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 |
| Protocol serial number | 3321; 078195 |
| Sponsor | Nuffield Orthopaedic Centre NHS Trust (UK) |
| Funder | The Wellcome Trust (UK) (grant ref: 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
Scientific
Old Road
Headington
Oxford
OX3 7LF
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional single centre treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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. |
| Key secondary outcome measure(s) |
1. Oswestry Disability Index |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 54 |
| 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
- United Kingdom
- England
Study participating centre
Old Road
Oxford
OX3 7LF
United Kingdom
OX3 7LF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
