Joseph R. Kardouni

Validation of a sham comparator for thoracic spinal manipulation in patients with shoulder pain

The evidence to guide use of spinal manipulative therapy (SMT) for patients with shoulder pain is limited. A validated sham comparator is needed to ascertain the unique effects of SMT. We investigated the plausibility of a thoracic sham-SMT comparator for SMT in patients with shoulder pain. Participants (n = 56) with subacromial impingement syndrome were randomized to thoracic SMT or a sham-SMT. An examiner blinded to group assignment took measures pre- and post-treatment of shoulder active range of motion (AROM) and perceived effects of the assigned intervention. Treatment consisted of six upper, middle and lower thoracic SMT or sham-SMT. The sham-SMT was identical to the SMT, except no thrust was applied. Believability as an active treatment was measured post-treatment. Believability as an active treatment was not different between groups (χ(2) = 2.19; p = 0.15). Perceptions of effects were not different between groups at pre-treatment (t = 0.12; p = 0.90) or post-treatment (t = 0.40; p = 0.69), and demonstrated equivalency with 95% confidence between groups at pre- and post-treatment. There was no significant change in shoulder flexion in either group over time, or in the sham-SMT for internal rotation (p > 0.05). The SMT group had an increase of 6.49° in internal rotation over time (p = 0.04). The thoracic sham-SMT of this study is a plausible comparator for SMT in patients with shoulder pain. The sham-SMT was believable as an active treatment, perceived as having equal beneficial effects both when verbally described and after familiarization with the treatment, and has an inert effect on shoulder AROM. This comparator can be considered for used in clinical trials investigating thoracic SMT. IRB number: HM 13182.

Development of a sham comparator for thoracic spinal manipulative therapy for use with shoulder disorders

Prior studies indicate thoracic spinal manipulative therapy (SMT) improves shoulder pain and disability. However, these studies are limited by no control or sham-treatment group. A valid sham comparator for thoracic SMT is needed. Subjects (n=69) without shoulder pain were randomized to one of three groups: thoracic SMT, sham-SMT, or sham-ultrasound; and told they were randomized to manual therapy, range of motion, or ultrasound respectively. Perceived effects of the treatment on shoulder motion, pain, and functional were questioned before and after treatment. Believability was assessed by asking if the subject believed they received the active or inactive intervention. Shoulder active range of motion (AROM) was measured with a digital inclinometer before and after treatment by a blinded examiner. Believability of treatment was not significantly different between the SMT and sham-SMT (p=0.12), but a greater proportion (p=0.03) believed they received the active treatment in the SMT group (78.3%) as compared to the sham-ultrasound (47.8%). No differences in perception of treatment effects between the treatment groups were detected (p≥0.1). Shoulder internal rotation AROM increased in the thoracic SMT group (mean difference=3.7°; p=0.006), but did not change within the sham-SMT (p=0.44) or sham-ultrasound (p=0.18) groups. Shoulder flexion did not change within any group. These preliminary results indicate the sham-SMT is an adequate sham comparator for SMT with similar expectations and believability as SMT active treatment. The sham-SMT had an inert effect on shoulder AROM. Sham-ultrasound was not believable as an active treatment. Future studies need to validate these results in patients with shoulder pain.

Immediate changes in pressure pain sensitivity after thoracic spinal manipulative therapy in patients with subacromial impingement syndrome: A randomized controlled study

BACKGROUND Thoracic SMT can improve symptoms in patients with subacromial impingement syndrome. However, at this time the mechanisms of SMT are not well established. It is possible that changes in pain sensitivity may occur following SMT. OBJECTIVES To assess the immediate pain response in patients with shoulder pain following thoracic spinal manipulative therapy (SMT) using pressure pain threshold (PPT), and to assess the relationship of change in pain sensitivity to patient-rated outcomes of pain and function following treatment. DESIGN Randomized Controlled Study. METHODS Subjects with unilateral subacromial impingement syndrome (n = 45) were randomly assigned to receive treatment with thoracic SMT or sham thoracic SMT. PPT was measured at the painful shoulder (deltoid) and unaffected regions (contralateral deltoid and bilateral lower trapezius areas) immediately pre- and post-treatment. Patient-rated outcomes were pain (numeric pain rating scale - NPRS), function (Pennsylvania Shoulder Score - Penn), and global rating of change (GROC). RESULTS There were no significant differences between groups in pre-to post-treatment changes in PPT (p ≥ 0.583) nor were there significant changes in PPT within either group (p ≥ 0.372) following treatment. NPRS, Penn and GROC improved across both groups (p < 0.001), but there were no differences between the groups (p ≥ 0.574). CONCLUSION There were no differences in pressure pain sensitivity between participants receiving thoracic SMT versus sham thoracic SMT. Both groups had improved patient-rated pain and function within 24-48 h of treatment, but there was no difference in outcomes between the groups.

Incidence of Shoulder Dislocations and the Rate of Recurrent Instability in Soldiers.

PURPOSE Shoulder dislocations present a potentially debilitating injury for soldiers and other groups of physically active adults. The purpose of this study was to determine the 10-yr incidence rate of shoulder dislocations in soldiers, the percentage with recurrent instability, and risk factors for these injuries. METHODS This retrospective cohort study used medical encounter data from U.S. Army soldiers to calculate the 10-yr incidence rate for shoulder dislocations and the percentage of chronic or recurrent injuries >3 months and ≤2 yr after the initial diagnosis. A Cox proportional hazards model was constructed using demographic variables (age, race, education level, marital status, and sex) to determine incidence rate ratios for risk factors related to shoulder dislocation. Logistic regression was used to calculate odds ratio for risk factors for recurrent injury, including concurrent diagnoses (brachial plexus or peripheral nerve injuries and fractures of the scapula or proximal humerus). RESULTS There were 15,426 incident shoulder dislocations, with a 10-yr incidence rate of 3.13 per 1000 person-year. Soldiers ≤40 yr old showed greater risk for injury compared with those older than 40 yr. The incidence rate ratio for males compared with females was 1.64, 95% confidence interval = 1.55-1.74. Recurrent injury occurred in 28.7% of cases. Concurrent axillary nerve injury (odds ratio = 3.64, 95% confidence interval = 1.56-8.46) and age ≤35 yr were associated with greater risk of recurrence. CONCLUSION Within the active duty U.S. Army, men and younger individuals showed greater risk for shoulder dislocations. Over one-quarter of incident cases became recurrent. Axillary nerve injuries and younger age increased the odds of recurrent injury.

Thoracic Spine Manipulation in Individuals With Subacromial Impingement Syndrome Does Not Immediately Alter Thoracic Spine Kinematics, Thoracic Excursion, or Scapular Kinematics: A Randomized Controlled Trial

STUDY DESIGN Randomized controlled trial. OBJECTIVES To determine if thoracic spinal manipulative therapy (SMT) alters thoracic kinematics, thoracic excursion, and scapular kinematics compared to a sham SMT in individuals with subacromial impingement syndrome, and also to compare changes in patient-reported outcomes between treatment groups. BACKGROUND Prior studies indicate that thoracic SMT can improve pain and disability in individuals with subacromial impingment syndrome. However, the mechanisms underlying these benefits are not well understood. METHODS Participants with shoulder impingement symptoms (n = 52) were randomly assigned to receive a single session of thoracic SMT or sham SMT. Thoracic and scapular kinematics during active arm elevation and overall thoracic excursion were measured before and after the intervention. Patient-reported outcomes measured were pain (numeric pain-rating scale), function (Penn Shoulder Score), and global rating of change. RESULTS Following the intervention, there were no significant differences in changes between groups for thoracic kinematics or excursion, scapular kinematics, and patient-reported outcomes (P>.05). Both groups showed an increase in scapular internal rotation during arm raising (mean, 0.9°; 95% confidence interval [CI]: 0.3°, 1.6°; P = .003) and lowering (0.8°; 95% CI: 0.0°, 1.5°; P = .041), as well as improved pain reported on the numeric pain-rating scale (1.2 points; 95% CI: 0.3, 1.8; P<.001) and function on the Penn Shoulder Score (9.1 points; 95% CI: 6.5, 11.7; P<.001). CONCLUSION Thoracic spine extension and excursion did not change significantly following thoracic SMT. There were small but likely not clinically meaningful changes in scapular internal rotation in both groups. Patient-reported pain and function improved in both groups; however, there were no significant differences in the changes between the SMT and the sham SMT groups. Overall, patient-reported outcomes improved in both groups without meaningful changes to thoracic or scapular motion. LEVEL OF EVIDENCE Therapy, level 1b-.

Neovascularization prevalence in the supraspinatus of patients with rotator cuff tendinopathy.

Objective:A high prevalence of neovascularity in lower extremity tendinopathies has been reported. Neovascularity in those with rotator cuff tendinopathy exclusively has not been examined. The objective was to determine the prevalence of neovascularization in patients with rotator cuff tendinopathy compared with asymptomatic controls. Design:Single-blind cross-sectional study. Setting:Research laboratory. Participants:Participants (n = 40; age = 44.9 years, 23-62 years; 20 females) with rotator cuff tendinopathy (n = 20) but without full-thickness rotator cuff tears, and asymptomatic controls that were age, gender, and hand dominance matched (n = 20) to the patients. Interventions:The participants laying in supine had their shoulder positioned in internal rotation and extension. Ultrasound images were collected of the supraspinatus tendon and subacromial bursae in the transverse and longitudinal planes using a linear transducer in color Doppler mode. Main Outcome Measures:Images were assessed for neovascularization by 2 trained raters who were blinded to group (rotator cuff tendinopathy or asymptomatic group). Results:No statistically significant difference in neovascularization was identified between participants with and without rotator cuff tendinopathy (&khgr;2 = 0.13, df = 1, P = 0.72). Neovascularization was identified in 6 of 20 patients with rotator cuff tendinopathy (30%) and 5 of 20 asymptomatic control participants (25%). Conclusions:The authors found no differences in neovascularization rate in patients with rotator cuff tendinopathy (30%) and asymptomatic controls (25%). The study indicates that neovascularization is not related to presence of symptomatic tendinopathy in those with rotator cuff tendinopathy. Neovascularization may not be a relevant sonographic finding to aid the clinical assessment of those with rotator cuff tendinopathy.

Risk of Stress Fracture Varies by Race/Ethnic Origin in a Cohort Study of 1.3 Million U.S. Army Soldiers†

Stress fractures (SF) are common and costly injuries in military personnel. Risk for SF has been shown to vary with race/ethnicity. Previous studies report increased SF risk in white and Hispanic Soldiers compared with black Soldiers. However, these studies did not account for the large ethnic diversity in the US military. We aimed to identify differences in SF risk among racial/ethnic groups within the US Army. A retrospective cohort study was conducted using data from the Total Army Injury and Health Outcomes Database from 2001 until 2011. SF diagnoses were identified from ICD‐9 codes. We used Cox‐proportional hazard models to calculate time to SF by racial/ethnic group after adjusting for age, education, and body mass index. We performed a sex‐stratified analysis to determine whether the ethnic variation in SF risk depends on sex. We identified 21,549 SF cases in 1,299,332 Soldiers (more than 5,228,525 person‐years of risk), revealing an overall incidence rate of 4.12 per 1000 person‐years (7.47 and 2.05 per 1000 person‐years in women and men, respectively). Using non‐Hispanic blacks as the referent group, non‐Hispanic white women had the highest risk of SF, with a 92% higher risk of SF than non‐Hispanic black women (1.92 [1.81–2.03]), followed by American Indian/Native Alaskan women (1.72 [1.44–1.79]), Hispanic women (1.65 [1.53–1.79]), and Asian women (1.32 [1.16–1.49]). Similarly, non‐Hispanic white men had the highest risk of SF, with a 59% higher risk of SF than non‐Hispanic black men (1.59 [1.50–1.68]), followed by Hispanic men (1.19 [1.10–1.29]). When examining the total US Army population, we found substantial differences in the risk of stress fracture among racial/ethnic groups, with non‐Hispanic white Soldiers at greatest risk and Hispanic, American Indian/Native Alaskan, and Asian Soldiers at an intermediate risk. Additional studies are needed to determine the factors underlying these race‐ and ethnic‐related differences in stress fracture risk.

