The PET Project: Patient Education Tool for Home Exercise (PET)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain; Greater Trochanteric Pain Syndrome
• Intervention / Treatment: Other: Exercise therapy; Other: Standard Care

Detailed Description

Musculoskeletal conditions are a very common, if not the most common, reason to visit the family doctor, comprising an estimated one-in-six to over half6 of all primary care visits. Under this umbrella of musculoskeletal conditions fall many different aliments: this paper will investigate chronic nonspecific low back pain and greater trochanter pain syndrome.

Boasting titles for greatest number of disability-years caused by a disease and most common non-communicable disease, one would hope that researchers and clinicians would thoroughly understand what causes this pervasive morbidity. Unfortunately, when it comes to chronic nonspecific low back pain (CNLBP), no clear pathoanatomic cause is attributed to the symptoms.

Low back pain is localized below the costal margin and above the inferior gluteal folds and is deemed chronic when it lasts for more than 12-weeks. Although most cases of low back pain seem to resolve prior to the 12-week mark, chronic low back pain is responsible for the vast majority of workers' compensation costs. In 90% of cases of chronic low back pain, clinicians cannot pinpoint the etiology, hence the 'non-specific' modifier.

Greater trochanter pain syndrome (GTPS) boasts a slightly less impressive resume - affecting a mere 10% to 25% of the general population. GTPS presents as lateral hip pain, specifically over the greater trochanter, and is worse when lying or bearing weight on that side.

It too has a plethora of potential aetiologies, and although it can be challenging to elucidate lateral hip pain's true etiology this clinical diagnosis comprises of trochanteric bursitis, gluteus medius and minimus tendinopathies, and external coxa saltans (commonly referred to as "snapping hip").

CNLBP and GTPS seem to coexist in about a third of the time and general treatment recommendations are similar. They range from analgesic medication to load management, though because between CNLBP and GTPS, a wide demographic is affected, treatments should be accessible and applicable to the wider population. Exercise therapies generally to meet these criteria. Exercise has also routinely demonstrated to be efficacious, cost-effective and low risk.

A multitude of different exercise modalities have routinely been shown to reduce chronic pain and improve physical function. Furthermore, specific exercises can be leveraged to treat chronic pain of broad aetiologies. Systematic reviews and meta-analyses alike have shown these to hold true in the realm of chronic non-specific low back pain as well. Commonly communicated is the relative paucity of research on GTPS, however, minimizing pain and performing strengthening and stretching exercises for the region appears to be a mainstay of the current therapy.

It is well known that exercise program adherence is a major issue when it comes to exercise interventions. A minimum level of adherence must be obtained for an exercise intervention to be efficacious. And when that level of adherence is attained in patients with CNLPB, exercise-based programs have shown to decrease pain and improve function. Similar results are show in the little amount of research on exercise therapies for GTPS, and in clinical practice it is assumed to be true.

Adherence is higher when people are highly supervised. So it is unsurprising that patients have higher rates of adherence after seeing their physiotherapist for extra 'booster' sessions. However, additional sessions with healthcare providers is not always feasible, due to high costs, poor accessibility, or unavailable providers, amongst other reasons. With the ever-increasing use of technology, though, patients can have somewhat similar care - such as guidance while doing exercises - through pre-recorded online videos. Some preliminary studies suggest that these online videos are able to increase patient adherence.

While many YouTube exercise rehabilitation videos are of high quality, there are also many that are not. This can leave the patient - even with an abundance of online resources - paradoxically without answers: unsure and unable to know what is relevant. Additionally, patients report better trust towards those who adequately understand their medical conditions, such as their healthcare team.

It would then be conceivable that physician-produced videos that are endorsed by the patient's healthcare team would alleviate this issue. Furthermore, it could circumvent the challenges associated with in-person care as well as alleviate some of the pitfalls of sifting through endless YouTube videos. The aim of this study was to investigate whether a patient education tool - an accompanying set of explanatory videos - will increase patient adherence when compared to prescribing an evidence-based, personalized set of exercises without these videos.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steven Macaluso, MD; Phone Number: 45062 5196854292; Email: westernpetproject@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care	Other: Standard Care; An exercise prescription and verbal instructions in clinic
Experimental: Patient Education Tool	Other: Exercise therapy; A series of home exercise videos to improve patient adherence to exercise prescription

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Adherence Rate	Daily log of adherence to the exercise prescribed is recorded by participants and submitted on a weekly basis.	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	Use of the Self Efficacy in Exercise (SEE) standard survey to determine patients' level of confidence to complete the assigned exercises despite various barriers. Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.	0 weeks (day of entry to program)
Self efficacy and confidence of participants	Use of the Self Efficacy in Exercise (SEE) standard survey to determine patients' level of confidence to complete the assigned exercises despite various barriers. Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.	6 weeks
Self efficacy and confidence of participants	Use of the Self Efficacy in Exercise (SEE) standard survey to determine patients' level of confidence to complete the assigned exercises despite various barriers. Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.	12 weeks

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: October 9, 2021
• First Posted (Actual): October 13, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Exercise
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 119395

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No