Manual Therapy Informed by the Fascia Distortion Model for Plantar Heel Pain: Results of a Single-arm Prospective Effectiveness Study
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 33
- Locations
- 2
- Primary Endpoint
- Foot pain subscale of the Foot Health Status Questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
The AI taking the ultrasound images was blinded to study phase of the participant he was screening.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- Visual analog pain scale (100 point)(Change from baseline to 1 week to 4 months)
Investigators
Joshua D Boucher
Primary Investigator
Eisenhower Army Medical Center