Cupping Glass Massage and Acupuncture in the treatment of female patients with chronic non-specific low back pain – a non-inferiority randomized trial

Not Applicable

• Conditions: M54.5; M47; Low back pain; Spondylosis

• Registration Number: DRKS00007491
• Lead Sponsor: Klinik f. Naturheilkunde, Klinik Blankenstein

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2010-03-05
• Study Start: 2015-04-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 136

Inclusion Criteria

Inpatients of the clinic for Naturopathy of the clinic of Blankenstein.
-Informed consent
-Anamnesis of chronic non-specific low back pain more than 6 month
-Point value in the Hannover Functional Ability Questionaire: 0-16 Points
-Low back pain defined as pain in the area of lumbar spine with and without segmental spread
-At least one of the following diagnoses (ICD 10) in the principal or secondary diagnosis:
1.M 47.20, 47.25, 47.26, 47.27, 47.28:
2.M 51.1, 51.2
3.M 54.1, 54.4, 54.5, 54.8, 54.10

Exclusion Criteria

-Chronic pain due to other diseases taking low back pain in the backseat
-Osteoporotic and traumatic vertebral fractures or severe abnormalities in the spine, spondylolisthesis
-Inflammatory rheumatic illness of the spine
-Dermatosis that does not allow Cupping Glass Massage
-Participation in this study at another point of time
-Actual participation in another clinical study concerning the treatment of low back pain
-Patrient, who are not able to understand the meaning of the study (e.g. language, dementia)
-Opioid or drug dependency, alcoholism, compliance not guaranteed
-Antecedent operations at the spine in the last 3 month before recruitment
-Bechterew´s syndrome
-Cachexia
-Pain catheder/ CT-controlled Intra-articular injections in the last 10 days in the lumbar spine
-Cupping Glass Massage (CGM) or acupuncture therapy (ACU) up to one month before treatment onset
-Progressive systemic diseases like tuberculosis, leukosis, carcinoma (except for long-therm complete remission), collagenoses, multiple sclerosis, AIDS, HIV - Infection
-Severe depression (psychiatric diagnosis)
-Severe cardiopathies
-fever
-known pregnancy
-severe coagulopathy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
on-inferiority of CGM compared to acupuncture therapy as related to functional disability operationalized by Hannover Functional Ability Questionnaire (HFAQ), after 3 months

Secondary Outcome Measures

Name	Time	Method
Change in functional disability operationalized by Hannover Functional Ability Questionnaire (HFAQ) at discharge from hospital. Reduction of pain intensity and the reduction of impairments in everyday life due to pain measured by ‘von Korff’ Questionnaire at discharge from hospital and after 3 months. Further secondary outcomes were the improvement of Quality of Life (measured by SF-12 Questionnaire at the beginning and after 3 months) und the reduction of pain (measured by a visual analog scale [VAS] at the beginning, at discharge from hospital and after 3 months). Additionally the reduction of need of analgesics (at discharge from hospital and after 3 months) and the patients’ evaluation of therapy was measured by a five step graded scale<br>(at discharge from hospital and after 3 months).