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Completed

NCT Number: NCT01981798

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

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.

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Key information

Conditions

Chronic Low Back Pain Chronic Pain Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopedic Hospital Vienna Speising

Vienna, State of Vienna, 1130, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

physiotherapy and occupational therapy

Behavioral

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 outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. Functional impairment

    Time frame: After 0 / 6 / 58 weeks

    The Oswestry disability index was used to measure functional impairment.

  3. 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.

  4. 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.

  5. Painkillers

    Time frame: After 0 / 58 weeks

    The number of painkillers taken per day were inquired.

  6. 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)

Sponsors and collaborators

Lead sponsor

Orthopedic Hospital Vienna Speising

Other

Registry information

Official study 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

Acronym: CPS

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 13, 2013
Registry last updated
Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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