Plantar Heel Pain: Multisegment Foot Motion and Muscle Function, FFI Translation, and Evaluation of Treatments (Subproject1) Effectiveness of Strengthening Exercise Program on Symptoms in Patients With PHP (Subproject3)
Condition: Plantar Fasciitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      (Subproject 1) "Plantar heel pain (PHP)" or "plantar fasciitis" is one of the major foot
      problems which can occur in any age group. It is a commonly encountered musculoskeletal
      problem that can cause disability, activity limitation, discomfort, and affect the quality of
      life. It involves pain and inflammation of the plantar fascia, which runs across the bottom
      of the foot and connects the heel bone to toes. PHP frequently found in active workers aged
      between 25 and 65 years with the highest incidence in people aged between 40 and 60 years.

      However, very few studies investigated the alterations of the multisegmental foot motions and
      muscle functions in patients with PHP. To prescribe the relevant program of treatment and
      reduce the risk of symptoms chronicity, it is necessary to have an in-depth understanding of
      changing mechanisms in patients with PHP. To explain how the symptoms occur in patients with
      PHP, foot function is another aspect that should be determined. One of the popular
      questionnaires determining foot function is the Foot Function Index (FFI) questionnaire. It
      has been proved to have good reliability and validity and has been translated into several
      languages. To be able to use the international standard questionnaire, it is necessary to
      translate the FFI into Thai. This can be implemented in Thailand and be able to compare the
      findings of the interventional effect internationally. In addition, very few studies reported
      the effectiveness of the treatment program for patients with PHP. Among previous evidences,
      the controversial findings existed. Thus, the intervention program should be evaluated for
      obtaining the effective treatment for this population.

      (Subproject 3) The objectives of the study will be General Objective is to investigate the
      effectiveness of strengthening exercise program on symptoms in patients with plantar heel
      pain.

      Specific Objectives is to compare the effectiveness between physical therapy treatment
      program with strengthening exercise and with stretching exercise on foot function score, pain
      at worst score, plantar fascia thickness, muscles strength, ankle motion, and gait parameters
      in patients with plantar heel pain among baseline, after 4th and 8th of treatments, and after
      1st and 2nd month of self-home based exercise.
    

Detailed description: 
      (Sub-project 1) Procedure

      Each participant will attend data collection on a single occasion and allocate into the
      healthy or patients with PHP with the selection criteria before enrollment. They will dress
      with short pants which researcher prepare. Before testing, the NORAXON TeleMyo Receiver will
      be synchronized with the forceplate and video. The real-time signal of motion, EMG, and force
      data will simultaneously synchronize and present on the screen.

      EMG preparation

      The skin will be prepared over the sites for electrode placements by shaving, lightly
      abrading, and cleaning with 70% alcohol prior to electrode application. The electrodes will
      place 20 mm center to center interelectrode space over the site in each muscle.
      Interelectrode impedance is less than 10 kiloohm. The elastic adhesive tape is used to fixed
      electrodes to control movement artefacts. Participants will perform reference contractions to
      check the placement and cross-talk of the electrodes between EMG signals from different
      muscles prior to data collection.

      EMG placement

      Muscle activation will be measured by electromyography (TeleMyo DTS Telemetry, NORAXON USA
      Inc.) at a sampling frequency of 1000 Hz in order to quantify the dynamic muscle function of
      the lower extremity. Surface electrodes will be placed according to recommendations of the
      European Recommendations for Surface Electromyography (SENIAM). Pairs of wet-gelled bipolar
      Ag-AgCl Dual surface electrodes (Ag/AgCl NORAXON Dual electrodes 20 mm spacing) are selected
      for surface EMG sensor. The location and orientation of electrode placements are localized in
      the supine position by the same researcher. The electrode will be placed on Peroneus longus
      (PL) which will be placed at 1/4 on the line between the tip of the fibular and tip of the
      lateral malleolus. Tibialis anterior (TA) electrode will be placed at 1/3 on the line between
      the tip of the fibular and tip of the medial malleolus. Gastrocnemius medial head (GM) and
      Gastrocnemius lateralis (GL) electrodes will be placed on the largest bulb of the muscle at
      medial head. All exact position of the muscles will confirm by their actions.

      Maximum Voluntary isometric contraction (MVIC) test

      Participants perform 5 seconds MVIC against manual resistance in each of the muscle for 3
      times. The PL and TA will be assessed in supine lying position and gastrocnemius will be
      assessed in standing position. Participants will perform the action of each muscle against
      manual resistance from researcher and equipment. The peak amplitude of EMG signal in each
      trial will be selected and will be averaged from 3 seconds over the EMG. The peak mean
      amplitude of the 3 trials for each muscle will be used for normalization.

      Anthropometric data assessment

      Anthropometric data will be obtained from each subject for calculating the kinematic and
      kinetic data. It includes body height, body weight, leg length, and joint widths of the knee
      and ankle. Leg length is the distance between anterior superior iliac spine (ASIS) and medial
      malleolus. The knee width is the distance between medial and lateral condyles across the knee
      joint. The ankle width is the distance between medial and lateral malleoli.

      Marker placement

      The lower body markers of Plug-in-Gait will be used in the study to observe lower extremity
      motion data during walking. The model consists of left and right anterior superior iliac
      crests, left and right posterior superior iliac crests, left and right knees, left and right
      thighs, left and right ankles, left and right tibias, left and right toes, left and right
      heels. Right back marker will be used for the markers auto-label process in order to
      discriminate the left or the right.

      Foot model

      The markers will be placed on foot bony prominence following the Oxford Foot Model to obtain
      multisegmental foot motion during walking. The Oxford Foot Model has been used in previous
      studies to determine the multisegmental foot motion (35, 36) and proved to be validated and
      reliable (35, 36).

      To define the forefoot segment, markers will be placed on the most distal, medial aspect of
      the first metatarsal shaft, the most proximal and distal lateral aspects of the fifth
      metatarsal shaft, and midway between second and third metatarsal heads. For the rearfoot
      segment, markers will be placed on sustentaculum tali, lateral calcaneus, heel (distal part
      of the calcaneus), posterior proximal calcaneus and a peg marker will be placed on posterior
      calcaneus between the heel and proximal calcaneus markers. For the tibial segment, markers
      will be placed on medial malleolus, lateral malleolus, anterior aspect of tibial crest,
      tibial tuberosity and head of fibula.

      Prior to comparing the foot and ankle kinematic data between patients with PHP and normal
      healthy, repeatability of data will be assessed by intraclass correlation coefficient (ICC)
      values among trials of walking for ensuring the data can be acceptable, especially in the
      pathologic condition of the foot as PHP.

      Gait measurement

      Participants will walk on the 8-meters walkway until they familiar with the environment of
      the laboratory. Then, gait data will be collected for 3 success trials at their comfortable
      speed. Motion data will be collected at 100 Hz and will be filtered by using the Butterworth
      filtering technique at 5 Hz. Averaged data of EMG and motion from 3 trials will be used for
      further analysis.

      (Sub-project 3)

      This study will recruit patients with Plantar heel pain (PHP) from the Physical Therapy
      Center, Faculty of Physical Therapy, Mahidol University. The eligible participants will be
      screened and recruited following the inclusion and exclusion criteria. The participants will
      be screened according to the criteria. Purposes, procedures, and possible risks of the study
      will be explained to the participants. Prior to participating in the study, they will sign in
      the informed consent. The participants will be allocated into the group of intervention,
      which is the experimental (strengthening) group and the control (stretching) group, according
      to the stratified randomization technique. The participants will be assessed all outcomes for
      the baseline; pain at worst, FFI, plantar fascia thickness, muscle strength, ankle range of
      motion and gait measurement.

      After that, all participants will be received the same conservative treatment (therapeutic
      ultrasound, tissue mobilization, and joint mobilization) by the experienced physician. Then,
      the participants will be instructed to do the exercise following the program of their
      allocated group. The experimental group will be performed toe flexor muscle exercise, ankle
      evertor muscles exercise, and high-loading strength training, but the control group will be
      performed the gastrocnemius muscle, soleus muscle and plantar fascia stretching. All
      participants will be treated for 8 times (2 times per week) and perform the home-based
      exercise program three times a day. After the treatment end, the participants will continue
      their home-based exercise for 2 months. The home-based exercise protocol will be prescribed
      by the physical therapist.

      The assessment of all outcomes data will perform for 5 times; 1) baseline, 2) after 4th and
      3) 8th of treatments, and 4) after 1st and 5) 2nd month of self-home based exercise. The
      researcher who evaluates the outcome data will be blinded to the group of participant. They
      will be involved only in the admission, randomization, physical examination, and discharge.
      All physical therapists will be undergoing the meeting and practical session to clarify the
      study protocol and treatment guidelines. To ensure the participants able to do home program
      exercise properly, the understanding and compliance will be checked by phone call and record
      the number of exercise in the logbook.

      The statistical significance will be estimated at probability (p-value < 0.05). The
      descriptive statistic will be used to analyze the demographic and baseline characteristics of
      the participants. The Kolmogorov- Smirnov Goodness of Fit test will be tested the data
      distribution. The baseline data will be compared between groups to investigate the difference
      by using the independent t-test and Mann-Whitney U test for normal and non-normal
      distribution of data. The outcome measurements are the VAS score, FFI score, gait parameter,
      plantar fascia thickness, muscle strength, and ankle ROM will be analyzed by the two-way
      repeated ANOVA among baseline, after 4th and 8th of treatments, and after 1st and 2nd month
      of self-home based exercise. If the data are not normally distributed, Friedman test will be
      used to compare the mean differences.
    

Intervention name(s): Conservative physical therapy treatment with strengthening exercise program, and Conservative physical therapy treatment with stretching exercise program
Intervention type(s): Procedure
Intervention description(s): (Sub-project 3) conservative physical therapy treatment with self-strengthening and with self-stretching home based exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Plantar Fasciitis; Plantar Heel Pain; Multisegment Foot Motion; EMG; Gait; treatment; strengthening; stretching; exercise