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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: www.pactr.org

Trial no.: PACTR201303000500157 Date registered: 2013/02/09
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
Purpose of the trial Treatment
Anticipated trial start date 2012-01-09
Actual trial start date 2012-05-01
Anticipated date of last follow up 2014-12-31
Actual date of last follow up
Anticipated target sample size (number of participants) 102   
Actual target sample size (number of participants)   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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

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
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 Min age Max 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 Years 90 Years 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 2011/10/28 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 2011/10/28 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
A Basson physiotherapist 407 Stonewall Ave Pretoria 0043 South Africa
H Steenkamp physiotherapist Rubenstein drive Pretoria 0045 South Africa
L vd Berg Physiotherapist Heuwel rd Centurion 0063 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

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

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Mrs Cato Annaie Henning nee Basson annalieb@intekom.co.za +27129914499 +27862169918
Street address City Postal code Country Position / Affiliation
407 Stonewall Ave Pretoria 0043 South Africa Private Practice
Role Name Email Phone Fax
Public Enquiries Ms Annalie Basson annalieb@intekom.co.za +27129914499 +27862169918
Street address City Postal code Country Position / Affiliation
407 Stonewall Ave Pretoria 0043 South Africa Private Practice
Role Name Email Phone Fax
Scientific Enquiries Prof Aimee Stewart aimee.stewart@wits.ac.za +27117173718 +27117173719
Street address City Postal code Country Position / Affiliation
1 Jan Smuts Ave Braamfontein 2000 South Africa Associate Proffessor