Clinical trial NCT04571073: Recovery From Plantar Heel Pain Using the Fascial Distortion Model a Pilot Study
Official title: Manual Therapy Informed by the Fascia Distortion Model for Plantar Heel Pain: Results of a Single-arm Prospective Effectiveness Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Plantar Fasciitis of Both Feet
Lead sponsor: Eisenhower Army Medical Center
Sponsor class: FED
First posted: 2020-09-30
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Active duty military service members
* Ages of 18 to 65 with self-reported heal pain for 30 or more days
* Clinical diagnosis of Plantar heel pain

Exclusion Criteria:

* history of aneurysm
* bleeding disorders
* active cancer
* phlebitis
* thromboembolism
* foot site contraindications (infection, open wound, hematoma, or edema)
* planned deployment within the four months post-screening
* medical condition that would preclude study participation
* pain that would interfere with foot pain reporting.

Primary outcomes:
measure: Foot pain subscale of the Foot Health Status Questionnaire
timeFrame: Change from baseline to 1 week to 4 months
Secondary outcomes:
measure: Visual analog pain scale (100 point)
timeFrame: Change from baseline to 1 week to 4 months
measure: Plantar fascia thickness measured by ultrasound
timeFrame: change from baseline to 4 months
measure: 7 other subscales of the Foot Health Status Questionnaire
timeFrame: Change from baseline to 1 week to 4 months
Other outcomes:
measure: Use of Non steroidal anti-inflammatory medications (NSAID)
timeFrame: change from baseline to 4 months
measure: Physical profile
timeFrame: change from baseline to 4 months
Locations:
city: Fort Gordon
country: United States
facility: Dwight D. Eisenhower Army Medical Center
state: Georgia
Study officials:
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