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

Not Applicable

Completed

• Conditions: Low Back Pain

• Registration Number: NCT02497625
• Lead Sponsor: Universidade Cidade de Sao Paulo

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.

Study Timeline

• Study First Submitted: 2015-07-10
• Study First Submitted QC: 2015-07-10
• Study First Posted: 2015-07-14
• Study Start: 2015-09
• Primary Completion: 2017-06-30
• Status Verified: 2021-02
• Study Completion: 2021-02-11
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Specific disability	Six and twelve months after randomization	Specific disability associated with low back pain will be measured by the 11-point Patient Specific Functional Scale.
Global impression of recovery	One, six and twelve months after randomization	Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale
Pain intensity	Six and twelve months after randomization	Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Disability	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

Trial Locations

Locations (1)

Physical Therapy Outpatient Department; 🇧🇷 Sao Paulo, SP, Brazil