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.: PACTR202407678852150 Date of Approval: 19/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Efficacy of Telerehabilitation-Based and Clinic-Based Neck Stabilization Exercises on Selected Clinical And Psychological Variables In Patients with Non-Specific Chronic Neck Pain.
Official scientific title Comparative Efficacy of Telerehabilitation-Based and Clinic-Based Neck Stabilization Exercises on Selected Clinical And Psychological Variables In Patients with Non-Specific Chronic Neck Pain.
Brief summary describing the background and objectives of the trial Neck pain is a significant personal and socioeconomic burden, affecting over 30% annually and ranking as the fourth most common disability. Non-specific chronic neck pain, caused by mechanical and postural factors, significantly reduces quality of life, leading to psychological and social issues. Pain-related disability limits physical, occupational, and social functioning. Kinesiophobia, the fear of movement due to pain, exacerbates chronic pain, anxiety, and depression, further diminishing quality of life. Neck stabilization exercises, aimed at improving muscle control and stabilizing the spine, have been shown to reduce pain and disability. Both clinic-based and telerehabilitation-based neck stabilization exercises improve pain, disability, and exercise adherence. However, there is a lack of studies comparing their efficacy on psychological variables such as kinesiophobia, anxiety, and depression. This trial seeks to compare the effectiveness of telerehabilitation-based and clinic-based neck stabilization exercises in managing pain-related disability and psychological factors in patients with non-specific chronic neck pain. The main study objectives are; 1To determine the efficacy of telerehabilitation-based neck stabilization exercise on pain-related disability, and psychological variables (Kinesiophobia,depression and anxiety) of patients with non-specific chronic neck pain. 2. To determine the efficacy of clinic-based neck stabilization exercise in the management of pain-related disability,and psychological variables (Kinesiophobia, depression and anxiety) of patients with non-specific chronic neck pain. 3. To compare the efficacy of telerehabilitation-based neck stabilization exercise and clinic-based neck stabilization exercise on pain-related disability, and psychological variables (Kinesiophobia, depression and anxiety) 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
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 20/02/2024
Actual trial start date 20/02/2024
Anticipated date of last follow up 24/05/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants) 36
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Telerehabilitation based Neck Stabilization Exercises Two times a week 8 week Participants will engage in a telerehabilitation-based neck-stability exercise program using pre-recorded videos for 30 minutes, twice a week for eight weeks. Exercises will be supervised virtually via video conferencing, video visits, phone calls, and text messages. They will receive initial training on exercise positions and durations before starting. Monitoring and feedback will be provided throughout the program. Chin Tuck-in: Participant lies supine on the plinth or exercise mat with the neck supported. Participant will be instructed to tuck their chin in or look at the floor without bending their head -12 counts for 2 sets. Participants will hold each count for 5 seconds (Anuja et al, 2012). Head lift: Patient will lie supine on the plinth or exercise mat and will be instructed to tuck their chin in and lift the head just 3-4 inches above the floor and return their head – 12 repetition, 3 sets (Anuja et al, 2012). Neck flexion: Patient will lie supine, knees bent and feet on the floor, they will be instructed to put their fingers at the base of the skull and lift about 1/8th inch above the floor and feel for a bony bump (7th cervical vertebrae) and the instructed to gradually release their head – 12 repetitions, 3 sets (Anuja et al, 2012). Craniocervical flexion with cervical flexion: Patient will lie supine and be instructed to tuck the chin and lift the head off so that the chin touches the chest (Anuja et al, 2012). Shoulder blade stabilization: This is an integral part for neck stabilization. Participants will be instructed to stand with arms by the sides and the head and neck kept in neutral position, with chest lifted patients will gently but firmly blades backward and downwards. Patient will hold for 10 seconds and perform 2 sets of 5 repetitions. Patient will gradually progress to 20 seconds hold, 2 sets of 10 repetitions (Anuja et al, 2012). Patients will progress to the next phase of exercises at week 4 if they can perform the initial exercises with good control and endurance. For craniocervical flexion with cervical flexion, patients will manually apply resistance, starting with 3 sets of 12 repetitions for 2 weeks, progressing to 3 sets of 15 repetitions by week 6. For the chin tuck-in, patients will switch to a quadruped position and perform 3 sets of 15 repetitions. 18
