Do Epidural Injections Provide Short- and Long-term Relief for Lumbar Disc Herniation? A Systematic Review

Background

As part of a comprehensive nonsurgical approach, epidural injections often are used in the management of lumbar disc herniation. Recent guidelines and systematic reviews have reached different conclusions about the efficacy of epidural injections in managing lumbar disc herniation.

Questions/purposes

In this systematic review, we determined the efficacy (pain relief and functional improvement) of the three anatomic approaches (caudal, lumbar interlaminar, and transforaminal) for epidural injections in the treatment of disc herniation.

Methods

We performed a literature search from 1966 to June 2013 in PubMed, Cochrane library, US National Guideline Clearinghouse, previous systematic reviews, and cross-references for trials studying all types of epidural injections in managing chronic or chronic and subacute lumbar disc herniation. We wanted only randomized controlled trials (RCTs) (either placebo or active controlled) to be included in our analysis, and 66 studies found in our search fulfilled these criteria. We then assessed the methodologic quality of these 66 studies using the Cochrane review criteria for RCTs. Thirty-nine studies were excluded, leaving 23 RCTs of high and moderate methodologic quality for analysis. Evidence for the efficacy of all three approaches for epidural injection under fluoroscopy was strong for short-term (< 6 months) and moderate for long-term (≥ 6 months) based on the Cochrane rating system with five levels of evidence (best evidence synthesis), with strong evidence denoting consistent findings among multiple high-quality RCTs and moderate evidence denoting consistent findings among multiple low-quality RCTs or one high-quality RCT. The primary outcome measure was pain relief, defined as at least 50% improvement in pain or 3-point improvement in pain scores in at least 50% of the patients. The secondary outcome measure was functional improvement, defined as 50% reduction in disability or 30% reduction in the disability scores.

Results

Based on strong evidence for short-term efficacy from multiple high-quality trials and moderate evidence for long-term efficacy from at least one high quality trial, we found that fluoroscopic caudal, lumbar interlaminar, and transforaminal epidural injections were efficacious at managing lumbar disc herniation in terms of pain relief and functional improvement.

Conclusions

The available evidence suggests that epidural injections performed under fluoroscopy by trained physicians offer improvement in pain and function in well-selected patients with lumbar disc herniation.

Electronic supplementary material

The online version of this article (doi:10.1007/s11999-014-3490-4) contains supplementary material, which is available to authorized users.     

Surgical techniques for sciatica due to herniated disc, a systematic review

Introduction

Disc herniation with sciatica accounts for five percent of low-back disorders but is one of the most common reasons for spine surgery. The goal of this study was to update the Cochrane review on the effect of surgical techniques for sciatica due to disc herniation, which was last updated in 2007.

Materials and methods

In April 2011, we conducted a comprehensive search in CENTRAL, MEDLINE, EMBASE, CINAHL, PEDRO, ICL, and trial registries. We also checked the reference lists and citation tracking results of each retrieved article. Only randomized controlled trials (RCT) of the surgical management of sciatica due to disc herniation were included. Comparisons including chemonucleolysis and prevention of scar tissue or comparisons against conservative treatment were excluded. Two review authors independently selected studies, assessed risk of bias of the studies and extracted data. Quality of evidence was graded according to the GRADE approach.

Results

Seven studies from the original Cochrane review were included and nine additional studies were found. In total, 16 studies were included, of which four had a low risk of bias. Studies showed that microscopic discectomy results in a significantly, but not clinically relevant longer operation time of 12 min (95 % CI 2–22) and shorter incision of 24 mm (95 % CI 7–40) compared with open discectomy, but did not find any clinically relevant superiority of either technique on clinical results. There were conflicting results regarding the comparison of tubular discectomy versus microscopic discectomy for back pain and surgical duration.

