Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0191187010
Study information
Scientific title
Investigation to see if cervical spine mobilisation can influence Cervicobrachial Syndrome
Acronym
Study hypothesis
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
Added 21/09/09: South Staffordshire Local Research Ethics Committee
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
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/02/2007
Overall trial end date
01/06/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Added 21/09/09: 18
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/02/2007
Recruitment end date
01/06/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Musculoskeletal Physiotherapy Lead
Burton upon Trent
DE13 0RB
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Not defined
Website
Funders
Funder type
Government
Funder name
Burton Hospitals NHS Trust (UK), Own Account NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary