Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000446066
Ethics application status
Approved
Date submitted
28/05/2010
Date registered
1/06/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Short-term efficacy of neural mobilisation for patients with nerve-related neck and arm pain
Scientific title
Short-term efficacy of standardised neural mobilisation for patients with nerve-related neck and unilateral arm pain
Secondary ID [1] 251879 0
Nil
Universal Trial Number (UTN)
U1111-1115-1797
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical radicular pain 257475 0
Condition category
Condition code
Musculoskeletal 257627 257627 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants assigned to neural mobilisation will receive one-on-one treatments with a physiotherapist (4 treatments over 2 weeks). The physiotherapist will apply 2 manual therapy techniques and prescribe 2 nerve gliding exercises for a home program at each treatment session. The manual therapy techniques include a cervical lateral glide away from the symptomatic arm and a shoulder girdle oscillation technique. Each manual therapy technique will be applied for a total of 4 minutes at each treatment session. The nerve gliding exercises for the home program include a 'sliding' technique and a 'tensioning' technique biased toward the median nerve and cervical nerve roots. In a 'sliding' technique, a movement that lengthens the median nerve bed (e.g., elbow and wrist extension) is counterbalanced by another movement that shortens the nerve bed (e.g., neck side-bending toward the symptomatic arm). A 'tensioning' technique involves simultaneous movements that lengthen the median nerve bed (e.g., elbow and wrist extension combined with neck side-bending away from the symptomatic arm). Participants will perform 10-15 repetitions of the 'sliding' and 'tensioning' techniques 3 times daily on days they do not attend treatment. On days that participants attend treatment, 10-15 repetitions of the 'sliding' and 'tensioning' techniques will be performed under the guidance of the physiotherapist. This will enable the physiotherapist to check that nerve gliding exercises are performed correctly and to progress exercises as necessary. All manual therapy techniques and nerve gliding exercises will not provoke participants' symptoms. The maximum sensory response allowed during each technique is a gentle stretching or pulling sensation that settles immediately upon completion of the technique.
Intervention code [1] 256571 0
Treatment: Other
Intervention code [2] 256572 0
Rehabilitation
Comparator / control treatment
Participants assigned to the wait-and-see approach will not receive any physiotherapy treatment. They will continue their daily activities as tolerated during the 4 weeks of the trial. It is expected that the level of daily activity will vary on a case-by-case basis for participants assigned to the wait-and-see approach.
Control group
Active

Outcomes
Primary outcome [1] 258536 0
Patient-reported improvement on a global rating of change scale
Timepoint [1] 258536 0
Four weeks after baseline
Secondary outcome [1] 264374 0
Neck pain (mean of patient's current, greatest, and least pain over previous 24 hours on 0 - 10 numeric pain rating scale)
Timepoint [1] 264374 0
Four weeks after baseline
Secondary outcome [2] 264375 0
Arm pain (mean of patient's current, greatest, and least pain over previous 24 hours on 0 - 10 numeric pain rating scale)
Timepoint [2] 264375 0
Four weeks after baseline
Secondary outcome [3] 264376 0
Neck Disability Index (0 - 50 points)
Timepoint [3] 264376 0
Four weeks after baseline
Secondary outcome [4] 264377 0
Patient-Specific Functional Scale
Timepoint [4] 264377 0
Four weeks after baseline

Eligibility
Key inclusion criteria
1. Neck pain that spreads into one arm below the level of the deltoid tuberosity

2. Non-traumatic onset of symptoms

3. Symptoms present for at least four weeks

4. Composite pain rating of at least 3/10 (mean of patient's ratings of the average level of neck pain and arm pain during the previous week; pain ratings will be measured with separate 0 - 10 numeric pain rating scales)

5. Symptoms reproduced by a median nerve biased neurodynamic test

6. Ability to speak and read English for self-report items measured at baseline and four weeks after baseline
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Bilateral arm symptoms

2. Traumatic onset of symptoms

3. Two or more abnormal neurologic findings at the same nerve root level (C5 - T1) (i.e., decreased strength, decreased deep tendon reflex, decreased sensation)

4. Evidence of central nervous system involvement

5. Medical "red flags" that suggest non-musculoskeletal pathology

6. Physiotherapy treatment for neck and arm pain in the previous six months

7. Previous surgery on the neck or upper limb

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers will be screened by phone for age, symptom onset and duration, symptom location, composite pain rating, previous physiotherapy treatment, surgical history, and English fluency. Volunteers who pass the phone screen will come to the research lab to provide informed consent and undergo an examination to determine if they meet all enrollment criteria. The examination will confirm enrollment criteria screened by phone and will include assessment of medical "red flags", the median nerve biased neurodynamic test, and neurologic status. Consecutive volunteers who meet all enrollment criteria will be admitted into the study.

