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

NCT05093543 | Completed

• 1 other identifier: HUB-COT-ENFORMA-2021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (5)

• Number of sessions performed out of the 8 sessions scheduled

  number of telematics multidisciplinary sessions performed out of the 8 sessions scheduled acording the study protocol

  6 months

• Number of scheduled visits attended

  Number of visits attended by the patients out of the total of scheduled visits

  6 months

• Number of questionnaires fulfilled

  Number of questionnaires fulfilled by the patients out of the total scheduled questionnaires

  6 months

• Number of telematics multidisciplinary sessions attended

  Number of telematics multidisciplinary sessions attended by the patients out of the total scheduled sessions

  6 months

• Number of withdrawals

  Number of withdrawals out of the total patients enrolled in the study

  6 months

Secondary Outcomes (1)

• SF-36 (Short Form-36) total punctuation

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

The experimental group is based on a telematic multidisciplinary approach for CnsLBP. Scheduled and periodic telematic sessions will be performed. The multidisciplinary approach (to be carried out by telematic means) consists of a biopsychosocial rehabilitation program for patients with CnsLBP that includes physical rehabilitation/physiotherapy and psychosocial group sessions (performed by psychologists, social workers), which will be offered as part of the integrated program. Patients assigned to the experimental group will receive a Google Meet® link by email, so that they may join the weekly 2-hour group sessions (every Tuesday at 9 a.m.). Google Meet® is a free real-time meeting app by Google that does not require download, has no session time limit, and neither limits the number of users per session. Patients assigned to the experimental group will receive a single-use link by email to access each online group session.

Behavioral: physical rehabilitation/physiotherapy and psychosocial group sessions

Control

NO INTERVENTION

Explanation for choice of comparators {6b} The telematics multidisciplinary approach (experimental group) will be compared to Standard of Care (SoC) (control group). SoC consists of a patient's follow up according to the usual clinical practice. In Bellvitge University Hospital's setting, the treatment protocol for CnsLBP indicates physical rehabilitation/physiotherapy as the first treatment step, and Pain Clinic evaluation as a second step for those who did not improve. For patients who did not improve with the previous steps and that still demand a solution for their CnsLBP, a third step would be to refer the patient for surgical evaluation - a spine surgeon would, then, evaluate, alongside with the patient, whether a surgical approach would be appropriate for his/her case. If the surgery is ruled out by the spine surgeon, the patient may be referred, once more, to physical rehabilitation/physiotherapy and/or to the Pain Clinic, at the surgeon's discretion.

Interventions

physical rehabilitation/physiotherapy and psychosocial group sessions BEHAVIORAL

physical rehabilitation/physiotherapy and psychosocial group sessions

Intervention

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Hospital de Bellvitge

Barcelona, 08907, Spain

Location

Related Publications (7)

• Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur Spine J. 2018 Sep;27(Suppl 6):796-801. doi: 10.1007/s00586-017-5432-9. Epub 2018 Feb 26.

  PMID: 29480409 RESULT

• Latremoliere A, Woolf CJ. Central sensitization: a generator of pain hypersensitivity by central neural plasticity. J Pain. 2009 Sep;10(9):895-926. doi: 10.1016/j.jpain.2009.06.012.

  PMID: 19712899 RESULT

• Searle A, Spink M, Ho A, Chuter V. Exercise interventions for the treatment of chronic low back pain: a systematic review and meta-analysis of randomised controlled trials. Clin Rehabil. 2015 Dec;29(12):1155-67. doi: 10.1177/0269215515570379. Epub 2015 Feb 13.

  PMID: 25681408 RESULT

• Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.

  PMID: 16550448 RESULT

• Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49:1. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20.

  PMID: 26487293 RESULT

• Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.

  PMID: 21982256 RESULT

• Garreta-Catala I, Planas-Balague R, Abouzari R, Carnaval T, Nolla JM, Videla S, Agullo-Ferre JL; EN-FORMA study group. Feasibility of a multidisciplinary group videoconferencing approach for chronic low back pain: a randomized, open-label, controlled, pilot clinical trial (EN-FORMA). BMC Musculoskelet Disord. 2023 Aug 9;24(1):642. doi: 10.1186/s12891-023-06763-6.

  PMID: 37558990 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Iago Garreta-Catala, MD

  Orthopaedics Attending physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant of Orthopaedics Surgery, Principal Investigator

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: October 26, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)