Trial Review

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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 information initially 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] 292901 0
'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 304752 0
Condition category
Condition code
Physical Medicine / Rehabilitation 304474 304474 0 0
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] 299135 0
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] 303397 0
Neck pain assessed using 100mm VAS.
Timepoint [1] 303397 0
Before the first session and at the end of each.
Secondary outcome [1] 338833 0
NDI - Neck disability index scale
Timepoint [1] 338833 0
Before the first session and at the end of the last.
Secondary outcome [2] 339934 0
Mark- 10 Corp algometer
Timepoint [2] 339934 0
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?
No
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
20
Accrual to date
Final
11
Recruitment outside Australia
Country [1] 9215 0
United Kingdom
State/province [1] 9215 0
London

Funding & Sponsors
Funding source category [1] 297534 0
University
Name [1] 297534 0
University College of Osteopathy
Country [1] 297534 0
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] 296540 0
None
Name [1] 296540 0
Address [1] 296540 0
Country [1] 296540 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298629 0
UCO Research Ethics Committee (UCO REC)
Ethics committee address [1] 298629 0
275 Borough High Street,
London
SE1 1JE
Ethics committee country [1] 298629 0
United Kingdom
Date submitted for ethics approval [1] 298629 0
29/09/2017
Approval date [1] 298629 0
19/10/2017
Ethics approval number [1] 298629 0
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 77702 0
Mr Vincenzo Masullo
Address 77702 0
University College of Osteopathy
275 Borough High Street, London
SE1 1JE
Country 77702 0
United Kingdom
Phone 77702 0
+447845438739
Fax 77702 0
Email 77702 0
vincenzomasu@hotmail.it
Contact person for public queries
Name 77703 0
Dr Mike Ford
Address 77703 0
University college of Osteopathy
275 Borough High Street, London
SE1 1JE
Country 77703 0
United Kingdom
Phone 77703 0
+44 20 7407 0222
Fax 77703 0
Email 77703 0
MikeFord@uco.ac.uk
Contact person for scientific queries
Name 77704 0
Dr Mike Ford
Address 77704 0
University college of Osteopathy
275 Borough High Street, London
SE1 1JE
Country 77704 0
United Kingdom
Phone 77704 0
+44 207089 5353
Fax 77704 0
Email 77704 0
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.TypeCitationLinkEmailOther DetailsAttachment
1127Ethical approval    373661-(Uploaded-22-01-2019-01-42-04)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 373661-(Uploaded-22-01-2019-01-58-52)-Basic results summary.doc
Plain language summaryNo Background Neurodynamic mobilizations(NM) are con... [More Details]

Documents added automatically
No additional documents have been identified.