Effect of an Outpatient Intervention Program in Patients With Chronic Back or Neck Pain (CPS)

November 5, 2013 updated by: Florian Wepner, Orthopedic Hospital Vienna Speising

The Long-term Effect of an Outpatient Intervention Program With a Behavioral Therapy Approach in Patients With Chronic Back or Neck Pain With a Focus on Psychosocial Aspects

To investigated whether an ambulant intervention program with a behavioral therapy approach would exert a long-term effect on chronic unspecific back or neck pain. Specifically, the effect on patients with pronounced fear avoidance behavior and/or with psychosocial limitations was addressed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND: Sustained success of ambulant intervention programs consisting of individual and group physiotherapy in patients with with chronic unspecific back or neck pain (cBP) has not been conclusively proven. It's still not clear whether one can achieve such success by devoting greater attention to psychosocial factors.

OBJECTIVE: We investigated whether an ambulant intervention program with a behavioral therapy approach would exert a long-term effect on cBP. Specifically, the effect on patients with pronounced fear avoidance behavior and/or with psychosocial limitations was addressed.

DESIGN: Prospective, randomized controlled trial

SETTINGS, INTERVENTION: 64 patients were assigned to intervention group (IG) and 57 to control group (CG). All were examined, informed about cBP, and were encouraged to stay active and perform exercises according to specific instructions provided in a neck- or back-book. The IG received 9 units of physiotherapy and 2 units of occupational therapy, conducted with a behavioral therapy approach. Efficacy of treatment was evaluated after 6 and 58 weeks.

MEASUREMENTS: Pain (VAS), quantity of painkillers consumed, sick leave days, Oswestry-Disability-Index (ODI), SF-36, FABQ.

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1130
        • Orthopedic Hospital Vienna Speising

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • minimum age 18 years, maximum age: men 55 years, women 50 years.
  • the patients had been on sick leave for a minimum of 4 and a maximum of 22 days during the preceding 12 months because of nonspecific spinal symptoms in the back or neck.
  • The patients had to be working at the start of the study.

Exclusion Criteria:

  • Specific causes of spinal symptoms (after spinal surgery, known vertebral body fractures, disk prolapse with motor deficits or other radicular lesions, tumor, osteomyelitis, spondylodiscitis, rheumatic disease, osteoporosis).
  • Retired persons, those in the process of being screened for retirement, unemployed persons,
  • pregnancy or persons on maternity leave
  • Planned surgery during the phase of intervention
  • persons who were unable to participate in the intervention program for other reasons (physical, psychological, linguistic or organizational).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Training group
Physiotherapy and occupational therapy: Training group received 9 units of physiotherapy and 2 units of occupational therapy, each with a duration of one hour.
Behavioral: Physiotherapy and occupational therapy
Members of the training group received 9 units of physiotherapy and 2 units of occupational therapy, each with a duration of one hour. Every patient of the IG was trained to perform a neck or back intervention program specifically suited to his/her needs. The training was conducted in a single session by one of three experienced physiotherapists (with mean work experience of 6 years). After this training the patients completed eight group training units consisting a maximum number of 8 participants, each unit with a duration of one hour, over a maximum period of six weeks.
No Intervention: Control Group
Members of the control group were referred to their general practitioner or specialist for further care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: After 0 / 6 / 58 Weeks
To evaluate the main hypothesis, current pain and mean pain during the preceding week and the preceding 3 months were determined on a visual analog scale (VAS; 0-100, lower scores indicate less severe pain)
After 0 / 6 / 58 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social function, psychological wellbeing and emotional role function
Time Frame: After 0 / 6 / 58 weeks
To evaluate social function, psychological wellbeing and emotional role function we used the 36-item short form health survey (SF-36; scales 0-100, lower scores indicate poorer social, psychological and emotional quality of life)
After 0 / 6 / 58 weeks
Functional impairment
Time Frame: After 0 / 6 / 58 weeks
The Oswestry disability index was used to measure functional impairment.
After 0 / 6 / 58 weeks
Anxiety, insecurity in social contacts and compulsiveness
Time Frame: After 0 / 6 / 58 weeks
Anxiety, insecurity in social contacts and compulsiveness were registered on the brief symptoms inventory (BSI), which is an abridged version of SCL-90_R. The BSI addresses subjective experience of impairment based on a list of symptoms that are partly physical and partly psychological. The time frame is seven days.
After 0 / 6 / 58 weeks
Sick leave days
Time Frame: After 0 / 58 weeks
The number of (self-reported) days of sick leave due to pain during the preceding twelve months were inquired.
After 0 / 58 weeks
Painkillers
Time Frame: After 0 / 58 weeks
The number of painkillers taken per day were inquired.
After 0 / 58 weeks
Fear avoidance behavior
Time Frame: After 0 / 6 / 58 weeks
Fear avoidance behavior was determined by means of the fear avoidance beliefs questionnaire (FABQ; scale 0-66; lower scores indicate lower fear-avoidance beliefs)
After 0 / 6 / 58 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orthopedic Hospital Vienna Speising

Investigators

  • Principal Investigator: Florian Wepner, Dr., Orthopedic Hospital Vienna Speising
  • Study Chair: Martin Friedrich, Prof., Orthopedic Hospital Vienna Speising
  • Study Director: Julia Hahne, Mag., Orthopedic Hospital Vienna Speising

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

August 29, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimate)

November 13, 2013

Study Record Updates

Last Update Posted (Estimate)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Praev123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neck Pain

Clinical Trials on Physiotherapy and occupational therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe