The PET Project: Patient Education Tool for Home Exercise

NCT05076994 | Unknown

• 1 other identifier: 119395
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients presenting to an musculoskeletal (MSK) outpatient clinic who fit the study inclusion criteria (low back pain, outer hip pain) will be randomized to receive an exercise prescription with patient education alone, or in clinic patient education and access to the Patient Education Tool (Series of videos). Weekly surveys will be done via email to assess patient adherence: the main outcome. Two follow-up in-clinic visits at weeks 6 and 12 will assess pain, function and exercise self-efficacy: the secondary outcomes. Comparisons will be made between the group of the patients who received the videos and those who did not.

Conditions

Low Back Pain; Greater Trochanteric Pain Syndrome

Keywords

Exercise

Outcome Measures

Primary Outcomes (3)

• Pain

  Change in Visual Analogue Scale (VAS) ("No Pain" on one end of scale (0 out of 100), and "Worse pain you can imagine" on the opposite end of the scale (100 out of 100)

  0 weeks (Day of entry to trial)

• Pain

  Change in Visual Analogue Scale (VAS) ("No Pain" on one end of scale (0 out of 100), and "Worse pain you can imagine" on the opposite end of the scale (100 out of 100)

  6 weeks

• Pain

  Change in Visual Analogue Scale (VAS) ("No Pain" on one end of scale (0 out of 100), and "Worse pain you can imagine" on the opposite end of the scale (100 out of 100)

  12 weeks

Secondary Outcomes (4)

• Exercise Adherence Rate

  Number of exercises performed each 1 day (24 hours). Data collected once weekly for 12 weeks via online automated survey.

• Self efficacy and confidence of participants

  0 weeks (day of entry to program)

• Self efficacy and confidence of participants

  6 weeks

• Self efficacy and confidence of participants

  12 weeks

Study Arms (2)

Patient Education Tool

EXPERIMENTAL

Other: Exercise therapy

Standard Care

ACTIVE COMPARATOR

Other: Standard Care

Interventions

Exercise therapy OTHER

A series of home exercise videos to improve patient adherence to exercise prescription

Patient Education Tool

Standard Care OTHER

An exercise prescription and verbal instructions in clinic

Standard Care

Eligibility Criteria

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

You may qualify if:

• Over 18 years old
• The ability to perform at least 5 of the 10 total exercises, as cleared by the physiatrist
• The willingness to comply with the study criteria for its 12-week duration
• The written informed consent of the participant
• Sufficient English comprehension to understand the questionnaires
• Sufficient English comprehension to consent to the study
• Chronic lower back pain:
• o A history of lower back pain exceeding 3 months
• Greater trochanter pain syndrome:
• A history of lateral hip pain exceeding 3 months
• Pain in at least three of the following tests: palpation of the greater trochanter, FABER test, resisted external de-rotation test, modified resisted external de-rotation test

You may not qualify if:

• Pregnancy
• Condition that makes the exercising ill advisable, as determined by the physiatrist
• Chronic lower back pain:
• Known lumbar disc herniation
• Acute phase of lumbar disc protrusion
• Known vertebral fractures
• Known infectious, inflammatory, or malignant diseases of the vertebrae
• Known presence of severe spinal deformity
• Greater trochanter pain syndrome:
• Acute hip pathology such as fracture, dislocation, infection, etc.
• Known diagnosis moderate to severe hip osteoarthritis causing significant range of motion restriction

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Interventions

Exercise Therapy; Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Steven Macaluso, MD

CONTACT

5196854292; westernpetproject@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two Randomized Groups

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: October 13, 2021
• Study Start: November 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: July 1, 2023
• Last Updated: November 30, 2021

Record last verified: 2021-11