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.: PACTR202106715244474 Date of Approval: 07/06/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of Pilates and Isometric Neck Strengthening Exercises on Pain, Neck Disability, Psychological Status and Sleep Disturbance in Patients with Non-specific Chronic Neck Pain
Official scientific title Effects of Pilates and Isometric Neck Strengthening Exercises on Pain, Neck Disability, Psychological Status and Sleep Disturbance in Patients with Non-specific Chronic Neck Pain
Brief summary describing the background and objectives of the trial This study determines the effects of Pilates exercise and isometric neck strengthening exercise on pain, neck disability, psychological status and sleep disturbance in patients with non-specific chronic neck pain. The specific objectives of this study are: 1. To determine the effects of Pilates exercise, plus neck care education, plus soft tissue massage on pain, neck disability, psychological status (anxiety and depression) and sleep disturbance in patients with NSCNP. 2. To determine the effects of isometric neck strengthening exercise, plus neck care education on pain, neck disability, psychological status (anxiety and depression) and sleep disturbance in patients with NSCNP. 3. To compare the effects of Pilates exercise, plus neck care education, plus soft tissue massage and isometric neck strengthening exercise, plus neck care education, plus soft tissue massage on pain, neck disability, psychological status (anxiety and depression) and sleep disturbance in patients with NSCNP. To determine the effects of neck care education and soft tissue massage on pain, neck disability, psychological status (anxiety and depression) and sleep disturbance in patients with NSCNP.
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 Education /Training
Anticipated trial start date 02/08/2020
Actual trial start date
Anticipated date of last follow up 05/10/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants)
Recruitment status 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 a randomization table created by a computer software program Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pilates exercise twice weekly 8 weeks patients will receive Pilates exercise plus neck care education plus soft tissue massage for a period of 20 minutes; on a frequency of 2 treatment session peer week for 8 weeks 12
Experimental Group isometric neck strengthening exercise twice weekly 8 weeks patients will receive isometric neck strengthening exercise plus neck care education plus soft tissue massage for a period of 20 minutes; on a frequency of 2 treatment session peer week for 8 weeks 12
Control Group soft tissue massage and neck care education twice weekly 8 weeks patients will receive neck care education plus soft tissue massage for a period of 15 minutes; on a frequency of 2 treatment session per week for 8 weeks 12 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
I. Participants with history of non-specific chronic neck pain, with or without pain radiating to one or both upper limbs. II. Participants with non-specific chronic neck pain with 5/10 and above level of pain on Numeric Pain Rating Scale. I. Patients with non-specific chronic neck pain with previous spinal surgeries and deformity. II. Patients with non-specific chronic neck pain with history of trauma to the neck. III. Patients with specific neck pain e.g. referred pain as a result of malignancy. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 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 23/09/2020 CMUL HREC
Ethics Committee Address
Street address City Postal code Country
2 nd Floor Biomedical Engineering Block College of Medicine University of Lagos, Idi-Araba, Lagos P.M.B.12003, Lagos Nigeria Lagos 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome neck disability assessment pre and post intervention-0, 4th and 8th wk
Secondary Outcome Psychological status pre and post intervention - 0, 4th and 8th week
Secondary Outcome sleep disturbance pre and post intervention- 0, 4th and 8th week
Primary Outcome Pain threshold Pre and post intervention - 0, 4th and 8th week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos university teaching hospital idi araba lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Chidozie Eric Odidika Physiotherapy department, College of medicine , University of Lagos Lagos Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Odidika Chidozie Eric Physiotherapy department, College of medicine university of Lagos Lagos Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Ashiyat Akodu Physiotherapy department, College of Medicine, University of Lagos Lagos Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chidozie Odidika rickman2ace@gmail.com +2347038000486 Physiotherapy department, College of Medicine, University of Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Master student
Role Name Email Phone Street address
Public Enquiries Chidozie Odidika rickman2ace@gmail.com +2347038000486 Physiotherapy department, College of Medicine, University of Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Master student
Role Name Email Phone Street address
Scientific Enquiries Ashiyat Akodu akoduashiyat@yahoo.com +2348034269053 Physiotherapy department, college of medicine, University of Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary of Individual participant data will be made available. Data to be shared will include IPD that underlie the results that will be reported in this article. Informed Consent Form,Statistical Analysis Plan,Study Protocol immediately following publication Researchers with methodological proposals
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