Conclusions

Due to the limited amount and quality of evidence, no firm conclusions on effectiveness of the current surgical techniques being open discectomy, microscopic discectomy, and tubular discectomy compared with each other can be drawn. Those differences in leg or back pain scores, operation time, and incision length that were found are clinically insignificant. Large, high-quality studies are needed, which examine not only effectiveness but cost-effectiveness as well.     

Incidence of Low Back Pain After Lumbar Discectomy for Herniated Disc and Its Effect on Patient-reported Outcomes

Background

Long-term postdiscectomy degenerative disc disease and low back pain is a well-recognized disorder; however, its patient-centered characterization and quantification are lacking.

Questions/purposes

We performed a systematic literature review and prospective longitudinal study to determine the frequency of recurrent back pain after discectomy and quantify its effect on patient-reported outcomes (PROs).

Methods

A MEDLINE search was performed to identify studies reporting on the frequency of recurrent back pain, same-level recurrent disc herniation, and reoperation after primary lumbar discectomy. After excluding studies that did not report the percentage of patients with persistent back or leg pain more than 6 months after discectomy or did not report the rate of same level recurrent herniation, 90 studies, which in aggregate had evaluated 21,180 patients, were included in the systematic review portion of this study. For the longitudinal study, all patients undergoing primary lumbar discectomy between October 2010 and March 2013 were enrolled into our prospective spine registry. One hundred fifteen patients were more than 12 months out from surgery, 103 (90%) of whom were available for 1-year outcomes assessment. PROs were prospectively assessed at baseline, 3 months, 1 year, and 2 years. The threshold of deterioration used to classify recurrent back pain was the minimum clinically important difference in back pain (Numeric Rating Scale Back Pain [NRS-BP]) or Disability (Oswestry Disability Index [ODI]), which were 2.5 of 10 points and 20 of 100 points, respectively.

Results Systematic Review

The proportion of patients reporting short-term (6–24 months) and long-term (> 24 months) recurrent back pain ranged from 3% to 34% and 5% to 36%, respectively. The 2-year incidence of recurrent disc herniation ranged from 0% to 23% and the frequency of reoperation ranged from 0% to 13%.

Prospective Study

At 1-year and 2-year followup, 22% and 26% patients reported worsening of low back pain (NRS: 5.3 ± 2.5 versus 2.7 ± 2.8, p < 0.001) or disability (ODI%: 32 ± 18 versus 21 ± 18, p < 0.001) compared with 3 months.

Conclusions

In a systematic literature review and prospective outcomes study, the frequency of same-level disc herniation requiring reoperation was 6%. Two-year recurrent low back pain may occur in 15% to 25% of patients depending on the level of recurrent pain considered clinically important, and this leads to worse PROs at 1 and 2 years postoperatively.     

How Should We Grade Lumbar Disc Herniation and Nerve Root Compression? A Systematic Review

Background

MRI is the gold standard for evaluating the relationship of disc material to soft tissue and neural structures. However, terminologies used to describe lumbar disc herniation and nerve root compression have always been a source of confusion. A clear understanding of lumbar disc terminology among clinicians, radiologists, and researchers is vital for patient care and future research.

Questions/purposes

Through a systematic review of the literature, the purpose of this article is to describe lumbar disc terminology and comment on the reliability of various nomenclature systems and their application to clinical practice.

Methods

PubMed was used for our literature search using the following MeSH headings: “Magnetic Resonance Imaging and Intervertebral Disc Displacement” and “Lumbar Vertebrae” and terms “nomenclature” or “grading” or “classification”. Ten papers evaluating lumbar disc herniation/nerve root compression using different grading criteria and providing information regarding intraobserver and interobserver agreement were identified.

