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

Charite University, Berlin, Germany6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Low-back Pain

Interventions

Manual Therapy/ExercisesBEHAVIORAL

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

Physiotherapy/Back SchoolBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Charite University

Berlin, Germany

Outcomes

Primary Outcomes

Change from baseline in average pain intensity in previous week

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

Time frame: 3 months

Secondary Outcomes

Change from baseline for back pain specific disability

Use of standardized Roland Morris Disability Questionnaire (RMDQ) to assess back pain specific disability. The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.

Time frame: 3 months, 6 months

Change from baseline in average pain intensity in previous week

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

Time frame: 6 months

Change from baseline in pain bothersomeness in previous week

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

Time frame: 3 months, 6 months

Change from baseline in pain medication use in the previous week

Specific self-reported pain medication use in previous week.

Time frame: 3 months, 6 months

Change from baseline for health related quality of life

Use of standardized Short Form 36 Health Survey (SF-36). The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.

Time frame: 3 months, 6 months

Change from baseline for pain self-efficacy

Use of standardized Pain Self-Efficacy Questionnaire (PSEQ). The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.

Data from ClinicalTrials.gov

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