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

NCT04571073 | Completed Phase 1

• 1 other identifier: DDEAMC17005
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fasciitis of Both Feet

Outcome Measures

Primary Outcomes (1)

• Foot pain subscale of the Foot Health Status Questionnaire

  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.

  Change from baseline to 1 week to 4 months

Secondary Outcomes (3)

• Visual analog pain scale (100 point)

  Change from baseline to 1 week to 4 months

• Plantar fascia thickness measured by ultrasound

  change from baseline to 4 months

• 7 other subscales of the Foot Health Status Questionnaire

  Change from baseline to 1 week to 4 months

Other Outcomes (2)

• Use of Non steroidal anti-inflammatory medications (NSAID)

  change from baseline to 4 months

• Physical profile

  change from baseline to 4 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

The only arm in the study was the intervention arm as this is a pilot study.

Procedure: Fascial Distortion Model

Interventions

Fascial Distortion Model PROCEDURE

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.

Also known as: FDM

Treatment arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisenhower Army Medical Center: lead

Study Sites (1)

Dwight D. Eisenhower Army Medical Center

Fort Gordon, Georgia, 30909, United States

Location

Related Publications (40)

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  BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: The AI taking the ultrasound images was blinded to study phase of the participant he was screening.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 30, 2020
• Study Start: March 1, 2018
• Primary Completion: February 28, 2019
• Study Completion: March 12, 2019
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

US (1)