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.: PACTR201705002269381 Date of Approval: 06/05/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intrasound and Phonophoresis in Chronic Cervical Pain
Official scientific title Comparison of the Therapeutic Efficacy of Intrasound Therapy and Sodium Diclofenac Phonophoresis in the Management of Mechanical Chronic Cervical Spine Pain
Brief summary describing the background and objectives of the trial Prior studies have shown the efficacy of Intrasound Therapy (IST) in managing Osteoarthritis of the knee when compared with TENS but no comparative study has been done on its efficacy in the management of chronic cervical spine pain (CCSP) when compared with Sodium Diclofenac Phonophoresis (SDP). The aim of this study was to carry out a comparative study on the therapeutic efficacy of SDP and IST in the management of chronic cervical spine pain (CCSP).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mechanical Chronic Cervical Spine Pain,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial comparative study on the therapeutic efficacy of SDP and IST in the management of chronic cervical spine pain
Anticipated trial start date 09/02/2016
Actual trial start date 14/03/2016
Anticipated date of last follow up 23/06/2016
Actual Last follow-up date 15/07/2016
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 47
Recruitment status Completed
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 Fish bowl method The research assistant allocating the subjects was blinded to the groups Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Exercise and Massage Twice a week 20 minutes Massage, Isometric exercises, Muscle energy technique, Manual cervical traction 15 Active-Treatment of Control Group
Experimental Group Intrasound Group Twice a week 30 minutes Intrasound therapy, Massage, Isometric exercises, Muscle energy technique, Manual cervical traction 15
Experimental Group Phonophoresis Group Twice a week 30 minutes Sodium Diclophenac Phonophoresis, Massage, Isometric exercises, Muscle energy technique, Manual cervical traction 15
Experimental Group Group 1 Twice a week 40 minutes Sodium Diclophenac Phonophoresis, Massage, Isometric exercises, Muscle energy technique, Manual cervical traction 15
Experimental Group Group 2 Twice a week 40 minutes Intrasound therapy, Massage, Isometric exercises, Muscle energy technique, Manual cervical traction 15
Control Group Group 3 Twice a week 40 minutes Massage, Isometric exercises, Muscle energy technique, Manual cervical traction 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Chronic neck pain with definite diagnoses: Axial neck pain Whiplash associated disorder Cervical Spondylosis Severe chronic neck pain (using the Neck Disability Index Scores) Cognitive limitations Prior surgery of the cervical or upper thoracic spine. Rheumatic or degenerative conditions of the neck outside cervical spondylosis 35 Year(s) 76 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 14/04/2016 Health, Research & Ethics Committee of the Lagos University Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Idi-Araba Lagos 02341 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain Baseline End of treatment at 4 weeks
Primary Outcome Range of Movement Baseline 4 weeks post-intervention
Secondary Outcome Disability Baseline 4 weeks post-intervention
Secondary Outcome Quality of Life Baseline 4 weeks post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Physiotherapy Outpatient Clinic of the Lagos University Teaching Hospital, Idi-Araba, Lagos Idi-Araba Lagos 02341 Nigeria
Physiotherapy OUtpatient Clinic of the National Orthopaedic Hospital, Igbobi, Lagos Igbobi, Fadeyi Lagos 02341 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Authors' Personal Resources Idi-Araba Lagos 02341 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor College of Medicine, University of Lagos Idi-Araba Lagos 02341 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Dr Ayoola Aiyegbusi Idi-Araba Lagos 02341 Nigeria
Mr Hassan Sanni Idi-Araba Lagos 02341 Nigeria
Prof SRA Akinbo Idi-Araba Lagos 02341 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ayoola Aiyegbusi aaiyegbusi@unilag.edu.ng 2348023212513 Idi-Araba
City Postal code Country Position/Affiliation
Lagos 02341 Nigeria Senior Lecturer, College of Medicine, University of Lagos
Role Name Email Phone Street address
Public Enquiries Hassan Sanni tsanni58@yahoo.com 2348181498707 Idi-Araba
City Postal code Country Position/Affiliation
Lagos 02341 Nigeria Graduate Physiotherapist
Role Name Email Phone Street address
Scientific Enquiries Sunday Akinbo sraakinbo@cmul.edu.ng 2348028952344 Idi-Araba
City Postal code Country Position/Affiliation
Lagos 02341 Nigeria Professor, College of Medicine, University of Lagos
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information