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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05867888
Collaborator
(none)
75
3
3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: conventional therapy
  • Other: shock wave therapy
  • Other: low level laser therapy
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Shock Wave Therapy Versus Low Level Laser Therapy in Patients With Plantar Fasciitis
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control group

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

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

Experimental: Experimental group 1

Shock wave therapy + Conventional physical therapy.

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

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

Experimental: Experimental group 2

Low level laser therapy + Conventional physical therapy.

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

Other: low level laser therapy
The application of light to a biologic system to promote tissue regeneration, reduce inflammation and relieve pain.

Outcome Measures

Primary Outcome Measures

  1. Assess the change in pain intensity level [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 60 Years
Sexes Eligible for Study:
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:
  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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

  • Study Chair: Fatma S Amin, Professor, Cairo University
  • Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Reham Mohamed Lotfy Soliman, principal investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT05867888
Other Study ID Numbers:
  • P.T.REC/012/004154
First Posted:
May 22, 2023
Last Update Posted:
May 22, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Reham Mohamed Lotfy Soliman, principal investigator, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 22, 2023