Clinical trial NCT01981798: Effect of an Outpatient Intervention Program in Patients With Chronic Back or Neck Pain
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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Orthopedic Hospital Vienna Speising
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Pain
timeFrame: After 0 / 6 / 58 Weeks
Secondary outcomes:
measure: Social function, psychological wellbeing and emotional role function
timeFrame: After 0 / 6 / 58 weeks
measure: Functional impairment
timeFrame: After 0 / 6 / 58 weeks
measure: Anxiety, insecurity in social contacts and compulsiveness
timeFrame: After 0 / 6 / 58 weeks
measure: Sick leave days
timeFrame: After 0 / 58 weeks
measure: Painkillers
timeFrame: After 0 / 58 weeks
measure: Fear avoidance behavior
timeFrame: After 0 / 6 / 58 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Orthopedic Hospital Vienna Speising
Study officials:
affiliation: Orthopedic Hospital Vienna Speising
name: Florian Wepner, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopedic Hospital Vienna Speising
name: Martin Friedrich, Prof.
role: STUDY_CHAIR
affiliation: Orthopedic Hospital Vienna Speising
name: Julia Hahne, Mag.
role: STUDY_DIRECTOR
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