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.: PACTR201907694769013 Date of Approval: 11/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of Neck Stabilization and Isometric Neck Exercises on Pain-Related Disability, Psychological Status, Sleep Disturbance and Cardiopulmonary Function in Patients with Non-specific Chronic Neck Pain
Official scientific title Effects of Neck Stabilization and Isometric Neck Exercises on Non-specific Chronic Neck Pain
Brief summary describing the background and objectives of the trial This study aims to determine the efficacy of neck stabilization and isometric neck exercises on non-specific chronic neck pain and its complications.This will guide physiotherapists in the treatment of 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
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 28/06/2019
Actual trial start date
Anticipated date of last follow up 25/10/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants) 14
Recruitment status Closed to recruitment,follow-up continuing
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group NECK STABILIZATION AND ISOMETRIC NECK EXERCISES TWICE WEEKLY FOR FOUR WEEKS FOUR WEEKS Neck stabilization exercise will consist of chin tuck, cervical extension, shoulder shrug, shoulder rolls, scapular retraction. Subjects will be in standing and exercises will be repeated 15 times. Isometric neck exercises will consist of isometric neck flexion, isometric neck extension, isometric lateral flexion. Subjects will be in standing and exercises will be repeated 10 times. 17
Control Group ISOMETRIC NECK EXERCISES TWICE A WEEK FOR FOUR WEEKS FOUR WEEKS Isometric neck exercises will consist of isometric neck flexion, isometric neck extension, isometric lateral flexion. Subjects will be in standing and exercises will be repeated 10 times and held for 10 seconds 17 Active-Treatment of Control Group
Experimental Group NECK STABILIZATION EXERCISE TWICE A WEEK FOR FOUR WEEKS FOUR WEEKS Neck stabilization exercise will consist of chin tuck, cervical extension, shoulder shrug, shoulder rolls, scapular retraction. Subjects will be in standing and exercises will be repeated 15 times 17
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Subjects referred to physiotherapy clinic with diagnosis of non-specific chronic neck pain subjects with cognitive limitations or history of cardiovascular, pulmonary or endocrine disease subjects with medical or surgical conditions which might hinder exercise performance subjects with osteoporosis subjects with neurological disorders subjects with previous neck surgeries subjects with chronic neck pain with symptoms or signs at presentation that suggest a specific underlying condition Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 07/05/2019 HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
COLLEGE OF MEDICINE, UNIVERSITY OF LAGOS. P.M.B 12003, LAGOS, NIGERIA Lagos 100254 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Neck Pain Disability Index- This is a modification of the Oswestry Low Back Pain Disability Index. It is a patient-completed, condition specific functional status questionnaire which includes 10 items namely pain, lifting, personal care, reading, concentration, work, headaches, driving, sleeping and recreation. It is the most commonly used self-report measure for neck pain. Each of the 10 items is scored from 0-5, with 0 representing no pain or limitation and 5 representing as much pain as possible or maximal limitation. Baseline, Two weeks, Four weeks
Secondary Outcome Insomnia severity Index- This is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. It is available in several languages and is increasingly used as a metric of treatment response in clinical research. The insomnia severity index has 7 questions with a score from 0-4. Baseline, Two weeks, Four weeks
Secondary Outcome Hospital anxiety and depression scale - This is an instrument which was developed to assess depression and anxiety in patients and the general population. Fourteen items are equally divided into subscales: anxiety (HADS-D) and depression (HADS-D). The HADS-A includes items such as tension, worry, fear, panic, difficulties in relaxing and restlessness while the HADS-D includes items measuring anhedonia (not experiencing joy). Responses are rated on a 4-point likert scale and range from 0 to 3 Baseline, Two weeks and four weeks
Secondary Outcome Borg's scale of perceived exertion - This is a tool useful in measuring an indiviual’s effort and exertion, breathlessness and fatigue during physical work.. On the 15-point scale (6-20) the number 6 indicates “no feeling of exertion” while 20 indicates “very, very hard” Baseline, Two weeks, four weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
COLLEGE OF MEDICINE UNIVERSITY OF LAGOS P.M.B, 12003, LAGOS, NIGERIA. COLLEGE OF MEDICINE, UNIVESITY OF LAGOS LAGOS Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
MR Afolabi Sorunke House 7, citiview estate, arepo, ogun state ogun Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mr Afolabi SORUNKE House 7, citiview estate, arepo, ogun Ogun Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
DR A.K AKODU COLLEGE OF MEDICINE, UNIVERSITY OF LAGOS, IDI-ARABA, LAGOS LAGOS Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ASHIYAT AKODU akoduashiyat@gmail.com +2348034269053 COLLEGE OF MEDICINE, UNIVERSITY OF LAGOS. P.M.B 12003, LAGOS, NIGERIA
City Postal code Country Position/Affiliation
LAGOS Nigeria Conceptualization and research design
Role Name Email Phone Street address
Scientific Enquiries Mariam Sorunke mariamsorunke@gmail.com +2348127751503 COLLEGE OF MEDICINE, UNIVERSITY OF LAGOS. P.M.B 12003, LAGOS, NIGERIA
City Postal code Country Position/Affiliation
LAGOS Nigeria Data collection
Role Name Email Phone Street address
Public Enquiries TOBILOBA AJEPE tobigbarii@gmail.com +2348066704593 COLLEGE OF MEDICINE, UNIVERSITY OF LAGOS. P.M.B 12003, LAGOS, NIGERIA
City Postal code Country Position/Affiliation
LAGOS Nigeria Data Analysis
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the result in the article Statistical Analysis Plan,Study Protocol Immediately following publication. No end date Researchers who provide a methodologically sound proposal Analysis to achieve aims in the approved proposal. Proposals should be directed to akoduashiyat@gmail.com
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