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.: PACTR201712002791170 Date of Registration: 22/11/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative efficacy of muscle energy technique and neck stabilization exercise on pain and psychological status of patients with non specific chron
Official scientific title Comparative efficacy of muscle energy technique and neck stabilization exercise on pain and psychological status of patients with non specific chronic neck pain
Brief summary describing the background and objectives of the trial Use of exercise in neck pain management has been documented. The study aimed to compare the effects of muscle energy technique and neck stabilization exercise on pain, range of motion, functional disability, sleep disturbance and psychological status of patients with non specific chronic neck pain.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Neck pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/06/2017
Actual trial start date 20/06/2017
Anticipated date of last follow up 21/08/2017
Actual Last follow-up date 12/09/2017
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 35
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
Ethics committee Ethics committee
ADM/DST/HREC/APP/1535 Ethics committee
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 Simple randomisation using a randomisation table created by a computer software program Sealed opaque envelope Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Muscle energy technique group 5 seconds , 3 repetition twice weekly for 8 weeks Muscle energy technique, infrared for 10 minutes and neck care education 12
Experimental Group Neck stabilization exercise 5 different protocol;3 sets of 12 repetitions each 30 minutes, twice weekly for 8weeks Neck stabilization exercise, infrared radiation and neck care education. 12
Control Group Control group Infrared radiation for 15 minutes Twice weekly for 8 weeks Infrared radiation and neck care education 11 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with history of non specific chronic neck pain of not less than 3 months Patients with history of non specific chronic neck pain with or without pain radiating to one or both upper limbs. patients with history of spinal surgery Patients with history of trauma to the neck Patients with spinal deformity Patients with specific neck pain as a result of malignancy. 23 Year(s) 77 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 26/05/2017 Lagos University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Idi araba Lagos PMB 12003, Lagos. Nigeria
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 26/05/2017 Health Research and Ethics Committee of National Orthopeadic Hospital
Ethics Committee Address
Street address City Postal code Country
120/124 Ikorodu road , Igbobi, Lagos Lagos P.M.B. 2009, Yaba, Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain reduction Baseline After 4 weeks After 8 weeks
Primary Outcome Range of motion Baseline At 4 weeks At 8 weeks
Primary Outcome Functional Disability At baseline At 4 weeks At 8 weeks
Primary Outcome Sleep disturbance Baseline At 4 weeks At 8 weeks
Primary Outcome Psychological status Baseline At 4 weeks At 8 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Physiotherapy department of Lagos University Teaching Hospital. Idi Araba Lagos Nigeria
Physiotherapy department of National orthopaedic Hospital. Igbobi Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Sulaiman Zibiri NDA medical Centre Kaduna Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mrs Rasheedah Zibiri Kaduna Polytechnic Kaduna Nigeria Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Dr. A.K. Akodu College of Medicine University of Lagos Lagos Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rasheedah Zibiri rasheedahazibiri@gmail.com 07038374660 Kaduna
City Postal code Country Position/Affiliation
Kaduna Nigeria Physiotherapist
Role Name Email Phone Street address
Public Enquiries Rasheedah Zibiri rasheedahazibiri@gmail.com 07038374660 Kaduna
City Postal code Country Position/Affiliation
Kaduna Nigeria
Role Name Email Phone Street address
Scientific Enquiries Rasheddah Zibiri rasheedahazibiri@gmail.com 07038374660 Kaduna Polytechnic, Tudun Wada
City Postal code Country Position/Affiliation
Kaduna P.M.B. 2021 Nigeria Physiotherapist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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