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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202406664287232 Date of Registration: 04/06/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Correlation between neck pain and handgrip strength in patients with chronic mechanical neck pain
Official scientific title Correlation between neck pain and handgrip strength in patients with chronic mechanical neck pain
Brief summary describing the background and objectives of the trial One of the main causes of Chronic mechanical neck pain is abnormal posture . Abnormal cervical posture can impinge the exiting nerve root entrapment causing radiculopathy. Nerve root entrapment can can give both sensory and motor manifestations ( Parathesia or weakness). This study was conducted to determine the relationship between neck pain (mechanical) and hand grip strength ( root muscle weakness) in patients with chronic mechanical neck pain.
Type of trial Observational
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 Early detection /Screening
Anticipated trial start date 05/12/2022
Actual trial start date 05/12/2022
Anticipated date of last follow up 07/06/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
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
Single Group Non-randomised 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 Assessment of pain and hand grip strength one shot assessment All participants undergone evaluation of hand grip strength using hand held dynamometer and evaluation of neck pain using visual analogue scale (VAS) to detect any correlation 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Age ranged from 25 to 35 years. 2- Neck pain lasted more than 6 months. 3- Mild (5-44 mm) to moderate (45–74) neck pain as indicated by visual analogue scale (VAS). 4- Participants had right hand dominance and with normal body mass index (BMI) (18.5 - 24.99Kg/m2) 1- Patients with any cervical pathology rather than mechanical neck pain. 2- previous cervical or shoulder surgery or trauma. 3- diabetic patients with shoulder problems 4- history of any neurologic disease that may affect the hand functions such as carpal tunnel syndrome, De Quervain's disease, deformities in elbow or hand 5- patients suffering from psychological or cognitive disturbances. Adult: 18 Year(s)-44 Year(s) 25 Year(s) 35 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 22/08/2022 Ethical committee Faculty of physical therapy at Cairo university
Ethics Committee Address
Street address City Postal code Country
11 Ahmed El-Zayat street Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hand grip strength in KG Pre- intervention -one time.
Secondary Outcome Pain using Visual analogue scale Pre intervention One time assessment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinics at faculty of physical therapy Cairo UNI. 11 Ahmed el-zayat street Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Physical Therapy at Cairo University 11 Ahmed el-Zayat street Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy at Cairo University 11 Ahmed el-zayat street Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hager Arafa hagermagdiahmedarafa@gmail.com 00201008987574 11 Ahmed Elzayat Street
City Postal code Country Position/Affiliation
Giza Egypt Physical Therapist in the ministry of health
Role Name Email Phone Street address
Public Enquiries Shaimaa Abdelmageed Shaimaa.Abdelmageed@pt.cu.edu.eg 00201028202856 11 ahmed el-zayat st.
City Postal code Country Position/Affiliation
Giza Egypt Lecturer PhD faculty of physical therapy Cairo university
Role Name Email Phone Street address
Scientific Enquiries Ebtesam Fahmy em_fahmy@kasralainy.edu.eg 00201002007077 5 Handosa street , al kasr al ainy medical school
City Postal code Country Position/Affiliation
Cairo Egypt Professor of neurology at Al kasr al ainy medical school
Role Name Email Phone Street address
Scientific Enquiries Hoda Zakaria Alsaid_mostafa@pt.cu.edu.eg 00201013107750 11 ahmed el zayat street
City Postal code Country Position/Affiliation
Giza Egypt Professor of Physical therapy at Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of Individual Participant Data (IPD) collected during the trial , After deidentification will be shared for research purposes only Informed Consent Form Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Only Researchers in the project can see the data
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