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Recovery From Plantar Heel Pain Using the Fascial Distortion Model a Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04571073
Recruitment Status : Completed
First Posted : September 30, 2020
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Joshua D Boucher, Eisenhower Army Medical Center

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.

Condition or disease Intervention/treatment Phase
Plantar Fasciitis of Both Feet Procedure: Fascial Distortion Model Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: The AI taking the ultrasound images was blinded to study phase of the participant he was screening.
Primary Purpose: Treatment
Official Title: Manual Therapy Based on the Fascia Distortion Model for Plantar Heal Pain: Results of a Single Arm Pilot Study With Four Month Follow-up
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : March 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: Treatment arm
The only arm in the study was the intervention arm as this is a pilot study.
Procedure: Fascial Distortion Model
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 Name: FDM




Primary Outcome Measures :
  1. Foot Health Status Questionnaire [ Time Frame: Change from baseline to 4 months ]
    A validated disease-specific quality of life questionnaire with 19 100-point questions and eight subscales each ranging from 0-100 with higher scores denoting more favorable health status.


Secondary Outcome Measures :
  1. Visual analog pain scale (100 point) [ Time Frame: Change from baseline to 4 months ]
    Participant marked on a scale from zero (no pain) to severe (extremely painful) for each foot.

  2. Plantar fascia thickness measured by ultrasound [ Time Frame: change from baseline to 4 months ]
    An MSK trained sonographer with MSK radiologist oversight used the same ultrasound machine to obtain the image of the plantar fascia per the approved radiology protocol.


Other Outcome Measures:
  1. Use of Non steroidal anti-inflammatory medications (NSAID) [ Time Frame: change from baseline to 4 months ]
    A baseline NSAID use was assessed then at future visits it was asked, no change, decreased, or stopped.

  2. Physical profile [ Time Frame: change from baseline to 4 months ]
    A documented Department of the Army Form 3349, or "Physical Profile," the framework used by medical and behavioral health providers to indicate a soldier's functional limitations.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04571073


Locations
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United States, Georgia
Dwight D. Eisenhower Army Medical Center
Fort Gordon, Georgia, United States, 30909
Sponsors and Collaborators
Eisenhower Army Medical Center
Additional Information:
Publications:
Typaldos S. FDM Clinical and Theoretical Application of the Fascial Distortion Model Within the Practice of Medicine and Surgery. 4th Edition. Typaldos Publishing Co; 2002.
Typaldos S. Introducing the Fascial Distortion Model. Am Acad of Osteopath J. 1994. 14-36.
Baird CJ, Shumate SM, et al. The Effects of the Fascial Distortion Model on Chronic Hamstring Tightness. Topics in Integrative Health Care. 2014;5(3).
Ribar J, Capistrant T. Cranial and Fascial Distortion Techniques Used as Complementary Treatments Alleviate Migraine Headache: A Case Report. American Academy of Osteopathy. 2015; 25(3).
Landorf KB, Radford JA. Minimal important difference: values for the Foot Health Status Questionnaire, Foot Function Index and Visual Analogue Scale. Foot. 2008;18:15-19.
Tylpaldos S, Nagel M, et al. The Fascial Distortion Model as Developed by Stephen Tylpaldos. 1st ed. Edina, MN: Beaver Pond Press; c2015
About Adult BMI. Center for Disease Control and Prevention website. Updated June 30, 2020. Accessed July 11, 2020. https://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/index.html
Trescot AM. Peripheral Nerve Entrapments: Clinical Diagnosis and Management. Springer International Publishing; 2016

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Responsible Party: Joshua D Boucher, Primary Investigator, Eisenhower Army Medical Center
ClinicalTrials.gov Identifier: NCT04571073    
Other Study ID Numbers: DDEAMC17005
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If I am contacted by another study at that time I will decide whether or not to share the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases