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Completed

NCT Number: NCT02497625

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

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Therapy Outpatient Department

São Paulo, 03071000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Positive Therapeutic Alliance

Behavioral

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.

Usual Care

Behavioral

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.

Control Group

Other

Patients will not receive intervention in the first month in which they are enrolled. After a year, the treatment offered to the Positive Therapeutic Alliance or Usual Care group will be available for patients who are interested.

Primary outcomes

  1. Pain intensity

    Time frame: One month after randomization

    Pain intensity will be measured by an 11-point Pain Numerical Rating Scale

  2. Specific disability

    Time frame: One month after randomization

    Specific disability associated with low back pain will be measured by the 11-point Patient Specific Functional Scale.

Secondary outcomes

  1. Pain intensity

    Time frame: Six and twelve months after randomization

    Pain intensity will be measured by an 11-point Pain Numerical Rating Scale

  2. Specific disability

    Time frame: Six and twelve months after randomization

    Specific disability associated with low back pain will be measured by the 11-point Patient Specific Functional Scale.

  3. Disability

    Time frame: One, six and twelve months after randomization

    Disability associated with low back pain will be measured by the 0-100 scale of the Oswestry Disability Index

  4. Global impression of recovery

    Time frame: One, six and twelve months after randomization

    Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale

Other outcomes

  1. Empathy

    Time frame: One week after the first session of treatment

    Empathy will be measured by a 50-point scale of the Consultation and Relational Empathy (CARE) questionnaire

  2. Credibility

    Time frame: After the first session of treatment

    The credibility regarding the treatment will be evaluated using 0-24 point scale.

  3. Expectation of improvement

    Time frame: One week after the first session of treatment

    The expectation of improvement will be assessed with a numerical scale of 11 points

Sponsors and collaborators

Lead sponsor

Universidade Cidade de Sao Paulo

Other

Registry information

Official study title

Effectiveness of the Addition of Therapeutic Alliance to Minimal Intervention Treatment for Chronic Low Back Pain With Low Risk of Psychosocial Factors: a Randomized Controlled Trial

Acronym: TalkBack

Important dates

Study start
2015
Primary completion
2017
Study completion
2021
First posted
Jul 14, 2015
Registry last updated
Feb 12, 2021

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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