M54.8 M54.9
Conditions
Interventions
Group 1: communication of physician with regular expectation / regular side effects briefing before acupuncture treatment
Group 2: communication of physician with regular expectation / intense side ef
Sponsors
Institut für komplementäre und integrative MedizinUniversitätsSpital Zürich
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Male and female patients aged 18 to 65 years with chronic non-specific low back pain (CLBP) according to Deyo et al. (2014) with an average pain severity of at least 4 on a 0-10 numeric rating scale and at least half of the days per months with pain in the last 6 months will be eligible for this study.
Exclusion criteria
Exclusion criteria: Patients will be excluded if they had have acupuncture treatment within the last 12 months; are breast-feeding or are known pregnant, have a known blood coagulation disorder or take of coagulation inhibiting drugs with the exception of aspirin. Furthermore they are excluded in case of their CLBP being caused by a known malignant disease, trauma, the presence of a known rheumatic or autoimmune disorder, a history or planned surgery of the spinal column of the low back in the next 6 months, regular intake of analgesics (> once per week) because of additional disease, intake of centrally-acting analgesics, regular intake of corticosteroids or injections with corticosteroids within the last 8 weeks before randomization (specified in a studyspecific SOP), or a history of severe acute or chronic disorders that do not allow participation in the therapy. Further exclusion criteria are known alcohol or substance abuse, insufficient German language skills, current application for a pension claim.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Patient expectation after the briefing intervention (Expectation of Treatment Scale, ETS) and back pain (Numeric Rating Scale, NRS, 0 - 10), after the end of the acupuncture treatment (usually 4 weeks after treatment start); 2) side effects of acupuncture (side effect score after the end of the acupuncture treatment (usually 4 weeks after treatment start) | — |
Secondary
| Measure | Time frame |
|---|---|
| Back pain (NRS, 0 - 10), 2 weeks after treatment start, follow-up after 6 months; Health (Patient-Reported Outcomes Measurement Information System PROMIS 29), 2 and 4 weeks after treatment start, follow-up after 6 months; Working alliance (Working Alliance Inventory WAI-SR). 4 weeks after treatment start; Rescue medication (diary), weekly; Perceived Sensitivity to Medicines(PSM scale), 4 weeks after treatment start; Bothersomeness pain (NRS, 0-10), 2 and 4 weeks after treatment start, follow-up after 6 months Additional measures: Optimism (Life Orientation Test, LOT), before the first treatment; Empathy with the physician (Consultation and Relational Empathy, CARE) before the first treatment | — |
Countries
Switzerland
Contacts
Public ContactAlexandra Kern
UniversitätsSpital ZürichInstitut für komplementäre und integrative Medizin
Outcome results
None listed