Condition category
Musculoskeletal Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
17/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Emma Salt

ORCID ID

Contact details

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

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 subject’s 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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes

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