Results

To date, the Combined Task Force (CTF) and van Rijn classification systems are the most reliable methods for describing lumbar disc herniation and nerve root compression, respectively. van Rijn dichotomized nerve roots from “definitely no root compression, possibly no root compression, indeterminate root compression, possible root compression, and definite root compression” into no root compression (first three categories) and root compression (last two categories). The CTF classification defines lumbar discs as normal, focal protrusion, broad-based protrusion, or extrusion. The CTF classification system excludes “disc bulges,” which is a source of confusion and disagreement among many practitioners. This potentially accounts for its improved reliability compared with other proposed nomenclature systems.

Conclusions

The main issue in the management of patients with lumbar disc disease and nerve root compression is correlation of imaging findings with clinical presentation and symptomatology to guide treatment and intervention. Although it appears that the most commonly supported nomenclatures have strong interobserver reliability, the classification term “disc bulges” is a source of confusion and disagreement among many practitioners. Additional research should focus on the clinical application of the various nomenclatures.

Electronic supplementary material

The online version of this article (doi:10.1007/s11999-014-3674-y) contains supplementary material, which is available to authorized users.     

Morphological changes in disc herniation in the lower cervical spine: an ultrastructural study

Introduction

The basis of disc degeneration is still unknown, but is believed to be a cell-mediated process. Apoptosis might play a major role in degenerative disc disease (DDD). The aim of this study was to correlate the viability of disc cells with the radiological degeneration grades (rDG) in disc herniation.

Materials and methods

Forty anterior IVD’s (C4–C7) from 39 patients with DDD were studied histologically and ultrastructurally to quantify healthy, “balloon”, chondroptotic, apoptotic and necrotic cells. Patients were classified to their rDG, as having either prolapse (P: DGII + III) and/or osteochondrosis (O: DGIV + V). Similar studies were undertaken on eight control discs.

Results

Cell death by necrosis (mean 35%) was common but differed not significantly in both groups. All patients with a disc prolapse DGII + III revealed balloon cells (iAF: mean 32%). All appeared alive and sometimes were hypertrophic. However, significantly less balloon cells were found in the O-Group. Control samples revealed no evidence of “balloon” cells in DGII and only a minor rate in DGIII.

Conclusion

According to the different rDG, quantitative changes were obvious in healthy and “balloon” cells, but not for cell death. At the moment it can only be hypothesized if “balloon” cells are part of a repair strategy and/or cause of disc herniation.     

The Increased Expression of Matrix Metalloproteinases Associated with Elastin Degradation and Fibrosis of the Ligamentum Flavum in Patients with Lumbar Spinal Stenosis

Background

One of the characteristics of spinal stenosis is elastin degradation and fibrosis of the extracellular matrix of the ligamentum flavum. However, there have been no investigations to determine which biochemical factors cause these histologic changes. So we performed the current study to investigate the hypothesis that matrix metalloproteinases (MMPs), which possess the ability to cause extracellular matrix remodeling, may play a role as a mediator for this malady in the ligamentum flavum.

Methods

The ligamentum flavum specimens were surgically obtained from thirty patients with spinal stenosis, as well as from 30 control patients with a disc herniation. The extents of ligamentum flavum elastin degradation and fibrosis were graded (grade 0-4) with performing hematoxylin-eosin staining and Masson''s trichrome staining, respectively. The localization of MMP-2 (gelatinase), MMP-3 (stromelysin) and MMP-13 (collagenase) within the ligamentum flavum tissue was determined by immunohistochemistry. The expressions of the active forms of MMP-2, MMP-3 and MMP-13 were determined by western blot analysis, and the blots were quantified using an imaging densitometer. The histologic and biochemical results were compared between the two conditions.

Results

Elastin degradation and fibrosis of the ligamentum flavum were significantly more severe in the spinal stenosis samples than that in the disc herniation samples (3.14 ± 0.50 vs. 0.55 ± 0.60, p < 0.001; 3.10 ± 0.57 vs. 0.76 ± 0.52, p < 0.001, respectively). The expressions of the active form of MMPs were identified in all the ligamentum flavums of the spinal stenosis and disc herniation patients. The expressions of active MMP-2 and MMP-13 were significantly higher in the spinal stenosis samples than that in the disc herniation samples (both p < 0.05). The expression of active MMP-3 was slightly higher in the spinal stenosis samples than that in the disc herniation samples, but the difference was not statistically significant (p = 0.131). MMP-2, -3, and -13 were positively stained on the ligamentum flavum fibroblasts.

