Shock Wave Therapy Versus Low Level Laser Therapy in Patients With Plantar Fasciitis

NCT05867888 | Completed

• 1 other identifier: P.T.REC/012/004154
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Both shock wave therapy and low level laser therapy in plantar fasciitis are effective in improvement of such cases without any side effects but there are no previously published studies on the use of shock wave therapy versus low level laser therapy in plantar fasciitis and, hence, evidence of its acceptability and effectiveness compared with each other remains to be established.

Conditions

Plantar Fascitis

Keywords

low level laser therapy; shock wave therapy; stretching exercises

Outcome Measures

Primary Outcomes (5)

• Assess the change in pain intensity level

  The visual analogue scale (VAS) is a widely utilized pain intensity level assessment instrument in patients with plantar fasciitis. The visual analogue scale (VAS) is typically composed of a horizontal line from zero (minimum value) to 10 (maximum value) where zero signifies (no pain) and 10 signifies (worst pain) one can imagine.

  Before treatment and after 6 weeks treatment

• Assess the change in pain pressure threshold

  Pressure algometry will be used to evaluate the pain pressure threshold for the two predetermined locations on the affected leg: gastrocnemius (middle point over the muscle belly) and soleus (center point of the muscle belly 10 cm above the Achilles tendon). The participant will speak up at the point where the pressure evoke a painful sensation. This process will be repeated 3 times in the same manner, and three measurements will be recorded at the same point on the plantar fascia. An average of the three readings will be recorded. Higher algometer scores indicate greater pressure threshold, therefore less tenderness. Lower algometer scores indicate less pressure threshold, thus more tenderness.

  Before treatment and after 6 weeks treatment

• Assess the change in range of ankle motion

  Ankle range of motion (ROM) will be measured by using digital goniometer (ankle dorsiflexion and plantarflexion ranges will be measured). It can monitor the progress of intervention.

  Before treatment and after 6 weeks treatment

• Assess the change in foot functional disability

  Foot functional disability will be assessed by foot and ankle ability measure questionnaire (FAAM). Higher scores on the questionnaire indicate a higher level of physical functioning and lower scores on the questionnaire indicate a lower level of physical functioning.

  Before treatment and after 6 weeks treatment

• Assess the change in ankle stability

  The Human Assessment Computer (HUMAC) Balance System will be used in the current study to assess limits of stability of ankle joint.

  Before treatment and after 6 weeks treatment

Study Arms (3)

Control group

ACTIVE COMPARATOR

conventional physical therapy program (Instructions, Ice application, Deep tissue massage, Stretching exercises, Joint mobilization and isometric exercises).

Other: conventional therapy

Experimental group 1

EXPERIMENTAL

Shock wave therapy + Conventional physical therapy.

Other: conventional therapy; Other: shock wave therapy

Experimental group 2

EXPERIMENTAL

Low level laser therapy + Conventional physical therapy.

Other: conventional therapy; Other: low level laser therapy

Interventions

conventional therapy OTHER

conventional therapy ( instructions, ice application, deep tissue massage, stretching exercises, joint mobilization and isometric exercises )

Control group; Experimental group 1; Experimental group 2

shock wave therapy OTHER

Acoustic waves (shock waves) that can carry energy and can propagate through tissues promote healing effects.

Experimental group 1

low level laser therapy OTHER

The application of light to a biologic system to promote tissue regeneration, reduce inflammation and relieve pain.

Experimental group 2

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ranges from 40-60 years old.
• Both genders will be included.
• Unilateral plantar fasciitis.
• Duration of symptoms more than 4 weeks.
• Positive Windlass test and negative Tinel and calcaneus squeeze tests.
• Patients will be classified according to their BMI (18.5 - 24.9) kg/m2

You may not qualify if:

• Open wound, infection in plantar surface of foot.
• History of foot surgery.
• History of trauma or fracture in foot or ankle.
• Neuropathic pain as diabetes mellitus.
• Peripheral vascular disease.
• Calcaneal stress fracture or show evidence of a foreign body or tumor of the affected heel.
• Previously suffered a rupture or surgery of the plantar fascia. Existing or prior osteomyelitis of the involved calcaneus.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Reham

Giza, Egypt

Location

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy; Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Laser Therapy; Phototherapy

Study Officials

• Fatma S Amin, Professor

  Cairo University

  STUDY CHAIR

• Rania N Karkousha, Ass.prof

  Cairo University

  STUDY DIRECTOR

• Mohamed I Abd Elhay, Lecturer

  Cairo University

  STUDY DIRECTOR

• Ashraf N Moharram, Professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 29, 2023
• First Posted: May 22, 2023
• Study Start: May 1, 2023
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)