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

NCT04868591 | Completed

• 1 other identifier: 2021-2261
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Health care organization; Advanced practice; Physical Therapy; Spine; Musculoskeletal Pain Disorder; Economic evaluation

Outcome Measures

Primary Outcomes (6)

• Brief Pain Inventory (BPI) Short form, Pain interference scale (change from baseline)

  The BPI pain interference scale is a self-administered questionnaire which includes 7 items where the patient is asked to rate their perceived impact of pain on various functional activities. The finale score ranges from 0 to 10 (0=pain does not interfere; 10=pain completely interferes).

  Change from baseline to 6 weeks

• Brief Pain Inventory (BPI) Short form, Pain interference scale (change from baseline)

  The BPI pain interference scale is a self-administered questionnaire which includes 7 items where the patient is asked to rate their perceived impact of pain on various functional activities. The final score ranges from 0 to 10 (0=pain does not interfere; 10=pain completely interferes).

  Change from baseline to 12 weeks

• Brief Pain Inventory (BPI) Short form, Pain interference scale (change from baseline)

  The BPI pain interference scale is a self-administered questionnaire which includes 7 items where the patient is asked to rate their perceived impact of pain on various functional activities. The final score ranges from 0 to 10 (0=pain does not interfere; 10=pain completely interferes).

  Change from baseline to 26 weeks

• Brief Pain Inventory (BPI) Short form, Pain severity scale (change from baseline)

  The BPI pain severity scale is a self-administered questionnaire which includes 4 items where the patient is asked to rate their pain intensity (wort, least, general and current). The final score ranges from 0 to 10 (0=no pain; 10=pain as bad as you can imagine).

  Change from baseline to 6 weeks

• Brief Pain Inventory (BPI) Short form, Pain severity scale (change from baseline)

  The BPI pain severity scale is a self-administered questionnaire which includes 4 items where the patient is asked to rate their pain intensity (wort, least, general and current). The final score ranges from 0 to 10 (0=no pain; 10=pain as bad as you can imagine).

  Change from baseline to 12 weeks

• Brief Pain Inventory (BPI) Short form, Pain severity scale (change from baseline)

  The BPI pain severity scale is a self-administered questionnaire which includes 4 items where the patient is asked to rate their pain intensity (wort, least, general and current). The final score ranges from 0 to 10 (0=no pain; 10=pain as bad as you can imagine).

  Change from baseline to 26 weeks

Secondary Outcomes (19)

• Neck Disability Index (NDI) (change from baseline)

  Change from baseline to 6 weeks

• Neck Disability Index (NDI) (change from baseline)

  Change from baseline to 12 weeks

• Neck Disability Index (NDI) (change from baseline)

  Change from baseline to 26 weeks

• Oswestry Disability Index (ODI) (change from baseline)

  Change from baseline to 6 weeks

• Oswestry Disability Index (ODI) (change from baseline)

  Change from baseline to 12 weeks

Study Arms (2)

Single session APP arm

ACTIVE COMPARATOR

Participants in this group will received one session with the advanced practice physiotherapist.

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

Multiple sessions APP arm

EXPERIMENTAL

Participants in this group will received 6 sessions (in 12 weeks) with the advanced practice physiotherapist.

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

Interventions

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

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.

Single session APP arm

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

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.

Multiple sessions APP arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• adults consulting for a neck or back condition;
• aged 65 years old or older;
• referred for a consultation in neurosurgery to the CareAxis group, either directly by family physicians or from the Centre de répartition des demandes de service de Montréal and
• not considered as a potential surgical candidate based on the initial APPT assessment.

You may not qualify if:

• \. Considered as a potential surgical candidate based on the initial advanced practice physiotherapist assessment.

Sponsors & Collaborators

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

Study Sites (1)

CareAxis

Montreal, Quebec, H3H2L3, Canada

Location

Related Publications (1)

• Lafrance S, Santaguida C, Perreault K, Bath B, Thavorn K, Feldman D, Hebert LJ, Fernandes J, Desmeules F. 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. BMJ Open. 2021 Sep 7;11(9):e053004. doi: 10.1136/bmjopen-2021-053004.

  PMID: 34493525 DERIVED

MeSH Terms

Conditions

Collagen Diseases

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: May 3, 2021
• Study Start: May 15, 2021
• Primary Completion: August 28, 2023
• Study Completion: August 28, 2023
• Last Updated: August 30, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)