Manual Therapy/Exercises vs. Physiotherapy/Back School vs. Waiting List in Patients With Chronic Low Back Pain

Charité University Medicine Berlin

Status: Terminated

Conditions: Chronic Low-back Pain

Treatments: Behavioral: Manual Therapy/Exercises; Behavioral: Physiotherapy/Back School

Study type: Interventional

Funder types: Other

Identifiers

NCT05843149

NHKManual

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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
• Severe comorbidities
• Pregnancy/lactation
• Current participation in another clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6 participants in 3 patient groups

Manual Therapy/Exercises

Experimental group

Description:

Three individual therapy sessions and nine group sessions manual therapy/exercises of 60 min. duration under the guidance of a trained therapist.

Treatment:

Behavioral: Manual Therapy/Exercises

Physiotherapy/Back School

Experimental group

Description:

Three individual therapy sessions and nine group sessions physiotherapy/back school of 60 min. duration under the guidance of a trained therapist.

Treatment:

Behavioral: Physiotherapy/Back School

Waiting List

No Intervention group

Description:

Study arm 3 consists of a waiting list control group, combined with the offer to participate in one of the above mentioned interventions after 6 months.