Condition category
Musculoskeletal Diseases
Date applied
31/03/2010
Date assigned
31/03/2010
Last edited
03/12/2012
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

Prof Jeremy C T Fairbank

ORCID ID

Contact details

Old Road
Headington
Oxford
OX3 7LF
United Kingdom

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

http://www.noc.nhs.uk/

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

  1. 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.

Additional files

Editorial Notes