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

Not Applicable

Completed

• Conditions: Chronic Low Back Pain; Neck Pain
• Interventions: Behavioral: Physiotherapy and occupational therapy

• Registration Number: NCT01981798
• Lead Sponsor: Orthopedic Hospital Vienna Speising

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.

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted: 2013-08-29
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-05
• Last Update Submitted: 2013-11-05
• Study First Posted: 2013-11-13
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pain	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)

Secondary Outcome Measures

Name	Time	Method
Fear avoidance behavior	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)
Social function, psychological wellbeing and emotional role function	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)
Functional impairment	After 0 / 6 / 58 weeks	The Oswestry disability index was used to measure functional impairment.
Anxiety, insecurity in social contacts and compulsiveness	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.
Painkillers	After 0 / 58 weeks	The number of painkillers taken per day were inquired.
Sick leave days	After 0 / 58 weeks	The number of (self-reported) days of sick leave due to pain during the preceding twelve months were inquired.

Trial Locations

Locations (1)

Orthopedic Hospital Vienna Speising; 🇦🇹 Vienna, Austria