Customized Foot Orthoses With Orthotic Wedges for Plantar Heel Pain

NCT06319066 | Completed

• 1 other identifier: RGNS65-152
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Foot Orthoses; Fasciitis, Plantar

Outcome Measures

Primary Outcomes (4)

• Pain intensity and foot function

  Pain intensity during the last week will be assessed using the visual analog scale (VAS) which is the high-reliability measurement (ICC = 0.88). The highest pain level is 10 and the lowest pain level is 0. In addition, the foot function will be assessed by the 23-item foot function index (FFI). The present study will use the Thai version of FFI that has been translated forward and backward from the English version. The previous study showed high internal consistency (Cronbach alpha = 0.98) and high test-retest reliability (ICC = 0.86). It is appropriate to use among patients with PHP.

  Baseline, 3, 6 months

• Plantar Fascia Thickness

  Plantar fascia thickness will be assessed by a portable digital Ultrasound (US) diagnosis imaging system, D-6600 (Mindray, China) with a 10 MHz wideband linear array probe. Intra-rater reliability from the assessment showed an ICC(3,1) of 0.97. To evaluate the plantar fascia thickness, scan depth will be set at 4 cm. The measurement protocol will follow the recommendation from the European Society of Musculoskeletal Radiology.

  Baseline, 3, 6 months

• Gait assessment

  A gait analysis system (Zebris FDM, Isny, Germany) will be used to collect the gait parameters at a sampling frequency of 100 Hz over a 3-m force distribution platform. The participants will be asked to walk with a self-selected speed to the other end of the platform for 3 trials. Data will be averaged and used in further analysis. The gait parameters include stance time (s), double support time (%), stride time (s), step length (cm), step width (cm), stride length (cm), cadence (steps/min), and walking velocity (km/h).

  Baseline, 3, 6 months

• Balance assessment

  A gait analysis system (Zebris FDM, Isny, Germany) will be used to collect the balance parameters at a sampling frequency of 100 Hz over a 3-m pressure distribution platform. The participants will be asked to stand with both legs on the firm and foam surface in two conditions i.e. eye closed and eye open, for 20 s in each condition. And then, they will be asked to walk at a self-selected speed to the other end of the platform. Each condition will be tested for 3 trials and averaged data will be used in further analysis. The following parameters from the platform will be acquired: 1. Sway path length of center of pressure (COP) (mm) is the total length of the path marked by COP 2. Average velocity of COP (mm/s) is the speed of changes in the COP location 3. COP area (mm2) is the size of the area marked by COP

  Baseline, 3, 6 months

Secondary Outcomes (2)

• Low back and Lower-extremity pain

  Baseline, 3, 6 months

• Transversus abdominis (TrA) Thickness

  Baseline, 3, 6 months

Other Outcomes (2)

• Subjective assessment

  Baseline

• Physical assessment

  Baseline

Study Arms (3)

CFO with W1

EXPERIMENTAL

The therapists will propose the orthotic wedges after examining the foot angles following the foot assessment from the study of Root, the forefoot angle will be determined for both the forefoot and rearfoot wedges. Previous studies recommended the posting at 60% of the measured forefoot angle, up to a maximum of 8 degrees, for extrinsic forefoot varus wedge and the posting at 50% of the measured forefoot angle, up to a maximum of 6 degrees, for extrinsic rearfoot varus wedge. After the posting, all participants will be asked to test the provided foot orthoses within their footwear. If any disturbance has been found during testing, the adjustment will be performed.

Device: orthotic wedge; Device: CFO

CFO with W2

EXPERIMENTAL

The therapists will propose the orthotic wedges after examining the foot angles following the foot assessment from the study of Monaghan et al., the forefoot will be posted at 50% of the measured forefoot angle, and the rearfoot will be posted at 20% of the measured rearfoot angle. After the posting, all participants will be asked to test the provided foot orthoses within their footwear. If any disturbance has been found during testing, the adjustment will be performed.

Device: orthotic wedge; Device: CFO

CFO without wedge

ACTIVE COMPARATOR

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.

Device: CFO

Interventions

orthotic wedge DEVICE

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.

CFO with W1; CFO with W2

CFO DEVICE

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.

CFO with W1; CFO with W2; CFO without wedge

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Reaching the specific criteria of PHP including
• A complaint of tenderness from the palpation of the medial calcaneal tubercle and the medial aspect of the proximal portion of the plantar fascia, or pain along the plantar fascia at medial longitudinal arch side
• The presence of heel pain immediately during the first few steps of walking in the morning or after a prolonged period of inactivity; and gradually decreased throughout the day with ordinary walking, and worsened with prolonged activity
• Having the symptom of heel pain for at least 6 weeks, indicates the chronic condition
• Having the maximum level of pain intensity during last week using the visual analog scale (VAS) at least 3 out of a full 10 scores

You may not qualify if:

• Having positive sciatica test, indicating the L5-S1 nerve root irritation
• Having a history of lower extremity fracture
• Having a history of lower extremity surgery
• Having been diagnosed with gout, diabetic neuropathy, rheumatoid arthritis, systemic lupus erythematosus (SLE), cancer, infectious disease, and tumor

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Mahidol University

Bangkok, Nakhonpathom, 73170, Thailand

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Pavinee Harutaichun, Ph.D.

  Faculty of Physical Therapy, Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The present study will use a randomized controlled trial (RCT) to determine the effectiveness of CFO for the treatment of patients with PHP. Three treatment groups including the CFO without wedge, the CFO with W1, and the CFO with 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.

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 19, 2024
• Study Start: April 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)