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.: PACTR202002648274347 Date of Approval: 12/02/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of extracorporeal shock wave therapy (ESWT) on cervical myofascial pain following neck dissection surgery.
Official scientific title Efficacy of extracorporeal shock wave therapy (ESWT) on cervical myofascial pain following neck dissection surgery.
Brief summary describing the background and objectives of the trial Myofascial pain syndrome (MPS) is a musculoskeletal disorder which is characterized by pain, muscle spasms and muscle tenderness, as well as a limited range of motion, weakness, and rarely, autonomous dysfunction. The occurrences of morbidity of the neck after cancer therapy were considerable and consisted of neck pain, loss of sensation, and decreased range of motion. Extracorporeal shock wave therapy (ESWT) is one of the treatment options used for patients with myofascial pain syndrome through elimination of ischemia and modulation of vasoneuroactive substance (two major causes of trigger pathophysiology) and mechanical transduction as a cellular response to external stimulation. the aim of this study was to investigate efficacy of extracorporeal shock wave therapy (ESWT) on cervical myofascial pain following neck dissection surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 03/03/2019
Actual trial start date 03/03/2019
Anticipated date of last follow up 01/04/2019
Actual Last follow-up date 01/04/2019
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants) 46
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group study group 25 ml/mm2, 1000 shocks, once a week 4 weeks Extracorporeal shock wave therapy (ESWT), Duolith SD1 device Storz medical, Tagerwilen, Switzerland 23
Control Group control group 1% topical diclofenac gel on the trigger point 3 times /day 4 weeks. 1% topical diclofenac gel 23 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Previous unilateral modified radical neck dissection. 2- Patients with myofascial pain of upper trapezius for at least 3 months. 3- Patients with palpable intramuscular taut band. 4- Restriction in cervical ROM of lateral flexion and rotation. 5-Provocation of the clinical symptoms by compression of the active trigger point 1- Patient who received medication or other therapies for MPS within the previous 2 months. 2- Patients with pacemaker, pregnancy 3- Open wound at the treatment area. 4- Cervical myelopathy or radiculopathy, cervical spine fracture or spondylolisthesis. 5- Rheumatoid arthritis. 6- Coagulopathy. 7- Epilepsy or any psychological disorder. Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 60 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 11/02/2018 FACULTY OF PHYSICAL THERAPY APPLICATION FOR ETHICAL REVIEW
Ethics Committee Address
Street address City Postal code Country
Street between chateaux / University of Cairo / Giza cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1-Visual analogue scale 2-Pressure pain threshold (PPT) assessment before, after 2 weeks and after 4 weeks of treatment
Secondary Outcome Cervical range of motion assessment before, after 2 weeks and after 4 weeks of the treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Institution of Oncology Street between chateaux / Cairo University / Giza cairo 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Nancy Aboelnour Pharmacy Syndicate street Damanhour Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Street between chateaux / University of Cairo / Giza cairo 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Fatma Elzahraa Hassan shubra street Giza Egypt
Maged Basha shubra street Giza Egypt
Islam Hewidy 302 72nd street Brooklyn United States of America
Ashwag Saleh Khaled king street Qassim Saudi Arabia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nancy aboelnour nancyabolnour@hotmail.com 01068904389 pharmacist syndicate street
City Postal code Country Position/Affiliation
Damanhour Egypt lecturer of physical therapy for surgery
Role Name Email Phone Street address
Public Enquiries walid abouelnaga walidabolnaga@yahoo.com 01005666892 zagazig
City Postal code Country Position/Affiliation
zagazig Egypt lecturer of physical therapy for surgery
Role Name Email Phone Street address
Scientific Enquiries hany elgohary gohary75pt@hotmail.com 01093182291 cairo
City Postal code Country Position/Affiliation
cairo Egypt lecturer of physical therapy for surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after de identification (text, tables, and figure) Analytic Code,Statistical Analysis Plan,Study Protocol Immediately following publication. No end date. Researchers who provide a methodologically sound proposal, to achieve the aims in the approved proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Pre-trial evaluations revealed non statistical difference between both study and control groups in all measured variables (p > 0.05). A significant increment of neck rotation, and side bending ROM in both directions away and toward the operated side with a marked improvement of PPT was reported at post I and II in the study group compared to control group (p > 0.001). Moreover, there was a significant decrease in VAS of the study group at post I and at post II compared to control group (p > 0.001). 30/12/2019 30/12/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://1drv.ms/w/s!AgZ-Hf6Gv-LAgQNfl64MNm9uniVy
Changes to trial information