Clinical trial NCT04967703: Physiotherapy Protocols in Treating Plantar Fasciitis
Official title: Effect of Radial Shock Wave and Ultrasound Therapy Combined With Traditional Physical Therapy Exercises on Foot Function and Dorsiflexion Range in Plantar Fasciitis: A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fascitis
Keywords: plantar fasciitis
foot function index
ultrasound
radial shock wave
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Jouf University
First posted: 2021-07-19
Enrollment: 69
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the efficacy of different physical therapy protocols in the treatment of chronic plantar fasciitis patients. Patients in this study were randomly assigned into 3 groups. Group A received ultrasound therapy protocol, group B received radial shock wave therapy protocol and group C received a combination of both ultrasound therapy and radial shock wave therapy protocol. All patients were also received a traditional physical therapy program. Foot function was evaluated by foot function index and ankle dorsiflexion range of motion was measured by Baseline® bubble inclinometer at the baseline and 4 weeks after treatment

Detailed description: Sixty nine patients having unilateral chronic plantar fasciitis will be recruited for the study from Al-Qurayyat General Hospital, in Al-Jouf Region, Saudi Arabia. The inclusion criteria were as follows: patients suffered planter fasciitis of more than 3 months, maximum tenderness near the medial calcaneal insertion and pain was greater than 4 on visual analogue scale during taking the first steps in the morning. Patients were excluded if they had previous ankle or foot surgery or pathology, or if they had a previous history of shock wave therapy or topical corticosteroid injections to the ankle or foot, circulatory disturbances in the lower extremities, neuropathic or radicular pain in the lower limbs. Participants with systemic diseases that cause foot discomfort, such as ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and gout, as well as those with type I or type II diabetes and pregnancy, were also excluded from the study.

The patients were randomly assigned into 3 equal groups (n = 23). Group A received ultrasound therapy protocol using Enraf Nonius Sonoplus 490, Netherlands. Group B received radial shock wave therapy protocol using Swiss DolorClast® Master, Electro Medical Systems, SA, Nyon, Switzerland. Group C received a combination of both ultrasound therapy and radial shock wave therapy protocol. All patients also received a traditional physical therapy program (3 sessions per week, for 4 weeks) consisting of Calf muscles stretching and plantar fascia stretching. Foot function and Ankle dorsiflexion range of motion were evaluated at the baseline and 4 weeks after treatment.

Eligibility criteria: Inclusion Criteria:

* Patients suffered plantar fasciitis of more than 3 months
* Maximum tenderness near the medial calcaneal insertion and pain was greater than 4 on visual analogue scale during taking the first steps in the morning

Exclusion Criteria:

* Bilateral plantar fasciitis
* Previous ankle or foot surgery or pathology
* If they had a previous history of shock wave therapy or topical corticosteroid injections to the ankle or foot
* Circulatory disturbances in the lower extremities
* Neuropathic or radicular pain in the lower limb
* Participants with systemic diseases that cause foot discomfort, such as ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and gout, as well as those with type I or type II diabetes and pregnancy, were also excluded from the study.

Primary outcomes:
measure: Foot function
timeFrame: From baseline to 4 weeks after treatment
Secondary outcomes:
measure: Ankle dorsiflexion range of motion
timeFrame: From baseline to 4 weeks after treatment
Other outcomes:
Locations:
city: Al Qurayyat
country: Saudi Arabia
facility: Al Qurayyat General Hospital
state: Jouf Region
Study officials:
affiliation: Associate Professor of Physical Therapy
name: Khaled Z. Fouda, PhD
role: PRINCIPAL_INVESTIGATOR
References: