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.: PACTR202306638021904 Date of Approval: 20/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Immediate effects of 850 nm Diode Laser on patients with Cervical Myofascial Pain Syndrome: a Randomized-controlled trial
Official scientific title Immediate effects of 850 nm Diode Laser on patients with Cervical Myofascial Pain Syndrome: a Randomized-controlled trial
Brief summary describing the background and objectives of the trial Background: Myofascial pain syndrome (MPS) is one of the most common causes of chronic neck pain that associated with specific trigger points. Low level laser therapy (LLLT) is a physical therapy modality and a light-based procedure that is used to reduce inflammation and edema; treat pain and neurological disorders; and to promote healing of wounds and deeper tissues of patients with MPS. Therefore, the aim of this randomized controlled trial was to assess and evaluate the immediate effects of LLLT added to the conventional physical therapy in comparison with the conventional physical therapy alone on pain intensity, pressure pain threshold (PPT) and cervical range of motion (ROM) in cervical MPS patients.
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 Rehabilitation
Anticipated trial start date 31/07/2021
Actual trial start date 01/08/2021
Anticipated date of last follow up 01/04/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 24
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Laser therapy once 30-45 min LLLT in addition to the conventional physical therapy program. Laser therapy group received LLLT on the affected side of neck and shoulder. 12
Control Group control group once 30 min conventional physical therapy program alone. 12 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Adults; over 18 years old. -Diagnosis of MPS in accordance with Travell and Simons' criteria. -Had active and palpable TrPs with pain duration less than one week. fractures or open wound, other neuro-musculo-skeletal disorders causes neck pain such as fibromyalgia, cervical disc lesion, radiculopathy or myelopathy, other systemic diseases, previous surgical procedures, or recent trigger point injection. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Male
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 01/11/2021 Cairo University
Ethics Committee Address
Street address City Postal code Country
giza giza 0000 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain intensity, pressure pain threshold, and cervical range of motion pre-treatment and post-treatment evaluation, to determine the immediate effects of the laser and conventional therapies.
Secondary Outcome NA NA
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Private physical therapy clinic cairo cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Ali Cairo Caito 0000 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed Ali Zahreldin cairo cairo 0000 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Ali ahmed_zahreldin@stud.cu.edu.eg +201112193896 cairo
City Postal code Country Position/Affiliation
cairo Egypt Medical Applications of Lasers in Physical Therapy National Institute of Laser Enhanced Sciences Cairo University Egypt
Role Name Email Phone Street address
Public Enquiries Ahmed Ali ahmed_zahreldin@stud.cu.edu.eg +201112193896 cairo
City Postal code Country Position/Affiliation
cairo Egypt Medical Applications of Lasers in Physical Therapy National Institute of Laser Enhanced Sciences Cairo University Egypt
Role Name Email Phone Street address
Scientific Enquiries Ahmed Ali ahmed_zahreldin@stud.cu.edu.eg +201112193896 cairo
City Postal code Country Position/Affiliation
cairo Egypt Medical Applications of Lasers in Physical Therapy National Institute of Laser Enhanced Sciences Cairo University Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual deidentified participant data will be shared upon request from the principle investigator. Data in particular will be shared; include demographic criteria and outcomes results. Additional related documents will be available such as the study protocol. The data will become available after months. Data will be shared with researcher who provide a methodological sound proposal; to achieve aims in the provided proposal. Proposals should be directed to the principle investigator (ahmed_zahreldin@stud.cu.edu.eg) and sign a data access agreement. Clinical Study Report 6 months open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information