NCT01158339

Brief Summary

Unspecific low back pain (LBP) is a major world wide health problem. The purpose of this study is to improve the care of LBP. Our hypothesis is that Cognitive Behavioural Therapy (CBT) with physical intervention during group sessions focusing on fear and avoidance behaviour will be more effective than physical therapy alone. The study has two arms. Both will receive education related to LBP and appropriate advice regarding how to react and behave towards their LBP. The main focus in the intervention group will be:

  • Identifying their fear of movements and perform the frightened movements during the group sessions.
  • Reassuring that gradually normalizing daily activities will not be harmful but rather reduce their pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 8, 2010

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

10.9 years

First QC Date

May 21, 2010

Last Update Submit

September 6, 2021

Conditions

Low Back Pain

Keywords

Low back painCognitive behavioural therapyGroup therapyExposure in session

Outcome Measures

Primary Outcomes (1)

  • Absenteeism from work

    Registrations of absenteeism will be given by the Norwegian Sick leave Register. This has certainly to be retrospectively (Is already approved)

    Week 52

Secondary Outcomes (8)

  • Pain

    Will be done the following weeks: -1., 6., 14., and 52.

  • Physical functioning.

    Will be done the following weeks: -1., 6., 14., and 52.

  • Emotional functioning

    Will be done the following weeks: -1., 6., 14., and 52.

  • Patient ratings of improvement and satisfaction with treatment

    Will be done the following weeks: -1., 6., 14., and 52.

  • Health-related quality of life

    Will be done the following weeks: -1., 6., 14., and 52.

  • +3 more secondary outcomes

Study Arms (2)

Arm 1: CBGT

ACTIVE COMPARATOR

Cognitive Behavioural Group Therapy (CBGT)

Behavioral: Arm 1: CBGT

Arm 2: CBGT-ISE

EXPERIMENTAL

Cognitive Behavioural Group Therapy, with in-Session Exposure (CBGT-ISE).

Behavioral: Arm 2: CBGT-ISE

Interventions

Arm 2: CBGT-ISEBEHAVIORAL

Intervention with active performance of the feared movements during group sessions.

Arm 2: CBGT-ISE
Arm 1: CBGTBEHAVIORAL

Intervention according to previously mentioned methods.

Arm 1: CBGT

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Low Back Pain (LBP) lasting from 3 months to 10 years.
  • Pain of such a severity that life of quality is reduced.
  • The patient's main problem must be LBP, localized from L1 to S1.
  • The pain must not be caused by nerve root affection (e.g. herniated disc)
  • The patient has to be able to understand instructions given in Norwegian and to take part in a group activity.
  • The patient must be partly or fully on sick leave from work.
  • The patient must have a regular work to return to.

You may not qualify if:

  • % disability pension, of any reason.
  • LBP that clearly is secondary to other somatic or psychiatric disorders.
  • Alcohol and drug abuse.
  • LBP caused by ankylosing spondylitis and other spondylarthropathies.
  • Patients with "red flags" such as bladder- and anal paresis, impotence or progressing paresis.
  • Ongoing insurance affairs for all types of sickness, injuries and accidents both against insurance companies and NAV (The Norwegian Labour and Welfare Administration)
  • Indication for back surgery or performed back surgery last 12 months
  • On medication known to cause depression or other psychiatric symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Levanger Hospital

Levanger, 7600, Norway

Location

Related Publications (1)

  • Ryum T, Hartmann H, Borchgrevink P, de Ridder K, Stiles TC. The effect of in-session exposure in Fear-Avoidance treatment of chronic low back pain: A randomized controlled trial. Eur J Pain. 2021 Jan;25(1):171-188. doi: 10.1002/ejp.1659. Epub 2020 Oct 6.

    PMID: 32964624RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tore Charles Stiles, prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2010

First Posted

July 8, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

September 14, 2021

Record last verified: 2021-09

Locations

NO(1)