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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Positive Therapeutic Alliance
Usual care
Control group
Sponsored by
Universidade Cidade de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Empathy, Subgroups, Minimal intervention

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Physical Therapy Outpatient Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Positive Therapeutic Alliance

Usual Care

Control group

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Pain intensity
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Specific disability
Specific disability associated with low back pain will be measured by the 11-point Patient Specific Functional Scale.

Secondary Outcome Measures

Pain intensity
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Specific disability
Specific disability associated with low back pain will be measured by the 11-point Patient Specific Functional Scale.
Disability
Disability associated with low back pain will be measured by the 0-100 scale of the Oswestry Disability Index
Global impression of recovery
Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale

Full Information

First Posted
July 10, 2015
Last Updated
February 11, 2021
Sponsor
Universidade Cidade de Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02497625
Brief Title
Effectiveness of Therapeutic Alliance and Minimal Intervention for Chronic Low Back Pain
Acronym
TalkBack
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
February 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cidade de Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Empathy, Subgroups, Minimal intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive Therapeutic Alliance
Arm Type
Experimental
Arm 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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm 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.
Arm Title
Control group
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Positive Therapeutic Alliance
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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 Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Time Frame
One month after randomization
Title
Specific disability
Description
Specific disability associated with low back pain will be measured by the 11-point Patient Specific Functional Scale.
Time Frame
One month after randomization
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Time Frame
Six and twelve months after randomization
Title
Specific disability
Description
Specific disability associated with low back pain will be measured by the 11-point Patient Specific Functional Scale.
Time Frame
Six and twelve months after randomization
Title
Disability
Description
Disability associated with low back pain will be measured by the 0-100 scale of the Oswestry Disability Index
Time Frame
One, six and twelve months after randomization
Title
Global impression of recovery
Description
Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale
Time Frame
One, six and twelve months after randomization
Other Pre-specified Outcome Measures:
Title
Empathy
Description
Empathy will be measured by a 50-point scale of the Consultation and Relational Empathy (CARE) questionnaire
Time Frame
One week after the first session of treatment
Title
Credibility
Description
The credibility regarding the treatment will be evaluated using 0-24 point scale.
Time Frame
After the first session of treatment
Title
Expectation of improvement
Description
The expectation of improvement will be assessed with a numerical scale of 11 points
Time Frame
One week after the first session of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe RC Fagundes, MsC
Organizational Affiliation
Universidade Cidade de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Therapy Outpatient Department
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
03071000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28143504
Citation
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.
Results Reference
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Effectiveness of Therapeutic Alliance and Minimal Intervention for Chronic Low Back Pain

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