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.: PACTR202402541572962 Date of Approval: 06/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of low-level laser and polarized light therapy on treatment of carpal tunnel syndrome in type 2 diabetic patients
Official scientific title Effectiveness of low-level laser and polarized light therapy on treatment of carpal tunnel syndrome in type 2 diabetic patients
Brief summary describing the background and objectives of the trial Carpal tunnel syndrome is one of the most common upper limb compression neuropathies, it accounted for approximately 90% of all entrapment neuropathies. It is due to an entrapment of the median nerve in the carpal tunnel at the wrist. Carpal tunnel syndrome is widely reported in up to between 15-20% of people with diabetes and associated with negative consequences. Carpal tunnel syndrome not only causes discomfort for the patient, but can also interfere with social and occupational activities as well as activities of daily living. Recently, light therapy including low level laser as a coherent source of light and polarized polychromatic noncoherent light therapy as a polychromatic and non-coherent light have been proposed as a non-expensive therapeutic option for the treatment of several musculoskeletal disorders including carpal tunnel syndrome. Low-intensity laser therapy has been extensively used for treatment of several musculoskeletal disorders including the carpal tunnel syndrome and was associated with improved functional outcome and electrophysiological parameters. Similarly, polarized light is recommended as a non-aggressive, safe and cost-effective treatment option for the treatment of carpal tunnel syndrome with significant benefits on pain severity and electrodiagnostic measurements. Several studies solely listed the benefits of these two different therapeutic modalities on different outcomes in patients with carpal tunnel syndrome without identifying the most effective form of training. So, the main objective of this study is to compare the effect low-level laser and polarized light therapy on treatment of carpal tunnel syndrome in type 2 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,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 09/02/2024
Actual trial start date 11/02/2024
Anticipated date of last follow up 15/05/2024
Actual Last follow-up date 18/05/2024
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Low level laser Low-level laser 3 sessions /week plus wrist splinting Low-level laser 3 sessions /week plus wrist splinting for 10 weeks It will include 20 patients receiving low-level laser plus wrist splinting 20
Experimental Group Polarized light therapy 3 sessions /week 10 weeks 20 patients receiving polarized light therapy 3 sessions /week plus wrist splinting for 10 weeks 20
Control Group Wrist splinting Wrist splinting 20 hours /day for 10 weeks 10 weeks 20 patients only receiving wrist splinting week for 10 weeks 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Mild to moderate carpal tunnel syndrome. 2. Well-controlled type 2 diabetes mellitus with HbA1c≤7. 3. Their ages will be ranged from 40 to 60 years old. 4. Their BMI will range from 18.5 to 29.9 Kg/m2. 5. Female gender. 1. Other types of diabetes as type 1. 2. Patients with diabetic polyneuropathy. 3. Patients with previous carpal tunnel release. 4. Steroid injections into the carpal tunnel 5. Pregnancy. 6. Electroneurographic and clinical signs for axonal degeneration of the median nerve Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 60 Year(s) Female
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 27/01/2024 Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
Ahmed Elzayat Cairo 8655 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Nerve conduction measures of the median nerves (Sensory and motor distal latency) Before and after 10 weeks of the intervention
Secondary Outcome The cross sectional area of the median nerve using ultrasound Before and after 10 weeks of the intervention
Secondary Outcome Health status using Boston carpal tunnel syndrome questionnaire before and after 10 weeks of the intervention
Secondary Outcome Hand grip strength measurement using a hand held dynamometer. before and after 12 weeks of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Mahalla general hospital Bahr street El Mahalla Alkobra 31953 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Saher lotfy abo ali mahala 12611 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Saher Elgayar Aboali Mahalla 12611 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
saher lotfy abo ali mahala 12611 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Saher Elgayar saherlotfy020@gmail.com +201020429911 Gehad
City Postal code Country Position/Affiliation
Mahalla 31951 Egypt Assistant Professor Department of Physiotherapy Faculty of Allied Medical Sciences Middle East University
Role Name Email Phone Street address
Public Enquiries Mohamed Elhamrawy saher_lotfi@yahoo.com +201060667075 Bahrawy
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Assistant Professor Department of Physiotherapy Faculty of Allied Medical Sciences Middle East University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Gamil saherelgayar@yahoo.com +201022429914 Bosta
City Postal code Country Position/Affiliation
Cairo 11555 Egypt Lecturer Physical therapy for women health Faculty of Physical Therapy October University for Modern Sciences and Arts
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 carpal tunnel syndrome. 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,Statistical Analysis Plan Data requests can be submitted starting 1 month after article publication and the data will be made accessible for up to 36 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