Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201707002394235 Date of Approval: 30/06/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Extracorporeal Shock Wave Therapy versus Low-Level Laser Therapy in the Management of Chronic Plantar Fasciitis
Official scientific title Extracorporeal Shock Wave Therapy versus Low-Level Laser Therapy in the Management of Plantar Fasciitis
Brief summary describing the background and objectives of the trial this study is designed to compare the results of using ESWT versus LLLT in the management of plantar fasciitis in terms of pain and foot function. Extracorporeal shock wave therapy (ESWT) has been introduced for the treatment of chronic inflammatory and degenerative processes of bone-tendon junctions since the induction of hyperemia, neovascularization, and regeneration of tendon tissue have been demonstrated. Therapeutic laser offers a safe often effective, easily utilized primary or adjunctive therapy that is relatively cost effective for clinician & patient. Low-level laser therapy (LLLT) is more effective in pain relief and in the improvement of functional ability & quality of life thus LLLT can be an important adjunct especially in patients with adverse side effects to drugs and invasive treatment. LLLT at low doses has been shown to enhance cell proliferation of fibroblasts, and lymphocytes. Proliferation is thought to result from photo-stimulation of the mitochondria leading to activation of signaling pathways and up regulation of transcription factors eventually giving rise to increases in growth factors.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,plantar fasciitis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Extracorporeal Shock Wave Therapy versus Low-Level Laser Therapy
Anticipated trial start date 01/07/2017
Actual trial start date 03/07/2017
Anticipated date of last follow up 02/09/2017
Actual Last follow-up date 02/09/2017
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants) 46
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Extracorporeal Shock Wave Therapy o Each patient will receive two sessions of ESWT with one week interval that comprised 2050 shocks at a frequency of 10.0 Hz and intensity of 2 bar two weeks o The point of the ESWT (BTL-5000 Series) site will be located over the plantar aspect of the heel. The probe will be oriented perpendicular to the patient's heel, and ultrasound gel was used as a coupling agent. o Ensuring the heel is inconstant contact with the gel, the physician moves the heel in a slow, circular motion within the focal zone. 23
Control Group low level laser therapy o LLLT (BTL-4000 Series) 830 nm of laser light, at a frequency of 10.0 Hz leading to a total dose of 27.0 J/cm2. three weeks o LLLT (BTL-4000 Series) 830 nm of laser light, at a frequency of 10.0 Hz leading to a total dose of 27.0 J/cm2 delivered to the skin of the plantar aspect of the heel, will be administered per session. 23
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
o Both genders. o Adult over 18 years. o Diagnosis of painful heel syndrome by clinical examination, with the following positive clinical signs: 1. Pain in the morning or after sitting a long time. 2. Local pain where the fascia attaches to the heel. 3. Increasing pain with extended walking or standing for more than 15 minutes. o History of 1 month of unsuccessful conservative medical treatment (NSAIDs or others not including ESWT or LLLT). o Able to understand the informed consent. o Neurological heel pain resulting from nerve entrapment. o Arthritis of the foot. o Traumatic heel pain. o Sensory neuropathy. o Peripheral vascular disease. o Autoimmune disease. o Pregnancy. o Local malignancy. o Bleeding Dyscrasias. o Cellulites, skin ulceration at area of therapy application. o Inability to fulfill follow-up criteria. 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/12/2016 ethics committee of suez canal university
Ethics Committee Address
Street address City Postal code Country
al dairee street ismailia Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome measurement of plantar fascia thickness by ultrasound before intervention four weeks later
Secondary Outcome Visual analogue scale (VAS) for pain before intervention four weeks later
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
seuz canal university hospitals,Rheumatology and Rehabilitation departement circular street ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
gehad gamal el sehrawy, samah ismail nasef, aziza el said omar suez canal university ismailia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor suez canal university suez canal university ismailia Egypt University
COLLABORATORS
Name Street address City Postal code Country
samah ismail nasef suez canal university ismailia Egypt
aziza el said omar suez canal university ismailia Egypt
mostafa said ahmed suez canal university ismailia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator gehad el sehrawy dr.ggrheu@gmail.com 01008162192 suez canal university
City Postal code Country Position/Affiliation
ismailia Egypt physical medicine, rheumatology and rehabilitation resident
Role Name Email Phone Street address
Public Enquiries samah nasef dr.samah.ismaeel@gmail.com 01093155272 suez canal university
City Postal code Country Position/Affiliation
ismailia Egypt lecturer of rheumatology an rehabilitation, fucaly of medicine
Role Name Email Phone Street address
Scientific Enquiries gehad el sehrawy dr.ggrheu@gmail.com 01008162192 suez canal university
City Postal code Country Position/Affiliation
ismailia Egypt physical medicine, rheumatology and rehabilitation resident
REPORTING
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