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

NCT ID: NCT02490722

Last Updated: 2022-09-29

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Intervention

Four times two hours interdisciplinary patient education and usual care

Group Type ACTIVE_COMPARATOR

Patient education

Intervention Type OTHER

Four times two hours group based patient education

Control

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Patient education

Four times two hours group based patient education

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nordsjaellands Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stig Molsted, PhD

Role: PRINCIPAL_INVESTIGATOR

Nordsjaellands Hospital

Locations

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Nordsjællands Hospital

Hillerød, Capital Region, Denmark

Site Status

Countries

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Denmark

References

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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;2004(4):CD000261. doi: 10.1002/14651858.CD000261.pub2.

Reference Type BACKGROUND
PMID: 15494995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20147878 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21508915 (View on PubMed)

Other Identifiers

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H-15006949

Identifier Type: -

Identifier Source: org_study_id

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