Effectiveness of Therapeutic Alliance and Minimal Intervention for Chronic Low Back Pain (TalkBack)

Universidade Cidade de Sao Paulo

Status: Completed

Conditions: Low Back Pain

Treatments: Behavioral: Positive Therapeutic Alliance; Other: Control group; Behavioral: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT02497625

44720315.5.0000.5372

Details and patient eligibility

About

This study aims to evaluate the effectiveness of minimal intervention and therapeutic alliance in pain, specific and general disability, global perceived effect, empathy, credibility and expectation of improvement in patients with chronic non-specific low back pain

Full description

Low back pain remains a global public health problem. The classification of patients in low back pain subgroups aims to optimize the health system and provide the quantity and the type of proper technique for each patient. Several factors may influence physical therapy. The therapeutic alliance may be defined as harmony or social connection between the therapist and the patient and may influence the treatment effect. The aim of this study is to evaluate the effectiveness of the addition of the therapeutic alliance to a minimum intervention for the treatment of chronic non-specific low back pain with low risk of psychosocial factors.

Enrollment: 222 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Patients waiting for treatment in the waiting list of physical therapy clinics
• Diagnosis of chronic non-specific low back pain (over 12 weeks)
• More than 18 years
• Able to read and write the Portuguese language
• Low risk of psychosocial factors (less than 3 points in the STarT Back Screening Tool).

Exclusion criteria

• Spine surgery history
• Nerve root compromise
• Cognitive impairment related disorders
• Pregnants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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222 participants in 3 patient groups

Positive Therapeutic Alliance

Experimental group

Description:

Intervention involving reassurance and information related to the return to daily activities, advice on dealing with the pain and clear explanation of signs and symptoms. The session will take 60 minutes and will be structured to increase the therapeutic alliance and empathy. Patients will be instructed to return in a week for further consultation to clarify doubts.

Treatment:

Behavioral: Positive Therapeutic Alliance

Usual Care

Active Comparator group

Description:

Information about low back pain based on Back Book. The therapy will be performed with limited interaction between patient and therapist and the information will be transmitted in a clear and direct way. The limited interaction between patient and therapist in this group will be established at the first session lasting 45-60 minutes. Patients will be instructed to return for a visit after a week to clarify questions.

Treatment:

Behavioral: Usual care

Control group

Other group

Description:

Patients will not receive intervention in the first mo nth of enrollment. After a year, the treatment offered to the Positive Therapeutic Alliance or Usual Care group will be available for patients who are interested.

Treatment:

Other: Control group