James S. Thomas, Ph.D., PT - US grants

[unreadable] DESCRIPTION (provided by applicant): The primary aims of this proposal are to determine how physical and psychological factors interact in the recovery process following an initial episode of low back pain and to determine how these factors contribute to risk for recurrence. Specifically, we propose to assess the relationship between motor coordination strategies (changes in lumbar and pelvic movement patterns) and levels of kinesiophobia (fear of painful re-injury upon physical movement) following an initial episode of low back pain. Two studies are proposed. [unreadable] Study 1 will examine movement patterns during performance of standardized reaching tasks in low back pain patients with high versus low levels of kinesiophobia. Participants will be assessed at 3, 6, and 12 weeks after onset of symptoms to track changes in motor coordination. By examining the relative magnitude of lumbar and pelvic motions used by low back pain patients who are high and low kinesiophobia, this design will allow us to track changes in the dynamic relationship between motor coordination and kinesiophobia during the process of recovery from acute low back pain. We hypothesize that lumbar motion will be significantly reduced in low back pain patients who are high versus low in kinesiophobia. [unreadable] Study 2 will examine movement patterns during standardized reaching tasks in individuals who have recently recovered from low back pain. Using a longitudinal design, we will develop a survival model to assess the risk for recurrence in the year following an initial episode of low back pain based on measures of spinal motion and kinesiophobia. We hypothesize that the highest risk of recurrent back pain will be observed in those who are high in kinesiophobia and who exhibit reduced spinal motion. [unreadable] The current proposal brings together promising ideas from motor coordination and health psychology literatures to provide an innovative integration of the best predictors of recurrent low back pain. The short-term goal of this research is characterize how spinal motion parameters and kinesiophobia interact to promote or delay recovery from acute low back pain. Our long-term goal is to use this information to develop an assessment protocol that can be easily adopted into clinical practice. [unreadable] [unreadable]

The OSUCCC Clinical Trials Office (CTO), ratedOutstanding in the 2004 review, supports the centralized administration of protocol development, implementation and conduct for all clinically active research groups. This shared resource provides the trial administration, protocol tracking and monitoring, data management, regulatory processing and financial supervision necessary for the successful conduct of clinical trials in a methodologically-sound, expedient, and cost-effective manner. The CTO came under the medical leadership of James P. Thomas, M.D., Ph.D. in 2005 and the administrative leadership of Janie Hofacker, R.N., B.S.N., M.S. in 2008. The incorporation of independent research groups into the CTO (1999-2004) combined with the ongoing growth of the clinical enterprise (1999-present) is responsible for the growth of the CTO from 38.5 FTEs at the time of the last CCSG submission to 90 FTEs currently. The growth of the CTO has facilitated a 89% increase in accrual to therapeutic clinical trials from 671 in 2004 to 1265 in the most recent 12-month period, 12/30/2008 - 11/30/2009. Accrual to interventional clinical trials has likewise increased 152% from 939 in 2004 to 2,274 in the same twelve months. In 2007, the CTO restructured the clinical coordinating staff into disease-specific teams to provide dedicated and efficient clinical trials support to clinical investigators specializing in the treatment of defined tumor types. This new structure mirrors the reinvlgorated disease-specific committee structure for clinical research implemented by the OSUCCC in 2004. The acquisition of 7,000 nsf of renovated space in Stariing-Loving Hall adjacent and connected to the James Cancer Hospital in 2005 has permitted the spatial centralization of CTO operations. Management infrastructure was improved with the creation of two new supervisory roles, the Clinical Research Manager (who manages all the coordinators within a disease team) and the Data Manager (who manages the data collection team). The creation of the Regulatory and Business Manager positions within the CTO has led to improved utilization of CTO resources. Also in 2007, web-based support for the management of CTO activities was significantly improved via implementation of the OnCore® commercial clinical trial management (CTMS) software solution from Percipenz (Madison, Wl). The OnCore® system is the most widely adopted CTMS among academic cancer centers across the United States and is actively being integrated with our CaBIG capabilities. This system provides for vastly improved tracking of all clinical research activities and provides CTO staff as well as OSUCCC leadership and membership with the tools to monitor all phases of the process of patient accrual and trial implementation. The CTO interacts with other CCC shared resources including the Biostatistics, Leukemia Tissue Bank, Clinical Trials Unit/Clinical Trials Processing Lab and Biorepository Biospecimen Shared Resources and supports the activities of the Clinical Scientific Review Committee and Data and Safety Monitoring Committee. The training and continuing education of clinical research staff and OSUCCC physicians is a central function of the CTO.

