Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
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Trial no.: PACTR201801002968301 Date registered: 11/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Cervical sagittal configuration aid in the management of myofascial trigger point
Official scientific title Does improvement towards a normal cervical sagittal configuration aid in the management of myofascial trigger point pain of the neck: A 1- year randomized controlled trial
Brief summary describing the background and objectives of the trial Despite the fact that there is some evidence of a link between myofascial pain and head posture, there is limited experimental data to support a cause-and-effect relationship and interventional outcomes. Accordingly, The present randomized controlled trial was undertaken to investigate the functional and pain response outcomes of denneroll cervical traction compared to standard care in patient cases with chronic myofascial pain syndrome , with a verified hypo-lordosis of the cervical spine. The primary hypothesis of this study was that cervical lordosis restoration will have short and long term effects on functional and pain outcomes in cervical myofascial pain syndrome patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Myofascial pain syndrome
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 11/10/2016
Actual trial start date 11/10/2016
Anticipated date of last follow up 01/02/2018
Actual Last follow-up date 01/02/2018
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
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 Randomised The randomization was restricted to permuted blocks of different sizes 4,6,8 Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Denneroll extension traction the intervention was repeated three times per week for 10 weeks the duration of each session started at approximately three minutes and increased one minute per session until reaching the goal of 20 minutes per session The participants were instructed to lie flat on their back on the ground with their legs extended and arms by their sides gently folded across their stomach. The subject placed the denneroll on the ground and the examiner positioned the apex of the denneroll in one of two regions (mid cervical placement and lower cervical placement)depending on the apex of each participant┬┐s cervical curvature 60
Control Group Integrated neuromuscular inhibition technique three times per week for 10 weeks The total time for one session is approximately 15-20 minutes. Using a pincer grasp, the practitioner moved throughout the fibers of the upper trapezius and made note of any active TrPs . Once the TrPs were identified treatment began. The first technique applied was ischemic compression. 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Craniovertebral angleless than 50. Regional pain complaint in the neck. Pain complaint or altered sensation in the expected distribution of referred pain from a myofascial trigger point. Taut band palpable in an accessible muscle. Excruciating spot tenderness at one point along the length of the taut band. Some degree of restricted range of motion (ROM), when measurable. the presence of any signs or symptoms of medical red flags (e.g., tumor, fracture, rheumatoid arthritis, osteoporosis, and prolonged steroid use). A history of previous cervical or thoracic spine surgery. Signs or symptoms of upper motor neuron disease. Vestibulobasilar insufficiency. Amyotrophic lateral sclerosis. Bilateral upper extremity radicular symptoms. 20 Year(s) 30 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 02/10/2016 Research Ethics Committee-Faculty of Physical Therapy-Cairo University
Ethics Committee Address
Street address City Postal code Country
7-Ahmed El zaiat St-ben Elsaryat-El Dokki-Giza Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Neck Disability Index (NDI) All outcome measures were obtained at three intervals; Pre-treatment. After 10 weeks of treatment. At one after the intervention period.
Secondary Outcome Cervical sagittal alignment Pre-treatment. After 10 weeks of treatment. At one after the intervention period
Secondary Outcome Cervical ROM Pre-treatment. After 10 weeks of treatment. At one after the intervention period.
Secondary Outcome Pressure-pain threshold algometric measurement Pre-treatment. After 10 weeks of treatment. At one after the intervention period
Secondary Outcome Neck pain intensity Pre-treatment. After 10 weeks of treatment. At one after the intervention period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy-Cairo university 7-ahmed Elziat st.Ben Elsaryat-el Dokki-Giza-Egypt Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
CBP Nonprofit (a spine research foundation) 950 E Riverside Eagle, ID 83616 ID United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ibrahim Moustafa 7-Mohamed hassan El gamel st-Nacer City Giza 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ibrahim Moustafa 7-Mohamed hassan El gamel st-Nacer City cairo 12612 Egypt
aliaa 7-Mohamed hassan El gamel st-Nacer City cairo 12612 Egypt
Deed 950 E Riverside Eagle, ID 83616 ID United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ibrahim Moustafa ibrahiem.mostafa@pt.cu.edu.eg 00201227022334 7-Mohamed hassan El gamel st-Nacer City
City Postal code Country Position/Affiliation
Cairo 12612 Egypt Assistant professor- Basic science departmen,Faculty of Physical therapy, Cairo University
Role Name Email Phone Street address
Public Enquiries Aliaa Diab aliaa.atya@pt.cu.edu.eg 002010036237275 7-Mohamed hassan El gamel st-Nacer City
City Postal code Country Position/Affiliation
Cairo 12612 Egypt Assistant professor- Basic science departmen,Faculty of Physical therapy, Cairo University
Role Name Email Phone Street address
Scientific Enquiries ibrahim Moustafa ibrahiem.mostafa@pt.cu.edu.eg 00201227022334 7-Mohamed hassan El gamel st-Nacer City
City Postal code Country Position/Affiliation
Cairo 12612 Egypt Assistant professor- Basic science departmen,Faculty of Physical therapy, Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result URL Hyperlinks Baseline Characters Participant Flow Adverse Events Outcome Measures Description
Link To Protocol
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 15/01/2018 edit cervical sagittal configuration aid in the management of myofascial trigger point Cervical sagittal configuration aid in the management of myofascial trigger point
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 05/07/2018 pactr update Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Purpose of the trial 05/07/2018 pactr update Treatment: Other Treatment: Devices
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 05/07/2018 pactr update Other Musculoskeletal Diseases, Other