Low Back PainPETNCT05076994
The PET Project: Patient Education Tool for Home Exercise
A study testing Exercise therapy in people with Low Back Pain and Greater Trochanteric Pain Syndrome, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Greater Trochanteric Pain Syndrome
- What is being tested?
- Exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Low Back Pain, Greater Trochanteric Pain Syndrome
- Being tested
- Exercise therapy, Standard Care
- Keywords
- Exercise
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise therapyOther
A series of home exercise videos to improve patient adherence to exercise prescription
Standard CareOther
An exercise prescription and verbal instructions in clinic
| Study group | Role | What they receive |
|---|---|---|
| Patient Education Tool | Experimental | Not described Receives: Other: Exercise therapy |
| Standard Care | Active comparator | Not described Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 12 weeks
Secondary outcomes (4)
Exercise Adherence Rate
Daily log of adherence to the exercise prescribed is recorded by participants and submitted on a weekly basis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study startNov 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two Randomized Groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Macaluso, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076994
- Sponsor's protocol ID
- 119395
- Acronym
- PET
- Status last verified
- Nov 2021
- First submitted
- 10 Aug 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PET Project: Patient Education Tool for Home Exercise
- ClinicalTrials.gov ID
- NCT05076994
- Acronym / sponsor ID
- PET / 119395
- Conditions
- Low Back Pain, Greater Trochanteric Pain Syndrome
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two Randomized Groups
| Arm | Type | Receives |
|---|---|---|
| Patient Education Tool | Experimental | Other: Exercise therapy |
| Standard Care | Active comparator | Other: Standard Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- Pregnancy
- Condition that makes the exercising ill advisable, as determined by the physiatrist
- Chronic lower back pain:
- Greater trochanter pain syndrome:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise therapyA series of home exercise videos to improve patient adherence to exercise prescription | Other | Patient Education Tool |
| Standard CareAn exercise prescription and verbal instructions in clinic | Other | Standard Care |
Primary outcome
Pain
Time frame: 0 weeks (Day of entry to trial)
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)
Pain
Time frame: 6 weeks
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)
Pain
Time frame: 12 weeks
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)
4 secondary outcomes
Exercise Adherence Rate
Time frame: 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
Time frame: 0 weeks (day of entry to program)
Self efficacy and confidence of participants
Time frame: 6 weeks
Self efficacy and confidence of participants
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise therapy in people with Low Back Pain and Greater Trochanteric Pain Syndrome, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven Macaluso, MD (5196854292 ext. 45062, westernpetproject@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 0 weeks (Day of entry to trial)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.