DESCRIPTION (provided by applicant): Low back pain is the second most common reason for a visit to a physician, with direct medical costs exceeding $90 billion per year in the United States alone. These costs are driven primarily by 7-10% of patients who develop a chronic pain disorder that can last for many years. A fundamental clinical problem in individuals with chronic low back pain is the significant alteration in movement patterns that restrict lumbar spine motion. This restriction of lumbar motion is particularly evident in patients with kinesiophobia; that isa fear of movement due to possible injury or reinjure. Accordingly, we propose a novel approach that manipulates movement feedback in a gaming environment to improve spinal motion and decrease expectation of pain and harm in participants with chronic low back pain and high kinesiophobia. We will compare the ability of this game to increase lumbar motion when compared to a no treatment control condition. Participants in the game condition will complete laboratory sessions on five consecutive days. Session 1 (baseline) will be used to assess lumbar spine motion and expectations of pain and harm during standardized reaching tasks. In lab sessions 2 through 4 participants will play a game of virtual dodge ball. They will be instrumented with sensors that track their body movements in real time and display them as an on-screen avatar. The game has 4 levels of difficulty that are tailored to each participant's baseline lumbar spine flexion. Session 5 (post-test) will be used to reassess lumbar spine motion and expectations of pain and harm during constrained and unconstrained reaching. Participants in the control condition will complete baseline and post-test standardized reaching tasks, but will not play the game in the intervening three days. Aim 1 will determine the effect of game play on lumbar spine motion and expectations of pain and harm and Aim 2 will determine the effect of altered movement gain on lumbar spine flexion. The use of a gaming environment is an innovative approach to address fear of movement and reduced lumbar motion in chronic low back pain patients with kinesiophobia, and this proof-of-concept study represents the critical first step to evaluate a promising new approach for chronic back pain and will provide the data necessary to assess power for a full-scale randomized clinical trial.

Abstract Low back pain is the second most common reason for a visit to a physician, with direct medical costs exceeding $90 billion per year in the United States alone. These costs are driven primarily by 7-10% of patients who develop a chronic pain disorder that can last for many years. Fear of movement (i.e., kinesiophobia) due to expectations of pain and harm is an important risk indicator for the development of persistent pain and disability, with studies consistently showing that high fear is one of the strongest predictors of the transition to chronic low back pain (CLBP). Specifically, fear encourages the adoption of maladaptive movement patterns wherein tasks of daily living are performed with reduced lumbar spine flexion and compensatory increases of knee, hip, and arm shoulder flexion. While avoidance of lumbar flexion may benefit these back pain sufferers in the short-term by reducing their fear of injury, in the long-term limited lumbar flexion becomes an entrenched pattern that can lead to shortening of spinal peri-articular connective tissues, changes in surrounding muscles, and increased risk for chronicity. With the support of an NIH R21, we recently completed a Phase I trial of an immersive virtual reality dodgeball game designed specifically to increase lumbar flexion among individuals with CLBP and high fear of movement. The results of this proof-of-concept study demonstrated that 3 daily sessions of virtual dodgeball was safe, did not exacerbate existing back pain, was highly rated by participants, and increased lumbar spine flexion during gameplay. We now propose a Phase II RCT to determine the efficacy of a 9?week course of treatment of virtual dodgeball to reduce pain and disability. CLBP participants will be randomly assigned to play one of two versions of our virtual reality game. In the experimental group, gameplay will promote progressive increases in lumbar flexion. The control group will play the same immersive video game, but the parameters of the game will be modified such that only small excursions of lumbar flexion are needed to successfully complete gameplay. The co-primary clinical outcomes of changes in pain and disability will be assessed at 1-, 6-, 12-, 24-, and 48-weeks post-treatment. Additionally, individual differences in expected pain, expected harm, and lumbar flexion will be measured at pre-treatment baseline and at each of the follow-up intervals in the laboratory. Finally, participant activity in their natural environment will be monitored for 7 days following each follow-up laboratory visit. We have developed an innovative immersive video game that safely reduces expectations of pain/harm and increases lumbar flexion among individuals with CLBP. The proposed Phase II trial will have a significant impact on public health by testing the ability of this unique intervention to motivate CLBP sufferers to re-engage in the specific spinal motions necessary to promote recovery and to maintain these treatment gains.