RütmuS-II - Back Therapy with Multimodal Pain Therapy (prospective study section)

• Conditions: M42; M50; M51; M53; M54; Spinal osteochondrosis; Cervical disc disorders; Other intervertebral disc disorders; Other dorsopathies, not elsewhere classified; Dorsalgia

• Registration Number: DRKS00015800
• Lead Sponsor: Rheinische Fachhochschule Köln gGmbH, Institut für Medizinökonomie & Medizinische Versorgungsforschung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-14
• Study Completion: 2021-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 513

Inclusion Criteria

1. Age> = 18 and <= 85 years
2. Insured by participating health insurance company
3. Patient consent is available
4. ICD diagnosis M42, M50, M51, M53 or M54
5. chronic back pain (coded diagnosis in two consecutive quarters)

Exclusion Criteria

1. Age <18 years or> 85 years
2. Not insured by the participating health insurance company
3. Missing informed consent
4. Lack of german language skills
5. Lack of patient adherence for beeing participant of study for a period of one year
6. Participation in a selective contract with similar diagnosis or rehabilitation because of the back pain diagnosis within the previous year
7. Carcinoma diseases
8. Contraindications for physiotherapeutic treatment
9. Application for disability pension (self-assessment of the patient)
10. Existing degree of care

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of patients severity of pain according to Numeric-Rating-Scale (NRS) by self-declaration at five predefined dates using a standardized evaluation concept. <br>Measurements: with enrolment, after 12/26/39/52 weeks; standardized questionnaires

Secondary Outcome Measures

Name	Time	Method
Observating patient-relevant and health-economic secondary endpoints to evaluate possible differences between intervention and control group.<br>Use of questionnaire tools: General health status (SF-12), health-related quality of life (EQ-5D-5L), functional impairment due to back pain (Functional Questionnaire Hannover), pain disability index, Hospital Anxiety and Depression Scale (HADS-D), work motivation (DIAMO) - dates of measurement: with enrolment, after 26/52 weeks - standardized questionnaires; medical economic outcome parameters (cost and performance data) - standardized questionnaire / accounting data of the health insurance company - time of measurement: with enrolment, after 26/52 weeks / during the treatment period