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.: PACTR201402000727807 Date of Approval: 20/12/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECTS OF EXERCISES ON PATIENTS WITH NECK PAIN
Official scientific title EFFECTS OF NECK STABILIZATION AND DYNAMIC EXERCISES ON SELECTED CLINICAL AND PSYCHOSOCIAL VARIABLES IN PATIENTS WITH NON-SPECIFIC NECK PAIN.
Brief summary describing the background and objectives of the trial Background: Nonspecific Neck Pain (NSNP) is neck pain (with or without radiation) without any specific systematic disease being detected as the underlying cause of the complaints (Green, 2008). Neck Pain appears to be very frequent all over the world and in the Western countries in particular. Psychosocial factors play an important role in persisting symptoms and disability, and influence the response to treatment and rehabilitation (Daffner et al, 2003). Exercise programs for managing neck pain differ with regard to duration, training frequency, intensity, and mode of exercise. Previous studies have shown that isometric exercises and strength training can have positive effects on neck pain (Chiu et al 2004). The aim of this study is to investigate the effects of neck stabilization and dynamic exercises on selected clinical and psychosocial variables in patients with non-specific neck pain Research design: This is a randomized clinical trial Method: The participants for this study will be individuals aged between 18 and 65 years with non-specific neck pain (NSNP) who will be placed in either Group A, (the Neck stabilization and dynamic exercise group) or Group B, (the stabilization exercise group). Instrument: 1. Inform consent form, A biodata form, Neck Disability Index Questionnaire, Thera-band, Beck Depression Inventory, Beck Anxiety Inventory, Fear-Avoidance belief Questionnaire, Alternate Visual Analogue Scale-Hausa, World Health Organization Quality of life BREF Questionnaire, Plastic chair, hooks and pulley system, wall bars Procedure: the study¿s procedure will be explained to prospective participants after which a written informed consent will be obtained from them prior to the intervention. Significance: the outcome of this study may serve as a useful tool in the treatment of 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,Non specific neck pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/10/2013
Actual trial start date 20/11/2013
Anticipated date of last follow up 19/12/2013
Actual Last follow-up date 19/12/2013
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
NOHD/RET/ETHIC/60 National Orthopaedic Hospital Dala Kano
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 randomisation by using coin-tossing Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Neck stabilization exercises 45 minute each session, three times in a week for eight weeks for eight weeks Patients do five set of exercises 30
Experimental Group Neck dynamic exercises and stabilization exercises three times in a week 1 hour participant will do neck dynamic exercises with thera-band, three set of exercises and five set of stabilization exercises 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Participant diagnosed with non specific neck pain 2.Participant with moderate to severe pain 3.Participant who can comprehend instruction in English or Hausa 4.Participants who are not involved in any others form of exercise training during the course of the study. 5.The pain should be for more than six weeks duration 6.Participant who consent to participate 1.Patients with co-morbidity that influence overall well-being, examples are sickle cell anaemia 2.Pregnant women with non-specific neck pain 18 Year(s) 60 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 20/09/2013 National orthopaedic hospital research ethics commitee
Ethics Committee Address
Street address City Postal code Country
malam aminu kano way Kano +234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual analogue scale for pain Base line Four weeks Eight weeks
Primary Outcome Neck disability index for neck disability Baseline Four weeks Eight weeks
Primary Outcome Fear avoidance beliefs for neck pain Baseline Four weeks Eight weeks
Secondary Outcome Beck anxiety inventory Baseline Four weeks Eight weeks
Secondary Outcome Beck depression inventory Baseline Four weeks Eight weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Orthopaedic Hospital Aminu kano way Kano +234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
TETFund Gwarzo road Kano +234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bayero University Kano Gwarzo road Kano +234 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Physiotherapy Department Queen Elizabeth road Ibadan +234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bashir Kaka kakabashir2000@gmail.com +2348028460237 Zaria road
City Postal code Country Position/Affiliation
Kano +234 Nigeria Assistant lecturer
Role Name Email Phone Street address
Public Enquiries Rufai Ahmad Y raysalim2001@yahoo.com +234836370098 Zaria road
City Postal code Country Position/Affiliation
Kano +234 Nigeria Lecturer physiotherapy department Bayero university
Role Name Email Phone Street address
Scientific Enquiries Omoyemi Ogwummike yemfide@yahoo.com +2348023256052 Queen Elizabeth road
City Postal code Country Position/Affiliation
Ibadan +234 Nigeria Lecturer physiotherapy department University of Ibadan
REPORTING
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