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

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

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Behavioral: Positive Therapeutic Alliance; Behavioral: Usual care; Other: Control group

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 222
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 03071000
      • Physical Therapy Outpatient Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positive Therapeutic Alliance; 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.	Behavioral: Positive Therapeutic Alliance; 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.
Active Comparator: Usual Care; 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.	Behavioral: Usual care; 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.
Other: Control group; 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.	Other: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity will be measured by an 11-point Pain Numerical Rating Scale	One month after randomization
Specific disability	Specific disability associated with low back pain will be measured by the 11-point Patient Specific Functional Scale.	One month after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity will be measured by an 11-point Pain Numerical Rating Scale	Six and twelve months after randomization
Specific disability	Specific disability associated with low back pain will be measured by the 11-point Patient Specific Functional Scale.	Six and twelve months after randomization
Disability	Disability associated with low back pain will be measured by the 0-100 scale of the Oswestry Disability Index	One, six and twelve months after randomization
Global impression of recovery	Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale	One, six and twelve months after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Empathy	Empathy will be measured by a 50-point scale of the Consultation and Relational Empathy (CARE) questionnaire	One week after the first session of treatment
Credibility	The credibility regarding the treatment will be evaluated using 0-24 point scale.	After the first session of treatment
Expectation of improvement	The expectation of improvement will be assessed with a numerical scale of 11 points	One week after the first session of treatment

Collaborators and Investigators

• Sponsor: Universidade Cidade de Sao Paulo
• Investigators: Principal Investigator: Felipe RC Fagundes, MsC, Universidade Cidade de Sao Paulo

Publications and helpful links

General Publications

• Fagundes FR, de Melo do Espirito Santo C, de Luna Teixeira FM, Tonini TV, Cabral CM. Effectiveness of the addition of therapeutic alliance with minimal intervention in the treatment of patients with chronic, nonspecific low back pain and low risk of involvement of psychosocial factors: a study protocol for a randomized controlled trial (TalkBack trial). Trials. 2017 Jan 31;18(1):49. doi: 10.1186/s13063-017-1784-z.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): February 11, 2021

Study Registration Dates

• First Submitted: July 10, 2015
• First Submitted That Met QC Criteria: July 10, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Low back pain; Empathy; Subgroups; Minimal intervention
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 44720315.5.0000.5372

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO