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.: PACTR202407767871918 Date of Approval: 16/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of telehealth based neck isometric exercise on pain related disability, pain self efficacy and psychological status among addicted smartphone users with nonspecific neck pain.
Official scientific title Effect of telehealth based neck isometric exercise on pain related disability, pain self efficacy and psychological status among addicted smartphone users with nonspecific neck pain.
Brief summary describing the background and objectives of the trial Background /introduction Non-specific neck pain is a disabling musculoskeletal disorder caused by occupation, lifestyle and age-related factors, neck pain is a common symptom affecting people in their daily lives (Kazeminasab et al, 2021). Due to unhealthy lifestyle, stress, and poor posture in work and study, people assume bad posture with their heads bent forward and their heads bowed at their desks, which causes strain to the neck muscle and ligament, cervical spine stability disorder, cervical nerve compression, slow blood flow, and carotid artery stimulation (Alodaibi et al, 2022).Isometric exercises (static exercises) strengthen weak muscles without stimulating pain-sensitive structures such as ligaments, tendons, or neck joints, making them more acceptable to the patient, they cause contraction in a specific group of muscles without changing muscle length, impeding involved joint's movement (Gross et al, 2016). Studies have shown that isometric exercise relieves neck pain and improves neck function and its range of motion (Alodaibi et al, 2022) Telehealth Physiotherapy (PT), a branch of telerehabilitation, has demonstrated promising results (Zischke et al, 2021) expanding access to remote areas while mitigating travel and its associated costs for patients with reduced mobility (Tenforde et al, 2017). The extreme inappropriate usage of smart phones results in multiple health and physical issues including sleeping disorders for either falling asleep or maintain the sleep, eye health, musculoskeletal system (Abdulmanan et al, 2022). It has also been found that mobile phone addiction has been associated with subsequent stress, sleep complications, behavioral changes, mood swings, and even depression (Mustafaoglu et al, 2021). The objectives of this study was to determine the effect of telehealth-based neck isometric exercise on pain-related disability, pain self-efficacy and psychological status (sleep disturbance, anxiety and depression) among addicted smartphone users with non-specific neck pain.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 02/06/2024
Actual trial start date 08/06/2024
Anticipated date of last follow up 31/07/2024
Actual Last follow-up date 31/07/2024
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants)
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
Single Group Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pre and Post Intervention Study Twice a week for eight weeks Eight weeks intervention INTERVENTION PROCEDURE Protocol for isometric exercise : To do the exercises, participants will sit in an upright posture. Each set of neck isometric strengthening exercises comprised of 6 movements, holding each movement for 10 seconds and repeating each 3 times with a 5 seconds rest between, twice weekly for 8 consecutive weeks (Iversen et al, 2018), as follows: 1. Right Rotation: Participants will be instructed to sit in an upright position and put palm of the right hand on right side of face, rotate the head slightly to the right while resisting the movement with hand. 2. Left Rotation: Participants will be instructed to sit in an upright position and put palm of the left hand on left side of face, rotate the head slightly to the left while resisting the movement with hand. 3. Right Lateral Flexion: Participants will be instructed to sit in an upright position and keep the neck straight, put palm of the right hand on right side of the head, push the head towards the hand to bring head down to the right shoulder while pushing the hand vice versa. 4. Left Lateral Flexion: Participants will be instructed to sit in an upright position and keep the neck straight, put palm of the left hand on left side of the head, push the head towards the hand to bring head down to the left shoulder while pushing the hand vice versa. 5. Cervical flexion: Participants will be instructed to sit in an upright position and lean the neck slightly forward, place palm of both hands on forehead and push the head towards the hands while resisting the movement with hands. 6. Cervical extension: Participants will be instructed to sit in an upright position and keep the neck straight, put palm of both hands behind the head, push the head backwards the hands while resisting the movement with hands. 36
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The following participants will be included into this study: i. Individual with or without referral to the clinic ii. Male and female individual with neck pain due to smartphone addiction iii. Individuals who have moderate score (4-6) on NPRS The following participants will be excluded from this study: i. Individual with history of previous neck surgeries or trauma. ii. Individual with neck pain due to underlying condition. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 15 Year(s) 45 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
No 07/06/2024 College of Medicine of the University of Lagos Health Research Ethics Committee.
Ethics Committee Address
Street address City Postal code Country
Surulere Idi araba street Lagos 101283 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Smartphone Addiction Scale and Numerical Pain Rating Scale. Only once which is the pre intervention outcome measure
Secondary Outcome Pain Disability Index , pain self efficacy questionnaire, Insomnia Severity Index and Depression nd Anxiety Stress Scale. The outcomes will be measured pre intervention, during intervention and after intervention.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital and virtual Surulere, idi araba Lagos 101283 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funded Ya zara street Damaturu 620101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Asmau Ahmad Tijjani Ya zara street Damaturu 620101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Asmau Ahmad Tijjani ahmdasmau03@gmail.com 07036660002 Ya zara street
City Postal code Country Position/Affiliation
Damaturu 620101 Nigeria Researcher
Role Name Email Phone Street address
Public Enquiries Ganiyu Sokunbi Oluwaleke gsokunbi.pth@buk.edu.ng 08138468412 BUK old site
City Postal code Country Position/Affiliation
Kano 700231 Nigeria Professor
Role Name Email Phone Street address
Scientific Enquiries Asiyat K. Akodu Aakodu@unilag.edu.ng 08059643996 Surulere
City Postal code Country Position/Affiliation
Lagos 101283 Nigeria Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data collected during the trail, after deidentification sharing statement will be done Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol It will be available immediately following publication with no end date specified Researchers who provide methodological sound proposal
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