Contact information
Type
Scientific
Primary contact
Dr Jacqueline Gracey
ORCID ID
Contact details
School of Health Sciences
University of Ulster
Shore Road
Newtownabbey
BT37 0QB
United Kingdom
+44 (0)28 9036 8284
jh.gracey@ulster.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
To compare the effectiveness of two treatment protocols (manual therapy, exercise and advice with or without traction) in the management of acute/subacute Low Back Pain (LBP) with nerve root involvement.
Ethics approval
Approval received from the local ethics committee at the University Ulster in March 2004.
Study design
Pragmatic single-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Low back pain
Intervention
Group 1: Manual therapy, exercise and advice
Group 2: Manual therapy, exercise, advice and continous lumbar traction
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Roland Morris Disability Questionnaire
2. McGill pain questionnaire
3. Acute low back pain screening questionnaire
4. Short Form health survey 36
Secondary outcome measures
1. Visual analogue scale - pain
2. Medication diary
3. Percentage improved - subjective patient score
Overall trial start date
01/03/2004
Overall trial end date
26/02/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 to 65 years of age (male and female), presenting with acute/sub-acute LBP with accompanying radiculopathy
2. Nerve root was identified by the presence of:
a. dermatomal pain distribution radiating below the knee (one or both limbs)
b. sharp/severe quality, often worse in the leg than back (leg pain threshold of 3/10 on Visual Analogue Scale [VAS])
With at least one of the following signs and symptoms:
c. pins and needles in the distal dermatome (where this was present patients with leg pain were accepted even if not extending below the knee)
d. increased pain in the leg on coughing, sneezing or straining
e. neurological deficit, i.e., decreased muscle strength/sensory loss/reflex loss
f. positive straight leg raise test stretch, i.e., limb pain reproduced on test
3. Acute/sub acute LBP, defined as LBP of less than 12 weeks duration, or a recurrent episode with a pain free period of at least three months prior to the onset of this episode. Only one study has considered recovery rates with sciatica and reported that both back and leg pain decreased, on average, by 69%, and disability decreased by 57% within one month from onset. Current physiotherapy practice would suggest that treatment begins as soon as possible; therefore patients were accepted after four weeks of onset of leg pain
4. Able to attend for physiotherapy two to three times a week for four to six weeks
5. Patients were literate with English as their first language
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Previous spinal surgery
2. Formal therapeutic or medical intervention within the last three months (e.g., epidural injection, facet joint block, physiotherapy etc..,)
3. Co-existing conditions (anklyosing spondolytitis, rheumatoid arthritis, spinal stenosis [diagnosed], spondolythesis, recent spinal fracture, spinal tumor or a patient where secondary metastases was suspected)
4. Concomitant severe medical problem preventing participation in the trial (cardiac condition, respiratory conditions, neurological disorder or organ disease)
5. Long term oral steroid intake (due to the risk of osteoporosis)
6. Current anti-coagulant therapy or blood clotting disorders
7. Pregnancy
8. History of major psychiatric illness
9. Roland Morris disability questionnaire score of below four, and/or a VAS score of less than three on a ten point scale for leg pain (to avoid floor effects)
Recruitment start date
01/03/2004
Recruitment end date
26/02/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Health Sciences
Newtownabbey
BT37 0QB
United Kingdom
Sponsor information
Organisation
University of Ulster (UK)
Sponsor details
c/o Dr Annette Harte
School of Health Sciences
Shore Road
Newtownabbey
BT37 0QB
United Kingdom
+44 (0)28 9036 6650
aa.harte@ulster.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Ulster (UK)
Alternative name(s)
University of Ulster, UU
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
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
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18047650
Publication citations
-
Results
Harte AA, Baxter GD, Gracey JH, The effectiveness of motorised lumbar traction in the management of LBP with lumbo sacral nerve root involvement: a feasibility study., BMC Musculoskelet Disord, 2007, 8, 118, doi: 10.1186/1471-2474-8-118.