Conclusions

The current results suggest that the increased expression of active MMPs by the ligamentum flavum fibroblasts might be related to the elastin degradation and fibrosis of the ligamentum flavum in the patients who suffer with lumbar spinal stenosis.     

Conservatively treated massive prolapsed discs: a 7-year follow-up

INTRODUCTION

The natural history of a lumbar hernia of the nucleus pulposus (HNP) is not fully known and clear indications for operative intervention cannot be established from the literature. Several studies have shown that the largest discs appear to have the greatest tendency to resolve. The aim of this study was to investigate whether massive prolapsed discs can be safely managed conservatively once clinical improvement has occurred.

PATIENTS AND METHODS

Thirty-seven patients were studied by clinical assessments and serial magnetic resonance imaging (MRI) over 2 years. Patients had severe sciatica at first, but began to show clinical improvement despite the large disc hernia-tions. Clinical assessment included the Lasegue test and neurological appraisal. The Oswestry Disability Index was used to measure function and changes in function. Serial MRI studies allowed measurement of volume changes of the herniated disc material over a period of time.

RESULTS

Initial follow-up at an average of 23.2 months revealed that 83% had a complete and sustained recovery at the initial follow-up. Only four patients required a discectomy. The average Oswestry disability index improved from 58% to 15%. Volumetric analysis of serial MRI scans found an average reduction of 64% in disc size. There was a poor correlation between clinical improvement and the extent of disc resolution.

CONCLUSIONS

A massive disc herniation can pursue a favourable clinical course. If early progress is shown, the long-term prognosis is very good and even massive disc herniations can be treated conservatively.     

Reoperation after lumbar disc surgery in two hundred and seven patients

Purpose

The purpose of this study was to compare the causes and characteristics of reoperations after different primary operations for lumbar disc herniation (LDH).

Methods

Out of a series of 5,280 patients who underwent operations for LDH between 2001 and 2012, 207 patients (135 male and 72 female, mean age 47.7 years) underwent primary and revision operations, which were included in this study. The following clinical parameters were retrospectively assessed: the primary surgical methods, the intervals between primary and revision operations, and surgical findings in the revisions.

Results

In total, 232 lumbar discs underwent reoperations. One hundred and nineteen reoperations were performed after microendoscopic discectomy (MED group), 68 after percutaneous endoscopic lumbar discectomy (PELD group) and 45 after open disc surgery (open group). The locations of revision operations had priority over those of primary surgery, with a moderate correlation (kappa coefficient = 0.533). A total of 46.6 % of reoperations were performed within 0.5 years after primary surgery, and 35.3 % were performed between one and five years. Real recurrent herniation (homolateral herniations at the same level) was significantly more common than other reoperative surgical findings (70.6 % in PELD group, 47.1 % in MED group, 37.8 % in open group). The overall mean interval until revision surgery was 18.9 months (8.1 months in the PELD group vs. 19.7 months in the MED group vs. 33.1 months in the open group, p < 0.01).

Conclusions

For LDH, real recurrent herniation was the most common cause of reoperations, and more reoperations for real recurrent herniations and shorter intervals were found after minimally invasive endoscopic discectomy than after open disc surgery.     

Conservative management of a 31 year old male with left sided low back and leg pain: a case report

Objective:

This case study reported the conservative management of a patient presenting with left sided low back and leg pain diagnosed as a left sided L5-S1 disc prolapse/herniation.

Clinical features:

A 31-year-old male recreational worker presented with left sided low back and leg pain for the previous 3–4 months that was exacerbated by prolonged sitting.

