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

Low Back Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497625
• Other study ID #: 44720315.5.0000.5372
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: February 11, 2021

Study information

• Verified date: February 2021
• Source: Universidade Cidade de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: February 11, 2021
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• 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 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.

Locations

Country	Name	City	State
Brazil	Physical Therapy Outpatient Department	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Fagundes FR, de Melo do Espírito 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Credibility	The credibility regarding the treatment will be evaluated using 0-24 point scale.	After the first session of treatment
Other	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
Primary	Pain intensity	Pain intensity will be measured by an 11-point Pain Numerical Rating Scale	One month after randomization
Primary	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	Pain intensity	Pain intensity will be measured by an 11-point Pain Numerical Rating Scale	Six and twelve months after randomization
Secondary	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
Secondary	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
Secondary	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