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.: PACTR201303000500157 Date of Approval: 09/02/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Neural Mobilisation for cervico- brachial pain
Official scientific title The effect of neural mobilisation on cervico-brachial pain
Brief summary describing the background and objectives of the trial Patients with neck and arm pain are more disabled than patients with only neck pain or radicular pain. Cervico-brachial pain syndrome is an upper quarter pain syndrome in which neural tissue sensitivity to mechanical stimulus is thought to play a role. Objectives of study,To establish the effect of NM on the pain, function and quality of life of patients with acute cervico-brachial pain. To establish if high catastrophising scores and neuropathic pain have an influence on treatment outcomes
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Neck, arm, pain,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 02/01/2012
Actual trial start date 01/05/2012
Anticipated date of last follow up 27/10/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 102
Actual target sample size (number of participants) 86
Recruitment status Closed to recruitment,follow-up continuing
Publication URL http://www.biomedcentral.com/1471-2474/15/419
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 computer generated randomisation 2:1 ratio Independent assistant supply allocation by telephone after baseline measures have been done Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group usual care discretion of treating physiotherapist treatment of half an hour to an hour joint mobilisation, exercise, advice 34 Active-Treatment of Control Group
Experimental Group Neural Mobilisation discretion of the treating physiotherapist treatment of half an hour to an hour Cervical and throacic mobilisation, exercise, advice to satay active and neural mobilisation 68
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Patients over the age of 18 years. 2.Patients with cervico-brachial pain according to Hall and Elvey (1999) who present with the following a.Positive upper limb neurodynamic test 1 (ULNT1) b.Mechanical allodynia along the course of the nerve c.Pain in neck and/or shoulder / arm / hand 3.Pain present for less than 12 weeks 1.Previous surgery of the cervical spine 2.Serious neurological signs such as signs of spinal cord pressure or involvement of more than two nerve roots. 3.Medical ¿red flag¿ conditions such as carcinoma or inflammatory diseases. 4.Spinal cord compression. 5.Previous or recent cervical spine fractures 18 Year(s) 90 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 28/10/2011 Human Research Ethics Committee University of Witwatersrand
Ethics Committee Address
Street address City Postal code Country
Senate House, Main Campus Johannesburg 0002 South Africa
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 28/10/2011 Human Research Ethics Committee University of Witwatersrand
Ethics Committee Address
Street address City Postal code Country
Senate House, Main Campus Johannesburg 0002 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain baseline 3 weeks 6 weeks 6 months 12 months
Primary Outcome function baseline 3 weeks 6 weeks 6 months 12 months
Primary Outcome quality of life baseline 3 weeks 6 weeks 6 months 12 months
Secondary Outcome neuropathic pain baseline 6 months 12 months
Secondary Outcome upper limb neurodynamic test baseline 6 months 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
L vd Berg Physiotherapist Heuwel rd Centurion 0063 South Africa
A Basson physiotherapist 407 Stonewall Ave Pretoria 0043 South Africa
H Steenkamp physiotherapist Rubenstein drive Pretoria 0045 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South Africans Society of Physiotherapists Research Fund Parade on kloof Bedfordview 0002 South Africa
Medical Faculty Research Endowment Fund of the University of the Witwatersrand 7 York road Park Town 2193 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of the Witwatersrand 1 Jan Smuts Ave Braamfontein 2000 South Africa University
COLLABORATORS
Name Street address City Postal code Country
R Ellis Private Bag 92006 Auckland 1142 New Zealand
M W Coppieters Amsterdam Netherlands
B Olivier 7 York road Park Town 2193 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Cato Annaie Henning nee Basson annalieb@intekom.co.za +27129914499 407 Stonewall Ave
City Postal code Country Position/Affiliation
Pretoria 0043 South Africa Private Practice
Role Name Email Phone Street address
Public Enquiries Annalie Basson annalieb@intekom.co.za +27129914499 407 Stonewall Ave
City Postal code Country Position/Affiliation
Pretoria 0043 South Africa Private Practice
Role Name Email Phone Street address
Scientific Enquiries Aimee Stewart aimee.stewart@wits.ac.za +27117173718 1 Jan Smuts Ave
City Postal code Country Position/Affiliation
Braamfontein 2000 South Africa Associate Proffessor
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information