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.: PACTR202304493866557 Date of Approval: 28/04/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Role of exercise in the management of neck pain
Official scientific title Comparative effect of eight weeks neck and scapular stabilisation exercises on clinical and psychosocial variables of individuals with non-specific neck pain
Brief summary describing the background and objectives of the trial Non specific neck pain (NsNP) refers to neck pain with or without radiation whose underlying cause cannot be traced to a specific systemic disease. pain is the most prominent symptom of NsNP and the most important determinant of disability. pain affects different aspects of life including the physical and psychosocial aspects (fear of movement and quality of life). studies have reported lower isometric strength of cervical flexors and extensor muscles of chronic neck pain patients. alterations in dynamic scapular stabilization has also been reported in the literature. Exercise is one of the most frequently used modality in the management of neck pain. studies that investigate the effect of scapula stabilization exercise on NsNP are scarce. This study propose to investigate the effect of scapular stabilization exercise on neck pain and to compare the effect of neck versus scapula stabilization exercise on clinical and psychosocial variables of individuals with non specific 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
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 10/04/2023
Actual trial start date
Anticipated date of last follow up 03/08/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Conventional physiotherapy Three times in week eight weeks infra-red radiation for 15 minutes. Transcutaneous electrical stimulation for 15 minutes. Soft tissue massage to painful areas, postural education 22 Active-Treatment of Control Group
Experimental Group Neck stabilisation exercise group Three times a week 8 weeks cervical retraction exercise (chin tuck): in standing position, participants pulls back the chin while keeping the eyes level. This will be done for 15 repetitions. Cervical extension: in standing position, participnts grasp the base of the neck with both hands while extending the neck as far as possible, this will be done for 15 repetitions. Education on proper neck positioning. Conventional physiotherapy which consist of infra-red application for 15 minutes, transcutneous electrical stimulation for 15 minutes, soft tissue massage to painful areas 23
Experimental Group scapula stabilisation exercise group Three times a week 8 weeks Scapula retraction: in standing position, participants brings the shoulder blades together in the back, then he relaxes and repeates procedure 15 times. Patients placed a gym ball between the chest and abdomen , lower both arms thumbs up and make an 'I' shape.after this, patient lift both arms up to 45 degrees to make a 'Y' shape and lift both arms horizontally to make a'T' shape.lastly, patients then bend both arms to 90 degrees and horizontally to make a 'W' shape.10 repetitions, hold for 3 seconds, 3 sets. Education on proper neck positioing, conventional physiotherapy which consist of infrared therapy for 15 minutes, transcutaneous electrical stimulation for 15 minutes, soft tissue massage to painful areas 22
Experimental Group Neck plus scapular stabilization exercise group Three times per week 8 weeks neck stabilisation exercise. Scapula stabilisation exercise, education on proper neck positioning. Conventional physiotherapy 23
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with clinical features of non-specific neck pain such as pain . Patients must be literate in english, yoruba or both languages. Patients who are not involved in any other form of exercise training during the course of the study patients with obvious spinal deformity or neurological disease will be excluded from the study Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 14/04/2023 University of Ibadan and University College Hospital Joint Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University college hospital, university of ibadan, Ibadan, Nigeria Ibadan 3170 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain: it will be measured using the visual analogue scale. This is a continous scale comprising of horizontal line which measure from 0-100cm, it is anchored by 2 verbal description with 0cm indicating no pain, 50cm indicating moderate pain and 100cm indicating worse imaginable pain. This measure will be used to measure patients pain. Baseline, end of 4 weeks and end of eight weeks
Primary Outcome Neck disability: this will be measured using the neck disability index. This is a patient completed, condition specific functional status questionnaire that consist of 10 items including pain, personal care,lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Baseline, at the end of 4 weeks and at the end of 8 weeks
Primary Outcome Weight and height will be measured using a stadiometer Baseline, at the end of four weeks and at the end of eight weeks
Secondary Outcome Fear of movement: this is the irrational fear of movement by the patient and it will be measured using the fear avoidance beliefs questionnaire which is a patient reported questionnaire that cocis on how a patient fear avoidance beliefs about physical activity and work may affect or contribute to their pain and resulting disability Baseline, at the end of four weeks and the end of eight weeks
Secondary Outcome Health related quality of life: this will be measured using the short form-36 health survey, this is a patient reported survey of patients health and its a measure of health status. It consists of eight domains or sections. Baseline, at the end of four weeks and end of eight weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Physiotherapy Department Federal Medical Center Abeokuta Olisa street, Ijebu-ode, Ogun state Nigeria Ijebu ode 1201101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Olofin olushola dorcs No 9 adeyemi street, ijebu ode, ogun state Ibadan Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Olofin oluwole gabriel no 9 adeyemi street, ijebu ode, ogun state Ibadan Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olushola olofin Sholababey5k@yahoo.com +23408130943665 no 9 adeyemi street, ijebu ode ogun state
City Postal code Country Position/Affiliation
Ibadan Nigeria Assistant chief physiotherapist
Role Name Email Phone Street address
Public Enquiries Adesola odole adesola_odole@yahoo.com +2348034051960 Physiotherapy department, university college hospital, ibadan
City Postal code Country Position/Affiliation
ibadan Nigeria Chief physiotherapist
Role Name Email Phone Street address
Scientific Enquiries Omoyemi ogwumike yemfide@yahoo.com +2348023256052 University college hospital, university of ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Chief physiotherapist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data will be made available including data dictionaries. All individual participant data that underlie the results reported in this article after de-identification (texts, tables, figures and appendices will be made available. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The data will be made available immediately following publication and there will be no end date. The data will be made available to anyone who wishes to access the data and for any purpose and data will be made available indefinitely
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