RecruitingACTRN12617000161325

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


Sponsor

National Yang-ming University

Enrollment

60 participants

Start Date

Oct 23, 2017

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 20 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether custom-made shoe insoles (foot orthoses) and special taping methods can reduce pain and improve function in people with plantar heel pain — a very common condition also known as plantar fasciitis, where the bottom of the heel is painful, especially in the morning or after sitting. You may be eligible if: - You are between 20 and 80 years old - You have had heel or arch pain for at least 4 weeks - Your pain is at least 3 out of 10 on average - Your pain is located at the heel or along the plantar fascia (arch of the foot) You may NOT be eligible if: - You have nerve-related symptoms in the leg or foot (neurological symptoms) - You have had a lower limb injury in the last 6 months - You have had lower limb surgery in the last 6 months - You are currently receiving other treatment for this condition Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 tapi

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..


Locations(1)

Taiwan, Province Of China

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ACTRN12617000161325


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