Intervention and Outcome:

The plan of management included interferential current, soft tissue trigger point and myofascial therapy, lateral recumbent manual low velocity, low amplitude traction mobilizations and pelvic blocking as necessary. Home care included heat, icing, neural mobilizations, repeated extension exercises, stretching, core muscle strengthening, as well as the avoidance of prolonged sitting and using a low back support in his work chair. The patient responded well after the first visit and his leg and back pain were almost completely resolved by the third visit.

Summary:

Conservative chiropractic care appears to reduce pain and improve mobility in this case of a L5-S1 disc herniation. Active rehabilitative treatment strategies are recommended before surgical referral.     

Comparison of wire and disc leads to activate the expiratory muscles in dogs

Objective

Respiratory complications account for a major cause of morbidity and mortality in subjects with spinal cord injury (SCI) due to paralysis of the expiratory muscles and the consequent inability to generate effective cough. We demonstrated previously that effective cough can be restored in SCI via spinal cord stimulation (SCS) with disc leads positioned on the lower thoracic and upper lumbar spinal cord via laminotomy incisions. In this study, the effectiveness of wire leads, which can be placed using minimally invasive techniques, to activate the expiratory muscles was evaluated.

Design

Animal study.

Setting

Research laboratory.

Animals

Dogs (n = 8).

Interventions

In separate trials, disc and wire leads were inserted onto the dorsal epidural space at the T9, T11, and L1 spinal cord levels. Effects of electrical stimulation with disc, single wire, and two wire leads placed in parallel were compared.

Outcome measures

Airway pressure generation following stimulation with disc and various configurations of wire leads were compared.

Results

Several different configurations of wire leads resulted in airway pressures that were similar to those generated with monopolar stimulation with disc leads (MSDLs). For example, combined monopolar stimulation with parallel wire leads at the T9 + T11 and T9 + L1 levels resulted in airway pressures that were 103.5 ± 6.4 and 101.9 ± 7.0%, respectively, of those achieved with MSDL. Bipolar stimulation with parallel wire leads at T9–T11 and T9–L1 resulted in airway pressures that were 94.2 ± 3.4 and 96.8 ± 5.0%, respectively, of the pressures achieved with MSDL. Other wire configurations were also evaluated, but were generally less effective.

Conclusion

These results suggest that specific configurations of wire leads, which can be placed via minimally invasive techniques, result in comparable activation of the expiratory muscles compared to disc leads and may be a useful technique to restore cough in persons with SCI.     

Effects of Acute Nitric Oxide Synthase Inhibition on Lower Leg Vascular Function in Chronic Tetraplegia

Background/Objective:

To improve our understanding of the lower-leg vascular responses of nitric oxide synthase inhibition in persons with tetraplegia.

Participants:

Six people with chronic tetraplegia and 6 age-matched controls.

Methods:

Lower-leg relative vascular resistance and venous volume variation were obtained by venous occlusion plethysmography and blood pressure by auscultation at baseline. Postintravenous infusion of the nitric oxide synthase inhibitor N^G-nitro-l-arginine-methyl-ester (1 mg·kg⁻¹) or placebo on separate days.

Results:

At baseline in the group with tetraplegia compared with controls, mean arterial pressure and relative vascular resistance of the leg were significantly lower. After nitric oxide synthase inhibition, mean arterial pressure and lower leg vascular resistance were significantly elevated in both groups. There were no group or intervention differences in venous volume variation.

Conclusion:

These preliminary results suggest that nitric oxide synthase inhibition with 1 mg·kg⁻¹ N^G-nitro-l-arginine-methyl-ester normalizes seated blood pressure and lower leg vascular resistance to control group baseline levels.     

