Study protocol for targeted interventions to prevent chronic low back pain in high-risk patients: A multi-site pragmatic cluster randomized controlled trial (TARGET Trial).

BACKGROUND: Low back pain (LBP) is one of the most prevalent and potentially disabling conditions for which people seek health care. Patients, providers, and payers agree that greater effort is needed to prevent acute LBP from transitioning to chronic LBP. METHODS AND STUDY DESIGN: The TARGET (Targeted Interventions to Prevent Chronic Low Back Pain in High-Risk Patients) Trial is a primary care-based, multisite, cluster randomized, pragmatic trial comparing guideline-based care (GBC) to GBC + referral to Psychologically Informed Physical Therapy (PIPT) for patients presenting with acute LBP and identified as high risk for persistent disabling symptoms. Study sites include primary care clinics within each of five geographical regions in the United States, with clinics randomized to either GBC or GBC + PIPT. Acute LBP patients at all clinics are risk stratified (high, medium, low) using the STarT Back Tool. The primary outcomes are the presence of chronic LBP and LBP-related functional disability determined by the Oswestry Disability Index at 6 months. Secondary outcomes are LBP-related processes of health care and utilization of services over 12 months, determined through electronic medical records. Study enrollment began in May 2016 and concluded in June 2018. The trial was powered to include at least 1860 high-risk patients in the randomized controlled trial cohort. A prospective observational cohort of approximately 6900 low and medium-risk acute LBP patients was enrolled concurrently. DISCUSSION: The TARGET pragmatic trial aims to establish the effectiveness of the stratified approach to acute LBP intervention targeting high-risk patients with GBC and PIPT. TRIAL REGISTRATION: ClinicalTrials.govNCT02647658 Registered Jan. 6, 2016.

Use of localized human growth hormone and testosterone injections in addition to manual therapy and exercise for lower back pain: a case series with 12-month follow-up.

OBJECTIVE: The objective of this case series was to investigate the feasibility and safety of a novel method for the management of chronic lower back pain. Injections of recombinant human growth hormone and testosterone to the painful and dysfunctional areas in individuals with chronic lower back pain were used. In addition, the participants received manual therapies and exercise addressing physical impairments such as motor control, strength, endurance, pain, and loss of movement. Pain ratings and self-rated functional outcomes were assessed. STUDY DESIGN: This is a case series involving consecutive patients with chronic lower back pain who received the intervention of injections of recombinant human growth hormone and testosterone, and attended chiropractic and/or physical therapy. Outcomes were measured at 12 months from the time of injection. SETTING: A community based hospital affiliated office, and a private practice block suite. PARTICIPANTS: A total of 60 consecutive patients attending a pain management practice for chronic lower back pain were recruited for the experimental treatment. Most participants were private pay. INTERVENTIONS: Participants who provided informed consent and were determined not to have radicular pain received diagnostic blocks. Those who responded favorably to the diagnostic blocks received injections of recombinant human growth hormone and testosterone in the areas treated with the blocks. Participants also received manipulation- and impairment-based exercises. OUTCOME MEASURES: Outcomes were assessed at 12 months through pain ratings with the Mankowski Pain Scale and the Oswestry Disability Index. RESULTS: Of the 60 patients recruited, 49 provided informed consent, and 39 completed all aspects of the study. Those patients receiving the intervention reported a significant decrease in pain ratings (P<0.01) and a significant improvement in self-rated Oswestry Disability Index scores (P<0.01). In addition, in the Oswestry Disability Index results, 41% of the patients demonstrated a 50% or greater change in their disability score. Of the subjects who withdrew from the study, one was due to the pain created by the injections and nine were for nonstudy factors. CONCLUSION: The intervention appeared to be safe and the results provide a reasonable expectation that the intervention would be beneficial for a population of individuals with chronic nonradicular lower back pain. Due to the design of the study, causality cannot be inferred, but the results do indicate that further study of the intervention may be warranted.

A randomized clinical trial comparing extensible and inextensible lumbosacral orthoses and standard care alone in the management of lower back pain.

