Anterior cervical fusion with interbody cage containing beta-tricalcium phosphate augmented with plate fixation: a prospective randomized study with 2-year follow-up. The value of somatosensory- and motor-evoked potentials in predicting and monitoring the effect of therapy in spondylotic cervical myelopathy. Prospective randomized study. Cervical collar or physiotherapy versus wait and see policy for recent onset cervical radiculopathy: randomised trial. Objective assessment of morbidity and quality of life after surgery for low rectal cancer. Anterior cervical discectomy with or without fusion with ray titanium cage: a prospective randomized clinical study. Prenatal and postnatal milk supplementation and adult insulin-like growth factor I: long-term follow-up of a randomized controlled trial. Pain and quality of life following radical retropubic prostatectomy. Effects of resistance and all-round, functional training on quality of life, vitality and depression of older adults living in long-term care facilities: a 'randomized' controlled trial [ISRCTN87177281]. Neck collar, "act-as-usual" or active mobilization for whiplash injury? A randomized parallel-group trial. Effectiveness of prolonged use of continuous passive motion (CPM), as an adjunct to physiotherapy, after total knee arthroplasty. Can chronic disability be prevented? A randomized trial of a cognitive-behavior intervention and two forms of information for patients with spinal pain.
A variety of bone graft substitutes, interbody cages, and anterior plates have been used in cervical interbody fusion, but no controlled study was conducted on the clinical performance of beta-tricalcium phosphate (beta-TCP) and the effect of supplemented anterior plate fixation. The objective of this prospective, randomized clinical study was to evaluate the effectiveness of implanting interbody fusion cage containing beta-TCP for the treatment of cervical radiculopathy and/or myelopathy, and the fusion rates and outcomes in patients with or without randomly assigned plate fixation. Sixty-two patients with cervical radiculopathy and/or myelopathy due to soft disc herniation or spondylosis were treated with one- or two-level discectomy and fusion with interbody cages containing beta-TCP. They were randomly assigned to receive supplemented anterior plate (n = 33) or not (n = 29). The patients were followed up for 2 years postoperatively. The radiological and clinical outcomes were assessed during a 2-year follow-up. The results showed that the fusion rate (75.0%) 3 months after surgery in patients treated without anterior cervical plating was significantly lower than that (97.9%) with plate fixation (P < 0.05), but successful bone fusion was achieved in all patients of both groups at 6-month follow-up assessment. Patients treated without anterior plate fixation had 11 of 52 (19.2%) cage subsidence at last follow-up. No difference (P > 0.05) was found regarding improvement in spinal curvature as well as neck and arm pain, and recovery rate of JOA score at all time intervals between the two groups. Based on the findings of this study, interbody fusion cage containing beta-TCP following one- or two-level discectomy proved to be an effective treatment for cervical spondylotic radiculopathy and/or myelopathy. Supplemented anterior plate fixation can promote interbody fusion and prevent cage subsidence but do not improve the 2-year outcome when compared with those treated without anterior plate fixation. A 2-year follow-up prospective randomized electrophysiologic and clinical study of patients with spondylotic cervical myelopathy.
                To assess the value of somatosensory- and motor-evoked potentials in the evaluation and prediction of the effect of therapy.
                Previous studies have yielded conflicting data concerning the correlation between the changes in evoked potential parameters and the clinical postsurgical outcome in spondylotic cervical myelopathy.
                Sixty-one patients with magnetic resonance images suggesting spondylotic cervical cord compression and clinical signs of cervical myelopathy were divided into two groups according to the degree of clinical cervical cord involvement. The 49 patients with mild and moderate spondylotic cervical myelopathy were randomized into groups that underwent either surgical or conservative therapy. Patients were evaluated clinically and by the means of somatosensory- and motor-evoked potentials.
                The clinical and evoked potential changes showed good correlation on the group level, but poor correlation intraindividually. There were no significant evoked potential and clinical group changes after 6 months and 2 years in the mild myelopathy group treated either surgically and conservatively, whereas patients with severe myelopathy displayed significant improvement in clinical and evoked potential parameters after surgery. In a subgroup of patients, the isolated segmental medullar N13 abnormality could potentially predict favorable postsurgical clinical outcome.
