Recovery From Plantar Heel Pain Using the Fascial Distortion Model a Pilot Study
Condition: Plantar Fasciitis of Both Feet
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess feasibility and determine preliminary efficacy of Fascial Distortion Model (FDM)
      for plantar heel pain (PHP) in a pilot study. The FDM is a hands on direct technique that is
      non-invasive and has been shown in preliminary studies to be effective in treating
      musculoskeletal (MSK) injuries. Study participants will be Active Duty Service Members (SM)
      in the Fort Gordon catchment area.
    

Detailed description: 
      This prospective, single arm pilot study was approved by the Dwight D. Eisenhower Army
      Medical Center human subjects Institutional Review Board. Participants were recruited from
      Dwight D. Eisenhower Army Medical Center from March 2018 to February 2019.

      Visit 1-Screening and treatment visit The research staff will review the informed consent
      with potential research participant(s) and will answer any questions the participant may have
      about the information in the informed consent. Participants that are willing to participate
      and sign the informed consent will be eligible to be screened for the study. Participants
      will be provided copies of their signed informed consent.

      Participants will be screened for eligibility to participate in the study based on the
      inclusion/exclusion criteria and their understanding and acceptance of possible side effects
      that will be clearly identified in the consent form. Participants must have a current history
      of PHP and be an Active Duty SM. Participants will be required to have provide detailed
      information on the quantity of pain medications they consume daily and have a stable history
      of PHP for at least 30 days prior to the start of screening and treatment.

      The inclusion and exclusion criteria will be reviewed with the participant to assure the
      participant meets the criteria required for participation in the study. Initially,
      participants who meet the study criteria will screened and treatment on day one. During
      screening, participants will provide or update a demographics questionnaire, Foot Health
      Status Questionnaire (FHSQ), medication history, medical history information including
      history of PHP and events leading up to the diagnosis, profile history, and will undergo a
      musculoskeletal exam and a general physical exam, including vital signs. The involved
      foot/feet will be undergo ultrasonography to and a thickness of the fascia will be measured
      via ultrasound. Medication history includes any and all medications currently taking
      including vitamins and minerals.

      Prior to treatment the patient will be seated for at least 30-60 minutes and provide a visual
      analogue scale (VAS) measurement of their pain at rest, first step, one and two foot jump,
      squat, walk, and run.

      The participant will meet with a provider educated in the FDM who will follow the protocols
      for treatment of the plantar heel pain to include diagnosis and treatment of: Continuum
      distortions, trigger bands, herniated trigger points, folding distortions, cylinder
      distortions, and tectonic fixations. These treatment may/can start in the foot and extend up
      the lower leg and may involve treatment of decreased range of motion in the foot, ankle, or
      lower extremity.

      The participant will be instructed to not apply heat to the area for the next 48 hours,
      maintain profile (if they have one) status, and continue to limit their activity as to not
      re-injure the foot/feet. The participant will return in two to seven days following the
      treatment.

      Visit 2-Second intervention At Visit 2 which will occur at two to seven days, the inclusion
      and exclusion criteria will be reviewed with the participant to assure the participant
      continues to meet the criteria required for participation in the study. Patient will report
      on their activities since the last treatment and if they applied heat to the affected area.

      Participants will provide or update a demographics questionnaire, FHSQ, medication history,
      medical history, profile history, any adverse reactions to prior treatment, and will undergo
      a musculoskeletal exam and a general physical exam, including vital signs with body mass
      index.

      Prior to treatment the patient will be seated for at least 30-60 minutes and provide a VAS
      measurement of their pain at rest, first step, one and two foot jump, squat, walk, and run.

      The participant will meet with the same provider as during visit one. The provider educated
      with the FDM will follow the protocols for treatment of the plantar heel pain to include
      diagnosis and treatment of continuum distortions, trigger bands, herniated trigger points,
      folding distortions, cylinder distortions, and tectonic fixations. These treatment may/can
      start in the foot and extend up the lower leg and may involve treatment of decreased range of
      motion in the foot, ankle, or lower extremity.