STUDY DESIGN: Single blinded, randomized clinical trial for the evaluation of lumbosacral orthoses (LSOs) in the management of lower back pain (LBP). OBJECTIVE: To evaluate the effects of two types of LSOs on self-rated disability in patients with LBP. SUMMARY OF BACKGROUND DATA: LSOs are commonly used for the management of LBP, but their effectiveness may vary because of design. An inextensible LSO (iLSO) reduces trunk motion and increases trunk stiffness, whereas an extensible LSO (eLSO) does not. METHODS: A total of 98 participants with LBP were randomized to 3 groups: (1) standard care (SC) group, which included medication and physical therapy (n = 29), (2) SC with eLSO (eLSO group) (n = 32), and (3) SC with iLSO (iLSO group) (n = 37). Outcome measures were evaluated before and after 2 weeks of treatment: modified Oswestry Disability Index (ODI), Patient Specific Activity Scale, pain ratings, and Fear Avoidance Beliefs Questionnaire. RESULTS: There were no statistically significant differences between groups at baseline. Compared with the SC alone, iLSO group showed greater improvement on the ODI scores (P = 0.01) but not the eLSO group. The ODI scores improved by a mean of 2.4 (95% confidence interval [CI], 2.2-7.1), 8.1 (95% CI, 2.8-13.4), and 14.0 (95% CI, 8.2-19.8) points for SC, eLSO, and iLSO groups, respectively. Individuals wearing the iLSO had 4.7 times higher odds of achieving 50% or greater improvement in the ODI scores than those assigned to SC (95% CI, 1.2-18.5, P = 0.03). Both the eLSO and iLSO groups had a greater improvement in the Patient Specific Activity Scale scores than the SC group (P = .05 and P = 0.01, respectively), but the change did not meet the minimal clinically important difference. Pain ratings improved for all 3 groups, with no statistical difference between them. Finally, no significant differences across groups were found for the Fear Avoidance Beliefs Questionnaire. CONCLUSION: An iLSO led to greater improvement in ODI scores than SC and an eLSO. We surmise that the likely mechanism responsible for this difference in outcome was the added trunk stiffness and motion restriction by the iLSO. LEVEL OF EVIDENCE: 2.

Association between reliance on devices and people for walking and ability to walk community distances among persons with spinal cord injury.

OBJECTIVE: To identify and describe the frequency of reliance on assistive devices and/or people for ambulating distances and stair climbing. DESIGN: Survey. SETTING: A total of 429 adults with traumatic spinal cord injury who were able to walk at least 10 m were identified through inpatient and outpatient hospital databases at a specialty hospital in the southeast United States. OUTCOME MEASURE: Data were collected using a self-report questionnaire including items related to distances walked and devices used for ambulation. RESULTS: Participants best able to ambulate community distances were those who were independent with ambulation and those who used one cane or crutch. Reliance on people or use of a walker was associated with walking shorter distances. Regression analysis indicated reliance on devices or people for walking predicted variation in ability to ambulate community distances after controlling for demographic and injury characteristics. CONCLUSION: This study suggests that reliance on devices or a person for assistance is important to consider when assessing potential for achieving functional community ambulation.

Comparison of trunk stiffness provided by different design characteristics of lumbosacral orthoses.

BACKGROUND: Lumbosacral orthoses (LSOs) are class I medical devices that are used in conservative and postoperative management of low back pain. The effectiveness of LSOs depends on their design aimed at enhancing trunk stiffness. Therefore, the purpose of this study was to compare two lumbar supports: extensible (made of neoprene and lycra) and non-extensible (made of polyester and nylon). METHODS: Trunk stiffness and damping was estimated from trunk displacement data in response to a quick force release in trunk flexion, extension, and lateral bending. Fourteen male and 6 female subjects performed five trials at each experimental condition: (1) No LSO, (2) extensible LSO, (3) non-extensible LSO, (4) non-extensible LSO with a small rigid front panel, and (5) non-extensible LSO with a large rigid front panel. Testing order was randomized and the LSOs were cinched to a pressure of 70 mmHg (9.4 kPa) measured between posterior aspect of the iliac crest and the orthosis. FINDINGS: The non-extensible LSO reduced trunk displacement by 14% and increased trunk stiffness by 14% (P<0.001). The extensible LSO did not result in any significant change in trunk displacement or stiffness. The addition of rigid front panels to the non-extensible LSO did not improve its effectiveness. The trunk damping did not differ between the LSO conditions. INTERPRETATION: A non-extensible LSO is more effective in augmenting trunk stiffness and limiting trunk motion following a perturbation than an extensible LSO. The rigid front panels do not provide any additional trunk stiffness most likely due to incongruence created between the body and a brace.

Lumbosacral orthoses reduce trunk muscle activity in a postural control task.

