Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
3321; 078195
Study information
Scientific title
Comparison of efficacy of transcutaneous nerve stimulation and sensory discrimination education in patients with chronic low back pain: a randomised interventional single centre treatment trial
Acronym
Study hypothesis
This is a comparison of transcutaneous nerve stimulation and sensory discrimination education in patients with chronic low back pain.
Ethics approval
Milton Keynes REC approved on the 2nd August 2005 (ref: 05/Q1603/34)
Study design
Randomised interventional single centre treatment trial
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
Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
Intervention
Patients aged greater than 18 years with greater than 3 months chronic low back pain awaiting physiotherapy at the Nuffield Orthopaedic Centre will be asked to complete one week of diary record of pain. An average of one week of diary record of pain by linear analogue scale will be the baseline measure of the primary outcome measure. Patients will be excluded if they complete the diary on less than 3 days during this week.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
0 - 100 mm Linear Analogue Pain Scale (LAS) for back pain, taken daily for one week recording best, worst and average. Outcome was based on mean score of 7 daily average scores.
Secondary outcome measures
1. Oswestry Disability Index
2. Euroqol
3. DRAM
4. An open questionnaire to assess satisfaction and comments on treatment.
Measured at baseline, 3 weeks, 6 weeks and 3 months.
Overall trial start date
01/01/2006
Overall trial end date
01/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Chronic low back pain
2. Aged 18 years or older, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 90. Actual sample size: 54 (reduced from 3-arm to 2-arm study)
Participant exclusion criteria
1. Aged less than 18 years
2. Treatment likely to harm patient
Recruitment start date
01/01/2006
Recruitment end date
01/01/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Old Road
Oxford
OX3 7LF
United Kingdom
Sponsor information
Organisation
Nuffield Orthopaedic Centre NHS Trust (UK)
Sponsor details
c/o Fiona Parker
Windmill Road
Oxford
OX3 7LD
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 078195)
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
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18588702
Publication citations
-
Results
Barker KL, Elliott CJ, Sackley CM, Fairbank JC, Treatment of chronic back pain by sensory discrimination training. A Phase I RCT of a novel device (FairMed) vs. TENS., BMC Musculoskelet Disord, 2008, 9, 97, doi: 10.1186/1471-2474-9-97.