                Longitudinal evoked potentials showed limited use for evaluating the results of therapy in an individual patient. They could be useful in the group assessment of therapy results and in labeling a subgroup of patients with potentially favorable postsurgical outcome. To evaluate the effectiveness of treatment with collar or physiotherapy compared with a wait and see policy in recent onset cervical radiculopathy.
                Randomised controlled trial.
                Neurology outpatient clinics in three Dutch hospitals.
                205 patients with symptoms and signs of cervical radiculopathy of less than one month's duration
                Treatment with a semi-hard collar and taking rest for three to six weeks; 12 twice weekly sessions of physiotherapy and home exercises for six weeks; or continuation of daily activities as much as possible without specific treatment (control group).
                Time course of changes in pain scores for arm and neck pain on a 100 mm visual analogue scale and in the neck disability index during the first six weeks.
                In the wait and see group, arm pain diminished by 3 mm/week on the visual analogue scale (beta=-3.1 mm, 95% confidence interval -4.0 to -2.2 mm) and by 19 mm in total over six weeks. Patients who were treated with cervical collar or physiotherapy achieved additional pain reduction (collar: beta=-1.9 mm, -3.3 to -0.5 mm; physiotherapy: beta=-1.9, -3.3 to -0.8), resulting in an extra pain reduction compared with the control group of 12 mm after six weeks. In the wait and see group, neck pain did not decrease significantly in the first six weeks (beta=-0.9 mm, -2.0 to 0.3). Treatment with the collar resulted in a weekly reduction on the visual analogue scale of 2.8 mm (-4.2 to -1.3), amounting to 17 mm in six weeks, whereas physiotherapy gave a weekly reduction of 2.4 mm (-3.9 to -0.8) resulting in a decrease of 14 mm after six weeks. Compared with a wait and see policy, the neck disability index showed a significant change with the use of the collar and rest (beta=-0.9 mm, -1.6 to -0.1) and a non-significant effect with physiotherapy and home exercises.
                A semi-hard cervical collar and rest for three to six weeks or physiotherapy accompanied by home exercises for six weeks reduced neck and arm pain substantially compared with a wait and see policy in the early phase of cervical radiculopathy. Trial registration Clinical trials NCT00129714. OBJECTIVE: To determine whether an anterior resection for low rectal cancer is associated with less morbidity and a better quality of life than an abdominoperineal resection. PATIENTS AND METHODS: Fifty-three patients who had anterior resection for low rectal cancer were individually matched with 53 other patients, who had an abdominoperineal resection during the same period of time, for gender, age and socioeconomic status. There was no evidence of tumour recurrence in these patients. All patients answered three quality of life questionnaires at least one year after surgery: Short Form 36 version 2, EORTC QLQ-C30 and EORTC QLQ-CR38. Details on short-term and long-term complications were collected prospectively. RESULTS: There was no significant difference in both the short-term and the long-term complication rates between the two groups of patients. There was also no difference in the global quality of life score on the QLQ-C30. However, patients who had an anterior resection had a better perception of body image than those who had an abdominoperineal resection, as measured on the QLQ-CR38 questionnaire (P=0.009), but were more prone to suffer from constipation (P=0.001). CONCLUSIONS: The overall similarities in quality of life between the two groups is probably a reflection of better stoma care, although problems with body image still persist in stoma patients. A prospective randomized clinical study.
                To compare 2 surgical methods in the treatment of cervical radiculopathy caused by hard or soft disc herniation; namely, simple discectomy versus discectomy with an additional interbody fusion with a Ray titanium cage.
                Although an interbody fusion after anterior decompressive surgery for hard or soft disc herniation is widely accepted, there is no scientific evidence that convincingly demonstrates that insertion of graft material for interbody fusion is necessary after discectomy and decompression of the nervous elements have been performed. To date, no randomized studies have compared simple discectomy with discectomy followed by an interbody fusion with a titanium cage.
