Mahidol University
Bangkok, Nakhonpathom, 73170, Thailand
NCT Number: NCT06319066
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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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Bangkok, Nakhonpathom, 73170, Thailand
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline, 3, 6 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.
Time frame: Baseline, 3, 6 months
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.
Time frame: Baseline, 3, 6 months
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).
Time frame: Baseline, 3, 6 months
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:
Time frame: Baseline, 3, 6 months
LBP during the last week will be assessed using the Thai version of the Roland-Morris disability questionnaire. The previous study showed high internal consistency (Cronbach alpha = 0.83), which is a reliable tool to assess functional disability of LBP in Thai persons. In addition, hip pain during the last week will be assessed using the Thai version of the hip disability and osteoarthritis outcome (HOOS). The previous study showed high internal consistency for the pain subscale (Cronbach alpha = 0.89) and high test-retest reliability (ICC = 0.94). Regarding the assessment of knee pain during last week, the Thai version of the knee osteoarthritis outcome score (KOOS) will be used. The previous study showed high internal consistency (Cronbach alpha = 0.90) and moderate test-retest reliability for the pain subscale (ICC = 0.78).
Time frame: Baseline, 3, 6 months
TrA 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. The measurement protocol will follow the recommendation from the European Society of Musculoskeletal Radiology. TrA thickness will be assessed for three trials and the averaged data will be used for the comparison in data analysis.
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.
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.
Mahidol University
Other
Effectiveness of Customized Foot Orthoses With Orthotic Wedges for the Treatment of Patients With Plantar Heel Pain
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