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

Summary

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.

Conditions

• Musculoskeletal Pain Disorder
• Spinal Pain

Interventions

OTHER

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

In a one-hour consultation, the APPT will assess and triage surgical candidates, recommend medical care (medication or injection), as well as provide education and prescribe a self-management exercise program aimed at impairments and functional limitations identified during the initial assessment. Participant will not receive additional care by the APPT.

OTHER

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

In a one-hour consultation, the APPT will assess and triage surgical candidates, recommend medical care (medication or injection), as well as provide education and prescribe a self-management exercise program aimed at impairments and functional limitations identified during the initial assessment. Participants will receive five additional consultations with the APPT within a 12-week period. During the follow-up visits, the APPT will reassess the participants, provide further education and recommendations, review and modify the home exercise program and may provide other rehabilitation interventions.

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-15

Primary Completion

2023-08-28

Completion

2023-08-28

Countries

• Canada

Study Locations