Awarded January 2019
Title:Dose parameters in Achilles tendinopathy rehabilitation
Principal Investigator: Peter Malliaras, BPhysio (Hons), PG Diploma (Statistics), PhD
Aims: To determine the feasibility of conducting a future full-scale randomised trial to assess the efficacy of specific load-intensity and time-under-tension exercise interventions for improving pain and function in mid-portion Achilles tendinopathy (plantar flexion contractile dysfunction).
Research design: Single-centre, outcome assessor-blind double-blind, feasibility factorial randomised pilot trial.
Methods: A total of 48 male participants with mid-portion Achilles tendinopathy (plantar flexion contractile dysfunction) will be recruited from the community. Participants will be randomised into one of the four factorial arms that include high (6 repetitions to failure) or low (18 repetitions to fatigue) load-intensity calf exercise, and each will be performed with high (6 second per repetition) or low (2 seconds per repetition) time under tension. Exercise will be home-based and performed 3 times per week over 12 weeks. One exercise session per week will be monitored via telerehabilitation (videoconference). The primary outcomes will be study processes used to determine feasibility of a future full-scale randomised trial. Process outcomes will include recruitment and retention rates, adherence to interventions, response rates to self-reported questionnaire outcomes, adverse events, and participants’ and telerehabilitation observers’ experiences with the interventions. Clinical outcomes including patient rated pain, function, global satisfaction, health-related quality of life, physical activity, kinesiophobia, as well as measures of plantarflexion function and Achilles tendon stiffness will be collected to explore trends in treatment effects and variability observed between the groups at the study outcome times of 6 and 12 weeks.
Clinical relevance: Muscle and tendon adaptation is dose-dependent, and preliminary evidence in shoulder tendinopathy suggests clinical outcomes may also be dose-dependent. The proposed trial is, to the best of the applicants’ knowledge, the first to investigate the efficacy of dose parameters in the management of Achilles tendinopathy (plantar flexion contractile dysfunction). Maximising and monitoring dose and exercise adherence is critical to addressing the aims of this research. Therefore, we have developed a telerehabilitation methodology to maximise and monitor exercise fidelity and adherence. This research will ultimately improve the quality and effectiveness of exercise interventions for tendinopathy (contractile dysfunction). Based on the literature, twelve weeks is sufficient to observe between group differences in pain, function, neuromuscular and tendon stiffness outcomes and therefore is longest outcome time. Based on the outcome of the current feasibility trial, a high-quality, adequately powered randomised trial will be conducted. The proposed pilot and feasibility trial and full-scale trial will be among men as they are more commonly affected by Achilles tendinopathy and this means recruitment is feasible. However, if our findings are positive, we plan to conduct future trials among females and other musculoskeletal conditions.
Awarded January 2017
Title: Combined Mechanical Diagnosis and Treatment and Transforaminal Epidural Steriod Injections versus Usual Care for Chronic Lumbar Radiculopathy: An RCT
Principal Investigator: Audrey L Long, BSc PT, Dip MDT
Study Design: Pragmatic randomized controlled trial (RCT).
Background: Lumbar spine surgery is a common treatment option for patients with chronic lumbar radiculopathy. Unfortunately, the current wait for lumbar surgery in Alberta is 2.5 years or more. Since surgery can be associated risks, high costs, and questionable long term outcomes, effective non-surgical treatment options are needed to improve current care and reduce waitlists.
A recent prospective cohort study from the Netherlands showed promise for lumbar disc surgery candidates when treated with combined Mechanical Diagnosis and Treatment (MDT) and transforaminal epidural steroid injection (TESI). However, no control group was included to account for natural history, nor was this combined treatment approach compared to the surgical approach typically offered to this group of patients. While this research is promising, it has not been conducted in a Canadian context nor has it been sufficiently tested using a definitive randomized clinical trial design.
Objective: The main aim of this study is to conduct a pragmatic RCT that compares outcomes for patients with chronic radiculopathy secondary to lumbar disc protrusion receiving a novel combined treatment approach (MDT, with or without TESIs) to a control group of usual care (wait list for surgical consult).
Methods: Candidates for lumbar disc surgery will be randomized to:
- Remain on the usual wait list for surgical consultation, or
- A two-session MDT assessment resulting in one of two classification-guided treatment options:
a. Centralizers and patient with a clear directional preference will continue with an additional 4 MDT treatment sessions
b. Non-centralizers will be offered TESI, followed MDT reassessment and up to four treatment sessions if indicated by clinical responses.
The primary outcome will be leg pain ratings. Secondary outcomes will include the Roland Morris Disability Questionnaire (RMDQ) adapted for sciatica, Global Perceived Effect (GPE), medication use, SF12 score, fear avoidance, healthcare utilization, and number of surgeries performed. Outcomes measures will be collected at baseline, 1, 3, and 12 months.
PROJECT CANCELLED BY PI – ALL FUNDS RETURNED
Awarded January 2016
Title: Secondary prevention of a recurrence of Low Back Pain
Principal Investigator: Mark J Hancock, BaSc, MaSc, PhD
Aims: The aim of this pragmatic trial is to establish the effectiveness of McKenzie based self-management method compared to no intervention in preventing recurrence of low back pain (LBP), in people who have recently recovered from an episode of LBP.
Design and Methods: The proposed study is a pragmatic randomised controlled trial. Subjects will be randomised to (i) McKenzie based self-management approach or (ii) minimal intervention and followed for a minimum of 12 months, to assess if and when a recurrence of LBP occurs. An inception cohort of 396 participants who have recovered from an episode of LBP within the last month will be recruited. Randomisation will be stratified by history of more than 2 previous episodes of LBP. Participants allocated to minimal intervention group will receive simple advice over the phone and be referred to publically available online information about prevention of back pain. Participants allocated to the McKenzie self-management approach group will attend 2 x 30 minute individual sessions with a trained physiotherapist. The participant will be trained in a simple specific exercise program focusing on movements that balance/counteract the postures or positions used throughout the day. For most people this will involve lumbar extension to counteract the large amount of flexion activity typical of most people’s lives either in sitting or manual tasks. The primary outcome will be days to an episode of activity limiting LBP (moderate or greater activity limitation measured using an adaptation of item 8 of the SF36). The secondary outcomes will include days to recurrence of (i) an episode of LBP (intensity > 3/10, lasting longer than 24 hours) (ii) an episode of care seeking LBP. We will also assess the total burden of LBP over 1 year. These outcomes are defined using the consensus definition of recurrence agreed to by international LBP researchers. To ensure precise estimates of time to recurrence participants will be contacted each month and asked if they have had a recurrence of LBP.
Clinical Relevance: Much of the burden of LBP is due to the recurrent nature of the condition, yet few large studies have investigated prevention. If the simple, cheap McKenzie self-management approach can reduce recurrences it will be a very important finding for patients, insurers and government.
Title: MDT for Patients with Cervicalgia via a Telehealth Platform
Principal Investigator: Bryan L. Williams, PT, MS, cert. MDT
Mechanical Diagnosis and Treatment (MDT) is a common method of examination and treatment used by physical therapists for patients with non-specific cervical pain. In the MDT system, examination and treatment of patients often requires minimal hands-on intervention. This may allow some patients to be successfully managed through a telehealth interface.
The purposes of this study are to examine the inter-rater reliability of credentialed MDT practitioners to conduct a cervical spine evaluation via a telehealth interface. Inter-rater reliability between face-to-face examination and a telehealth interface will be examined for posture, cervical range-of-motion (ROM), ROM change, and aberrant movements between pairings of three MDT credentialed therapists. As a component of the evaluation, the authors will also assess whether or not the therapist conducting the telehealth examination can identify a provisional diagnosis and agree upon an initial treatment strategy.
Descriptive statistics will be used to characterize the patients at the outset of the study. Kappa coefficients will be used to assess levels of agreement between the pairs of therapists.
The significance of the study is that it will assess whether or not telehealth is a viable medium for evaluation of patients who have pain originating from the cervical spine. Conceivably, this may provide a means for greater access to credentialed MDT providers and potentially more affordable care for patients.
Awarded January 2014
Title: MDT vs. Usual Care for Musculoskeletal Disorders: A Cost Comparison
Principal Investigator: Ronald G. Donelson, MD, MS
Background/Aims: Michelin North America, a large self-insured employer, currently partners with Integrated Mechanical Care (IMC), a clinical network that provides high-quality Mechanical Diagnosis & Therapy (MDT) methods of care in several of Michelin’s facilities for employees with musculoskeletal (MSk) complaints. These employees choose to seek care in one of these IMC clinics or from community providers delivering “usual” (non-MDT-based) care. Michelin has generously agreed to share de-identified claims, co-morbidity, wage replacement and time-off-work data for all employees with these disorders. They additionally have employee satisfaction data, but only for those employees undergoing IMC care. The lack of patient self reported oucomes data forn non-IMC treated employees limits our ability to conduct a patient-centered value-comparison study whrere value is defined as “quality/cost”. However, quality can also be measured from the employer’s perspective using wage replacemnet and time-off-work data as direct measures of patient’s functional status at work. Given the strong current emphasis in improving the value of U.S. health care, employer’s perspective of quality is tied directly to improving employee’s productivity and functioning in the workplace as well as in cutting the health care costs. Improving quality while decreasing costs is considered “the holy grail”.
