Clinical trial NCT05093543: Feasibility and Effect of a Multidisciplinary Telematics Approach for Chronic Non-specific Low Back Pain: a Randomized, Open-label, Controlled, Pilot Clinical Trial. Study Protocol
Official title: Feasibility and Effect of a Multidisciplinary Telematics Approach for Chronic Non-specific Low Back Pain: a Randomized, Open-label, Controlled, Pilot Clinical Trial. Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low back pain is a challenging condition, with a lifetime prevalence of up to 84%. The estimated prevalence of chronic non-specific low back pain is of approximately 23%. Although pain is a sensory experience triggered by a peripheral stimulus, psychosocial factors influence on its perception and on the risk of chronification.

Chronic Low Back Pain imposes a substantial socioeconomic burden to patients, families, and healthcare systems worldwide. It is a multifactorial condition, characterized by a combination of physical, psychosocial and occupational factors. We have planned two working hypotheses: (1) coordinating several healthcare professionals is feasible to manage chronic non-specific low back pain through telematics multidisciplinary approach; (2) telematics multidisciplinary approach improves the quality of life of patients with chronic non-specific low back pain and in whom conservative treatment has failed. Hence, we aim to assess the feasibility and effect of telematics multidisciplinary approach in patients suffering from chronic non-specific low back pain and who have not improved with conservative treatment.

Patients will be randomized to the telematics multidisciplinary approach (Experimental Group) or to the Standard of Care (Control Group). Scheduled and periodic telematics multidisciplinary sessions will be performed. Each session will consist of an integrated program that combines rehabilitation (i.e., group-based exercise program), psychological treatment and social work sessions. Standard of Care, after conservative treatment failure, depends mainly on the physician in charge's discretion and on the patients' preferences. An exploratory analysis will be performed.

The results of this clinical trial will provide evidence that a scheduled telematics multidisciplinary approach will improve the quality of life of these patients and empower them to be more autonomous. Likewise, telematics multidisciplinary approach is feasible to manage chronic non-specific low back pain in patients unresponsive to conservative treatment. Consequently, these patients are less likely to wander through different medical specialties seeking for a solution to their condition, presumably avoiding ineffective back surgeries. The results will also highlight the importance of patients playing an active role in their own treatment to successfully manage chronic non-specific low back pain.

Detailed description: Objectives {#7}:

Hypothesis:

Two working hypothesis have been planned: i) the coordination of several health care professionals is feasible to manage CnsLBP (Chronic non-specific Low Back Pain) through telematics multidisciplinary approach; ii) telematics multidisciplinary approach improves the quality of life of patients who suffer from CnsLBP and in whom conservative treatment has failed

Primary Objective The primary aims are to assess the feasibility and effect of the telematics multidisciplinary approach in patients who suffer from non-specific CnsLBP and in whom conservative treatment has failed.

Secondary objectives

The secondary objectives are:

1. to quantify the desertion rate
2. to study the level of usual physical activity
3. to quantify disability due to CnsLBP
4. to study anxiety and depression
5. to assess chronic pain coping strategies
6. to study self-awareness and emotional self-regulation
7. to evaluate perceived social support
8. to estimate mental well-being

Trial Design {#8}:

This is an open-label, randomized, controlled, parallel-group, pilot clinical trial. Patients will be randomized to the telematic multidisciplinary biopsychosocial approach (Experimental Group) or to the Standard of Care (Control Group).

This pilot clinical trial will provide evidence on the feasibility of the coordination of several health care professionals to manage CnsLBP through telematics multidisciplinary approach; and it will provide the first evidence on the impact of the telematics multidisciplinary approach on the QoL of these patients.

The target population will be patients with CnsLBP who have already undergone rehabilitation and pain clinic therapy and are still in pain and seeking for a solution (i.e., patients on a waiting list to see a spine surgeon for surgical assessment, patients who might be candidates to lumbar surgery depending on their evolution, patients being followed up by a Pain Clinic specialist or by their assigned General Practitioner specialist). If during the trial it is decided to perform a lumbar surgical intervention on an included patient, he/she will be automatically excluded from the trial.

Methods: Participants, Interventions and Outcomes

Study Setting {#9}:

This trial will be carried out in the premises of the Bellvitge University Hospital (a tertiary hospital), the Viladecans Hospital (a secondary hospital) and primary care centers: Delta del Llobregat Primary Care Center, L'Hospitalet de Llobregat Mental Health Unit, Santa Eulalia Primary Care Center.

Eligibility criteria: Eligibility Criteria {#10}:

Inclusion Criteria:

* Patients between 18 and 67 years of age (i.e., working age population).
* Both genders.
* Patients with chronic non-specific low back pain that does not improve with conservative treatment (including rehabilitation and Pain Clinic evaluation and follow-up).
* The predominant symptom must be low back pain (and not pain radiating to the extremities).
* Patients who sign the informed consent form

Exclusion Criteria:

* Patients who have previously undergone lumbar arthrodesis.
* Patients diagnosed with lumbar instability or non-degenerative pathologies (fractures, tumors, infections, etc.) that justify their chronic low back pain.
* Patients who cannot move independently.
* Patients who have a contraindication to perform light aerobic exercise or physical therapy exercises for the treatment of low back pain.
* Patients with a psychiatric history that interferes with their daily life
* Patients who are possible candidates for low back surgery, with a planned intervention during the study period.
* Patients who have a programmed Pain Clinic intervention or extra rehabilitation sessions scheduled during the study period.
* Patients who lack motivation or show no commitment to the program.
* Patients who do not have access to a device with internet connection and/or to a webcam (smartphone, tablet, or computer).

Note: Since this is a pilot clinical trial with a small sample size, patients who receive extra sessions of rehabilitation or interventions in Pain Clinic will be withdrawn from the study to minimize the impact on the results, although these treatments are also part of the SoC.

Primary outcomes:
measure: Number of sessions performed out of the 8 sessions scheduled
timeFrame: 6 months
measure: Number of scheduled visits attended
timeFrame: 6 months
measure: Number of questionnaires fulfilled
timeFrame: 6 months
measure: Number of telematics multidisciplinary sessions attended
timeFrame: 6 months
measure: Number of withdrawals
timeFrame: 6 months
Secondary outcomes:
measure: SF-36 (Short Form-36) total punctuation
timeFrame: 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
Study officials:
affiliation: Orthopaedics Attending physician
name: Iago Garreta-Catala, MD
role: PRINCIPAL_INVESTIGATOR
References:
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