Investigation to see if cervical spine mobilisation can influence Cervicobrachial Syndrome

ISRCTN	ISRCTN87397856
DOI	https://doi.org/10.1186/ISRCTN87397856
Secondary identifying numbers	N0191187010

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 17/10/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Emma Salt
Scientific

Musculoskeletal Physiotherapy Lead
Queen's Hospital
Belvedere Road
Burton upon Trent
DE13 0RB
United Kingdom

Study information

Study design	Pilot study using a randomised controlled design, with the assessor masked to allocation
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Investigation to see if cervical spine mobilisation can influence Cervicobrachial Syndrome
Study objectives	1. To investigate whether a self-management protocol with lateral glide mobilisation is more advantageous than a self-management protocol in isolation for subjects with cervicobrachial syndrome. 2. To establish whether subjects with symptoms of parasthesia, numbness and or weakness in their affected arm in addition to their pain have a different outcome from subjects with pain alone. 3. To determine whether subjects preference is linked with outcome. 4. To determine feasibility and enable thorough planning for a phase III trial.
Ethics approval(s)	Added 21/09/09: South Staffordshire Local Research Ethics Committee
Health condition(s) or problem(s) studied	Musculoskeletal Diseases: Cervicobrachial syndrome
Intervention	Subjects will receive either lateral glide mobilisations and a self-management programme (Intervention group) or self-management alone (Control group) for the management of cervicobrachial syndrome. Due to the nature of the intervention, it will not be possible to mask subjects and treating physiotherapists to allocation. Assessment will occur at consent, and 6 weeks after initiation of treatment.
Intervention type	Other
Primary outcome measure	Added 21/09/09: Visual analogue scale for pain
Secondary outcome measures	Added 21/09/09: 1. Neck and Upper Limb Index (NULI) 2. SF36 (RAND) 3. Global Rating of Change Score (GROC)
Overall study start date	01/02/2007
Completion date	01/06/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Added 21/09/09: 18
Key inclusion criteria	This study includes patients with any symptoms radiating from the neck to upper limb. Added 21/09/09: 1. Patients with pain that had started in the neck and spread to one arm (below level of shoulder joint) in a dermatological distribution and been present for more than two months 2. There were no known systemic rheumatological (e.g. Rheumatoid Arthritis RA or Ankylosing Spondylitis AS) or neurological disorders (e.g. Multiple Sclerosis MS, Parkinson's Disease PD) 3. Not involved with any litigation issues regarding neck and arm pain and no symptoms of myelopathy or sinister pathology 4. No previous fractures to the neck or thoracic spine
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/02/2007
Date of final enrolment	01/06/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Musculoskeletal Physiotherapy Lead

Burton upon Trent
DE13 0RB
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health (UK)
Not defined

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Burton Hospitals NHS Trust (UK), Own Account NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

17/10/2016: No publications found in PubMed, verifying study status with principal investigator.