Biomechanical modeling estimated that trunk muscle activity during various tasks could be reduced by 1-14% without the loss of spine stability when a lumbosacral orthosis (LSO) is worn [Cholewicki, J., 2004. The effects of lumbosacral orthoses on spine stability: what changes in EMG can be expected? Journal of Orthopedic Research 22, 1150-1155]. The present study experimentally tested these theoretical predictions in an unstable sitting task. This task required subjects to balance on a seat supported by a plastic hemisphere (slashed circle=30cm) and placed on a force plate that tracked the center of pressure (CoP). The average CoP velocity quantified subjects' performance. Healthy subjects (12 males, 11 females) balanced for 20s in 3 trials performed with and without the LSO in random order. EMG was recorded bilaterally from rectus abdominis (RA), external oblique (EO), thoracic (TES) and lumbar erector spinae (LES), and expressed as the % of maximum voluntary activation (%MVA). There was no difference in the balance performance with and without the LSO (p=0.13). However, EMG averaged across the trials was significantly lower in the LSO, as compared to the No LSO condition, for TES (5.8+/-3.2 vs. 6.4+/-3.7%MVA, p=0.02) and LES (3.7+/-1.5 vs. 5.9+/-3.9%MVA, p=0.01). No significant differences were present in the abdominal muscle activity. These results agree with earlier spine modeling simulations, which predicted the greatest reduction in muscle activity due to LSO to occur in TES and LES. It was hypothesized that such a reduction in muscle co-contraction could benefit patients with low back pain, who exhibit elevated muscular activity during postural tasks such as walking, standing and sitting.

The effects of trunk stiffness on postural control during unstable seated balance.

This paper focused on the relationship between trunk stiffness and postural control during unstable seated balancing. We hypothesized that an increase in trunk stiffness would degrade postural control, and further hypothesized that signal dependent noise (SDN), resulting in increased muscle force variability, was responsible for this impairment. Ten subjects balanced on an unstable seat during four randomized conditions: normal balancing (control condition), trunk muscle co-activation (active stiffness), arm muscle co-activation (attention control), and belt (passive stiffness). Center of pressure (CoP) and EMG data were collected during three 20 s trials. Postural control was quantified by CoP velocity (total path divided by sample time in seconds). Trunk muscle co-activation resulted in significantly higher CoP velocity than the control (P < 0.001) and arm co-activation (P < 0.001) conditions. EMG data confirmed that the trunk co-activation condition had significantly higher muscle activity than the control (P = 0.001) and arm co-activation (P = 0.001) conditions. The belt condition, which increases passive trunk stiffness, showed no degraded postural control, but interestingly produced slightly lower levels of trunk muscle activity than the control condition (P < 0.001). Increased active trunk stiffness from muscle co-activation degraded postural control. Since the arm co-activation condition showed no impairment, attention demands cannot explain this result. Furthermore, since passive trunk stiffness from wearing a belt did not affect performance, it is believed that SDN from increased trunk muscle recruitment, and not an altered postural control strategy from increased joint stiffness, was responsible for the impairment.

Temperature change in lumbar periarticular tissue with continuous ultrasound.

STUDY DESIGN: Counterbalanced, within-subjects experimental design. OBJECTIVE: To determine the effect of continuous 1-MHz ultrasound, given at 1.5 W/cm2 and 2.0 W/cm2 for 10 minutes, on tissue temperature in the region of the L4-L5 zygapophyseal joint. BACKGROUND: Ultrasound is a modality commonly used for the treatment of lower back pain syndromes. Randomized controlled trials supporting the clinical effectiveness for ultrasound in the treatment of any type of lower back condition are lacking. While one purported purpose of ultrasound is the deep-heating effect, it has not been demonstrated that ultrasound can heat tissues in the area of the lumbar zygapophyseal joints, and the specific parameters needed for a heating effect have not been investigated. To aid in the design of the ultrasound intervention for future randomized controlled trials, it would be beneficial to have insight into the thermal effects of ultrasound on tissues of the lumbar spine and the parameters needed to produce a thermal effect. The present study examined the heating effect of ultrasound on periarticular tissue in the lumbar spine. METHODS AND MEASURES: Continuous, 1-MHz ultrasound at intensities of 1.5 W/cm2 and 2.0 W/cm2 was applied for 10 minutes to the lower back of 6 healthy individuals without lower back pain, while temperature measurements were taken with a hypodermic thermocouple implanted next to the L4-L5 zygapophyseal joint. ANOVA models were used for statistical analysis. RESULTS: Statistical analysis confirmed that the 2.0-W/cm2 ultrasound application produced (a) a more rapid increase in temperature over time, (b) a greater overall level of heating, and (c) significantly greater heating 6 minutes after the beginning of ultrasound administration. The mean terminal temperatures (at 10 minutes) obtained during the 1.5-W/cm2 and 2.0-W/cm2 ultrasound applications were 38.1 degrees C and 39.3 degrees C, respectively. CONCLUSION: Continuous 1-MHz ultrasound given at either 1.5-W/cm2 or 2.0-W/cm2 intensity has the capability of heating lumbar periarticular tissue. The higher-intensity ultrasound resulted in greater and faster temperature increase.