Clinical trial NCT06319066: Customized Foot Orthoses With Orthotic Wedges for Plantar Heel Pain
Official title: Effectiveness of Customized Foot Orthoses With Orthotic Wedges for the Treatment of Patients With Plantar Heel Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Orthoses
Fasciitis, Plantar
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity and foot function
timeFrame: Baseline, 3, 6 months
measure: Plantar Fascia Thickness
timeFrame: Baseline, 3, 6 months
measure: Gait assessment
timeFrame: Baseline, 3, 6 months
measure: Balance assessment
timeFrame: Baseline, 3, 6 months
Secondary outcomes:
measure: Low back and Lower-extremity pain
timeFrame: Baseline, 3, 6 months
measure: Transversus abdominis (TrA) Thickness
timeFrame: Baseline, 3, 6 months
Other outcomes:
measure: Subjective assessment
timeFrame: Baseline
measure: Physical assessment
timeFrame: Baseline
Locations:
city: Bangkok
country: Thailand
facility: Mahidol University
state: Nakhonpathom
Study officials:
affiliation: Faculty of Physical Therapy, Mahidol University
name: Pavinee Harutaichun, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: