Efficacy of Educating Physical Therapists in the Treatment of Patients With Nonspecific Chronic Low Back Pain

NCT ID: NCT02417402

Last Updated: 2017-10-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-07-31

Brief Summary

The aim of this trial is to investigate if patients treated by physical therapists who received an update on clinical practice guidelines and pain management have better outcomes than patients treated by physical therapists who did not received such training.

Detailed Description

The training "Update on the treatment of patients with nonspecific chronic low back pain" will be announced in the social network by members of the study. Interested physical therapists will send an email to one of the study authors with their information regarding the inclusion criteria. After two months of notice, interested and eligible physiotherapists will be randomized into two groups of 15 participants each.

The study arms are: 1) control group (physical therapist who will not receive training) and 2) experimental group (physical therapist who will receive training). Before and after training, attitudes, beliefs and knowledge about low back pain guidelines will be evaluated.

Each physical therapist will recruit for the study a total of fifteen consecutive patients with chronic nonspecific low back pain (total sample=150 patients). All the patients will be assessed before the first session by a blinded examiner who will be unaware about the group allocation.

Clinical outcomes (pain, disability, fear avoidance beliefs and pain catastrophizing) will be collected at baseline and at 5 weeks, 3 and 6 months after randomization. All statistical analysis will be conducted following the principles of intention to treat analysis and the between-group differences will be performed using Mixed Linear Models.

Conditions

Back Pain

Keywords

back pain; low back pain; chronic low back pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Untrained Physical Therapists

The patients allocated to the Control group will be treated by physical therapists who did not receive any training about clinical practice guidelines and pain management. These patients will receive the usual care from their physical therapists.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

The patients allocated to the Control group will be treated by physical therapists who did not carry out the training before treatment. The physical therapists will use their usual care for nonspecific chronic low back pain. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). Each treatment session has an estimated duration of 50-60 minutes.

Trained Physical Therapists

The patients allocated to the Experimental group will be treated by physical therapists who received training about clinical practice guidelines and pain management.

Group Type: EXPERIMENTAL

Trained

Intervention Type: OTHER

The patients allocated to the Experimental group will be treated by physical therapists who carried out the training before treatment. The training will be designed to guide the physical therapists beliefs and attitudes to a biopsychosocial model; update knowledge contained in clinical practice guidelines; and enable physical therapists to identify, integrate and address psychosocial factors in patients with nonspecific chronic low back pain. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). Each treatment session has an estimated duration of 50-60 minutes.

Interventions

Control

The patients allocated to the Control group will be treated by physical therapists who did not carry out the training before treatment. The physical therapists will use their usual care for nonspecific chronic low back pain. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). Each treatment session has an estimated duration of 50-60 minutes.

Intervention Type: OTHER

Trained

The patients allocated to the Experimental group will be treated by physical therapists who carried out the training before treatment. The training will be designed to guide the physical therapists beliefs and attitudes to a biopsychosocial model; update knowledge contained in clinical practice guidelines; and enable physical therapists to identify, integrate and address psychosocial factors in patients with nonspecific chronic low back pain. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). Each treatment session has an estimated duration of 50-60 minutes.

Intervention Type: OTHER

Other Intervention Names

physical therapist education; guidelines implementation; physical therapist education; guidelines implementation

Eligibility Criteria

Inclusion Criteria

• patients seeking care for chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 months), with a pain intensity of at least 3 points measured by a 0-10 pain numerical rating scale, aged between 18 and 65 years.
• physiotherapists who treat exclusively patients with musculoskeletal pain, duly accredited by the National Council of Physical Therapy, physiotherapists offering private or medical insurance treatment individually to their patients, lasting 50-60 minutes each session, physiotherapists from 2 to five years of graduation and / or working in the area for the same period, that treat at least 2 patients with low back pain per month, and who are willing to treat at least 10 patients for the study.

Exclusion Criteria

• patients will be excluded if they have any contraindication to physical exercise or ultrasound or short wave therapy, evidence of nerve root compromise (i.e one or more of motor, reflex or sensation deficit), serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases), serious cardiovascular and metabolic diseases, previous back surgery and pregnancy.
• physiotherapists who want to stop the activities for some reason that prevents participation in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Cidade de Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Rossi Nogueira Rizzo

Masters student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leonardo OP Costa, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Cidade de São Paulo

Other Identifiers

UNICID032015

Identifier Type: -

Identifier Source: org_study_id