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.: PACTR201801002928362 Date of Approval: 01/01/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative Effects of Thoracic Spine Manipulation and Vertical Oscillatory Pressure in the Management of Chronic Neck Pain
Official scientific title Comparative Effects of Thoracic Spine Manipulation and Vertical Oscillatory Pressure on Physical, Psychosocial and Physiological variable in Adults with Long Term Mechanical Neck Pain
Brief summary describing the background and objectives of the trial This randomized clinical trial aims to investigate and compare the effects of Thoracic Spine Manipulation (TSM) and cervical Vertical Oscillatory Pressure (VOP) on Pain Intensity (PI), disability, Cervical Range of Motion (CROM), Cervical Muscle Electrical Activity (CEA), Fear Avoidance Beliefs (FAB), General Health Status (GHS) and Self-Esteem (SE) in patients with Chronic Neck Pain (CNP). This is with a view to providing evidence to assist physiotherapists in making informed decisions on the choice of manual therapy techniques appropriate for CNP.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied CHRONIC MECHANICAL NECK PAIN,Injury, Occupational Diseases, Poisoning,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/02/2018
Actual trial start date
Anticipated date of last follow up 31/10/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 42
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Ethical approval with protocol number ERC/2017/07/03 Ethics and Research committee of the Obafemi Awolowo University Teaching Hospitals Complex, Nigeria
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 Block Randomization: Using a block size of 2 (2, 4 or 6) to assign sample numbers equally to each group. The block size was randomly mixed Sealed opaque envelopes will be used Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cervical mobilization (vertical Oscillatory Pressure) twice weekly 8 weeks Participants would be in prone lying position on a standard adjustable plinth, with their chin placed on the extensor surface of both hands superimposed on each other. The principal investigator will perform a bout of central posterior-to-anterior cervical spine non-thrust mobilization to the spinous processes of C2-C7. 25
Experimental Group Thoracic spine manipulation twice weekly 8 weeks Thoracic spine manipulation will be performed to the upper and mid thoracic segments with the participant in supine position. The therapist will target between segments T1 and T4 for the upper thoracic spine manipulation in each participant. Participants will be instructed to clasp their hands across the base of the neck 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with neck pain of mechanical origin to be included in this study: Had neck pain for a minimum of 3 months duration. Were between the ages of 18 and 65. Individuals with any medical signs suggestive of a non-musculoskeletal aetiology of symptom. Patients with serious pathologies such as myelopathy, underlying malignancy, neoplasms, infections, osteoporosis, inflammatory joint diseases, and fractures Patients with a history of a whiplash injury within 6 weeks of the examination A previous diagnosis of cervical spinal stenosis Individuals with evidence of any central nervous system involvement or with signs consistent with nerve root compression (at least 2 of the following have to be diminished for nerve root involvement to be considered: myotomal strength, sensation, or reflexes). Patients with headache of cervical or non-cervical origin. History of a previous cervico-thoracic surgery. 18 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 03/07/2017 Ethics and Research committee of the Obafemi Awolowo University Teaching Hospitals Complex n
Ethics Committee Address
Street address City Postal code Country
Obafemi Awolowo University Teaching Hospital, Ile-Ife, Nigeria Ile-ife Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain Baseline 4th week 8th week
Primary Outcome Range of Motion Baseline 4th Week 8th week
Primary Outcome Disability Baseline 4th eek 8th week
Primary Outcome Electrical activity of the muscle Baseline 4th week 8th week
Secondary Outcome Self-esteem Baseline 4th week 8th week
Secondary Outcome General health status Baseline 4th week 8th week
Secondary Outcome Fear-avoidance belief Baseline 4th week 8th week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Teaching Hospital Complex Ilesha road Ile-Ife Nigeria
Obafemi Awolowo University Teaching Hospital Complex Wesley Guild road Ilesha Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
None yet
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oyinade Akindele Rd 7b house L2 O.A.U Quarters Ile-Ife Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Egwu M.O Department of Medical Rehabilitation, Obafemi Awolowo University Ile-Ife Nigeria
Mbada CE Department of Medical Rehabilitation, Obafemi Awolowo University Ile-Ife Nigeria
Awotidebe TO Department of Medical Rehabilitation, Obafemi Awolowo University Ile-Ife Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Oyinade Akindele honeycrown12@yahoo.com +2348053516107 Faculty of Basic Medical Sciences, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Ile-Ife Nigeria Teaching/Research assistant/ Department of Medical Rehabilitation, Obafemi Awolowo University
Role Name Email Phone Street address
Public Enquiries Oyinade Akindele honeycrown12@yahoo.com +2348053516107 Faculty of Basic Medical Sciences, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Ile-Ife Nigeria Research & Teaching Assistant / Department of Medical Rehabilitation, Obafemi Awolowo University
Role Name Email Phone Street address
Scientific Enquiries Chidozie Mbada doziembada@yahoo.com +2348028252543 Faculty of Basic Medical Sciences, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Ile-Ife Nigeria Senior Lecturer/Department of Medical Rehabilitation, Obafemi Awolowo University
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information