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.: PACTR202008545567834 Date of Approval: 05/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Manual techniques for low back pain
Official scientific title Efficacy of different manual therapy techniques on trigger points in chronic low back pain patients: a randomized blinded clinical trial
Brief summary describing the background and objectives of the trial Low back pain is one of the most enormous disorders. Manual therapy is one of the most effective treatments however determining the most effective manual technique is required. This study will be conducted to examine the effect of different manual techniques
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 14/08/2020
Actual trial start date
Anticipated date of last follow up 26/11/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Traditional therapy 4 weeks Infra red radiation ultrasound waves TENS exercises 20 Active-Treatment of Control Group
Experimental Group Ischemic compression 4 weeks Compression applied by the thump of the therapist on the trigger point with the traditional therapy 20
Experimental Group Muscle energy technique 4 weeks Hold relax technique for the muscle of trigger point with the traditional therapy 20
Experimental Group Strain counter strain 4 weeks Putting the muscle in shortened position for 90 second followed by passive movement to the neutral position in addition to the traditional therapy 20
Experimental Group Integrated neuromuscular inhibition technique 4 weeks Traditional therapy + iscemic compression + muscle energy technique + strain counterstrain 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
low back pain longer than 3 months duration mild to moderate disability radiculopathy visual or auditory problems scoliosis surgery 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
No 30/07/2020 research ethics committe of faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed elzayat street cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain intensity immediately before and after the treatment program
Secondary Outcome disability immediately before and after the treatment program
Secondary Outcome pressure pain threshold immediately before and after the treatment program
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Clinic of Faculty of Physical Therapy Pharos University Elmahmoudeya street Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Aliaa M Elabd Sabry aboallam Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aliaa Elabd Sabry Aboallam street Alexandria Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Omar M Elabd Hamdy kandil Shebin Elkom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aliaa Elabd aliaelabd88@gmail.com 00201069352446 sabry aboallam street
City Postal code Country Position/Affiliation
Alexandria Egypt Pharos university faculty of physical therapy lecturer
Role Name Email Phone Street address
Public Enquiries Aliaa Elabd aliaelabd88@gmail.com 00201069352446 sabry aboallam street
City Postal code Country Position/Affiliation
alexandria Egypt pharos university faculty of physical therapy lecturer
Role Name Email Phone Street address
Scientific Enquiries Aliaa Elabd aliaelabd88@gmail.com 00201069352446 sabry aboallam street
City Postal code Country Position/Affiliation
alexandria Egypt pharos university faculty of physical therapy lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data collocted during the study Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan Immediatly after publication Any one
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