Condition category
Musculoskeletal Diseases
Date applied
16/06/2010
Date assigned
14/04/2011
Last edited
12/06/2015
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

Physiotherapy Department
Queen's Hospital
Belvedere Road
Burton on Trent
DE13 0RB
United Kingdom
-
EJS495@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

09/H1203/45

Study information

Scientific title

A randomised controlled trial to assess the effectiveness of a lateral glide cervical spine mobilisation on cervicobrachial (neck and arm) pain

Acronym

CBS Trial

Study hypothesis

The primary objective of this study is to investigate whether a self-management protocol with lateral glide mobilisation is more beneficial than a self-management protocol in isolation for participants with cervicobrachial syndrome (CBS).

Ethics approval

South Staffordshire Local Research Ethics Committee approval pending as of 17/06/2010

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Musculoskeletal pain

Intervention

Patients will be randomised to
1. Lateral glide with self-management
2. Self-management

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Pain, assessed by Visual Analogue Score (VAS)

Secondary outcome measures

1. Short Form 36-item Health Survey (SF36) (RAND)
2. Neck and Upper Limb Index (NULI)
3. Tampra scale of Kinesiophobia
4. Global Rating of Change (GROC)
5. Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
6. Upper limb nerve extensability test
7. Cervical Active Range Of Motion (AROM)

Overall trial start date

24/06/2009

Overall trial end date

24/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 - 65 years experiencing CBS (described as pain originating in the neck with associated pain radiating below the level of the shoulder joint into the arm) with or without parasthesia and or weakness in a dermatomal distribution
2. Had symptoms for greater than 6 weeks
3. Adequate knowledge of English to participate in a neuro-musculoskeletal examination and to answer the study questionnaire
4. Able to attend assessment and treatment appointments
5. Will have verbally agreed to attend the review appointment at 6, 26 and 52 weeks following initiation of the treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

96

Participant exclusion criteria

1. Presenting with any red flags: severe unremitting night pain, unexplained weight
loss, history of cancer, general malaise, and constant unvarying pain
2. Bilateral arm symptoms
3. Signs and symptoms strongly suggestive of thoracic outlet syndrome or a specificperipheral pathology e.g. adhesive capsulitis, sub acromial impingement etc.
4. Specific pathology affecting nerve function e.g. multiple sclerosis, known peripheral vascular disease, diabetes
5. Known specific pathology affecting systemic joint function e.g. rheumatoid arthritis, ankylosing spondylitis
6. Cervical spine surgery, botulinum toxin injections or epidural injections to cervical spine or planned imminent treatment
7. Having other forms of manual therapy for their CBS symptoms e.g. osteopathy or chiropractics
8. Involved in compensation and or litigation associated with neck and or upper limb pain
9. Already involved in a research trial

Recruitment start date

24/06/2009

Recruitment end date

24/06/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen's Hospital
Burton on Trent
DE13 0RB
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

c/o Brendan Laverty
Research and Commercial Services
Edgbaston
B15 2TT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Manipulation Association of Chartered Physiotherapists (UK)

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