Comparison of efficacy of transcutaneous nerve stimulation and sensory discrimination education in patients with chronic low back pain

ISRCTN	ISRCTN94184937
DOI	https://doi.org/10.1186/ISRCTN94184937
Secondary identifying numbers	3321; 078195

Submission date: 31/03/2010
Registration date: 31/03/2010
Last edited: 03/12/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jeremy C T Fairbank
Scientific

Old Road
Headington
Oxford
OX3 7LF
United Kingdom

Study information

Study design	Randomised interventional single centre treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	This is a comparison of transcutaneous nerve stimulation and sensory discrimination education in patients with chronic low back pain.
Ethics approval(s)	Milton Keynes REC approved on the 2nd August 2005 (ref: 05/Q1603/34)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2006
Completion date	01/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 90. Actual sample size: 54 (reduced from 3-arm to 2-arm study)
Key inclusion criteria	1. Chronic low back pain 2. Aged 18 years or older, either sex
Key exclusion criteria	1. Aged less than 18 years 2. Treatment likely to harm patient
Date of first enrolment	01/01/2006
Date of final enrolment	01/01/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Old Road

Oxford
OX3 7LF
United Kingdom

Sponsor information

Nuffield Orthopaedic Centre NHS Trust (UK)
Hospital/treatment centre

c/o Fiona Parker
Windmill Road
Oxford
OX3 7LD
England
United Kingdom

Website	http://www.noc.nhs.uk/
"ROR"	https://ror.org/0036ate90

Funders

Funder type

Charity

The Wellcome Trust (UK) (grant ref: 078195)

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/06/2008		Yes	No