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CompletedNCT05867888Updated Feb 21, 2024

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

An interventional study of conventional therapy and shock wave therapy in Plantar Fascitis, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-02-21.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

Plantar fasciitis is a result of degenerative irritation of the plantar fascia origin at the medial calcaneal tuberosity of the heel as well as the surrounding perifascial structures, it is a common problem accounting for approximately one million patient visits per year, it is often an overuse injury. As a result tight gastrocnemius, soleus, and/or other posterior leg muscles have also been commonly found in patients with this condition.

Shock wave therapy is thought to provide long lasting analgesia and stimulate the healing process, Low level laser therapy has been used to relieve pain caused by plantar fasciitis, also stretching of the shortened and contracted plantar flexors may positively influence an individual's functional activities of daily living and decrease the risk of injury.

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Conditions studied

  • Plantar Fascitis

Keywords

  • low level laser therapy
  • shock wave therapy
  • stretching exercises
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In context

Fasciitis

235 studies on the registry are indexed under Fasciitis; 37 are open to participants now.

This study's enrollment of 75 is above the median of 54 across 192 interventional studies indexed under Fasciitis.

Browse Fasciitis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
75 participants (actual)

Study arms

  • Active comparator
    Control group

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

    Other: conventional therapy

  • Experimental
    Experimental group 1

    Shock wave therapy + Conventional physical therapy.

    Other: conventional therapy · Other: shock wave therapy

  • Experimental
    Experimental group 2

    Low level laser therapy + Conventional physical therapy.

    Other: conventional therapy · Other: low level laser therapy

Interventions

  • Otherconventional therapy

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

  • Othershock wave therapy

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

  • Otherlow level laser therapy

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Before treatment and after 6 weeks treatment

  2. 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.

    Time frame: Before treatment and after 6 weeks treatment

  3. 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.

    Time frame: Before treatment and after 6 weeks treatment

  4. 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.

    Time frame: Before treatment and after 6 weeks treatment

  5. 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.

    Time frame: Before treatment and after 6 weeks treatment

07

Study locations

1 site
  • Reham
    Giza, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05867888
Lead sponsor
Cairo University
Responsible party
Reham Mohamed Lotfy Soliman (principal investigator, Cairo University) — Principal investigator
First posted
May 22, 2023
Start date
May 1, 2023
Primary completion
Oct 10, 2023
Completion
Oct 10, 2023
Last update
Feb 21, 2024

Study contacts

Fatma S Amin, Professor
study chair · Cairo University
Rania N Karkousha, Ass.prof
study director · Cairo University
Mohamed I Abd Elhay, Lecturer
study director · Cairo University
Ashraf N Moharram, Professor
study director · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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