      The participant will return for last visit at 4 months.

      Visit 3 Follow-up, final visit Upon returning for the 4 month follow up, the participant will
      undergo an exit neurological exam, physical exam, concomitant medications will be reviewed
      and updated. Participants will provide a FHSQ, and updates to their profile, and any adverse
      reactions to prior treatment. Ultrasound will be performed to measure the thickness of the
      plantar fascia by the same provider that measure the fascia on the first visit. Participant
      will be seated for at least 30-60 minutes and provide a VAS measurement of their pain at
      rest, first step, one and two foot jump, squat, walk, and run.

      Study Termination

      The research team may terminate this study at any time and for any reason. If a participant
      is withdrawn or the study is terminated, investigators will initiate participant intervention
      according to institutional standard of care procedures. Participants will be terminated from
      the study for any one of the following reasons:

      Withdrawal of informed consent Failure to continue to meet inclusion criteria, meet any of
      the exclusion criteria or withdrawal by investigator Lost to follow up Serious Adverse event
      Protocol non compliance Completion of the study

      Procedures for early termination:

      Update medical history & medication history, Perform physical and musculoskeletal exams, if
      possible Document reported and/or observed adverse events VAS, FHSQ questionnaire, profile
      duration, ultrasound plantar fascia thickness measurement completed, if possible

      Intervention with the fascial distortion model will be the research procedure, it will be
      performed by the primary investigator (PI) or a trained member of the research team with
      direct supervision of the PI.

      Instructions for performing the FDM:

      Diagnose the correct distortion, one of six options: herniated trigger point (HTP), continuum
      distortion (CD), trigger band (TB), cylinder distortion (Cyd), folding distortion (FD), and
      tectonic fixation (TF).

      Diagnosis made by patients body language HTP: participant pushes two fingers into the tissues
      CD: participant pushes with one finger into the tissue on a bony prominence TB: participant
      sweeping fingers along the tissues in a linear pathway CyD: broad sweeping of tissues or
      repetitive squeezing FD: holding or cupping the tissues TF: moving tissues/joint through
      range of motion

      Treatment will depend on the diagnosis made HTP: Apply direct firm pressure with the distal
      phalanx of the first digit into the most tender portion of the tissues in the HTP for five to
      ten seconds CD: Apply direct firm pressure with the distal phalanx of the first digit through
      the tissues readjusting to find the most tender position and hold the position for five to
      thirty seconds.

      TB: Apply direct firm pressure with the distal phalanx along the linear plane of tissue drawn
      out by the patient CyD: Apply direct firm pressure with the distal phalanx of both hands
      spreading the tissues apart, or apply a cupping device to the tissues, or grab the tissues
      with the hands and twist the tissues in opposing directions as the PI deems appropriate.

      FD: Find the direction in which the fascia is torqued by pulling or pushing in different
      planes and then once that direction is found, apply traction in that plane that is constant
      and then quickly add a thrust in the same direction. TF: Find the direction in which the
      fascia is fixated and move the tissues through the range of motion while applying traction.

      Only HTP, CD, and TBs are expected to be discovered and treated throughout the study.

      Data Collection:

      Participants will be screened on-site at DDEAMC for general inclusion/exclusion criteria.
      They will be given a full description of the study procedures and asked to read and sign an
      IRB-approved informed consent form.

      Screening and treatment of DDEAMC recruited participants will occur on the DDEAMC outpatient
      clinic after the participants have been given a full description of the study procedures and
      have signed a IRB approved consent.

      The screening will include: Background information including medical+plantar heel
      pain+medication histories, inclusion & exclusion criteria evaluation, MSK and physical exams,
      vital signs, as well as a series of questionnaires listed below.

      Study Documentation Data for this trial will be primarily collected in an electronic data
      capture (EDC). This will be done with DoD AHTLA. It is the investigator's responsibility for
      the collection and reporting of all clinical and safety data entered and confirm the data is
      accurate, authentic, attributable, complete, and consistent. The investigator or sub
      investigator must sign the note in AHLTA to attest the information contained is true and
      causality of any safety information has been assessed.

