Clinical trial NCT05965986: Preoperative Rehabilitation and Education Program
Official title: Preoperative Patient Education and Rehabilitation Program for a Total Shoulder Arthroplasty Surgery: a Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Shoulder Arthritis
Patient Education
Prehabilitation
Shoulder Arthroplasty
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Western University, Canada
name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-07-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Shoulder problems affect many Canadians yearly. While surgery is one of the best treatments for shoulder problems, patients are unaware about shoulder replacement surgeries, the exercises needed after surgery and how to safely recover from the surgery without having another injury. Uncertainties about the surgery and recovery process can further cause post-surgery problems such as: pain, anxiety and re-injury. While some healthcare centers offer an in- class program to educate patients before surgery, some patients face issues with distance or transportation, and cannot regularly meet their doctor to address all their concerns. This project aims to create an online educational program that will teach patients through online videos and educational materials before they go into shoulder replacement surgery. By creating online modules, it can increase the accessibility for home use, and prepare patients on topics such as: their concerns about the surgery and proper exercises they can expect after surgery for a safe recovery. The aim is to study three groups of patients before surgery; 1. a group consisting of an online pre-rehabilitation program 6 weeks before surgery, 2. a group consisting of an online pre-rehabilitation program 6 weeks before surgery + therapist or 3. A group consisting of the current standard of care, which is a WebEx pre-operative education class lead by a physiotherapist and occupational therapist. Researchers will monitor all groups on their recovery before and after surgery. This will provide another alternative to informing patients before surgery and help them to prepare better for surgery. The online modules will contribute to improving the care in Southern Ontario and eventually be used for future care across Canada.

Detailed description: A total shoulder replacement is a common procedure to help those with shoulder osteoarthritis improve their quality of life. There is a lack of quality research on the effectiveness of prehabilitation and education on pain, function, and quality of life in patients undergoing this procedure. Researchers have developed a comprehensive, patient-centered program that combines exercise, preparedness for surgery, motivational interviewing, and pain management principles, in collaboration with patient partners on the wait list for a shoulder replacement, transdisciplinary healthcare team (i.e., surgeons, physiotherapists, occupational therapists, and rehabilitation researchers), and current scientific literature. This patient-centered program has the potential to improve postoperative pain, function, and patient-oriented outcomes, decrease postoperative opioid use and short and long-term healthcare costs. This pilot randomized controlled trial will evaluate feasibility and satisfaction of the program for individuals undergoing a shoulder replacement. Participants (n=90) undergoing a shoulder replacement will be randomized into 1) 6-week online pre-rehab and education program, 2) 6-week online pre-rehab and education program with a therapist or 3) standard of care group. The intervention groups will be delivered virtually with an online program of modules and a written handbook for participants. Participants in the standard of care group will receive usual care. Outcomes will be assessed at baseline and 1 day before surgery, then post-operatively at 6 weeks, 3 months, 6 months and 12 months.

Eligibility criteria: Inclusion Criteria:

* Over the age of 18 years old
* Patients who have consented for a total shoulder arthroplasty or reverse shoulder arthroplasty surgery at HULC.
* Date of surgery must be no shorter than 9 weeks, to ensure time for baseline measures
* Speaks and reads in English unless can provide a translator
* Able to provide informed consent.
* Willing to participate in study procedures for at least 1 year post-surgery.

Exclusion Criteria:

* Patients who have consented for a hemi-arthroplasty surgery
* Patients who have been consented less than 8 weeks before surgery
* Any contraindications to exercise

Primary outcomes:
measure: Recruitment Rate log
timeFrame: 6 months
measure: Adherence Rate log
timeFrame: 6 months
measure: Content Acceptability - visual analog scale
timeFrame: 12 months
measure: Study Acceptability - visual analog scale
timeFrame: 12 months
measure: Treatment Fidelity checklist
timeFrame: 12 months
Secondary outcomes:
measure: 5-level EQ-5D version
timeFrame: 12 months
measure: Simple Shoulder Test
timeFrame: 12 months
measure: Single Assessment Numeric Evaluation
timeFrame: 12 months
measure: Range of motion
timeFrame: 12 months
measure: Surgical Satisfaction Questionnaire
timeFrame: 3 months
measure: Decisional Regret
timeFrame: 3 months
measure: Adherence to rehabilitation
timeFrame: 12 months
measure: PASS
timeFrame: 12 months
measure: Shoulder Pain and Disability Index
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: Canada
facility: Roth | McFarlane Hand and Upper Limb Center
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Joy MacDermid, PhD
role: PRINCIPAL_INVESTIGATOR
References: