Comparative Efficacy of Laser, Extracorporeal Shockwave Therapy and Exercise Therapy on Plantar Fasciitis Outcomes

NCT06446167 | Completed

• 1 other identifier: İstanbulSBÜ-FTR-IEK-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fascitis

Keywords

Plantar Fasciitis; Exercise; Lasers; Extracorporeal Shockwave Therapy

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  VAS is a scale 10 cm in length, starting from "no pain" and ending with "unbearable pain" (0: no pain, 10: unbearable pain). Patients indicate the severity of their pain by marking the appropriate point on this scale. The distance between "no pain" and this marked point is measured and recorded in centimeters

  one month

Secondary Outcomes (4)

• Foot Function Index (FFI)

  one month

• Foot and Ankle Outcome Score (FAOS)

  one month

• Heel Tenderness Index (HTI)

  one month

• Biodex Fall Risk Assessment

  one month

Study Arms (3)

Exercise group

ACTIVE COMPARATOR

All groups received a regimen of daily exercises, including stretches for the plantar fascia and Achilles tendon, and strengthening exercises for the calf muscles and foot intrinsic muscles. Each type of exercise was demonstrated to the participants by the same physiotherapist at the beginning of the treatment process, to be performed twice a day with 10 repetitions each time.

Other: Exercises

Laser group

ACTIVE COMPARATOR

The MLS Laser applied to the treatment group was administered using an ASA brand Mphi model device. Patients in the Laser group were positioned in a prone position. Treatment was applied continuously for 7 minutes along the plantar fascia, sole of the foot, heel area, and Achilles tendon in accordance with the plantar fasciitis treatment program on the device, at a dose of 1.73 J/cm2 and a frequency of 700 Hz. A treatment program was established with 3 sessions per week, totaling 10 sessions. Patients receiving laser therapy also continued with their exercise programs.

Other: Exercises; Other: MLS Laser Treatment

ESWT group

ACTIVE COMPARATOR

The treatment group was administered with the Swiss DolorClast Master ESWT device, which produces radial shock waves. Patients in the ESWT group were positioned in a prone position. The most painful point in the heel area was identified through palpation. Gel was applied to this area, followed by the surrounding soft tissues, towards the plantar fascia and the attachment area of the Achilles tendon at the dorsal aspect of the heel. Radial ESWT treatment was applied at a frequency of 10 Hz, pressure of 2.5 bars, and 2000 impulses per session, once a week for a total of 4 sessions. Patients receiving ESWT therapy also continued with their exercise programs.

Other: Exercises; Other: ESWT treatment

Interventions

Exercises OTHER

All groups received a regimen of daily exercises, including stretches for the plantar fascia and Achilles tendon, and strengthening exercises for the calf muscles and foot intrinsic muscles. Each type of exercise was demonstrated to the participants by the same physiotherapist at the beginning of the treatment process, to be performed twice a day with 10 repetitions each time.

ESWT group; Exercise group; Laser group

MLS Laser Treatment OTHER

The MLS Laser applied to the treatment group was administered using an ASA brand Mphi model device. Patients in the Laser group were positioned in a prone position. Treatment was applied continuously for 7 minutes along the plantar fascia, sole of the foot, heel area, and Achilles tendon in accordance with the plantar fasciitis treatment program on the device, at a dose of 1.73 J/cm2 and a frequency of 700 Hz. A treatment program was established with 3 sessions per week, totaling 10 sessions

Laser group

ESWT treatment OTHER

The treatment group was administered with the Swiss DolorClast Master ESWT device, which produces radial shock waves. Patients in the ESWT group were positioned in a prone position. The most painful point in the heel area was identified through palpation. Gel was applied to this area, followed by the surrounding soft tissues, towards the plantar fascia and the attachment area of the Achilles tendon at the dorsal aspect of the heel. Radial ESWT treatment was applied at a frequency of 10 Hz, pressure of 2.5 bars, and 2000 impulses per session, once a week for a total of 4 sessions

ESWT group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Saglik Bilimleri University: lead

Study Sites (1)

İstanbul Medipol University

Istanbul, 34200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fasciitis, Plantar; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• İbrahim Ethem Kirez

  İstanbulSBÜ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluation of outcomes was performed by an assessor blinded to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Doctor

Model Details: 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

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: June 6, 2024
• Study Start: May 1, 2021
• Primary Completion: April 29, 2022
• Study Completion: April 29, 2022
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)