A prospective randomized controlled study of VAX-D and TENS for the treatment of chronic low back pain

Abstract

Low back pain is one of the most significant medical and socioeconomic problems in modern society. International guidelines call for evidence-based management for the pain and disability associated with musculoskeletal disorders. The purpose of this randomized controlled trial is to address the question of efficacy and appropriateness of vertebral axial decompression (VAX-D) therapy, a new technology that has been shown in clinical research to create negative intradiscal pressures, and has been shown to be effective in treating patients presenting with chronic low back pain (> 3 months duration) with associated leg pain. Successful outcome was defined as a 50% reduction in pain utilizing a 10 cm Visual Analog Pain Scale and an improvement in the level of functioning as measured by patient-nominated disability ratings. Patients were randomly assigned to VAX-D or to TENS which was used as a control treatment or placebo. The TENS treatment demonstrated a success rate of 0%, while VAX-D demonstrated a success rate of 68.4% (p < 0.001). A statistically significant reduction in pain and improvement in functional outcome was obtained in patients with chronic low back pain treated with VAX-D. [Neurol Res 2001; 23: 780-784]     

A prospective randomized controlled study of VAX-D and TENS for the treatment of chronic low back pain.

Low back pain is one of the most significant medical and socioeconomic problems in modern society. International guidelines call for evidence-based management for the pain and disability associated with musculoskeletal disorders. The purpose of this randomized controlled trial is to address the question of efficacy and appropriateness of vertebral axial decompression (VAX-D) therapy, a new technology that has been shown in clinical research to create negative intradiscal pressures, and has been shown to be effective in treating patients presenting with chronic low back pain (> 3 months duration) with associated leg pain. Successful outcome was defined as a 50% reduction in pain utilizing a 10 cm Visual Analog Pain Scale and an improvement in the level of functioning as measured by patient-nominated disability ratings. Patients were randomly assigned to VAX-D or to TENS which was used as a control treatment or placebo. The TENS treatment demonstrated a success rate of 0%, while VAX-D demonstrated a success rate of 68.4% (p < 0.001). A statistically significant reduction in pain and improvement in functional outcome was obtained in patients with chronic low back pain treated with VAX-D.     

A study of logotherapy for chronic low back pain patients]

DHEA-S (dehydroepiandrosterone sulfate) has many roles in human body as comprehensive vital power, whose metabolite is urine 17-KS-S (abbreviated S), having function of anti-cortisol. The metabolite of cortisol is urine 17-OHCS (abbreviated OH). DHEA-S is produced not only in adrenal glands but in brain. In order to examine the effects of logotherapy, urine S and OH were examined. Subjects were chronic low back pain patients treated by loxoprofen sodium (NSAID). In Group 1 (n = 11) logotherapy was not added, but in Group 2 (n = 10) it was added. Before the treatment, both groups showed low S and high OH. After 3 weeks, Group 2 showed higher S and lower OH than Group 1. After 18 weeks, 4 cases (40%) were relapsed in Group 2, and 10 (90.9%) were in Group 1 (p < 0.05). Group 2 was divided into 2 groups; relapsed group (n = 4) and non-relapsed group (n = 6). S, OH, S/OH were examined between 2 groups of Group 2 and Group 1. Relapsed group of Group 2 and Group 1 showed lower S and higher OH than non-relapsed group of Group 2. [Discussion] Logotherapy is a method to activate comprehensive human vital power. This is the mechanism through stimulating and activating human brain function.     

A controlled study of couple therapy in chronic low back pain patients. No improvement of disability

Family-oriented approaches and consequent conjoint marital sessions have been widely accepted as ingredients of comprehensive treatment and rehabilitation of chronic pain patients. However, no controlled trials have been conducted to confirm the effectiveness of couple therapy in these patients. We examined 63 chronic low back pain (CLBP) patients identified in primary health care centres. They were randomly allocated to a couple therapy group (n = 33) and to control group without couple therapy (n = 30). The therapy consisted of five monthly sessions and was attended by two family therapists. All patients attended an initial examination and a 12-month follow-up examination. Effects on self-reported pain, disability, and some clinical measures, as well as on the use of medical services were evaluated. The study groups did not differ significantly in any of the outcome measures. Hence, we conclude that couple therapy has no significant effects on disability in CLBP patients.     

