Clinical trial NCT02497625: Effectiveness of Therapeutic Alliance and Minimal Intervention for Chronic Low Back Pain
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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Empathy
Subgroups
Minimal intervention
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain intensity
timeFrame: One month after randomization
measure: Specific disability
timeFrame: One month after randomization
Secondary outcomes:
measure: Pain intensity
timeFrame: Six and twelve months after randomization
measure: Specific disability
timeFrame: Six and twelve months after randomization
measure: Disability
timeFrame: One, six and twelve months after randomization
measure: Global impression of recovery
timeFrame: One, six and twelve months after randomization
Other outcomes:
measure: Empathy
timeFrame: One week after the first session of treatment
measure: Credibility
timeFrame: After the first session of treatment
measure: Expectation of improvement
timeFrame: One week after the first session of treatment
Locations:
city: Sao Paulo
country: Brazil
facility: Physical Therapy Outpatient Department
state: SP
Study officials:
affiliation: Universidade Cidade de São Paulo
name: Felipe RC Fagundes, MsC
role: PRINCIPAL_INVESTIGATOR
References:
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.