Treatment allocation will be concealed. Group assignments have been placed in sealed opaque envelopes by a research not involved in data collection. Another research assistant not involved in data collection will reveal the group assignment to each patient after baseline measurements have been completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent body, The Queensland Clinical Trials Centre, prepared the randomisation list with a computerised random number generator. Block randomisation without stratification has been used to assign participants to the neural mobilisation and wait-and-see groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257067 0
Self funded/Unfunded
Name [1] 257067 0
Neuropathic Pain Research Group, Clinical Centre for Research Excellence in Spinal Pain, Injury and Health, School of Health and Rehabilitation Sciences, The University of Queensland
Country [1] 257067 0
Australia
Primary sponsor type
Individual
Name
Robert Nee
Address
Neuropathic Pain Research Group,
Clinical Centre for Research Excellence in Spinal Pain, Injury and Health,
School of Health and Rehabilitation Sciences,
The University of Queensland,
Brisbane, QLD 4072
Country
Australia
Secondary sponsor category [1] 256323 0
Individual
Name [1] 256323 0
Bill Vicenzino
Address [1] 256323 0
Clinical Centre for Research Excellence in Spinal Pain, Injury and Health,
School of Health and Rehabilitation Sciences,
The University of Queensland,
Brisbane, QLD 4072
Country [1] 256323 0
Australia
Secondary sponsor category [2] 256324 0
Individual
Name [2] 256324 0
Gwen Jull
Address [2] 256324 0
Clinical Centre for Research Excellence in Spinal Pain, Injury and Health,
School of Health and Rehabilitation Sciences,
The University of Queensland,
Brisbane, QLD 4072
Country [2] 256324 0
Australia
Secondary sponsor category [3] 256325 0
Individual
Name [3] 256325 0
Joshua Cleland
Address [3] 256325 0
Department of Physical Therapy,
College of Graduate and Professional Studies,
Franklin Pierce University,
Rindge, NH 03461
Country [3] 256325 0
United States of America
Secondary sponsor category [4] 256326 0
Individual
Name [4] 256326 0
Michel Coppieters
Address [4] 256326 0
Neuropathic Pain Research Group,
Clinical Centre for Research Excellence in Spinal Pain, Injury and Health,
School of Health and Rehabilitation Sciences,
The University of Queensland,
Brisbane, QLD 4072
Country [4] 256326 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259091 0
Medical Research Ethics Committee, The University of Queensland
Ethics committee address [1] 259091 0
The University of Queensland,
Brisbane, QLD 4072
Ethics committee country [1] 259091 0
Australia
Date submitted for ethics approval [1] 259091 0
Approval date [1] 259091 0
05/03/2009
Ethics approval number [1] 259091 0
2009000194

Summary
Brief summary
Some patients with neck and arm pain have symptoms because nerves in the neck and arm have become overly sensitive to movement. There is some evidence that this type of neck and arm pain can be well managed with specific treatment to the nerves in the neck and arm (nerve mobilisation). However, the evidence is limited and we cannot predict which patients respond best to nerve mobilisation. The primary aim of this trial is to determine whether nerve mobilisation leads to clinically important improvements in pain and function for patients with nerve-related neck and arm pain. The secondary aim is to determine if a set of clinical findings can accurately predict which patients with nerve-related neck and arm pain will respond best to nerve mobilisation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31231 0
Address 31231 0
Country 31231 0
Phone 31231 0
Fax 31231 0
Email 31231 0
Contact person for public queries
Name 14478 0
Michel Coppieters
Address 14478 0
Neuropathic Pain Research Group,
Clinical Centre for Research Excellence in Spinal Pain, Injury and Health,
School of Health and Rehabilitation Sciences,
The University of Queensland
Brisbane, QLD 4072
Country 14478 0
Australia
Phone 14478 0
+61 7 3365 1644
Fax 14478 0
+61 7 3365 1622
Email 14478 0
[email protected]
Contact person for scientific queries
Name 5406 0
Michel Coppieters
Address 5406 0
Neuropathic Pain Research Group,
Clinical Centre for Research Excellence in Spinal Pain, Injury and Health,
School of Health and Rehabilitation Sciences,
The University of Queensland
Brisbane, QLD 4072
Country 5406 0
Australia
Phone 5406 0
+61 7 3365 1644
Fax 5406 0
+61 7 3365 1622
Email 5406 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNeural tissue management provides immediate clinically relevant benefits without harmful effects for patients with nerve-related neck and arm pain: A randomised trial.2012https://dx.doi.org/10.1016/S1836-9553%2812%2970069-3
EmbaseBaseline characteristics of patients with nerve-related neck and arm pain predict the likely response to neural tissue management.2013https://dx.doi.org/10.2519/jospt.2013.4490
N.B. These documents automatically identified may not have been verified by the study sponsor.