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

Primary Purpose

Chronic Low Back Pain, Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Physiotherapy and occupational therapy
Sponsored by
Orthopedic Hospital Vienna Speising
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring outpatient intervention program, behavioral therapy approach, unspecific back pain, unspecific neck pain, chronic pain, physiotherapy, occupational therapy, psychosocial aspects, fear avoidance beliefs, health-related quality of life

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Orthopedic Hospital Vienna Speising

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Training group

Control Group

Arm Description

Physiotherapy and occupational therapy: Training group received 9 units of physiotherapy and 2 units of occupational therapy, each with a duration of one hour.

Members of the control group were referred to their general practitioner or specialist for further care.

Outcomes

Primary Outcome Measures

Pain
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)

Secondary Outcome Measures

Social function, psychological wellbeing and emotional role function
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)
Functional impairment
The Oswestry disability index was used to measure functional impairment.
Anxiety, insecurity in social contacts and compulsiveness
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.
Sick leave days
The number of (self-reported) days of sick leave due to pain during the preceding twelve months were inquired.
Painkillers
The number of painkillers taken per day were inquired.
Fear avoidance behavior
Fear avoidance behavior was determined by means of the fear avoidance beliefs questionnaire (FABQ; scale 0-66; lower scores indicate lower fear-avoidance beliefs)

Full Information

First Posted
August 29, 2013
Last Updated
November 5, 2013
Sponsor
Orthopedic Hospital Vienna Speising
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1. Study Identification

Unique Protocol Identification Number
NCT01981798
Brief Title
Effect of an Outpatient Intervention Program in Patients With Chronic Back or Neck Pain
Acronym
CPS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Orthopedic Hospital Vienna Speising

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain, Neck Pain
Keywords
outpatient intervention program, behavioral therapy approach, unspecific back pain, unspecific neck pain, chronic pain, physiotherapy, occupational therapy, psychosocial aspects, fear avoidance beliefs, health-related quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training group
Arm Type
Active Comparator
Arm Description
Physiotherapy and occupational therapy: Training group received 9 units of physiotherapy and 2 units of occupational therapy, each with a duration of one hour.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Members of the control group were referred to their general practitioner or specialist for further care.
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapy and occupational therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain
Description
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)
Time Frame
After 0 / 6 / 58 Weeks
Secondary Outcome Measure Information:
Title
Social function, psychological wellbeing and emotional role function
Description
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)
Time Frame
After 0 / 6 / 58 weeks
Title
Functional impairment
Description
The Oswestry disability index was used to measure functional impairment.
Time Frame
After 0 / 6 / 58 weeks
Title
Anxiety, insecurity in social contacts and compulsiveness
Description
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.
Time Frame
After 0 / 6 / 58 weeks
Title
Sick leave days
Description
The number of (self-reported) days of sick leave due to pain during the preceding twelve months were inquired.
Time Frame
After 0 / 58 weeks
Title
Painkillers
Description
The number of painkillers taken per day were inquired.
Time Frame
After 0 / 58 weeks
Title
Fear avoidance behavior
Description
Fear avoidance behavior was determined by means of the fear avoidance beliefs questionnaire (FABQ; scale 0-66; lower scores indicate lower fear-avoidance beliefs)
Time Frame
After 0 / 6 / 58 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florian Wepner, Dr.
Organizational Affiliation
Orthopedic Hospital Vienna Speising
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Friedrich, Prof.
Organizational Affiliation
Orthopedic Hospital Vienna Speising
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Julia Hahne, Mag.
Organizational Affiliation
Orthopedic Hospital Vienna Speising
Official's Role
Study Director
Facility Information:
Facility Name
Orthopedic Hospital Vienna Speising
City
Vienna
ZIP/Postal Code
1130
Country
Austria

12. IPD Sharing Statement

Citations:
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19363457
Citation
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Effect of an Outpatient Intervention Program in Patients With Chronic Back or Neck Pain

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