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Completed

NCT Number: NCT06318910

Customized Foot Orthoses on Muscle Activity During Standing and Gait in Plantar Heel Pain

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.

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Key information

Conditions

Foot Orthoses Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Mahidol University

Bangkok, Changwat Nakhon Pathom, 73170, Thailand

About this study

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, lower-extremity muscle activity during gait and standing 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 of the CFO use, all outcomes will be re-assessed by the 2nd physical therapist. And such outcomes will be then statistically analyzed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

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.

Primary outcomes

  1. Pain intensity and foot function

    Time frame: Baseline, 3 months

    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.

  2. EMG of lower leg muscles

    Time frame: Baseline, 3 months

    A Trigno Wireless EMG system at 2000 Hz (Delsys Inc., Boston, MA) will be used to collect the EMG data from Tibialis anterior, Peroneus longus, Medial gastrocnemius, Biceps femoris, and Rectus femoris in both legs. The skin will be cleaned with alcohol wipes and the standard EMG electrodes will be positioned following the SENIAM guidelines. Raw EMG data will be exported to Visual3D (C-Motion Inc., Germantown, USA). The dependent variables for the peak and integrated EMG (iEMG) values from such muscles will be found. Then, the data will be normalized to the maximal observed signal during the dynamic contraction during the movement tasks. 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 3-m pressure distribution platform.

Other outcomes

  1. Subjective assessment

    Time frame: Baseline

    A self-reported questionnaire will be divided into 4 parts, including individual information (i.e. sex, age, gender, dominant side, body mass index, job, average time during standing and walking), general health information (i.e. characteristics of heel pain, history of injury and fracture at the lower extremity, falling history, types of footwear), foot pain and function, low back pain and lower-extremity pain.

  2. Physical assessment

    Time frame: Baseline

    Physical characteristics of the participants will be assessed by the 1st physical therapist, including measurements of standing posture, leg length, quadriceps angle, tibiofemoral angle, knee recurvatum, dorsiflexion lunge test, navicular drop test, first metatarsophalangeal joint angle and posture, foot posture during standing and prone lying, neural tension test, lateral step down test, and star excursion balance test. Intra-rater reliability from data of each physical assessment among 10 persons showed the Intraclass Correlation Coefficients ICC(3,1) values ranging from 0.69 to 0.98.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Effects of Customized Foot Orthoses With Orthotic Wedges on Lower-extremity Muscle Activity During Standing and Gait in the Patients With Plantar Heel Pain: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 19, 2024
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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