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NCT Number: NCT05867888

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

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.

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Key information

Conditions

Plantar Fascitis

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reham

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Conventional Therapy

Other

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

shock wave therapy

Other

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

Low Level Laser Therapy

Other

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

Primary outcomes

  1. Assess the change in pain intensity level

    Time frame: Before treatment and after 6 weeks treatment

    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.

  2. Assess the change in pain pressure threshold

    Time frame: Before treatment and after 6 weeks treatment

    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.

  3. Assess the change in range of ankle motion

    Time frame: Before treatment and after 6 weeks treatment

    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.

  4. Assess the change in foot functional disability

    Time frame: Before treatment and after 6 weeks treatment

    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.

  5. Assess the change in ankle stability

    Time frame: Before treatment and after 6 weeks treatment

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 22, 2023
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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