Assessing the effectiveness of a lateral glide cervical spine mobilisation on cervicobrachial (neck and arm) pain
| ISRCTN | ISRCTN62431186 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62431186 |
| Secondary identifying numbers | 09/H1203/45 |
- Submission date
- 16/06/2010
- Registration date
- 14/04/2011
- Last edited
- 04/10/2017
- 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
Scientific
Physiotherapy Department
Queen's Hospital
Belvedere Road
Burton on Trent
DE13 0RB
United Kingdom
| EJS495@bham.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial to assess the effectiveness of a lateral glide cervical spine mobilisation on cervicobrachial (neck and arm) pain |
| Study acronym | CBS Trial |
| Study objectives | 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(s) | South Staffordshire Local Research Ethics Committee approval pending as of 17/06/2010 |
| Health condition(s) or problem(s) studied | Musculoskeletal pain |
| Intervention | Patients will be randomised to 1. Lateral glide with self-management 2. Self-management |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 24/06/2009 |
| Completion date | 24/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 96 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 24/06/2009 |
| Date of final enrolment | 24/06/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Queen's Hospital
Burton on Trent
DE13 0RB
United Kingdom
DE13 0RB
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
c/o Brendan Laverty
Research and Commercial Services
Edgbaston
B15 2TT
England
United Kingdom
"ROR" |
https://ror.org/03angcq70 |
|---|
Funders
Funder type
Other
Manipulation Association of Chartered Physiotherapists (UK)
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
MW 04/10/2017: No publications found in PubMed, verifying study status with principal investigator.
