NCT06319066

Customized Foot Orthoses With Orthotic Wedges for Plantar Heel Pain

Effectiveness of Customized Foot Orthoses With Orthotic Wedges for the Treatment of Patients With Plantar Heel Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The present study will use a randomized controlled trial (RCT) to determine the effectiveness of customized foot orthosis (CFO) for the treatment of patients with PHP. Three treatment groups including the CFO without wedge, the CFO with wedge type 1 (W1), and the CFO with wedge type 2 (W2) will be randomly assigned to each participant by a computer-generated randomization. The opaque-sealed envelopes will be used to allocate the groups of participant.

Detailed description

Participants will be allocated to the control (CFO without wedge) or experimental (CFO with W1 or W2) groups according to the seal-envelop randomization technique. Then, they will be assessed all outcomes for the baseline including pain intensity, foot function, plantar fascia thickness, balance outcomes, and gait parameters by the 2nd physical therapist. And the participants will receive the assigned treatment by the 1st physical therapist. All participants will be asked to use the CFO in daily life during weight-bearing activities, and logbook, chat LINE, or phone call will be used to monitor the participants during the treatment program. They will be asked about activity they done in daily and a number of hour they used CFO per day in diary book. At least 4 hours per day of wearing CFO will be required to each participant. After 3 months, and 6 months of the CFO use, all outcomes will be re-assessed by the 2nd physical therapist. And such outcomes will be then statistically analyzed.

Conditions

• Foot Orthoses
• Fasciitis, Plantar

Interventions

Type	Name	Description
DEVICE	orthotic wedge	The orthotic wedges with a full length of 3-mm soft foam layer will be provided to each participant under the molded orthoses; the amount of wedge angle will depend on the rearfoot and forefoot angles of the participants. The present study developed 3-degree, 6-degree, and 8-degree wedges for the rearfoot and forefoot. It was made from solid rubber with a cover of thin fabric. There are three sizes for these products which include small (S), medium (M), and large (L) sizes, according to the foot length of participants.
DEVICE	CFO	The 3-quarter-length CFO will be made from thermoplastic material (rigid foot orthoses) which consists of four layers i.e. two layers of 0.5-mm polyvinyl chloride (PVC), one layer of 1.5-mm thick fiber to increase strength of foot orthoses in the bottom layers as well as one layer of 1.2-mm genuine leather in the upper layer to increase comfort. It incorporates a heat-molding process to adjust individual foot shape in prone position. The materials will be set within approximately three minutes.

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2024-03-19
• Last updated: 2025-05-22

Locations

1 site across 1 country: Thailand