This unique opportunity enables our primary aim of conducting a cost-comparison study between MDT and non-MDT care as well as value comparison using quality from employer’s perspective. Further, there is very little published outcomes data on the treatment of cervical or non-spinal MSk disorders using MDT care. We also intend to stratify our findings to determine the value-added of MDT care for lumbar, cervical, shoulder, hip and knee disorders compared to usual non-MDT care.
Design: 1- A risk adjusted cost-comparison study; 2- An employee-perspective value-comparison study.
Methods: The costs of direct care, wage replacement and time-off-work for those seeking care within Michelin’s MDT-based facilities will be compared with those seeking care in the community where “usual” non-MDT care is provided. Primary outcome measures are Michelin’s claims-determined costs for both direct care and reutilization of post discharge services for one year. Costs will be adjusted for risk using co-morbidity claims data. The costs of MDT care for cervical, lumbar, shoulder, hip and knee pain patients will be also compared with non-MDT care. Michelin’s time-off-work data will inform quality outcome measures which will in turn infromm a “value-based” comparison, with both quality and cost data available for both MDT and non-MDT care.
Clinical relevance: Claims cost, wage replacement and time-off-work data are rarely accessible. We have a unique opportunity to document and analyze both MDT and non-MDT care using these outome measures. While it’s well-documented that the MDT assessment is reliable for well-trained clinicians and its treatments are beneficial in trials of lumbar patients who have a diretional preference or whose pain centralizes, there are very llittle data published regarding the benefiit of MDT care for cervical and non-spinal painful disorders. Our unique access to Michellin’s data enable these economic and value analyses.
Awarded January 2013
Title: MDT evaluation and stability tests
Principal Investigator: Adri T Apeldoorn, PhD, cred. MDT
Background/Problem: For clinicians, positive clinical tests for identification of lumbar spine instability are indicators for the use of stabilization exercises. However, in our clinical experience these tests frequently become negative after the patient has demonstrated a centralization response assessed with Mechanical Diagnosis & Therapy (MDT). Given that this response is commonly elicited during MDT assessment, it may be that instability tests should be preceded by a MDT assessment to ensure appropriate interpretation. The aim of this study will be to assess the influence of the centralization response on the outcome of instability tests in patients with low back pain. Design: Observational study Method: Patients will be recruited from a private physical therapy clinic. Each patient will be assessed by two examiners on the same day. The first examiner will conduct a standardized set of tests to identify signs of lumbar spine instability before and directly after a MDT session which is conducted by the second examiner. This second examiner will classify each patient as a centralizer or non-centralizer. The assessments of instability tests and the MDT assessment will be conducted independently and the examiners will be blinded to each other’s results. At least 100 patients will be included. The differences between pre-test and post-test results on the instability test will be described in percentages and via X2 tests for the two groups (centralizers and non-centralizers). Analyses will be performed to investigate whether selected baseline characteristics have an influence on the outcomes. Discussion:The present study will contribute to our knowledge about the influence of MDT, and more specifically the centralization response, on clinical lumbar spine stabilization measures in patients with low back pain.
Awarded January 2012
Title: Characteristics of LDD: Profile of patients who centralize symptoms
Principal Investigator: Carol P. Dionne, DPT, PhD
Background/Problem: Back pain (BP) is common and its cause multi-factorial. Intervertebral disc degradation, lumbar disc disease (LDD), is the most common underlying cause of BP, yet clear classification remains elusive. Misclassification results in inappropriate and costly treatment, thus differentiating BP related to LDD is paramount. Additionally, a subset of patients with BP centralizes symptoms with predictable outcome when managed by Mechanical Diagnosis and Therapy (MDT). Further, concurrent lumbar movement improvement has been clinically observed with symptom centralization. The investigators are currently using novel reference criteria (based on genotype, MRI) to determine which factors, among a cluster of clinical findings, are most highly associated with differentiating LDD from not LDD. However, neither the reference criteria for LDD nor the clinical findings have been examined in patients with BP who centralize symptoms. Little is known about the measurable changes in movement seen during gait following MDT intervention in patients with BP who centralize symptoms. Specific Aims/Research Design: Aims of this prospective pilot are to: (1) identify genetic, MRI, biomarker and clinical characteristics of, and (2) measure changes in gait following MDT intervention in patients with BP who centralize symptoms. We expect symptomatic patients who centralize symptoms have: (1) at least 1 set of genetic markers positive for LDD; (2) evidence of LDD on MRI; (3) near-normal levels of serous biomarkers for inflammation (no inflammation); (4) demonstrate progressively increased walking cadence and step length 2 weeks following initial visit. Methods: Ten consecutively-selected adults with BP will: (1) initially undergo MRI, biomarker, genetic, clinical (questionnaire, mechanical) testing and gait performance measurement; (2) receive MDT by one MDT-credentialed clinician for 5 visits over 2 weeks for classification (centralize, not centralize), treatment, and gait performance measurement. Relevance: Results will direct future research to: (1) test the comprehensive classification model in larger studies, compared with other subgroups for further validation of patient classification with best evidence intervention dosing for maximum functional outcomes; (2) test hypotheses regarding changes in human performance during every-day living in those who experience centralization with MDT.
Title: Loaded exercise for rotator cuff tendinopathy: A pilot study
Principal Investigator: Chris Littlewood, BHSc, MSc
Background: Shoulder pain is the third most common reason for consultation with a physiotherapist and up to half of the population might experience at least one episode of shoulder pain per year. Disorders relating to the rotator cuff tendons are thought to be the commonest cause of this pain. One treatment approach, known as mechanical diagnosis & therapy, used within physiotherapy, which promotes self-management, has demonstrated some success in the treatment of shoulder tendon disorders using loaded (against gravity or resistance) exercise. The value of loaded exercise in the treatment of tendon disorders in other areas of the body has been favourably evaluated but further investigation is needed to evaluate the impact of these exercises in the shoulder. Aims: The proposed pilot study would assess the feasibility of undertaking a full scale RCT which would be designed to evaluate whether a self-managed loaded exercise programme for shoulder muscle and tendon disorders leads to superior health and economic outcomes than usual physiotherapy. Research Design/ Methods: A pilot RCT will be conducted with participants diagnosed with rotator cuff tendinopathy according to pre-specified criteria. Baseline and follow up assessment will be completed at 0 and 12 weeks with a range of appropriate patient reported outcome measures. This investigation would be combined with qualitative evaluation of the therapist and patient experience of the study. Clinical Relevance: This pilot study would offer a platform upon which to develop a full scale RCT which would subsequently offer vital clinical and cost-effectiveness data in a burdensome but under researched area.
Awarded January 2011
Title: Effect of MDT in the recruitment of trunk muscles
Principal Investigator: Paulo H Ferreira, PT, PhD
Affiliation: University of Sydney, Lidcombe Australia
Low back pain causes a great impact on individuals and societies as a whole. The effects of conservative treatments for low back pain have been reported as moderate. It is argued that mechanisms of treatment need to be better understood so that management is more fruitful. Mechanical diagnosis therapy and motor control exercises appear to be conceptually different with direct impact on health utilization. While mechanical diagnosis therapy provides patients with a self management strategy, motor control exercises are highly dependent on therapists’ feedback of exercise performance.
Awarded January 2010
Title: Efficacy of Exercise Intervention as Determined by the McKenzie System of Mechanical Diagnosis and Therapy for Knee Osteoarthritis: A Randomized Controlled Trial
Principal Investigator: Richard A. Rosedale, PT, MDT
Affiliation: London Health Sciences Centre, London Canada
The Mechanical Diagnosis and Therapy (MDT) approach has been extensively used to manage patients with spinal pain. Studies have shown this approach to be valid and reliable. Although the approach is used for extremity joints there is no research on using this approach to classify individuals presenting with knee osteoarthritis (OA). The diagnosis of “OA knee” offers no indication as to the potential response to intervention. An assessment procedure that could potentially identify a subgroup of patients who might experience rapid improvement to conservative care would be valuable.
Title: Ultrasound imaging of lumbar spine flexion and extension
Principal Investigator: Gary Chleboun, PT, PhD
Affiliation: Ohio University, Athens USA
The outcomes of Mechanical Diagnosis and Therapy (MDT) are not only centralization of pain but also increased lumbar spine range of motion. However, the exact nature of the relationship between decreased pain and increased motion is not clear because previous studies assessed gross clinical measurements of lumbar range of motion rather than specific segmental lumbar motion. We have recently developed a novel method for measurement of segmental lumbar flexion and extension using ultrasound imaging to determine the distance between spinous processes.
Awarded January 2008
Title: The effectiveness of MDT in patients who meet the clinical prediction rule for spinal manipulation
Principal Investigator: Ronald J. Schenk, PT, PhD
Affiliation: Daemen College, Amherst, NY USA
Background/Problem: A clinical prediction rule (CPR) for spinal manipulation has been validated for specific patients with low back pain (LBP). Patient-specific exercise within Mechanical Diagnosis and Therapy (MDT) intervention has been validated in patients with mechanical LBP. The effectiveness of MDT rendered to these same specific patients has not been compared to use of spinal manipulation.