Phone 45130 0
+886 2 28267000 #7091
Fax 45130 0
Email 45130 0
[email protected]
Contact person for public queries
Name 45131 0
Mr Fu-Lien Wu
Address 45131 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University. No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country 45131 0
Taiwan, Province Of China
Phone 45131 0
+886 2 28267000 #5865
Fax 45131 0
Email 45131 0
[email protected]
Contact person for scientific queries
Name 45132 0
Mr Fu-Lien Wu
Address 45132 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University. No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country 45132 0
Taiwan, Province Of China
Phone 45132 0
+886 2 28267000 #5865
Fax 45132 0
Email 45132 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will analyze the mean values and standard deviations of all subects and will not report each subject's raw data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.