Manual Therapy/Exercises vs. Physiotherapy/Back School vs. Waiting List in Patients With Chronic Low Back Pain - a Randomized Controlled Trial

Charite University, Berlin, Germany1 site in 1 country6 target enrollmentMay 2, 2023

ConditionsChronic Low-back Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Low-back Pain
Sponsor: Charite University, Berlin, Germany
Enrollment: 6
Locations: 1
Primary Endpoint: Change from baseline in average pain intensity in previous week
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A randomized controlled trial for patients with chronic low back pain with two treatment arms and one waiting list control group. Primary outcome is pain intensity on VAS.

Registry

clinicaltrials.gov

Start Date

May 2, 2023

End Date

September 26, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Charite University, Berlin, Germany

Responsible Party

Principal Investigator

Andreas Michalsen

Principal Investigator

Charite University, Berlin, Germany

Eligibility Criteria

Inclusion Criteria

•pre-existing and specialist confirmed diagnosis of chronic low back pain for at least 3 months prior to inclusion
•Average pain intensity with at least 40 mm on the VAS from 0 to 100 mm and pain on at least 5 of 7 weekdays in the last 3 months.
•Exclusion criteria:
•Regular own exercise practice for the treatment of back pain (including yoga and other interventions)
•Invasive spinal procedures within the past 6 weeks or planned within the next 10 weeks
•Acute disc herniation (diagnosed within the last 3 months)
•Congenital deformities of the lumbar spine
•Rheumatoid arthritis
•Fibromyalgia
•Ankylosing spondylitis

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Change from baseline in average pain intensity in previous week

Time Frame: 3 months

Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100).

Secondary Outcomes

Change from baseline for back pain specific disability(3 months, 6 months)
Change from baseline for work productivity(3 months, 6 months)
Change from baseline for pain self-efficacy(3 months, 6 months)
Change from baseline in pain medication use in the previous week(3 months, 6 months)
Change from baseline for health related quality of life(3 months, 6 months)
Change from baseline in average pain intensity in previous week(6 months)
Change from baseline in pain bothersomeness in previous week(3 months, 6 months)
Change from baseline for anxiety and depression(3 months, 6 months)