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.: PACTR201808561062521 Date of Approval: 06/08/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECT OF MOBILIZATION WITH MOVEMENT ON SHOULDER ADHESIVE CAPSULITIS
Official scientific title EFFECT OF MOBILIZATION WITH MOVEMENT VERSUS DICLOFENAC PHONOPHORESIS ON SHOULDER ADHESIVE CAPSULITIS
Brief summary describing the background and objectives of the trial This study will be carried out to compare the effect of mobilization with movement technique with diclophenac phonophoresis on pain intensity level and shoulder range of motion in patients with shoulder adhesive capsulitis. It's a randomized control trial, three groups Pre-test Post-test design will be conducted in this study; the independent variables are mobilization with movement technique and diclophenac phonophoresis. The dependent variables are pain intensity level , ROM of shoulder joint and shoulder functional level.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MWV VS DPP ON AC
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2017
Actual trial start date 23/05/2017
Anticipated date of last follow up 23/07/2017
Actual Last follow-up date 23/09/2017
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 36
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group A 3 sessions per week 4 weeks Patients will receive conventional physical therapy :Gentle progressive stretching exercise at the directions of shoulder flexion, external rotation, internal rotation and abduction. Strengthening exercises in the form of isometric program in the same directions. Shoulder mobilizing exercises. Physical agents program : ultrasonic, TENS and hot packs. Daily home exercises and self- made mobilization. 14 Active-Treatment of Control Group
Experimental Group Group B 3 sessions per week 4 weeks Patients will receive diclophenac phonophoresis of pulsed U.S 1MHz 1.5 W/cm2 for 10 minutes plus the conventional treatment program. 11
Experimental Group Group C 3 sessions per week 4 weeks Patients will receive mobilization with movement (MWM) plus the conventional treatment. 11
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Each patient has the diagnosis of second stage adhesive capsulitis referred by physicians with Magnetic Resonance Imaging(MRI) (Prolonged immobilization and Diabetic patients) type II diabetes. 2- Both genders were included with Age range between 40-65 years old . 3- The severity of pain on numerical pain rating scale should be higher than three out of ten. 4- Pain aggravated by movements. 5- Patients suffering from pain and limitation in the motion for more than 3 months. 6- Consent to participate in the study and follow the treatment schedule. 7- All the patients with AROM/ PROM less than or equal to 90 degrees at external rotation, abduction, internal rotation and flexion. 8- The body mass index (BMI) of participants doesn’t exceed 35 kg/m^2. 1- All the objects having any intra articular injection in the glenohumeral joint during last three months. 2- Patients with musculoskeletal disorder (any type of fracture). 3- Any history of surgery on that shoulder and patients with tendon calcification. 4- Patients with cervical rib. 5- Rotator cuff complete tear patients (positive drop arm test). 6- All the patients with cervical and thoracic spine dysfunctions are first ruled out. 7- Patients with any neurological conditions. 8-The following conditions were excluded by physician examination (as X-Ray and Lab Analysis) • Thyroid disease (Hyperthyroidism, Hypothyroidism) • Trauma • Stroke • Cardiovascular disease • Myocardial infarction • Cervical disc disease • Intrathoracic disorders as TB, carcinoma, emphysema etc • Parkinsonism • Patients with osteoporosis or lumbar compression fracture. • Shoulder dislocation or sublaxation. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 65 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 30/04/2017 Faculty of physical therapy research ethics
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El Zayad street , Doki , Giza , Egypt Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain intensity assessment before treatment and after completing the intervention.
Secondary Outcome shoulder range of motion assessment before treatment and after completing the intervention.
Secondary Outcome shoulder joint functional assessment before treatment and after completing the intervention.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical therapy Cairo University 7 Ahmed El Zayad street, Dokki, Giza , Egypt Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo university 1 Gamaa street Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maha El sawabey mahyelsawabey@gmail.com +201228816336 ahmed el zoumour street
City Postal code Country Position/Affiliation
cairo Egypt physical therapist at fifth setllement medical center
Role Name Email Phone Street address
Scientific Enquiries Dalia Mosaad drdaliamosaad@gmail.com +201001469096 Alzahawy street, 6th District
City Postal code Country Position/Affiliation
Cairo Egypt Assisstant professor of Physical Therapy
Role Name Email Phone Street address
Public Enquiries Wadida Abd El Kader Dr.wadida.hassan@gmail.com +201001097571 al sudan street
City Postal code Country Position/Affiliation
Giza Egypt Professor of physical Therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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