Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201304000516174 Date of Approval: 12/03/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Physical Therapy
Official scientific title Axillary Ultrasound and Laser Combined with Post Isometric Facilitation in Treatment of Shoulder Adhesive Capsulitis
Brief summary describing the background and objectives of the trial Several review studies illustrated different treatment protocols and their effects in reducing symptoms of pain and limitation of ROM in AC, although the most recent review recommended future studies to incorporate other interventions within the scope of physiotherapy practice. The purpose of this study is to investigate Axillary Ultrasound and Laser Combined with Post Isometric Facilitation in Treatment of Shoulder Adhesive Capsulitis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Adhesive capsulitis,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 24/06/2010
Actual trial start date 24/06/2010
Anticipated date of last follow up 06/12/2011
Actual Last follow-up date 06/12/2011
Anticipated target sample size (number of participants) 59
Actual target sample size (number of participants) 45
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
N/A N/A
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 Sequentially Numbered Opaque Sealed Envelopes (SNOSE) allocation concealment method ¿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 Ultrasonic, Laser, Supervised exercise program, home program 3 sessions/week for 4 weeks (12 sessions) 4 weeks Pulsed Ultrasonic applied on painful shoulder points for 10 minutes, Scanning laser applied on same points for 20, in addition to supervised exercise program Codman¿s or pendulum exercises 2) passive stretching (for shoulder extensors, adductors and internal rotators) and home program 15 Dose Comparison
Experimental Group Axillary ultrasound and laser, supervised exercise program, home program 3 sessions/week for 4 weeks (12 sessions) 4 weeks Pulsed ultrasound and laser applied at axillary region, same supervised exercise program and home program as in control group 15
Experimental Group Axillary ultrasound and laser, post isometric facilitation technique, supervised and home program 3 sessions/week for 4 weeks (12 sessions) 4 weeks Axillary ultrasound and laser applied at axillar, post isometric facilitation technique (muscle energy technique), same supervised exercise program and home program as in control group 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
painful, restricted active and passive range of motion of the shoulder, capsular pattern of motion restriction, absence of radiological evidence of glenohumeral joint arthritis. The length of symptoms for all patients ranged from 3 -8 months local corticosteroid injection to the affected shoulder within the last 3 months. current corticosteroid therapy. neuromuscular disease. shoulder symptoms due to other causes (e.g shoulder impingement syndrome, rotator cuff tear) pregnancy, history of metastatic cancer or diagnosis of cancer within 12 months, unstable angina. insulin dependent diabete. history of shoulder surgery. 40 Year(s) 60 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 21/08/2011 Faculty of Physical Therapy ¿ Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzayyat Street, bein elsarayat, Giza Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain level, pain free range of motion of shoulder flexion, abduction, external rotation Pre-treatment immediately after treatment after 4 weeks of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy, Cairo University 7 Ahmed Elzayyat Street Bein Elsaraya, Giza Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Haytham M. Elhafez 7 Ahmed Elzayyat Street Bein Elsarayat, Giza Giza 12612 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Haytham Mohamed Elhafez 7 Ahmed Elzayyat Street, bein elsarayat, Giza Giza 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Salam Mohamed Elhafez 7 Ahmed Elzayyat Street Bein Elsarayat, Giza Giza 12612 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haytham Elhafez elhafez@yahoo.com +201001909630 7 Ahmed Elzayat St., Mroor bein elsarayat, Dokki
City Postal code Country Position/Affiliation
Giza 12612 Egypt Professor of Physical Therapy, Basic Science Department, Cairo University
Role Name Email Phone Street address
Public Enquiries Ghada Elhafez ghada.elhafez@googlemail.com +201094151932 7 Ahmed Elzayat St., bein elsarayat, Dokki
City Postal code Country Position/Affiliation
Giza 12612 Egypt Professor of Biomechanics, Biomechanics Departmant, Faculty of Physical Therapy, Cairo University
Role Name Email Phone Street address
Scientific Enquiries Salam Elhafez egyptsalam@yahoo.co.uk +201094084509 7 Ahmed Elzayat St., bein elsarayat, Dokki
City Postal code Country Position/Affiliation
Giza 12612 Egypt Professor and Chairman of Biomechanics Department, Faculty of Physical Therapy, Cairo University
REPORTING
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