Clinical trial NCT02490722: Effect of Patient Education on Functions in Patients With Non-specific and/or Degenerative Low Back Pain
Official title: The Effect of Interdisciplinary Group Based Patient Education on Functions in Patients With Non-specific and/or Degenerative Low Back Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Low Back Pain
Keywords: Patient education
Empowerment
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2015-07-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of functions
timeFrame: 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 outcomes:
measure: Change of pain
timeFrame: 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.
measure: Change of self-efficacy
timeFrame: 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.
measure: Change of quality of life
timeFrame: 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.
measure: Change of depression
timeFrame: 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.
measure: Change of physical function
timeFrame: 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.
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
state: Region Hovedstaden
Study officials:
affiliation: Nordsjællands Hospital
name: Stig Molsted, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1002/14651858.CD000261.pub2.
citation: 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.
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.