Patient Expectation and Treatment Outcomes of Acupuncture in Patients with Chronic Low Back Pai

Not Applicable

• Conditions: M54.8; M54.9; Other dorsalgia; Dorsalgia, unspecified

• Registration Number: DRKS00010191
• Lead Sponsor: Institut für komplementäre und integrative MedizinUniversitätsSpital Zürich

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-30
• Study Completion: 2017-12-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 152

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Back pain (NRS, 0 - 10), 2 weeks after treatment start, follow-up after 6 months;<br>Health (Patient-Reported Outcomes Measurement Information System PROMIS 29), 2 and 4 weeks after treatment start, follow-up after 6 months;<br>Working alliance (Working Alliance Inventory WAI-SR). 4 weeks after treatment start;<br>Rescue medication (diary), weekly;<br>Perceived Sensitivity to Medicines(PSM scale), 4 weeks after treatment start;<br>Bothersomeness pain (NRS, 0-10), 2 and 4 weeks after treatment start, follow-up after 6 months<br><br>Additional measures:<br>Optimism (Life Orientation Test, LOT), before the first treatment; Empathy with the physician (Consultation and Relational Empathy, CARE) before the first treatment<br><br>