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

O

Orthopedic Hospital Vienna Speising

Status

Completed

Conditions

Chronic Low Back Pain
Neck Pain

Treatments

Behavioral: Physiotherapy and occupational therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01981798
Praev123

Details and patient eligibility

About

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.

Full 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.

Enrollment

121 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

121 participants in 2 patient groups

Training group
Active Comparator group
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.
Treatment:
Behavioral: Physiotherapy and occupational therapy
Control Group
No Intervention group
Description:
Members of the control group were referred to their general practitioner or specialist for further care.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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