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Biomechanical and clinical effects of customized foot orthoses and biomechanical taping in patients with plantar heel pain

Biomechanical and clinical effects of customized foot orthoses and biomechanical taping in patients with plantar heel pain

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000161325
Enrollment
26
Registered
2017-01-30
Start date
2017-10-23
Completion date
2019-11-30
Last updated
2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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, fro

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..

Sponsors

National Yang-ming University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years
Healthy volunteers
No

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).

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026