Effect of Patient Education on Functions in Patients With Non-specific and/or Degenerative Low Back Pain

Low Back Pain Clinical Trial

Official title:

The Effect of Interdisciplinary Group Based Patient Education on Functions in Patients With Non-specific and/or Degenerative Low Back Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02490722
• Other study ID #: H-15006949
• Status: Withdrawn
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2017
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate effects of interdisciplinary group based patient education in patients with low back pain.

The patients will be recruited to four group based patient education lessons during a two months period. The study is a randomized controlled trial and the patients will be randomized to standard treatment or standard treatment and patient education. The patient education will be led by physiotherapists, nurses and physicians. The outcomes are functions, pain, quality of life, self-efficacy, and depression. The data are reported in questionnaires.

Description:

Design: Randomized controlled trial; intervention study. Patients: Patients with low back pain; referred to Nordsjaellands Hospital, Denmark. Inclusion criteria: adults, low back pain minimum scored 4 on numeric rating scale, able to conduct exercise training. Exclusion criteria: unable to understand Danish, psychiatric disorder, dementia, approaching operation, current or approaching settlement regarding working ability or compensation as a result of low back pain. Intervention: Randomization to usual care or usual care and four times two hours group based patient education with an interdisciplinary focus on self-management of low back pain. The patient education will be delivered by physiotherapists, nurses and physicians. Outcome: functions, pain, quality of life, self-efficacy, and depression. The data are reported in questionnaires. Sample size: 74 participants.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adults

• low back pain minimum scored 4 on numeric rating scale

• able to conduct exercise training

Exclusion Criteria:

• unable to understand Danish

• psychiatric disorder

• dementia

• approaching operation

• current or approaching settlement regarding working ability or compensation as a result of low back pain

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Patient education
Four times two hours group based patient education

Locations

Country	Name	City	State
Denmark	Nordsjællands Hospital	Hillerød	Region Hovedstaden

Sponsors (1)

Lead Sponsor	Collaborator
Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Dufour N, Thamsborg G, Oefeldt A, Lundsgaard C, Stender S. Treatment of chronic low back pain: a randomized, clinical trial comparing group-based multidisciplinary biopsychosocial rehabilitation and intensive individual therapist-assisted back muscle strengthening exercises. Spine (Phila Pa 1976). 2010 Mar 1;35(5):469-76. doi: 10.1097/BRS.0b013e3181b8db2e. — View Citation

Heymans MW, van Tulder MW, Esmail R, Bombardier C, Koes BW. Back schools for non-specific low-back pain. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD000261. Review. — View Citation

Morone G, Paolucci T, Alcuri MR, Vulpiani MC, Matano A, Bureca I, Paolucci S, Saraceni VM. Quality of life improved by multidisciplinary back school program in patients with chronic non-specific low back pain: a single blind randomized controlled trial. Eur J Phys Rehabil Med. 2011 Dec;47(4):533-41. Epub 2011 Apr 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of functions	Questionnaire	Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.
Secondary	Change of pain	Questionnaire	Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.
Secondary	Change of self-efficacy	Questionnaire	Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.
Secondary	Change of quality of life	Questionnaire	Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.
Secondary	Change of depression	Questionnaire	Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.
Secondary	Change of physical function	Performance test	Patients will be followed for a period of two months with four patients education sessions. Follow-up will be tested 12 weeks after the last education session.