Chronic Low Back Pain
Conditions
Keywords
low back pain, acupuncture
Brief summary
The aim of the study is to evaluate pain intensity over 8 weeks in acupuncture patients with chronic low back pain and to compare 2 different groups of patients which differ in the acupuncture method used to treat the pain.
Interventions
OTHERAcupuncture 1
Application of individualised acupuncture
OTHERAcupuncture 2
Application of standardised acupuncture
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of chronic low back pain (for at least 3 months) confirmed by a consultant * indication for treatment of low back pain with acupuncture confirmed by a consultant * at least 40 mm on a VAS pain scale
Exclusion criteria
* acupuncture during the last 6 months * start of a new therapy for low back pain within the last 4 weeks * pregnancy * substance or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity over 8 weeks (area under the curve) | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Duration of therapy | baseline to expected time frame 3 months |
| Adverse effects and severe adverse effects | baseline to expected time frame 3 months |
| Days with physical therapy because of back pain | baseline to end of week 8 |
| Sick leave days | baseline, at week 8, at week 26 |
| Number of therapy sessions | baseline to expected time frame 3 months |
| Back function (FFbH-R) | baseline, week 8, week 26 |
| QoL | baseline, week 8, week 26 |
| Days with medication intake | baseline to end of week 8 |
| Intensity of back pain at week 8 and week 26 | baseline, week 8, week 26 |
Countries
Germany
Outcome results
None listed