Long-term follow-up of chronic pain patients: a preliminary study

Patients who participated in a structured outpatient pain management program were followed for twenty-four to forty-three months with a mean of 31.8 months. Patients who were evaluated only were compared with patients who terminated prematurely or completed treatment. Patients completing treatment reported greater ability to handle domestic and occupational tasks, and greater tolerance for exercise. There appeared to be no significant effect of treatment on the subjective experience of pain, but patients who completed treatment reported markedly reduced use of medical resources for diagnosis and treatment of pain. Limitations of the present study are discussed.     

Dealing with doubt. How patients account for non-specific chronic low back pain

OBJECTIVE: To explore the ways that persons with long standing chronic low back pain respond to the problem of medical doubt about the presence of organic pathology. METHOD: Qualitative analysis of accounts provided by 12 persons attending a back pain rehabilitation clinic in NW England. RESULTS: Subjects rejected the notion that they were culpable for their pain. They were not culpable for the onset of their pain. They argued that despite their cooperation, no sensible explanation of their pain was forthcoming from health professionals. Finally, they asserted that medical scepticism had been damaging and dispiriting. CONCLUSION: Patients dealt with clinical doubt by stressing their own expertise. They constituted their beliefs about the cause and trajectory of their pain and disability as accurate accounts of their disability. They resisted the suggestion that there might be psychological factors involved in their ill-health by locating culpability among clinicians, who were confused or uncertain about diagnosis and treatment.     

Couple therapy improves mental well-being in chronic low back pain patients. A controlled, five year follow-up study.

Fifty-six chronic low back pain (CLBP) patients participated in a controlled, prospective 5-yr follow-up study evaluating the long-term effects of five-session couple therapy. Twenty-eight patients were included both in the treatment group and in the control group. Outcome measures were self-reported psychological distress, marital satisfaction, health locus of control, pain and disability as well as clinical examinations. The reliability of the outcome measures was statistically analysed and found acceptable. At the 5-yr follow-up assessments, psychological distress was found to be decreased in the treatment group and increased in controls. The difference between the groups was significant. No difference was found in the other self-reported or clinical outcome measures. We conclude that couple therapy has a prolonged beneficial effect on the mental well-being of CLBP patients.     

Central processing of acute muscle pain in chronic low back pain patients: an EEG mapping study.

The presence of perceptual sensitization and related brain responses was examined in 14 chronic low back pain (CLBP) patients and 13 healthy controls comparable in age and sex. Multichannel EEG recordings and pain ratings were obtained during the presentation of 800 painful electrical intramuscular and intracutaneous stimuli each to the left m. erector spinae and the left m. extensor digitorum. Perception and pain thresholds were not significantly different between the two groups, though patients showed significantly more perceptual sensitization. Across all stimulation conditions, a larger EEG component 80 milliseconds after stimulation was observed in the CLBP group. No significant group differences were found for the N150. The component 260 milliseconds after stimulus onset was significantly smaller in the CLBP group. N80, N150, and perceptual sensitization were significantly positively correlated. These results indicate enhanced perceptual sensitization and enhanced processing of the sensory-discriminative aspect of pain, as expressed in the N80 component, in CLBP patients. This may be one neurophysiologic basis of sensitization and the chronicity process. The lower P260 component in the patients may be explained in terms of tonic pain inhibiting phasic pain or may be related to the affective distress observed in this patient group.     

Botulinum toxin A and chronic low back pain: a randomized, double-blind study

OBJECTIVES: To investigate the efficacy of botulinum toxin A in chronic low back pain and associated disabilities. METHODS: Thirty-one consecutive patients with chronic low back pain who met the inclusion criteria were studied: 15 received 200 units of botulinum toxin type A, 40 units/site at five lumbar paravertebral levels on the side of maximum discomfort, and 16 received normal saline. Each patient's baseline level of pain and degree of disability was documented using the visual analogue scale (VAS) and the Oswestry Low Back Pain Questionnaire (OLBPQ). The authors reevaluated the patients at 3 and 8 weeks (visual analogue scale) and at 8 weeks (OLBPQ). RESULTS: At 3 weeks, 11 of 15 patients who received botulinum toxin (73.3%) had >50% pain relief vs four of 16 (25%) in the saline group (p = 0.012). At 8 weeks, nine of 15 (60%) in the botulinum toxin group and two of 16 (12.5%) in the saline group had relief (p = 0.009). Repeat OLBPQ at 8 weeks showed improvement in 10 of 15 (66.7%) in the botulinum toxin group vs three of 16 (18.8%) in the saline group (p = 0.011). No patient experienced side effects. CONCLUSION: Paravertebral administration of botulinum toxin A in patients with chronic low back pain relieved pain and improved function at 3 and 8 weeks after treatment.     

Psychosocial outcome in patients at clinical high risk of psychosis: a prospective follow-up

Purpose

In patients at clinical high risk (CHR) of psychosis, transition to psychosis has been the focus of recent studies. Their broader outcome has received less attention. We studied psychosocial state and outcome in CHR patients.

Methods

In the European Prediction of Psychosis Study, 244 young help-seeking CHR patients were assessed with the Strauss and Carpenter Prognostic Scale (SCPS) at baseline, and 149 (61.1 %) of them were assessed for the second time at the 18-month follow-up. The followed patients were classified into poor and good outcome groups.

Results

Female gender, ever-married/cohabitating relationship, and good working/studying situation were associated with good baseline SCPS scores. During follow-up, patients’ SCPS scores improved significantly. Good follow-up SCPS scores were predicted by higher level of education, good working/studying status at baseline, and white ethnicity. One-third of the followed CHR patients had poor global outcome. Poor working/studying situation and lower level of education were associated with poor global outcome. Transition to psychosis was associated with baseline, but not with follow-up SCPS scores or with global outcome.

Conclusion

The majority of CHR patients experience good short-term recovery, but one-third have poor psychosocial outcome. Good working situation is the major indicator of good outcome, while low level of education and non-white ethnicity seem to be associated with poor outcome. Transition to psychosis has little effect on psychosocial outcome in CHR patients. In treating CHR patients, clinicians should focus their attention on a broader outcome, and not only on preventing transition to psychosis.     

Alexithymia and depression in the recovery of chronic pain patients: a follow-up study

Background: Childhood adversities and emotional dysregulation are connected with chronic pain, alexithymia, and depression. Longitudinal studies exploring the impact of their co-occurrence on the pain situation are rare.

Aims: The influence of alexithymia, depression, baseline pain situation, and treatment options on the course of chronic pain in a clinical sample was studied.

Methods: The baseline data was collected from chronic pain patients (n?=?154) before their first pain clinic visit, and the follow-up data after 1 year by self-report questionnaires. Study variables consisted of pain intensity, pain disability, alexithymia (TAS-20), depression (BDI-II), and treatment interventions. Statistical analyses were performed to find out differences between baseline and follow-up, as well as between alexithymic and non-alexithymic patients, and to estimate the effect of the treatment provided.

Results: At follow-up, the majority of the patients had pain intensity and disability severe enough to disrupt with their daily living. None of treatment interventions was related to better outcome. Alexithymic patients reported more pain disability and depression at both baseline and at follow-up. The effect of alexithymia on pain disability was mediated by depression. The use of opioids was connected to alexithymia and depressiveness. Alexithymia and depression made a substantial contribution to poorer outcome.