Pre-procedural antibiotics for endoscopic urological procedures: Initial experience in individuals with spinal cord injury and asymptomatic bacteriuria

Objective

The objective of this study was to compare the safety, efficacy, quality-of-life impact, and costs of a single dose or a longer course of pre-procedural antibiotics prior to elective endoscopic urological procedures in individuals with spinal cord injury and disorders (SCI/D) and asymptomatic bacteriuria.

Design

A prospective observational study.

Setting

Hunter Holmes McGuire Veterans Affairs Medical Center, Richmond, Virginia, USA.

Participants

Sixty persons with SCI/D and asymptomatic bacteriuria scheduled to undergo elective endoscopic urological procedures.

Interventions

A single pre-procedural dose of antibiotics vs. a 3–5-day course of pre-procedural antibiotics.

Outcome measures

Objective and subjective measures of health, costs, and quality of life.

Results

There were no significant differences in vital signs, leukocytosis, adverse events, and overall satisfaction in individuals who received short-course vs. long-course antibiotics. There was a significant decrease in antibiotic cost (33.1 ± 47.6 vs. 3.6 ± 6.1 US$, P = 0.01) for individuals in the short-course group. In addition, there was greater pre-procedural anxiety (18 vs. 0%, P < 0.05) for individuals who received long-course antibiotics.

Conclusion

SCI/D individuals with asymptomatic bacteriuria may be able to safely undergo most endoscopic urological procedures with a single dose of pre-procedural antibiotics. However, further research is required and even appropriate pre-procedural antibiotics may not prevent severe infections.     

Analysis of immunostaining and western blotting of endothelin 1 and its receptors in mitral stenosis

Introduction

Rheumatic Fever represents a serious public health problem in developing countries, with thousands of new cases each year. It is an autoimmune disease, which occurs in response to infection by streptococcus A.

Objective

The aim of this study was to evaluate the immunolabeling and protein expression for endothelin-1 and 3 (ET-1, ET-3) and its receptors (ETA, ETB) in rheumatic mitral valves.

Methods

Immunohistochemistry was used to identify ET-1/ET-3 and ETA/ETB receptors in rheumatic and control mitral valves. Quantitative analysis of immunostaining for ET-1/ET-3 and ETA/ETB receptors was performed. In addition, western blot analysis was carried out to assess protein levels in tissue samples.

Results

ET-1 and ETA receptor immunostaining predominated in stenotic valves, mainly associated with fibrotic regions, inflammatory areas and neovascularization. Quantitative analysis showed that the average area with positive expression of ET-1 was 18.21±14.96%. For ETA and ETB, the mean expressed areas were respectively 15.06±13.13% and 9.20±11.09%. ET-3 did not have a significant expression. The correlation between the expression of both endothelin receptors were strongly positive (R=0.74, P=0.02), but the correlation between ET-1 and its receptor were negative for both ETA (R=-0.37, P=0.25), and ETB (R=-0.14, P=0.39). This data was supported by western blot analysis.

Conclusion

The strong correlation between ET-1 and its receptors suggests that both play a role in the pathophysiology of rheumatic mitral valve stenosis and may potentially act as biomarkers of this disease.     

Case report: The operation for the lumbar disk herniation just after cesarean delivery in the third trimester of pregnancy

INTRODUCTION

Low back pain is common during pregnancy. However, the incidence of symptomatic lumbar disc herniation during pregnancy is very rare. We report a case of lumbar disc herniation underwent discectomy just after cesarean delivery in the third trimester of pregnancy.

PRESENTATION OF CASE

A 33-year-old woman presented at 32 weeks gestation. She had a low back pain and the left-sided leg pain below the knee. At 34 weeks gestation, she had severe weakness of the left extension halluces longus, left ankle dorsiflexion. MRI showed a large disc herniation at L4/5 expanded to the spinal canal more. The cesarean delivery was performed in the supine position. The patient was then turned to a prone position, and a left L4/5 discectomy was performed. But the day after surgery, she had a severe low back pain and the right leg pain below the knee. MRI showed a disc herniation at L4/5 on the right side of the spinal canal. At 6 days after the first surgery, a right L4/5 discectomy was performed. In the immediate postoperative period, the patient experienced complete relief of the right leg pain.

