Effect of the back orthosis DONJOY LUMBOFORCE 3 in the treatment of lumbal chronic backpain

Effect of the back orthosis DONJOY LUMBOFORCE 3 in the treatment of lumbal chronic backpain - Lumboforce-01

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00005985

Enrollment

250

Registered

2014-03-27

Start date

2014-02-07

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M54

Interventions

Group 1: physiotherapy and additional back orthosis DONJOY LUMBOFORCE 3, Single treatment, approximately 3 hours daily, 3 weeks in hospital and 3 weeks outpatient Group 2: physiotherapy without back o

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - indication for treatment with back orthesis - stationary rehabilitation for 3 weeks - indicated physiotheraphy during rehabilitation

Exclusion criteria

Exclusion criteria: - patients younger than 18 years - patients, who are not able to give their consent - pregnant, or breast-feeding patients, as well as patients, who plan a pregancy within the study period - patients, which are not able to follow the physiotherapeutic concept caused by their physical ability - spinal surgical treatment during the last 3 month - treatment with back orthosis during the last 3 month - patients with a psychiatric/psychosomatic main diagnosis, which is the indication for rehabilitation measure

Design outcomes

Primary

Measure	Time frame
Proof of a benefit of therapy by comparing the course of ODI (impairment of quality of life caused by back pain), VAS (back pain) and SF-12 (quality of life). The evaluation will be conducted by comparing two treatment groups (physiotherapy with orthosis and physiotherapy without orthosis). Furthermore, all adverse events wil be recorded for both treatment groups. All parameters will be assessed before treatment, after hospital stay and at the end of outpatient period.	—

Measure

Time frame

Proof of a benefit of therapy by comparing the course of ODI (impairment of quality of life caused by back pain), VAS (back pain) and SF-12 (quality of life). The evaluation will be conducted by comparing two treatment groups (physiotherapy with orthosis and physiotherapy without orthosis). Furthermore, all adverse events wil be recorded for both treatment groups. All parameters will be assessed before treatment, after hospital stay and at the end of outpatient period.

—

Secondary

Measure	Time frame
Frequency and dose of pain medication (documented before treatment, after hospital stay and at the end of outpatient period). Specific data for back orthesis: - assessment of handling - assessmet of wearing confort - assessment of fitting A study-specific questionnaire was developed to be filled-in at the end of hospital stay and at the end of outpatient period.	—

Countries

Germany

Contacts

Public ContactJohannes Schröter

Klaus-Miehlke-Klinik

schroeter@rhm-kliniken.de0611575811

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026