Epidemiology of Ankle Sprains and the Risk of Separation From Service in US Army Soldiers

STUDY DESIGN Retrospective cohort study. OBJECTIVES To report the incidence rate of ankle sprains in active-duty soldiers and to examine if soldiers who sustain ankle sprain injuries are more likely to leave the Army than those who do not sustain an ankle sprain. BACKGROUND Ankle sprains are one of the most common musculoskeletal injuries in physically active people and have been identified as the most common foot or ankle injury in active-duty Army personnel, with a rate of 103 sprains per 1000 soldiers per year. METHODS Data were analyzed on the entire active-duty US Army population from 2000 to 2006 (n = 1 014 042). A semi-parametric Cox proportional hazard model was built. RESULTS The overall incidence rate for ankle sprains was 45.14 per 1000 person-years. After controlling for length of service prior to the study period, soldiers who sustained a single ankle sprain were 27% less likely (relative risk ratio = 0.73; 95% confidence interval: 0.73, 0.75) to leave the service than soldiers who had no documented history of an ankle sprain. However, this trend toward increased service time no longer held true for those who sustained a recurrent sprain (risk ratio = 1.07; 95% confidence interval: 0.99, 1.15). CONCLUSION It appears that individuals who sustain an incident ankle sprain have longer time in service in the Army than those who do not sustain this injury. However, this trend toward longer service time no longer held true for soldiers who sustained a recurrent. LEVEL OF EVIDENCE Prognosis, level 2b.

Distal Fibula Fracture Diagnosed With Ultrasound Imaging

The patient was a 31-year-old man serving in a military special forces unit at a remote location. He presented to a physical therapist with a chief complaint of worsening right lateral ankle pain that limited his ability to bear weight. Because the patient met the Ottawa ankle rules and there was concern for a fracture, radiographs were indicated. However, the nearest facility with radiographic capabilities was only available through air medical evacuation. Therefore, the physical therapist assessed the patients ankle with an onsite portable ultrasound imaging unit, which demonstrated cortical irregularity along the distal fibula.

Risk Factors for Training-Related Injuries during U.S. Army Basic Combat Training

Background Injuries during basic combat training (BCT) impact military health and readiness in the U.S. Army. Identifying risk factors is crucial for injury prevention, but few Army-wide studies to identify risk factors for injury during BCT have been completed to date. This study examines associations between individual and training-related characteristics and injuries during Army BCT. Methods Using administrative data from the Total Army Injury and Health Outcomes Database (TAIHOD), we identified individuals who apparently entered BCT for the first time between 1 January 2002 and 30 September 2007, based on review of administrative records. Injuries were identified and categorized based on coded medical encounter data. When combined with dates of medical services, we could count injuries per person, identify unique injuries, and identify the quantity and type of medical care delivered. Regression models produced odds ratios (ORs) and 95% confidence intervals (CIs) to identify risk factors for injury during BCT (yes/no), adjusted for potential confounders. Results Of the 278,045 (83.4%) men and 55,302 (16.6%) women who were apparently first-time trainees, 39.5% (n = 109,760) of men and 60.9% (n = 33,699) of women were injured during training based on over 2 million recorded medical encounters entries. The large cohort yielded statistically significant, small magnitude associations between injury and all individual and training-related covariates for men, and all but medical accession waivers and weight for women. After adjustment, largest magnitude effects among men were due to age > 25 yr vs. 17-18 yr (OR = 1.83, 95% CI: 1.75, 1.91); having been married in the past vs. being single (OR = 1.36, 95% CI: 1.24, 1.49); rank E4-E7 vs. E1 (OR = 0.56, 95% CI: 0.53. 0.59); training at Ft. Jackson (OR = 0.66, 95% CI: 0.64, 0.69), Ft. Leonard Wood (OR = 0.67, 95% CI: 0.65, 0.70), or Ft. Knox (OR = 0.69, 95% CI: 066, 0.72) vs. Ft. Benning. Odds of injury were highest during 2005, 2006, and 2007. After adjustment for weight and body mass index, taller men had higher odds of BCT injury than average height men (OR = 1.08, 95% CI: 1.05, 1.11). Among women, short stature (OR = 1.11; 95% CI: 1.04, 1.19), training at Ft Leonard Wood (OR = 1.10; 95% CI: 1.04, 1.16) and evidence of injury prior to training based on accession waiver (OR = 1.12; 95% CI: 1.00, 1.26) increased injury risk. Conclusions This Army-wide analysis reveals higher BCT-related injury rates for both men and women than prior studies and identifies risk factors for injuries during BCT. The large data set allows adjustment for many covariates, but because statistical analysis may yield significant findings for small differences, results must be interpreted based on minimally important differences determined by military and medical professionals. Results provide information that may be used to adapt training or medical screening and examination procedures for basic trainees.