Clinical trial NCT04461197: Efficacy of the Treatment of Plantar Orthoses With Extracorporeal Shock Wave Therapy in Plantar Fasciitis
Official title: Efficacy of the Therapeutic Effects of Adjunctive Treatment of Plantar Orthoses With Extracorporeal Shock Wave Therapy in Plantar Fasciitis: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasciitis, Plantar, Chronic
Keywords: Fasciitis, Plantar
Foot Orthoses
High-Energy Shock Waves
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Plantar fasciitis is inflammation of plantar fascia. It arises from degeneration and chronic inflammation. Treatment of plantar fasciitis contains conservative methods like rest, body weight control, stretching exercise, non-steroidal anti-inflammatory drugs and arch supports. ESWT has commonly been used for the treatment of plantar fasciitis. The shock waves can be radial or focused. The aim of this study was to evaluate the effectiveness of the adjuvant use of plantar orthoses in the process of plantar fasciitis when extracorporeal shock waves are applied. The hypothesis porposed was that the use of extracorporeal shock waves together with the use of custom foot orthotics improves the symptoms produced by plantar fasciitis. This study is planned as double-blind, randomized controlled trial. Participants are randomly allocated to two groups: the ESWT group and the custom foot orthotics and ESWT group. Radial ESWT will be applied in this study.

The people receiving the therapy and the people assessing the outcomes are blinded . Both group will recieve ESWT one session per week for three weeks. Each session will last for 2-5 minutes. The primary outcome measure of this study is change in heel pain of affected side assessed using Visual Analog Scale. The secondary outcome measure is Roles y Maudsley scores. The primary endpoint of this study is to determine a decrease in pain score according to Visual Analog Scale.


Eligibility criteria: Inclusion Criteria:

* Age between 18 - 65 years
* able to understand the explanations about the potential benefits and risks of participating in the study
* both genders
* diagnosis of chronic plantar fasciitis
* duration of symptoms equal or superior to 6 months at the time of enrollment
* Foot Posture Index ≥ +6 (pronated foot in one or both feet).

Exclusion Criteria:

* being younger than 18 years of age
* previous treatments with shock wave devices
* previous surgery on the painful heel; history of calcaneus fracture
* any inflammation at the level of the ankle
* infection in the treated area
* patients with diabetes mellitus or cardiac or respiratory disease
* osteomyelitis
* patients on anticoagulant drugs
* pregnancy
* patients on immunosuppressive therapy
* rheumatoid arthritis or history of rheumatic disease
* neurological deficits
* malignant disease with or without metastases
* significant liver function abnormalities
* neurological or vascular insufficiency in the painful heel; fasciotomy or heel spur surgery
* discrepancy in the length of the foot \> 5 mm; previous back of foot surgery
* patients treated with rigid plantar supports

Primary outcomes:
measure: visual analog scale (VAS)
timeFrame: Baseline
Secondary outcomes:
measure: Roles-Maudsley (RM) scores
timeFrame: Baseline
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Universidad de Sevilla
Study officials:
affiliation: University of Seville
name: Ana J Perez, Dra.
role: STUDY_DIRECTOR
References: