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Dynamic Versus Static Night Splinting of Plantar Fasciitis

ConditionPlantar Fascitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorStanford University

About this trial

The investigators are trying to study that there is no difference in improvement of motion between static progressive and dynamic splinting.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Demographic - Over 18 years of age and ambulatory without a gait aid with no history of narcotic use

Diagnosis - Unilateral or bilateral acute (< 6 months of pain) plantar fasciitis (i.e., Heel pain that increases with weightbearing, "First step pain": heel pain that occurs after a period of non-weightbearing, such as in the morning when arising from bed or when arising after prolonged sitting; the pain is improved after a few minutes walking but will worsen again with prolonged weightbearing, tenderness over the medial calcaneal tuberosity at the insertion of the plantar fasciitis)

Permitted - Icing, NSAIDS( ibuprofen), Custom Shoe Inserts, Diagnostic Ultrasound

Disqualifiers

Demographic - Under 18 year of age, requires a gait aid for ambulation; if not covered by insurance,

Diagnosis of - Arthritis of the Ankle, Midfoot, or Forefoot; Inflammatory Arthritis; Gout; Turf Toe; Hallux Rigidus; Hallux Limitus; Sesamoiditis; Tendonitis or Tendinopathy; Prior tear or Rupture of the Plantar Fascia; Fibromyalgia, Neuralgia, or Neuropathy; Peripheral Vascular Disease; Prior Trauma to the Heel, Fracture of the Calcaneus; Infection; Corn; Callus; Ingrown Nail.

Patient with history of Symptoms for over 6 months

Refractory to prior splint-based treatments

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dynamic splint

    Device

    Device treats plantar fasciitis and replacing boot immobilization which is quite benign

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Control( static splinting)Active comparator 1 intervention
Group B: Experiment( dynamic splinting)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

NO pain at 1 month follow up

We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)

Time frame
1 months
2

NO pain at 3 months follow up

We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)

Time frame
3 months
3

NO pain at 6 months follow up

We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)

Time frame
6 months

Secondary outcomes

1

Clinically relevant change in Foot Function Index (FFI)

Clinically relevant change in Foot Function Index (FFI) of \>6.5 points (MCID

Time frame
1 months
2

Clinically relevant change in Foot Function Index (FFI)

Clinically relevant change in Foot Function Index (FFI) of \>6.5 points (MCID

Time frame
3 months
3

Clinically relevant change in Foot Function Index (FFI)

Clinically relevant change in Foot Function Index (FFI) of \>6.5 points (MCID

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov
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