Clinical trial NCT06446167: Comparative Efficacy of Laser, Extracorporeal Shockwave Therapy and Exercise Therapy on Plantar Fasciitis Outcomes
Official title: Comparative Efficacy of Multiwave Locked System Laser, Extracorporeal Shockwave Therapy and Exercise Therapy on Plantar Fasciitis Outcomes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fascitis
Keywords: Plantar Fasciitis
Exercise
Lasers
Extracorporeal Shockwave Therapy
Lead sponsor: Istanbul Saglik Bilimleri University
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 60 patients met the eligibility criteria and were enrolled in the study. The eligible participants were randomized into three distinct groups each comprising 20 individuals: an exercise alone group (Exercise group), an exercise combined with MLS laser therapy group (Laser group), and an exercise combined with ESWT group (ESWT group). Randomization was conducted using a computer-assisted program
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effectiveness of exercise combined with ESWT (Extracorporeal Shockwave Therapy), exercise combined with MLS (Multiwave Locked System) laser therapy, and exercise alone in female patients diagnosed with unilateral plantar fasciitis, using Visual Analog Scale (VAS), Heel Tenderness Index (HTI), Foot and Ankle Outcome Score (FAOS), Foot Function Index (FFI) and fall risk, as clinical parameters to assess any differences in effectiveness levels among these treatments.

Detailed description: Plantar fasciitis (PF) is a prevalent condition characterized by the degeneration of the plantar fascia, a band of connective tissue that originates from the calcaneus to the proximal phalanges and the skin of the foot's anterior part. Despite common misconceptions, plantar fasciitis is not primarily an inflammatory process but results from repetitive microtears leading to a secondary inflammatory reaction of the plantar fascia.

Despite the condition's self-limiting nature, with 70% to 80% of patients experiencing symptom relief through conservative treatment alone, a combination of treatments is often necessary for many. Conservative interventions include rest, cold application, stretching and strengthening exercises, orthotic devices, lifestyle modifications, weight loss, and night splints. Additionally, non-invasive physical therapy modalities such as Extracorporeal Shock Wave Therapy (ESWT), laser, and ultrasound have shown to be cost-effective and accessible treatment options. Invasive treatments, including injections and surgery, are considered for resistant cases

Previous studies have examined the effectiveness of ESWT, Low level laser therapy, High intensity laser therapy, and exercise treatments in patients with PF, demonstrating their efficacy. Although there are studies investigating the effectiveness of MLS laser therapy on various musculoskeletal pathologies, to our knowledge, there is no study specifically examining its efficacy on PF

Eligibility criteria: Inclusion Criteria:

* Age between 18-65 years
* Female gender
* Symptoms persisting for at least 6 weeks
* Unilateral plantar fasciitis
* Consent to participate in the study

Exclusion Criteria:

* Male gender
* Bilateral plantar fasciitis
* Treatment with ESWT, laser or injection therapy for plantar fasciitis in the previous year
* Participation in a physical therapy program for plantar fasciitis in the last six months
* History of systemic inflammatory disease
* History of lower extremity fracture or surgery
* Pregnancy
* History of epilepsy
* Malignancy
* Active infection
* Coagulation disorders
* Severe cardiac disease or history of pacemaker
* History of neuromuscular disease affecting balance parameters
* Regular use of nonsteroidal antiinflammatory drugs

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: one month
Secondary outcomes:
measure: Foot Function Index (FFI)
timeFrame: one month
measure: Foot and Ankle Outcome Score (FAOS)
timeFrame: one month
measure: Heel Tenderness Index (HTI)
timeFrame: one month
measure: Biodex Fall Risk Assessment
timeFrame: one month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Medipol University
Study officials:
affiliation: İstanbulSBÜ
name: İbrahim Ethem Kirez
role: PRINCIPAL_INVESTIGATOR
References: