ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000175279

Ethics application status

Approved

Date submitted

15/09/2017

Date registered

5/02/2018

Date last updated

23/01/2019

Date data sharing statement initially provided

23/01/2019

Date results provided

23/01/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Comparison between neural mobilization techniques and joint articulation on patients suffering from neck pain only.

Scientific title

Effect of neural mobilization techniques compared to joint articulation on pain levels in patients suffering from neck pain only

Secondary ID [1]

'Nil known'

Universal Trial Number (UTN)

U1111-1202-2117

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

mechanical non-specific neck pain

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention: In addition to a weekly standard osteopathic treatment, a group of 10 participants will receive bilateral ULNT1 mobilizations while, the other, acromioclavicular mobilizations grade 1. Follow-up: one session per week for 5 weeks or less if the patient, practitioners or tutor consider inappropriate continuing with further sessions.
Both standard osteopathic sessions will be performed by third and fourth year students in Osteopathy, supervised by registered and experienced osteopaths. Each session will last 40 minutes and include soft tissue, mobilization, muscle energy, myofascial release, high velocity low amplitude, functional techniques, advices or home exercises according to what is most suitable to each patient at that time. On top of that, an interventional group will get 2*10 upper limb neuromobilization techniques (ULNT1 median nerve bias) mobilizations, while the control, acromioclavicular mobilizations grade 1. Sequence included within ULNT1 mobilizations will consist in: shoulder girdle depression, glenohumeral abduction to 110°, forearm supination, wrist and finger extension, glenohumeral external rotation and elbow extension as final component of the succession system. Both interventional and control group will approximately last 10 minutes each.
These two different approaches, will follow the osteopathic treatment and will be performed by a MSc student currently attending his second and last year (main researcher and author of this trial) of the Master course in Osteopathy. He is also a recognised HCPC physiotherapist with experience in Neurodynamic mobilizations. Each degree of movement will be monitored by the use of a goniometer.
Material required are:
- Consent form and Screening health Questionnaire
- Visual Analogue Scale (VAS), Neck Disability Index Scale and a Mark-10 algometer (applied on the area of main pain) which will subjectively and objectively measure the patient's pain level.
- Plinth
- Chair while patient waits to enter the treatment room.
- Cover plinth

Intervention code [1]

Rehabilitation

Comparator / control treatment

Acromioclavicular mobilizations grade 1.
Patient, laying supine, brings his hand on the opposite shoulder so that the arm is anteriorly flexed at 90 degrees, adducted and internally rotated.
The examiner, at this point, will proximally stabilize the joint while moving the other extremity with the opposite hand for 4 minutes. If patient shows pain the movement will be stopped earlier.

Control group

Active

Outcomes

Primary outcome [1]

Neck pain assessed using 100mm VAS.

Timepoint [1]

Before the first session and at the end of each.

Secondary outcome [1]

NDI - Neck disability index scale

Timepoint [1]

Before the first session and at the end of the last.

Secondary outcome [2]

Mark- 10 Corp algometer

Timepoint [2]

Before the first session and at the end of each.

Eligibility

Key inclusion criteria

- Patients suffering from mechanical non specific neck pain with no symptoms to arms or torso and that resulted negative to at least two of the following tests:
Spurling's test
Valsalva maneuver
Neck distraction test
Shoulder abduction test
- Subjects with an adequate English proficiency

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• Participants unable to lie comfortably in a supine position for at least 5 minutes
• Pre-existing diagnosed neck or upper limb pathologies or comorbid condition that may
affect neck or upper limb function;
• Cognitive or communicative deficits which would prevent the patient from providing
accurate feedback;
• Traumatic pathology of the arm;
• Red flags noted in the medical screening questionnaire such as tumour, fracture, infections,
history of metabolic disease, spinal surgery or prolonged use of corticosteroid use;
• Signs of central nervous system involvement;
• Inability to lie supine;
• History of diagnosed pathologies such as Parkinsonism, Alzheimer, Amyotrophic lateral
sclerosis , Multiple sclerosis, Guillain-Barré syndrome.

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)

sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using procedures like coin-tossing

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Parallel

Other design features

Considering the division of the experiment in two parts, it is important to clarify that:
all the 20 participants (blinded from the type of treatment) will receive standard osteopathic sessions by third and fourth year student of the Master Integrated Course in Osteopathy within the University College of Osteopathy.
Following that, both groups will be treated by the main researcher of the study (who is unmasked and knows about subjects' belonging to the case or control group). He will carry one of the two interventions by himself without let the student that had previously performed the treatment, to see the type of technique applied. It will reduce study bias.

Phase

Type of endpoint/s

Statistical methods / analysis

The sample size was calculated according to practicality, logistical and timing restrictions. The pilot research design is moreover considered as the most suitable for a possible larger trial (Ross-McGill et al., 2000; Burrows et al., 2001) by examining procedures, applicability and usefulness for further investigations (Hicks, 2009).

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

30/10/2017

Date of last participant enrolment

Anticipated

Actual

25/01/2018

Date of last data collection

Anticipated

23/02/2018

Actual

23/02/2018

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

United Kingdom

State/province [1]

London

Funding & Sponsors

Funding source category [1]

University

Name [1]

University College of Osteopathy

Address [1]

275 Borough High Street, London
United Kingdom
SE1 1JE

Country [1]

United Kingdom

Primary sponsor type

University

Name

University College Of Osteopathy

Address

275 Borough High Street, London
United Kingdom
SE1 1JE

Country

United Kingdom

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UCO Research Ethics Committee (UCO REC)

Ethics committee address [1]

275 Borough High Street, 
London 
SE1 1JE

Ethics committee country [1]

United Kingdom

Date submitted for ethics approval [1]

29/09/2017

Approval date [1]

19/10/2017

Ethics approval number [1]

UCO REC

Summary

Brief summary

Neurodynamic mobilizations (NM) have often been evaluated as useful diagnostic and therapeutic tools in case of nervous system impairment. However, no study has ever appraised their applicability in patients suffering from mechanical non-specific neck pain (MNSNP) or within the osteopathic field. For this purpose, eleven patients with MNSNP, in addition to the standard black box pragmatic osteopathic session, were  randomly assigned to either an intervention group of ULNT1a with median nerve bias (1a), or to an active control group of articulations of the acromion clavicular joint.
Considering the different myofascial mechanical load provided, the experimental hypothesis was ULNT1a group to show significantly greater improvements than the control group.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Vincenzo Masullo

Address

University College of Osteopathy
275 Borough High Street, London
SE1 1JE

Country

United Kingdom

Phone

+447845438739

Fax

vincenzomasu@hotmail.it

Contact person for public queries

Name

Mike Ford

Address

University college of Osteopathy
275 Borough High Street, London
SE1 1JE

Country

United Kingdom

Phone

+44 20 7407 0222

Fax

MikeFord@uco.ac.uk

Contact person for scientific queries

Name

Mike Ford

Address

University college of Osteopathy
275 Borough High Street, London
SE1 1JE

Country

United Kingdom

Phone

+44 207089 5353

Fax

MikeFord@uco.ac.uk

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

age, clinical temporal profile of the symptoms, analytical results from the clinical examination, screening health questionnaire.

When will data be available (start and end dates)?

Immediately after the pubblication, up to the 3rd of May 2024, as mentioned in the "Confidentiality and anonymity" part of the Ethics approval part received by the BSO Research Ethics Committee (BSOREC).

Available to whom?

Researchers with a methodological proposal, with the permission of the BSO Research Ethics Committee (BSOREC) and mine, author of the study.

Available for what types of analyses?

Any purpose.

How or where can data be obtained?

Access subjected to approvals by the BSO Research Ethics Committee (BSOREC) and myself, author of the study.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1127	Ethical approval					373661-(Uploaded-22-01-2019-01-42-04)-Study-related document.docx

Results publications and other study-related documents

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