      The following information will be collected throughout the study at all three encounters:

      Physical Exam Vital Signs Medical History PHP History Medication History Update Medications
      Collect Adverse Events FHSQ VAS Profile status Ultrasound measured plantar fascia thickness
      at visit one and three

      MSK and physical Examinations. A delegated physician AIs will examine the patient for any
      detectable abnormalities of the following body systems: general appearance; neck; head, eyes,
      ears, nose, and throat; lungs; heart/cardiovascular; abdomen; neurologic; extremities; back;
      musculoskeletal; lymphatic; skin; and other. The MSK examination will assess active and
      passive range of motion, reflexes, sensory, muscle strength with focus on the lower
      extremities. After the participant had been at rest for 30 minutes pain will be assessed at
      rest, first step, one and two foot jump, squat, walk, and run.

      Vital Signs. Vital signs with body mass index will be measured at screening, Visit 1, and
      each subsequent office visit. Systolic and diastolic blood pressure and pulse rate over 30
      seconds should be taken after patients have been at rest (seated) for at least 2 minutes.
      Blood pressure should be recorded in mmHg. Pulse rate should be measured in beats per
      minutes. Weight will be recorded at each office visit and measured in pounds. Height will be
      taken at screening and measured in inches.

      Foot Health Status Questionnaire: The FHSQ is a 29 question questionnaire that is a validated
      survey with a goodness-of-fit index of 0.9 suggesting a moderate fit of measurement of foot
      health related to quality of life.

      Visual analogue scale (VAS). The VAS will be used to assess the pain at the plantar heel
      location during rest, first step, one and two foot jump, squat, walk, and run. The
      participant will plot the pain level along a linear scale that gives a the opportunity for
      any potential score from zero to one hundred.

      Plantar thickness as measured by ultrasound. A trained AI will measure each participant at
      the beginning of visit one and during visit three with the ultrasound. Measurement will take
      place just distal to the calcaneus, an image will be saved for each participant and placed in
      the EDC.

      Available subject's data will be used if they withdraw from the project or the research team
      withdraws them from the project.

      Based on other studies related to Fascial Distortion Model and the amount of variables the
      goal will be to treat 50 feet.

      Analysis A per protocol analytic approach using SPSS 26.0 statistical package will be
      employed to investigate whether manipulation using the FDM for PHP improved outcomes.
      Descriptive statistics to be performed to describe outcomes at each time point; average value
      ± standard deviation (SD) will be reported at baseline unless otherwise specified.

      Repeated Measures Analysis of Variance (ANOVA) will test the hypothesis that there was a
      within subject omnibus improvement over time in FHSQ and VAS scores. Statistical assumptions
      including sphericity to be met. Post-hoc within-subject paired sample t-tests will be used to
      identify at which time points a statistically significant difference in FHSQ and VAS scores
      occurred (i.e., at 1- or 16-weeks later relative to baseline). Average values ± standard
      deviation (SD) will be reported for this analysis. The unit of analysis for both is the
      participant.

      The unit of analysis for plantar fascia thickness is the individual foot, regardless whether
      one or both feet were treated. A paired sample t-test will compare differences in the
      thickness of study plantar fascia at 16 weeks post intervention relative to baseline. Given
      that this is a pilot study, a conventional p-value of ≤ .05 was selected to denote
      statistical significance.
    

Intervention name(s): Fascial Distortion Model
Intervention type(s): Procedure
Intervention description(s): Using physical exam and manual manipulation skills informed by the FDM, he identified and treated locations of presumed fascial distortion about the plantar area of the foot; "distortions" could include any of the six reported fascial anomalies in the FDM: continuum distortions, trigger bands, herniated trigger points, folding distortions, cylinder distortions, and tectonic fixations. Each distortion is associated with a recommended reparative manipulation. The purported mechanism of action is that the distortion-specific manipulation restores normal fascial homogeneity.
Other intervention name(s): FDM
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment