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

NCT ID: NCT05843149

Last Updated: 2023-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-02

Study Completion Date

2023-09-26

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Low-back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Manual Therapy/Exercises

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

Group Type EXPERIMENTAL

Manual Therapy/Exercises

Intervention Type BEHAVIORAL

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

Physiotherapy/Back School

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

Group Type EXPERIMENTAL

Physiotherapy/Back School

Intervention Type BEHAVIORAL

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

Waiting List

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Manual Therapy/Exercises

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

Intervention Type BEHAVIORAL

Physiotherapy/Back School

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Andreas Michalsen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Charite University

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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NHKManual

Identifier Type: -

Identifier Source: org_study_id

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