Conclusions: Severe pain intensity and disability with depression and alexithymia predicted difficulties in achieving improvement. Depression and alexithymia probably impair compliance with treatment and adherence to interventions. Their co-occurrence with a more severe pain situation and with the use of opioids indicates psychological problems underlying the pain experience.     

Mortality among chronic schizophrenic patients: a prospective 14-year follow-up study of 150 schizophrenic patients

OBJECTIVE: The aim of this study was to quantify the mortality risk in chronic schizophrenic patients, ten to 14 years after the initial evaluation. Furthermore, using sociodemographical, clinical and psychometrical variables evaluated at inclusion, predictors of global or mortality by suicide were explored. METHODS: One hundred and fifty subjects meeting the research diagnostic criteria (RDC) for chronic schizophrenia were included in the study between 1991 and 1995. At the initial assessment, the following variables were assessed: sex, age, level of education, number of hospitalisations, mean duration of the illness, scores on the physical anhedonia scale, the brief psychiatric rating scale (BPRS), the positive and negative syndrome scale (PANSS), and Beck's depression inventory (BDI). In May 2005, all the subjects were assessed using direct or indirect methods. Survival analysis was conducted using the Kaplan-Meier product-limit estimator and a standardized mortality ratio (SMR) was calculated. Multivariate Cox regression was performed to detect predictive factors associated with mortality. RESULTS: The absolute mortality rate was of 18.57% and the RSM of 4.83. The absolute mortality rate for suicide was 6.98%. Multivariate Cox regression analyses showed that two factors (high rate of males, high dose of antipsychotics) were related to an increase in global mortality risk. Moreover, high dose of antipsychotics and a high rate of "positive" subjects, as evaluated by the PANSS, were related to an increase in mortality risk by suicide. CONCLUSION: High dose of neuroleptics could characterize the severe form of schizophrenia, the risk of mortality of which was higher than that of the less severe forms. Another explanation was that high doses of neuroleptics could lead to severe side effects and thus an increase in the vulnerability of schizophrenics to organic diseases. Positive, contrary to negative, symptoms could increase the risk of suicide. This 14-year follow-up study confirmed the increased mortality rates by natural and non natural causes observed in chronic schizophrenic subjects.     

Inpatient care and its outcome in a specialist psychiatric unit for people with intellectual disability: a prospective study

The outcome of treatment in care units has been thought to reflect the effectiveness of treatment. There have been only a few studies describing inpatient care and its outcome in patients with intellectual disability and psychiatric symptoms. The present study describes the psychiatric inpatient treatment in the specialist psychiatric unit of the Special Welfare District of South-west Finland and the need for aftercare among people with intellectual disability and psychiatric disorders (n = 40). As an outcome measure of care, the level of psychiatric symptoms was evaluated either with the Brief Psychiatric Rating Scale (BPRS) or with the Diagnostic Assessment for the Severely Handicapped (DASH) scale; self-reports (visual analogue scale) were also used. Patients’ psychotic symptoms were reduced significantly on the BPRS during inpatient care and aftercare, but non-psychotic symptoms were reduced significantly only during aftercare. For one patient, the psychiatric symptoms were reduced significantly during inpatient care on the DASH scale, while the psychiatric symptoms remained the same for three patients. Patients and their primary carers considered the patient’s psychiatric condition to have improved significantly during inpatient care, but not during aftercare. The specialist unit filled the gap in the care of people with intellectual disability and psychiatric problems in Southwest Finland. It is concluded that psychotic patients particularly benefit from the inpatient care in the specialist psychiatric unit. The care in the unit should include support for primary carers. All patients’ outpatient treatment should also be re-evaluated. The present study poses two important questions. Firstly, could these treatment outcomes have been achieved with other interventions? Secondly, what are the necessary services for people with intellectual disability?