The influence of a non-invasive electrical stimulation over an area of the brain on pain and disability in patients with long-standing back pai

Completed

• Conditions: Chronic low back pain; Musculoskeletal Diseases; Dorsalgia

• Registration Number: ISRCTN89874874
• Lead Sponsor: niversity Medical Center Hamburg-Eppendorf (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-05
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

1. Aged 18 - 65 years, either sex
2. Categorised as suitable for a pain management programme
3. Have non-specific CLBP (with a minimum of 3 months of low back pain without any relevant ongoing pathologies such as acute disc prolapse, acute inflammation, bone fractures, spondylolisthesis or general health restrictions that require medical attention)
4. Are waiting to attend a cognitive behavioural group programme at a back pain clinic in North Germany
5. Provide written consent

Exclusion Criteria

1. Other chronic pain syndromes
2. Spinal surgery in the past 6 month
3. Neurological disease
4. Psychiatric disease
5. Does not understand German
6. Pregnant or likely to become pregnant during the trial
7. Alcohol, drug, or medication abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Pain, measured using the Visual Analogue Scale (VAS) score (0 = no pain, 100 = unbearable pain)<br>2. Disability, measured using the Oswestry Disability Index<br>3. Measurements at baseline, after tDCS period, after CBT, at 4 weeks, 12 weeks and 24 weeks post CBT

Secondary Outcome Measures

Name	Time	Method
1. Subjective Functioning (Funktionsfragebogen Hannover)<br>2. Fear Avoidance Beliefs Questionnaire<br>3. Depression (Hospital Anxiety Depression Scale)<br>4. Quality of Life (SF 36)<br>5. Bothersomeness (5 point scale)<br>6. Patient Perceived Satisfactory Improvement (5 point scale)<br>Measurements at baseline, after tDCS period, after CBT, at 4 weeks, 12 weeks and 24 weeks post CBT.