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.: PACTR202208562111554 Date of Registration: 10/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative effectiveness of muscle energy technique versus low-level laser therapy among diabetic patients with frozen shoulder
Official scientific title Comparative effectiveness of muscle energy technique versus low-level laser therapy on clinical and psychological parameters among diabetic patients with frozen shoulder: a randomised controlled trial
Brief summary describing the background and objectives of the trial The trial will comprise two experimental groups and one control group. The main objective is to find a comprehensive treatment approach for frozen shoulder among diabetic patients.
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 Rehabilitation
Anticipated trial start date 15/08/2022
Actual trial start date 02/02/2023
Anticipated date of last follow up 30/08/2024
Actual Last follow-up date 29/11/2024
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 randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Muscle Energy Technique Muscle energy technique will be administered 3 times per week. In addition, the participants will receive and conventional therapeutic exercises 3 times per week. 8 weeks Muscle energy technique (MET) is a type of osteopathic manipulative medicine that will be to lengthen, strengthen and improve the range of movement of muscles in the shoulder region. Three METs will be administered to the patient's affected shoulder. In addition, participants will receive 8 conventional therapeutic exercises aiming to improve flexibility and strength of the muscles in the shoulder region. 20
Control Group Conventional therapeutic exercises Conventional therapeutic exercises will be administered 3 times per week. 8 weeks Eight conventional therapeutic exercises aiming to improve shoulder flexion, abduction, external rotation, internal rotation will be administered. Each exercise will be repeated 5–10 times per session. 20 Active-Treatment of Control Group
Experimental Group Low Level Laser Therapy 3 times per week for 8 weeks 8 weeks Low-level laser therapy is a low-intensity light therapy that will be used to treat shoulder to reduce symptoms and enhance healing. In addition, participants will receive 8 conventional therapeutic exercises aiming to improve flexibility and strength of the muscles in the shoulder region. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Both male and female diabetic patients (both type 1 and type 2). 2. Patients with shoulder pain within the last 3 months (painful or first stage). 3. Patients with limited active and passive glenohumeral mobility with more restriction of external rotation. 4. Patients having bilateral or unilateral shoulder symptoms. 1. Patients with history of trauma to the shoulder. 2. Neurological involvement such as stroke, branchial plexus injury, Parkinson’s disease, cervical spine injury with or without radiculopathy. 3. History of surgery to the shoulder, malignancy or tumour of the shoulder. 4. Shoulder arthritis, rotator cuff tear or other shoulder ligamentous injury. Middle Aged: 45 Year(s)-64 Year(s) 20 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 20/12/2023 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Shika, Zaria Zaria, Kaduna State PMB 06 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Shoulder function measured by the shoulder pain and disability index (SPADI). At baseline, 8 weeks post-intervention and after 3 months follow-up
Secondary Outcome Pain intensity, Shoulder ROM, interleukin 6, depression, anxiety, and quality of life. At baseline, 8 weeks post-intervention and after 3 months follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ahmadu Bello University Teaching Hospital Shika, Zaria Zaria Kaduna State PMB 06 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Halima Ibrahim Hassan Department of Physiotherapy, Ahmadu Bello University Teaching Hospital, Zaria, Kaduna State, Nigeria Zaria 810224 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Halima Ibrahim Shika, Zaria Zaria Kaduna State PMB 06 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Bashir Kaka Bkaka.pth@buk.edu.ng +237036954258 Gwarzo Road, P.M.B 3011, Kano
City Postal code Country Position/Affiliation
Kano 700214 Nigeria Senior Lecturer Physiotherapy Department Faculty of Allied Health Sciences College of Health Sciences Bayero University Kano
Role Name Email Phone Street address
Principal Investigator Halima Ibrahim Hassan ihhalimah@gmail.com +2348065364573 Physiotherapy Department, Ahmadu Bello University Teaching Hospital, Zaria
City Postal code Country Position/Affiliation
Zaria 810224 Nigeria Chief Physiotherapist Physiotherapy Department Ahmadu Bello University Teaching Hospital Zaria
Role Name Email Phone Street address
Public Enquiries Jibril Muhammad jmohammed.pth@buk.edu.ng +2348033537472 Gwarzo Road, P.M.B 3011, Kano
City Postal code Country Position/Affiliation
Kano 700006 Nigeria Head of Department Physiotherapy Department Faculty of Allied Health Sciences College of Health Sciences Bayero University Kano
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in diabetic frozen shoulder. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Informed Consent Form,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
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