Control Group Clinic Based Neck Stabilization Exercises Two times per week 8 weeks This group of patients will be treated in the clinic. Chin Tuck-in: Participant lies supine on the plinth or exercise mat with the neck supported. Participant will be instructed to tuck their chin in or look at the floor without bending their head -12 counts for 2 sets. Participants will hold each count for 5 seconds (Anuja et al, 2012). Head lift: Patient will lie supine on the plinth or exercise mat and will be instructed to tuck their chin in and lift the head just 3-4 inches above the floor and return their head – 12 repetition, 3 sets (Anuja et al, 2012). Neck flexion: Patient will lie supine, knees bent and feet on the floor, they will be instructed to put their fingers at the base of the skull and lift about 1/8th inch above the floor and feel for a bony bump (7th cervical vertebrae) and the instructed to gradually release their head – 12 repetitions, 3 sets (Anuja et al, 2012). Craniocervical flexion with cervical flexion: Patient will lie supine and be instructed to tuck the chin and lift the head off so that the chin touches the chest (Anuja et al, 2012). Shoulder blade stabilization: This is an integral part for neck stabilization. Participants will be instructed to stand with arms by the sides and the head and neck kept in neutral position, with chest lifted patients will gently but firmly blades backward and downwards. Patient will hold for 10 seconds and perform 2 sets of 5 repetitions. Patient will gradually progress to 20 seconds hold, 2 sets of 10 repetitions (Anuja et al, 2012). Patients will progress to the next phase of exercises at week 4 if they can perform the initial exercises with good control and endurance. For craniocervical flexion with cervical flexion, patients will manually apply resistance, starting with 3 sets of 12 repetitions for 2 weeks, progressing to 3 sets of 15 repetitions by week 6. For the chin tuck-in, patients will switch to a quadruped position and perform 3 sets of 15 repetitions. 18 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Participants referred to physiotherapy outpatient’s clinic with diagnosis of radiating or non-radiating non-specific chronic neck pain. 2.Patients who have smartphones and can operate at a basic level. Participants with cognitive limitations. 2. Participants with medical or surgical conditions which may hinder exercise performance e.g Systemic lupus erythematosus, Lymphedema. 3. Participants who have a history of orthopedic problems including conditions of the neck that would affect their abilities to sustain neck stability exercise. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 10/02/2024 COLLEGE OF MEDICINE OF THE UNIVERSITY OF LAGOS HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
2nd Floor Biomedical Engineering Block College of Medicine University of Lagos, Idi-Araba, Lagos Lagos 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain Disability. Pre -intervention stage. At 4 weeks. At 8 weeks.
Secondary Outcome Kinesiophobia. Levels of Anxiety and Depression. Pre-intervention stage. At 4 weeks. At 8 weeks.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital Idi-Araba Surulere Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Anjola Adebiyi Eleshin street,Ikorodu Lagos Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Anjola Adebiyi College of Medicine, University of Lagos Lagos Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Oluwaseun Fapojuwo College of Medicine,University of Lagos Lagos Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Anjola Adebiyi anjolar911@gmail.com +2347080210009 Eleshin street,Ikorodu
City Postal code Country Position/Affiliation
Lagos Nigeria Principal investigator
Role Name Email Phone Street address
Public Enquiries Oluseun Fapojuwo ofapojuwo@unilag.edu.ng +2348060081382 Department of Physiotherapy, College of Medicine,
City Postal code Country Position/Affiliation
Lagos Nigeria Lecturer
Role Name Email Phone Street address
Scientific Enquiries Anjola Adebiyi anjolar911@gmail.com +2347080210009 Eleshin street,Ikorodu
City Postal code Country Position/Affiliation
Lagos Nigeria Principal Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data to be shared will include specific information about each participant (after deidentification), encompassing demographic details such as age and gender, adherence to clinical interventions, and outcomes measured specific to the study, such as changes in pain related disability,levels of Kinesiophobia,anxiety and depression. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 2nd-20th of august 1. Eligible Requestors: • Researchers affiliated with recognized academic, medical, or research institutions. • Organizations conducting health-related research that aligns with public health interests. 2. Types of Analyses: • IPD will be shared for purposes of secondary analyses that aim to advance scientific knowledge and improve public health outcomes. • Specific types of analyses include meta-analyses, pooled analyses, and further exploratory research related to the original study topic. 3. Data Sharing Mechanism: • Data will be shared via a secure, controlled-access data repository. • Requestors must submit a detailed research proposal outlining the objectives, methodology, and intended use of the data. • Data access will be granted for a specific period, subject to renewal based on progress and continued alignment with the original proposal. 4. Review Process: • A Data Access Committee (DAC) comprising independent experts in the relevant field will review all requests. • The DAC will evaluate proposals based on scientific merit, the potential for public health benefit, and the feasibility of the proposed research. • Ethical considerations, including the protection of participant confidentiality, will be paramount in the review process. 5. Criteria for Reviewing Requests: • The scientific rationale and potential impact of the proposed research. • The qualifications and track record of the requestor and their institution. • The adequacy of the data management plan, including measures for maintaining data security and participant privacy. • The alignment of the proposed research with the original study’s objectives and ethical guidelines. 6. Additional Supporting Information: • Along with IPD, supporting documentation such as study protocols, statistical analysis plans, and informed consent forms will be shared, subject to the same review and approval process.
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