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.: PACTR201901664076560 Date of Approval: 02/01/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title axillary ultrasound versus tradional ultrsound on range of motion and function ability of patient with adhesive capsulitis
Official scientific title axillary ultrasound versus tradional ultrasound on function ability of patient with adhesive capsulitis
Brief summary describing the background and objectives of the trial Adhesive capsulitis is caused by tightening of the joint capsule and results instiffness and painThe therapeutic effects of Ultrasound are classified as thermal and nonthermal. Ultrasonic energy increases molecular motion which in turn, rises tissue temperature and affects tissue in different ways; such as changing nerve conduction velocity and increasing pain threshold, increasing collagen extensibility,increasing local blood flow and reducing muscle spasm .
Type of trial RCT
Acronym (If the trial has an acronym then please provide) DASH
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/12/2018
Actual trial start date
Anticipated date of last follow up 01/02/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL 30
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 Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group axillary ultrasound 3 session per week 1 month :patient is positioned in supine lying .axillary hair is removed either using scissors or a disposable shaving set .the affected shoulder is kept in maximum available flexsion,abduction and external rotation with elbow in flexsion.if possible hand behind neck position.ultrasound transmission gel is applied on th axilla and on the transducer head.Amild stretch on the inferior capsule is maintained during ultrasound application by applying passive downward pressure at the flexed elbow within the limits of pain.patient will receive axillary ultrasound and physical therapy program while keeping the patient in supine position with full shoulder abduction and external rotation.pulsed US was administered according to the following specification:medium trancducer,3MHz pulsed type (1:1),and 1.5 W/Cm applied for 10 minutes. 15
Control Group traditional ultrasound 3 session per week 1 month will receive traditional ultrasound and physical therapy program. ultrasound on the anterior and posterior aspect of the shoulder joint while keeping the patient in the sitting position,back erect. pulsed US was administered according to the following specification:medium trancducer,3MHz pulsed type (1:1),and 1.5 W/Cm applied for 10 minutes. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age from 45 to 55, 2. The condition comes on slowly , 3. Shoulder pain for at least one month, 4. Pain is felt near the insertion of deltoid , 5. Inability to sleep on the affected side , 6. painful and incomplete shoulder elevation and external rotation, 7. little local tenderness shoulder region , 8. X-rays negative except for bony atrophy, 9. the pain is very tiring to every one of patients but they are all able to continue their daily habits and routines 1. History of major shoulder injury or surgery 2. Clinical or radiological evidence of other pathology that could possibly account for symptoms 3. Patient with evidence of cervical radiculopathy,paresis,or other neurological changes in the upper limb on the involved side . 4. The presence of underlying fracture associated inflammatory arthritis,known renal or hepatic disease,haemopoietic disorder or malignancy interferes with the course or assessment and treatment of patients with frozen shoulder. 5. the presence of diabetes mellitus disease. 6. Mammography for female. 7. Cervical disorder ,posture deformity and thoracic outlet syndrome .   Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 55 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 29/11/2018 fuculty of physical therapy ethical comitte
Ethics Committee Address
Street address City Postal code Country
7 th el zyat streeet giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome function ability by using DASHThe disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. This 30-item disability/symptom scale is concerning the patient's health status during the preceding week. The items ask about the degree of difficulty in performing different physical activities because of the arm, shoulder, or hand problem (21 items), the severity of each of the symptoms of pain, activity-related pain, tingling, weakness and stiffness (5 items), as well as the problem's impact on social activities, work, sleep, and self-image (4 items). Each item has five response options. The scores for all items are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability). The score for the disability/symptom scale is called the DASH score. In this study we used the Arabic version of the DASH. The DASH-Arabic is a reliable, valid and responsive upper extremityoutcome measure for patients whose primary language is Arabic; it can be used to documentpatient status and outcomes and support evidence-based practice.DASH-Arabic is shown to have sound psychometric properties among Arabic-speaking patients with upper extremity conditions pre and after completion of study
Secondary Outcome range of motion pre and after completion of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
el azhar university specialized hospital of physiotherapy department madint nasr mokhem eldaem street madint nasr 11311 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 faculty of physical therapy 7 th elzayat street giza 12613 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
abeer abdel rahman mohamed 7 th el zayat street giza 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator abeer abdel rahman mohamed abeer.yamany@pt.cu.edu.eg 01006899872 7th elzayat street
City Postal code Country Position/Affiliation
giza 12613 Egypt prof of physical therapy
Role Name Email Phone Street address
Public Enquiries marwa shafiq afnanhamdy69@gmail.com 01008342466 7th elzayat street
City Postal code Country Position/Affiliation
giza 12613 Egypt dr of physical therapy
Role Name Email Phone Street address
Scientific Enquiries ali elgeushi afnanhamdy69@gmail.com 01019722129 7 th elzayat street
City Postal code Country Position/Affiliation
giza 12613 Egypt prof of faculty of medcine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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