Journal Club September 2016: Effects of Ramelteon on Sleep Disturbance After TBI

Article title: Pilot Study on the Effect of Ramelteon on Sleep Disturbance After Traumatic Brain Injury: Preliminary Evidence From a Clinical Trial.

Author: Lequerica A, Jasey N, Portelli Tremont JN, Chiaravalloti ND

Journal: Arch Phys Med Rehabil. 2015 Oct;96(10):1802-9. doi: 10.1016/j.apmr.2015.05.011. Epub 2015 May 28.


Many people with Traumatic Brain Injury (TBI) report sleep disorders, leading to anxiety, depression, and fatigue. These issues are associated with deficits in neurobehavioral, cognitive, and occupational issues. Currently used medications used to treat sleep disorders further complicate cognitive functioning. Benzodiazepines, Tricyclic antidepressant, Trazodone, and anti-histamines carry their own cognitive, sedating, or poor memory effects.

The suprachiasmatic nucleus of the hypothalamus regulates circadian rhythm, and Ramelteon (TAK-375) is a neurohormone that targets melatonin receptors in this nucleus. While Ramelteon is indicated for long-term management of insomnia, and it has minimal chance for addiction, few trials have studied its role in treating insomnia. Clinical trials showed promising results, but Ramelteon’s use in treating sleep disorder in TBI had not yet been studied.

This study tested Ramelteon’s use in treating sleep disorders after TBI. There were 18 participants, each with TBI for at least a month before enrollment. In addition to meeting inclusion criteria, they were screened for other confounding conditions and medications, and discontinued use of other sleep medications for 2 weeks before the study.

The study used a double-blind, placebo controlled crossover design. Participants were grouped into Ramelteon or placebo groups for the first of the study, at which point they were switched into the opposite group for the second half. Electronic accelerometers (actigraphs) were worn to track “sleep onset latency (SOL), number of awakenings, wake time after sleep onset, and total sleep time (TST)”. Participants kept a sleep log, had CNS vital signs recorded, and were measured with the Pittsburgh Sleep Quality Index and Brunel Mood Scale.

Ramelteon was found to significantly increase total sleep time. It was also found to increase time needed to fall asleep, yet this time was not clinically significant. Likely due to the mechanism of action regulating circadian rhythm, those on Ramelteon also  went to bed earlier. The study found promising benefit for the use of Ramelteon in treating sleep disorders in TBI. Use of polysomnography instead of actinography would provide more detailed data. Additionally, further research would benefit from a larger sample size.


Discussion Points:

1: What is the role of the physiatrist in treating TBI?

2: Who else plays a role in treating TBI?

3: Why are sleep disorders particularly troubling for TBI patients?

4: What are some of the side effects with medications currently used to treat sleep disorders?

5: Why was it important to use a double-blind, placebo-controlled crossover design?

6: In addition to use of the actinography, what are some other ideas for how sleep variables can be measured?

7: What benefit would there be if a study recruited participants with more recent injuries?

8: What other methods could be used to manage sleep disorders in TBI?

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Journal Club January 2016: Cellular Supplementation Technologies for Painful Spine Disorders

Article title: Cellular Supplementation Technologies for Painful Spine Disorders

Author: Michael J. DePalma, MD, Justin J. Gasper, DO

Journal: PM&R 7 (2015) S19-S25


Chronic low back pain (CLBP) is one of the most common complaints for which people seek medical attention. Although it is often not easy to diagnose the etiology of the back pain, doing so can have immense benefits in terms of targeted therapy. Some of the more common places of origin for CLBP include the intervertebral disk, facet joints, and sacroiliac joints. Unfortunately, none of the current therapies have proven to be very effective, but cellular supplementation techniques have shown promise.

In regards to the pathophysiology of disk degeneration, some of the treatment goals include either (1) increasing the amount of extracellular matrix available to promote disk regeneration via dehydration or (2) inhibit cytokines that degrade proteoglycans to try to reverse the degenerative process. However, intradiskal treatments will need to address not just the degenerative changes, but the non-healing annular fissure as well. The treatment that is most supported by current data involves cellular supplementation.

Cellular supplementation to treat diskogenic LBP involves the introduction of cells that can potentially regenerate disk tissue. One of the possible sources includes autologous human disk cells, but obtaining pure cells free of other cells provides its own set of challenges. As a result, there must be a clonal expansion of these cells once they are obtained and purified, which is both expensive and not yet FDA-approved for clinical use. The use of allogeneic stem cells is another intriguing possibility that may be more cost-effective and increase cell survival rates even more than using autologous disk cells, according to an FDA-regulated phase 2, randomized, controlled study. Other sources of cellular supplementation include juvenile and adult chondrocytes, but not enough research has been done yet to determine their efficacy.