DISCUSSION

It is necessary to cooperate with a pediatrician, an obstetrician, and an anethesiologists. For obtaining the best outcome on mother and child, it is important to discuss in advance to be able to respond quickly for changeable situation.

CONCLUSION

It is necessary to conduct the operation under pregnancy in consideration of the great influence on mother and child.     

Assessment of passive knee stiffness and viscosity in individuals with spinal cord injury using pendulum test

Objective

Stiffness and viscosity represent passive resistances to joint motion related with the structural properties of the joint tissue and of the musculotendinous complex. Both parameters can be affected in patients with spinal cord injury (SCI). The purpose of this study was to measure passive knee stiffness and viscosity in patients with SCI with paraplegia and healthy subjects using Wartenberg pendulum test.

Design

Non-experimental, cross-sectional, case–control design.

Setting

An outpatient physical therapy clinic, University of social welfare and Rehabilitation Science, Iran.

Patients

A sample of convenience sample of 30 subjects participated in the study. Subjects were categorized into two groups: individuals with paraplegic SCI (n = 15, age: 34.60 ± 9.18 years) and 15 able-bodied individuals as control group (n = 15, age: 30.66 ± 11.13 years).

Interventions

Not applicable.

Main measures

Passive pendulum test of Wartenberg was used to measure passive viscous-elastic parameters of the knee (stiffness, viscosity) in all subjects.

Results

Statistical analysis (independent t-test) revealed significant difference in the joint stiffness between healthy subjects and those with paraplegic SCI (P = 0.01). However, no significant difference was found in the viscosity between two groups (P = 0.17). Except for first peak flexion angle, all other displacement kinematic parameters exhibited no statistically significant difference between normal subjects and subjects with SCI.

Conclusions

Patients with SCI have significantly greater joint stiffness compared to able-bodied subjects.     

Randomized controlled trial of pharmacological replacement of melatonin for sleep disruption in individuals with tetraplegia

Objective

To determine the effectiveness of a melatonin agonist for treating sleep disturbances in individuals with tetraplegia.

Design

Placebo-controlled, double-blind, crossover, randomized control trial.

Setting

At home.

Participants

Eight individuals with tetraplegia, having an absence of endogenous melatonin production and the presence of a sleep disorder.

Interventions

Three weeks of 8 mg of ramelteon (melatonin agonist) and 3 weeks of placebo (crossover, randomized order) with 2 weeks of baseline prior to and 2 weeks of washout between active conditions.

Outcome

Change in objective and subjective sleep.

Measures

Wrist actigraphy, post-sleep questionnaire, Stanford sleepiness scale, SF-36.

Results

We observed no consistent changes in either subjective or objective measures of sleep, including subjective sleep latency (P = 0.55, Friedman test), number of awakenings (P = 0.17, Friedman test), subjective total sleep time (P = 0.45, Friedman test), subjective morning alertness (P = 0.35, Friedman test), objective wake after sleep onset (P = 0.70, Friedman test), or objective sleep efficiency (P = 0.78, Friedman test). There were significant increases in both objective total sleep time (P < 0.05, Friedman test), subjective time in bed (P < 0.05, Friedman test), and subjective sleep quality (P < 0.05, Friedman test), although these occurred in both arms. There were no significant changes in any of the nine SF-36 subscale scores (Friedman test, Ps >Bonferroni adjusted α of 0.005).

Conclusion

In this pilot study, we were unable to show effectiveness of pharmacological replacement of melatonin for the treatment of self-reported sleep problems in individuals with tetraplegia.

Trial Registration

ClinicalTrials.gov # {"type":"clinical-trial","attrs":{"text":"NCT00507546","term_id":"NCT00507546"}}NCT00507546.