Recovery From Plantar Heel Pain Using the Fascial Distortion Model a Pilot Study
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|ClinicalTrials.gov Identifier: NCT04571073|
Recruitment Status : Completed
First Posted : September 30, 2020
Last Update Posted : February 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Plantar Fasciitis of Both Feet||Procedure: Fascial Distortion Model||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|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.|
|Official Title:||Manual Therapy Informed by the Fascia Distortion Model for Plantar Heel Pain: Results of a Single-arm Prospective Effectiveness Study|
|Actual Study Start Date :||March 1, 2018|
|Actual Primary Completion Date :||February 28, 2019|
|Actual Study Completion Date :||March 12, 2019|
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
- Foot pain subscale of the Foot Health Status Questionnaire [ Time Frame: Change from baseline to 1 week 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.
- Visual analog pain scale (100 point) [ Time Frame: Change from baseline to 1 week to 4 months ]Participant marked on a scale from zero (no pain) to severe (extremely painful) for each foot.
- 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.
- 7 other subscales of the Foot Health Status Questionnaire [ Time Frame: Change from baseline to 1 week 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.
- 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.
- 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.
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
|United States, Georgia|
|Dwight D. Eisenhower Army Medical Center|
|Fort Gordon, Georgia, United States, 30909|