NCT04868591

Single Session Compared to Multiple Sessions of Education and Exercise for Older Adults With Spinal Pain in an Advanced Practice Physiotherapy Model of Care

Completed NA Last updated 30 August 2023

What this trial tests

NA trial testing Single session of education and exercise provided by an advanced practice physiotherapist. in Musculoskeletal Pain Disorder in 109 participants. Completed in 28 August 2023.

Timeline

15 May 2021

Primary endpoint
28 August 2023

28 August 2023

Quick facts

Lead sponsor	Ciusss de L'Est de l'Île de Montréal
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	109
Start date	15 May 2021
Primary completion	28 August 2023
Estimated completion	28 August 2023
Sites	1 location across Canada

Drugs / interventions tested

• Single session of education and exercise provided by an advanced practice physiotherapist.
• Multiple session of education and exercise provided by an advanced practice physiotherapist.

Conditions studied

• Musculoskeletal Pain Disorder — all drugs for Musculoskeletal Pain Disorder →
• Spinal Pain — all drugs for Spinal Pain →

Sponsor

Ciusss de L'Est de l'Île de Montréal — full company profile →

Who can join

65 and older, any sex, with Musculoskeletal Pain Disorder or Spinal Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objectives: To assess the effectiveness and cost-effectiveness of a single session compared to multiple sessions of education and exercise for older adults with spinal pain treated conservatively in an advanced practice physiotherapy (APP) model of care.

Methods and Analysis: In this pragmatic randomized controlled trial, 152 adults (≥ 18 years old) with neck or back pain initially referred for a consultation in neurosurgery, but treated conservatively, will be recruited through the APP neurosurgery CareAxis program in the Montreal region (Quebec, Canada). In the CareAxis program, older patients with spinal pain are triaged by an advance practice physiotherapist and are offered conservative care and only potential surgical candidates are referred to a neurosurgeon. Participants will be randomized into one of two arms: 1- a single session or 2- multiple sessions (6 sessions over 12 weeks) of education and exercise with the advance practice physiotherapist. The primary outcome measure will be the Brief Pain Inventory (pain severity and interference subscales). Secondary measures will include self-reported disability (the Neck Disability Index or Oswestry Disability Index), The Pain Catastrophizing Scale, satisfaction with care (VSQ-9 and MedRisk questionnaires), and health-related quality of life (EQ-5D-5L). Participants healthcare resources use, and related costs will be measured. Outcomes will be collected at baseline and at 6, 12 and 26 weeks after enrollment. Intention-to-treat analyses will be performed, and repeated mixed-model ANOVA will assess differences between treatment arms. Cost-utility analyses will be conducted from the perspective of the health care system.

Ethics and dissemination: Ethics approval has been obtained from the Comité d'éthique de la recherche du CIUSS de l'Est-de-l'Île-de-Montréal (FWA00001935 and IRB00002087). Results of this study will be presented to different stakeholders, published in peer-reviewed journals and presented at international conferences.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Single session compared with multiple sessions of education and exercise for older adults with spinal pain in an advanced practice physiotherapy model of care: protocol for a randomised controlled trial.
   Lafrance S, Santaguida C, Perreault K, Bath B, et al · · 2021 · cited 2× · PMID 34493525 · DOI 10.1136/bmjopen-2021-053004