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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Low Back Pain

Intervention / Treatment
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* Behavioral: Positive Therapeutic Alliance
* Behavioral: Usual care
* Other: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive Therapeutic Alliance<br>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<br>* 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.<br>|
| Active Comparator: Usual Care<br>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<br>* 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.<br>|
| Other: Control group<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, Empathy, Subgroups, Minimal intervention