Painful facet and SI joints are another common cause of CLBP. In osteoarthritis, disk degeneration leads to loss of disk height, which increases the compressive load and causes the synovial membrane, joint capsule, and cartilage to transmit pain via nociceptive type C fibers. A classic feature of OA involves an imbalance between matrix degradation and synthesis, leading to increased catabolism of hyaluronic acid and a decrease in the lubricating properties of the joint space.

Treatment for painful facet and SI joints is far more limited compared to diskogenic LBP due to the relative dearth of research available. A promising treatment involves intra-articular injections of exogenous hyaluronic acid, but more research needs to be done.

Discussion Points:

  1. What are the most common causes of chronic low back pain? Which causes are more prevalent in the elderly population (age > 65)?
  2. What therapeutic objectives should techniques for diskogenic low back pain aim to achieve?
  3. Describe some of the current limitations regarding cellular supplementation techniques.
  4. Regarding future research, what are some osteopathic techniques for the treatment of low back pain that should be explored further?
  5. Besides chronic low back pain, in what other conditions might you see cellular supplementation techniques eventually becoming successful mainstays of therapy?

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Article - Link to Full Article

Discussion - AOCPMR Journal Article Summary - January 2016

Journal Club December 2015: The relationship between glenohumeral joint total rotational range of motion and the functional movement screen shoulder mobility test

Article title: The relationship between glenohumeral joint total rotational range of motion and the functional movement screen shoulder mobility test

Author: Sprague, Mokha, Gatens, Rodriguez

Journal: The International Journal of Sports Physical Therapy, 2014


Competitive overhead athletes, such as those participating in baseball, swimming, softball, volleyball, and tennis just to name a few, tend to have upper extremity injuries due to their musculoskeletal development when training for their sport. Specifically, differences in the dominant versus non-dominant rotation of the glenohumeral (GH) joint have been associated with injuries in past studies.

This article discusses tools to assess the GH joint rotation, specifically the relationship between the 1) Functional Movement Screen (FMS) shoulder mobility test versus 2) the passive GH joint total rotational range of motion (TRROM). The article provides pictures of the two screening tests (Figures 1 and 2).  Pages 3 and 4 of Cook, et al is a supplemental attachment that provides greater detail about the shoulder mobility test, which is one of seven moves of the FMS developed by Gray Cook, PT, OCS. The TRROM is the total arc of external rotation plus internal rotation and is measured by a bubble goniometer.

The authors hypothesize that there is no relationship with the findings between these two tests when assessing the mobility of the GH joint in subjects.

The shoulder mobility test and the TRROM were measured during pre-participation examination in 114 NCAA Division II male and female athletes (male = 57, female = 57). The sports represented were baseball and swimming for male subjects and swimming, softball, volleyball, and tennis for female subjects.  For measurement consistency, each participant was asked to not complete physical activity before examination, in which both the shoulder mobility test or the TRROM were performed during one visit in a random order.

An athletic trainer certified in FMS testing completed all of the FMS shoulder mobility tests.  The subject is asked to reach one arm overhead and down their thoracic region and the other behind and up their back as shown in figure 1. A distance between hands less than measured hand length is a score of 3; a distance between one hand length and 1.5 hand lengths is a score of 2; a distance greater than 1.5 hand lengths is a score of 1. A score of zero is given if pain is felt during the test. Scores that are unequal between right and left represent asymmetry in the FMS. Subjects were either “symmetrical” or “asymmetrical” for FMS.

The TRROM was measured by two of the same authors of the study for all subjects shown in figure 2. Internal and external rotation was performed by examiner one (PS) in all subjects. Examiner one had 21 years of experience in orthopedic physical therapy practice. All goniometer measurements were performed by examiner two (RR), with five years of experience as a certified athletic trainer for collegiate and professional athletes. A side-to-side difference of greater than 10 percent was used to define asymmetry for TRROM.

Table 2 shows the results of symmetry vs. asymmetry in the FMS shoulder mobility test and symmetry vs. asymmetry of the TTROM. 40/114 (35.1%) athletes had asymmetries in total GH rotation. 45/114  (39.5%) athletes had asymmetries in the shoulder mobility test. Out of those 45 subjects with asymmetry in the shoulder mobility test, only 17 of them have GH joint rotation differences of greater than 10 degrees.  A Pearson Chi-square analysis (P<.05) was used to compare the presence or absence of asymmetries in FMS shoulder mobility test and TRROM in each subject tested. According to statistical analyses, the authors’ initial hypothesis was correct: athletes with asymmetrical GH joint rotation were not any more likely to have asymmetries in the shoulder mobility test.

10 degrees was chosen to be the threshold of asymmetry due to three reasons: 1) previous results in the literature defining normal asymmetry amounts 2) the amounts of rotation associated with bony morphological changes in overhead athletes and 3) standard goniometry measurement error and the use of a bubble goniometer specifically.  In fact, a TRROM deficit of greater than 5 degrees in overhead athletes has a clinical term: pathologic glenohumeral internal rotation deficit, or p-GIRD. The authors chose 10 degrees or greater to determine TRROM asymmetry to allow for measurement error.

There are several limitations to this study. First, the study did not address small yet clinically significant degree differences or large degree differences that define negatively excessive mobility. Specifically, p-GIRD is a small degree difference that is not detectable using the FMS shoulder mobility test.  Regarding excessive mobility, TRROM greater than 176 degrees have been reported to have an increased incidence of injuries. This study only defines injury with differences between function of non-dominant and dominant GH joints. Second, the study does not address the fact that poor performance on the FMS shoulder mobility test might suggest other underlying problems other than the GH joint. For example, thoracic extension mobility limitation or tissue extensibility dysfunction of the scapula can be some confounding causes of poor performance on the FMS shoulder mobility test.

In conclusion, due to the lack of association between the FMS shoulder mobility test and the TRROM, the FMS shoulder mobility test should not be used alone for injury prevention in overhead athletes. Both screening tools are encouraged to be used.


Discussion Points:

  1. Describe how to perform the FMS shoulder mobility test.
  2. Describe how to measure the passive TRROM of the GH joint.
  3. What are the limitations of the study?
  4. In your opinion, how, if anything, should overhead athletes be screened to prevent upper extremity injuries?

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Article - Link to Full Article

Discussion - AOCPMR Journal Club - Sports Med Dec 2015

Supplemental - Cook2014IJSPT       Cook2014IJSPT.2


Journal Club August 2015: Falls in the Elderly Population

Article title: Falls in older people: epidemiology, risk factors and strategies for prevention

Author: Laurence Z. Rubenstein

Journal: Age and Ageing, 2006

Discussion:  Falls are a major cause of morbidity and mortality in the elderly. Nearly 40% of older adults fall

at least once a year and 10-20% of these falls result in injury. Half of those hospitalized for a fall injury

died within one year. Falls are the cause of 45.4% of unintentional injury deaths in the elderly (CDC,

2009). However, studies have shown that most falls are associated with identifiable risk factors, many of

which are preventable. It is imperative that physicians can identify these risk factors and take appropriate

measures to reduce the risk of falls. Furthermore, effective methods to prevent falls have been developed

and should be utilized in the clinic setting.

    This review article by Laurence Rubenstein, MD, MPH is a quality summary of the epidemiology

and risk factors associated with falls in the elderly. Data from many major studies related to falls in the

elderly have been compiled, condensed, and contextualized in a clear summary of the most important risk

factors, clinical findings, and preventions. Dr. Rubenstein has identified those risk factors that are

modifiable and outlined the most efficacious means to prevent falls in the elderly. Furthermore, as a

clinician, Dr. Rubenstein has included recommendations on the clinical evaluation of patients who have

suffered a fall, adding to the value of this paper for medical students and residents.

Among the top causes of falls in those >65 years old are accidents, gait/balance disorders,

dizziness, confusion, and visual disorders. Some of these major causes are obvious and are clearly the

inevitable course of aging, however, many causes of falls are secondary to other things such as

medications, autonomic dysfunction, or even just the fear of falling. This study highlights the variety and

complexity of factors that contribute to falls in the elderly and emphasizes both the importance of a

complete medical evaluation in patients who have suffered a fall and the value of preventative measures.

Preventive measures - including environmental modification, exercise, and balance conditioning - have all

proven very effective in reducing falls.

    First it is essential to recognize the significant morbidity/mortality caused by falls in the elderly.

Having an understanding of the severity of this problem underlines the importance of taking measures to

prevent falls in patients over 65 years old.


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Article - Link to Full Article

Discussion - Age and Aging Journal Club Aug 2015