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.: PACTR202003764134697 Date of Approval: 25/03/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Influence of High Intensity Laser Therapy on Patients with Cervical Myofascial Trigger Points
Official scientific title Influence of High Intensity Laser Therapy on Patients with Cervical Myofascial Trigger Points
Brief summary describing the background and objectives of the trial LILT and it’s known effects have already been reviewed extensively. The most important clinical and therapeutic difference between Class IV Laser therapy and LILT is that the Class IV is able to produce a primary biostimulative effect on deeper tissues than lower powered lasers— while also producing substantial secondary and tertiary effects. This study will be conducted to investigate the effect of HILT on pressure pain threshold, pain intensity, neck functional activities and cervical range of motion in patients with cervical myofascial trigger point.
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 11/04/2019
Actual trial start date 12/04/2019
Anticipated date of last follow up 15/05/2019
Actual Last follow-up date 15/05/2019
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants) 52
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Physical Therapy twice weekly 4 weks HILT, US, TENS, stretching and strengthening of upper fibers of trapezius 10
Control Group Physical Therapy twice weekly 4 weeks US, TENS, stretching and strengthening of upper fibers of trapezius 10 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. The age is from 20-40 years old (Rodríguez-Fernández et al., 2011) 2. have an active upper trapezius TrP (an active upper trapezius TrP was defined as a tender nodule in a taut band that referred pain in a pattern specific for upper trapezius) 3. pain of at least 30 mm on a visual analogue scale (VAS) 4. Limitation in cervical range of motion. 1. Diagnosis of fibromyalgia syndrome. 2. History of a whiplash injury. 3. History of cervical spine surgery. 4. Diagnosis of cervical radiculopathy or myelopathy determined by their primary care physician. 5. Having undergone myofascial pain therapy within the past 3 months before the study. 6. Patients who had local anesthetics, and/or steroid injections into the trigger points within 6 months. 7. Patients with cervical disc herniation, cervical spinal stenosis, or any pathological findings on cervical X-rays. Adult: 19 Year-44 Year 20 Year(s) 40 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 05/05/2019 research ethics team faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed el zayat street, dokki, giza cairo 12622 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain ,range of motion of neck after completion of treatment
Secondary Outcome functional activities of the neck after completion of the treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Badr Oupatient clinic Badr City cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
hatem mostafa badr street cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hatem Mustafa Obour city Cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hatem mostafa hatem.mostafa@buc.edu.eg 00201004383414 nasr city
City Postal code Country Position/Affiliation
cairo Egypt assistant teacher badr university
Role Name Email Phone Street address
Public Enquiries fairouz ameen fairouz.hatem@yahoo.com 00201006328679 nasr city
City Postal code Country Position/Affiliation
cairo Egypt teacher badr university
Role Name Email Phone Street address
Scientific Enquiries enas abutaleb enas_abutaleb@yahoo.com 00201001468054 nasr city
City Postal code Country Position/Affiliation
cairo Egypt assistant professor cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 50 patients (male and female) were recruited to the study having cervical myofascial trigger points in the upper trapezius muscle age range from 18 to 40 years old. Informed Consent Form 2 days controlled
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