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

NCT02497625 | Completed DMC

• 1 other identifier: 44720315.5.0000.5372
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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

Conditions

Low Back Pain

Keywords

Low back pain; Empathy; Subgroups; Minimal intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Pain intensity

  Six and twelve months after randomization

• Specific disability

  Six and twelve months after randomization

• Disability

  One, six and twelve months after randomization

• Global impression of recovery

  One, six and twelve months after randomization

Other Outcomes (3)

• Empathy

  One week after the first session of treatment

• Credibility

  After the first session of treatment

• Expectation of improvement

  One week after the first session of treatment

Study Arms (3)

Positive Therapeutic Alliance

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Control group

OTHER

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

Interventions

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.

Positive Therapeutic Alliance

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.

Usual Care

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.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead

Study Sites (1)

Physical Therapy Outpatient Department

São Paulo, São Paulo, 03071000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 28143504 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Felipe RC Fagundes, MsC

  Universidade Cidade de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor PhD

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: July 14, 2015
• Study Start: September 1, 2015
• Primary Completion: June 30, 2017
• Study Completion: February 11, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)