The Right Intervention for the Right Patient

The Back Research Center, Denmark

Status: Completed

Conditions: Low Back Pain

Treatments: Procedure: Biopsychosocial intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00459433

258

Details and patient eligibility

About

Complicated and expensive interventions are used to treat unspecific low back pain and the intervention is not always targeted the patients specific problems.It is therefore not surprising that a large fraction of unspecific low back pain patients do not respond very well to the usual biopsychosocial intervention.

We would therefore like to identify the patients specific problems regarding the patients biomedical, psychological, and social needs.

Full description

Two quality assurance investigations are performed in the The Back Research Center Clinic, where one is published in The Spine. The systematics of Health Technology Assessment was used to throw light on important indicators in relation to Health Technology aspects, patient aspects, organisational aspects and economical aspects. At 12 months follow up in 1999, approximately one third of the patients stated that their low back pain was unchanged or worse. In 2004 in a new investigation this fraction was larger. Therefore it seems relevant to be able to identify the patients early in their course in the back ambulatory.

A Norwegian project has shown that when one divides the patients into 3 levels of severity, then the interdisciplinary biopsychosocial intervention had best effect in the intermediary and severe groups. Conversely the mono disciplinary intervention had best effect on the least severe patient group.

Therefore we would like to combine elements from the typical clinical investigation with a screening for psychosocial factors in order to sort patients according to their individual needs.

Even though the bio-psycho-social elements are a coherent continuum one can arbitrarily combine them in 4 groups of increasing complexity.

• mainly biological
• both biological and psychological
• both biological and social
• both biological, psychological and social It is probably not good enough to give more or less the same type of somatic treatment to all unspecific low back pain patients. It is important to take into account all three elements, the severity of the elements, and the combination of elements. To be able to do this it is important to use a combination of screening instruments that can isolate and quantify the manifestations of the three elements in the patients.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Unspecific low back pain
• Level of low back pain must be at least equal to leg pain
• Patients must have been sick listed during the past 12 months
• Age > 17 years and < than 60

Exclusion criteria

• Modic changes as seen on MRI
• Direct or progressive paresis or Cauda equina syndrome
• Known MB Bechterew or Sacroiliitis
• Suspicion of other serious malignancy
• Alcohol or medicine abuse
• A screening result of more than 30 in the Beck Depression Inventory

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

300 participants in 2 patient groups

1

Experimental group

Description:

psychosocial intervention

Treatment:

Procedure: Biopsychosocial intervention

2

Active Comparator group

Description:

Usual care

Treatment:

Procedure: Biopsychosocial intervention