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.: PACTR202305667568585 Date of Approval: 02/05/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of laser acupuncture on neurophysiological parameters of median nerve in postpartum women: A randomized Controlled Clinical Trial
Official scientific title Efficacy of laser acupuncture on neurophysiological parameters of median nerve in postpartum women: A randomized Controlled Clinical Trial
Brief summary describing the background and objectives of the trial BACKGROUND: Carpal tunnel syndrome (CTS), the most common entrapment neuropathy of the upper extremity, is caused by compression of the median nerve as it travels through the carpal tunnel CTs is a very common complication found in pregnancy, which is reported as high as 62% in pregnant females. The functioning of median nerve is compromised in almost all pregnant females especially during the third trimester of pregnancy, the majority may still feel some symptoms up to 3 years after delivery. Many clinicians have used LLLT on acupuncture points, which is called laser acupuncture (LA), to treat many clinical problems, such as musculoskeletal pain, lateral epicondylitis, headaches, etc. In contrast with traditional acupuncture needles, LA is a non-invasive therapy that does not cause tingling/pain during procedures Objective: to determine efficacy of laser acupuncture on electrophysiological parameters of median nerve in postpartum women
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CTS LLLT LA
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 25/03/2023
Actual trial start date 01/04/2023
Anticipated date of last follow up 25/06/2023
Actual Last follow-up date 05/07/2023
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 50
Recruitment status Closed to recruitment,follow-up continuing
Publication URL https://bfpt.springeropen.com/about
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Laser acupuncture 10 minutes, three times per week for 4 weeks (total of 12 sessions) . 4 weeks Each patient in this group will receive laser acupuncture on PC4 (Ximen), PC6 (Neiguan), PC7 (Daling), PC8 (Laogong), LI4 (Hegu), LI10 (Shousanli), LI11 (Quchi), HT3 (Shaohai), HT7 (Shenmen), LU10 (Yuji) acupoints in addition to wearing night splint. LA will be applied to each acupuncture point for 10 s with at least 4J/points based on the recommended LLLT treatment doses for CTS of the World Association of Laser Therapy. 25
Control Group Night splint Every night for 4 weeks 4 weeks Each patient in this group will wear night splint every night for 4 weeks 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Postpartum women with mild to moderate carpal tunnel syndrome will participate in this study. 2- Their ages will range from 25 to 35 years old. 3- Their BMI will be range from 25 to 30 Kg/m2. 4- The electrophysiological evidence of mild or moderate median nerve lesion at wrist (mild: sensory nerve latency >3.5 ms at third digit, moderate: sensory nerve latency >3.5 ms at third digit and median motor latency>4.2 ms) 5- Positive phalen's test. 6- Positive tinel's test. 7- Carpal tunnel of dominant hand could be participated. 1- History of brachial plexopathy or malignancy. 2-Radial, ulnar neuropathy, proximal median neuropathy or polyneuropathy. 3- Previous wrist surgery or steroid injection for carpal tunnel syndrome. 4- History of trauma, fracture, deformity or inflammation in the wrist, such as rheumatoid arthritis. 5- Coagulation abnormalities, pregnancy, fever and infections. 6- Skin disease and skin cancer. 7- Spots, birthmarks or tattoos over the work points. 8- Pacemaker and implementable medical devices. Adult: 19 Year-44 Year 25 Year(s) 35 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 11/12/2022 PT REC
Ethics Committee Address
Street address City Postal code Country
7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome electrophysiological parameters sensory and motor nerve conduction velocity at the beginning of the study and at the end of the treatment program
Secondary Outcome Hand grip strength at the beginning of the study and at the end of the treatment program
Secondary Outcome Hand function at the beginning of the study and at the end of the treatment program
Secondary Outcome Pain intensity through visual analogue scale at the beginning of the study and at the end of the treatment program
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
OUT CLINIC OF FACULITY OF PHYSICAL THERAPY University street Giza 3455 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Afaf Mohamed Botla Gamal Abd Elnaser street Qaliobia 1122 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy 7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Yasser Ramzy Lasheen University street Giza 12613 Egypt
Manal Ahmed ElShafei University street Giza 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Afaf Botla drafafmohamed@cu.edu.eg 002701283126608 Gamal Abd Enaser, El-Kanater ELKhairia
City Postal code Country Position/Affiliation
Qaliobia 1122 Egypt Associate Proffespr
Role Name Email Phone Street address
Public Enquiries Manal ElShafei manal.ahmed@cu.edu.eg 002701220664518 University street
City Postal code Country Position/Affiliation
Giza 12613 Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Yasser Lasheen Dr_yasser_1977@pt.cu.edu.eg 002701005251562 University street
City Postal code Country Position/Affiliation
GIZA 12613 Egypt Associate professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data obtained through this study will be provided to a qualified researcher who interested in this field and data that will be shared will be coded. approval of the request and execution of all applicable agreements will be a pre-request to the sharing of data Informed Consent Form,Statistical Analysis Plan,Study Protocol data requests can be submitted within 11 months after article publication and the data will be made accessible for up to 24 months 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 and execution of a data sharing agreement
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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 ana 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