ANZCTR - Registration

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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]

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

Condition category

Condition code

Musculoskeletal

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]

Treatment: Other

Intervention code [2]

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]

Patient-reported improvement on a global rating of change scale

Timepoint [1]

Four weeks after baseline

Secondary outcome [1]

Neck pain (mean of patient's current, greatest, and least pain over previous 24 hours on 0 - 10 numeric pain rating scale)

Timepoint [1]

Four weeks after baseline

Secondary outcome [2]

Arm pain (mean of patient's current, greatest, and least pain over previous 24 hours on 0 - 10 numeric pain rating scale)

Timepoint [2]

Four weeks after baseline

Secondary outcome [3]

Neck Disability Index (0 - 50 points)

Timepoint [3]

Four weeks after baseline

Secondary outcome [4]

Patient-Specific Functional Scale

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

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

Address [1]

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 [1]

Australia

Primary sponsor type

Individual

Name

Robert Nee

Address

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Bill Vicenzino

Address [1]

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]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Gwen Jull

Address [2]

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]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Joshua Cleland

Address [3]

Department of Physical Therapy,
College of Graduate and Professional Studies,
Franklin Pierce University,
Rindge, NH 03461

Country [3]

United States of America

Secondary sponsor category [4]

Individual

Name [4]

Michel Coppieters

Address [4]

Country [4]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Medical Research Ethics Committee, The University of Queensland

Ethics committee address [1]

The University of Queensland,
Brisbane, QLD 4072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

05/03/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Michel Coppieters

Address

Country

Australia

Phone

+61 7 3365 1644

Fax

+61 7 3365 1622

m.coppieters@uq.edu.au

Contact person for scientific queries

Name

Michel Coppieters

Address

Country

Australia

Phone

+61 7 3365 1644

Fax

+61 7 3365 1622

m.coppieters@uq.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Neural tissue management provides immediate clinically relevant benefits without harmful effects for patients with nerve-related neck and arm pain: A randomised trial.	2012	https://dx.doi.org/10.1016/S1836-9553%2812%2970069-3
Embase	Baseline characteristics of patients with nerve-related neck and arm pain predict the likely response to neural tissue management.	2013	https://dx.doi.org/10.2519/jospt.2013.4490

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically