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.: PACTR201602001462295 Date of Registration: 07/02/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title DRY NEEDLING VERSUS ISCHEMIC COMPRESSION IN TREATMENT OF LOWER BACK MYOFASCIAL PAIN SYNDROME
Official scientific title DRY NEEDLING VERSUS ISCHEMIC COMPRESSION IN TREATMENT OF LOWER BACK MYOFASCIAL PAIN SYNDROME
Brief summary describing the background and objectives of the trial this trial will be conducted to investigate the effect of DRY NEEDLING VERSUS ISCHEMIC COMPRESSION IN TREATMENT OF LOWER BACK MYOFASCIAL PAIN SYNDROME and my objectives in the trial to explore the effects of dry needling and to find out if it is effective as ischemic compression in treatment of trigger points
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 20/04/2015
Actual trial start date 20/05/2015
Anticipated date of last follow up 20/09/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status 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 Permuted block randomisation random number generator Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group dry needling followed by stretch 7 minutes 4 session in two weeks dry needling for trigger points in 4 muscles quadratus lumborum,iliocostalis lumborum,gluteus medius and piriformis for 7 minutes followed by streching exercise for each muscle 30 sec 3 times 30
Experimental Group ischemic compression followed by stretching exercise 5 minutes 4 sessions in 2 weeks ischemic compression on each trigger points on the same 4 muscles for 5 minutes followed by stretching exercise for these muscles 30 seconds 3 Times 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Age ranges from 18 to 45 years old ¿ Patients with lower back myofascial pain syndrome that has been diagnosed by orthopedist. ¿ Pain of at least 30 mm to 70 mm on a visual analogue scale (VAS) from 0 mm (no pain) to 100 mm (worst imaginable pain) ¿ Patients able to perform (ROM) test of Lumbar Spine (flexion, extension and side binding) but limited before treatment. ¿ Presence of active or latent MTrPs at least 4 trigger points. ¿ Patients had lower back myofascial pain syndrome for at least 3 months ago. ¿ History of previous back surgery. ¿ Neurologic deficit. ¿ Current lower extremity symptoms. ¿ Cardiopulmonary disease with decreased activity tolerance. ¿ Rheumatologic conditions such as mild systemic lupus erythematosus, polyarticular osteoarthritis, rheumatoid arthritis and advanced lumbar degenerative disease. ¿ Participants receiving other treatment, in the form of physical therapy or medication, for the duration of the study that may interfere with the results of this study. ¿ Bleeding disorders. ¿ Renal disorders. ¿ Disc lesion. 18 Year(s) 45 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 01/04/2015 faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
ben el-sarayat el behoos el-doki giza 12345 Egypt
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 01/04/2015 faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
ben el-sarayat el behoos el-doki giza 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome functional disability using Oswestery disability questionnaire before treatment 2 weeks after treatment
Secondary Outcome Pain assessment by visual analog scale before treatment 2 weeks after treatment
Secondary Outcome assessment of back (flexion and extension) using Modified-modified Schober technique before treatment 2 weeks after treatment
Secondary Outcome Assessment of Lateral flexion using tape measurement for 2 weeks
Secondary Outcome pain threshold using pressure algometer before treatment 2 weeks after treatment
Secondary Outcome Pain assessment by visual analog scale 2 weeks
Secondary Outcome assessment of back (flexion and extension) using Modified-modified Schober technique for 2 weeks
Secondary Outcome pain threshold using pressure algometer before treatment 2 weeks after treatment
Secondary Outcome Pain assessment by visual analog scale 2 weeks
Secondary Outcome pain threshold using pressure algometer before treatment 2 weeks after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
out patient clinic kasr el-einy 27 Nafezet Sheem El Shafaey St.¿ KASR EL AINY el sayeda zeinab 12345 Egypt
out patient clinic faculty of physical therapy cairo university ben el-sarayat el behoos el-doki giza 12345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
personal 19 makram ebid extension infront of 1st police station nasr city cairo 11759 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor amr moustafa yehia 19 makram ebid extension infront of 1st police station nasr city cairo 11759 Egypt Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
amr moustafa yehia 19 makram ebid extension infront of 1st police station nasr city cairo 11759 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator amr yehia amryehia8152@gmail.com 01159388770 19 iskan el-mohandseen makram ebid extension infront of 1st police station nasr city
City Postal code Country Position/Affiliation
cairo 11759 Egypt physical therapist
Role Name Email Phone Street address
Public Enquiries emad mohamed emad9111@live.com 01146808839 elhaei elsabe
City Postal code Country Position/Affiliation
6th october city 3785 Egypt physical therapist
Role Name Email Phone Street address
Scientific Enquiries emad mohsen emad_pt@outlook.com 01028799322 eldoky street
City Postal code Country Position/Affiliation
cairo 5473 Egypt physical therapist
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 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