                Eighty-six patients with symptoms of nerve root compression at 1 level were randomly allocated to either discectomy followed by fusion with a Ray titanium cage (40 patients) or to discectomy alone (46 patients). Clinical and radiologic follow-up was performed 3, 12, and 24 months after surgery.
                There was no statistically significant difference between the 2 groups concerning self-reported satisfaction or severity of pain in the neck and arm. Two years after the operation, 86.1% of the patients treated with cage stated a good outcome versus 76.7% in the discectomy group (P = 0.44). The rate of fusion was 83.3% in the cage group versus 81.0% in the discectomy group (P = 0.30). Furthermore, after 2 years, also the rates of new adjacent disc degeneration or spondylosis were the same in both groups.
                This study showed no statistically significant difference between simple discectomy and discectomy followed by interbody fusion with a titanium cage in the surgical treatment of cervical radiculopathy caused by disc herniation. Insulin-like growth factors (IGF) are increasingly recognized as important determinants of adult health, in particular risk of certain cancers. However, little is known about the determinants of adult IGFs and to what degree they may be programmed by early life influences.
                Randomized controlled trial of prenatal and postnatal milk supplementation among 951 subjects born in 1972 to 1974 in South Wales.
                Measures of IGF-I, IGF binding protein 3, and the molar ratio.
                Data on adult IGFs were available from 663 subjects at a mean age of 25 years. Subjects in the intervention arm had lower IGF-I (-8.5 ng/mL; 95% confidence interval, -15.1 to -1.8, P = 0.01) and ratio (-1.20; 95% confidence interval, -2.33 to -0.04, P = 0.04). These differences could not be explained by follow-up bias or confounding factors.
                These results provide experimental data on the role of early life programming either in the intrauterine or postnatal period that may have long-term influences on the IGF axis, with potential implications for disease risk. We assess pain and quality of life following radical retropubic prostatectomy and determine whether intraoperative anesthetic management has any long-term effects on outcomes.
                A total of 110 patients undergoing radical retropubic prostatectomy were randomly assigned to receive epidural and/or general anesthesia. Patients responded to a questionnaire mailed 3 and 6 months following surgery that assessed prostate symptoms, pain related to surgery, quality of life and mood.
                No long-term effects of anesthesia were observed. Of the 103 respondents (94%) at 3 months 49% had some pain related to surgery. Although pain was not related to anesthesic technique, patients who had it at 3 months used significantly more pain medication on postoperative day 3. Pain at 3 months was mild, averaging 1.5 on a scale of 0 to 10, and associated with poor perceptions of overall health (p <0.02), and reduced physical (p <0.01) and social (p <0.01) functioning. Pain at 3 months was associated with higher levels of preoperative anxiety (p <0.05). At 6 months 36 of 90 patients (35%) had some pain related to surgery and the impact was similar.
                Long-term effects of intraoperative anesthesic technique were not apparent. Mild pain following radical retropubic prostatectomy was common and associated with reduced quality of life, particularly social functioning. Affective distress, particularly anxiety, before surgery and use of pain medications following surgery may be predictors of chronic pain following radical retropubic prostatectomy. Regular physical activity may improve different aspects of wellbeing in older people, such as quality of life, vitality and depression. However, there is little experimental evidence to support this assumption. Therefore, we examined the effect of different training protocols on quality of life, vitality and depression of older adults living in long-term care facilities.
                Subjects (n = 173, aged 64 to 94 years, living in long-term care facilities), were randomized to six months of three different moderate-intensity group exercise training protocols, or to an 'educational' control condition. Exercise consisted of two 45-60-minute training sessions per week of 1) resistance training; 2) all-round, functional training; or 3) a combination of both. Perceived health, the Geriatric Depression Scale (GDS), the Vitality Plus Scale (VPS) and the Dementia Quality of Life questionnaire (DQoL) were administered at baseline and after six months.
                In the combined training group a small but significant decline was seen in perceived health, DQoL and VPS score compared to the control group.
                We conclude that neither strength training nor all-round, functional training of moderate intensity is effective in improving quality of life, vitality or depression of older people living in long-term care facilities. Randomized, parallel-group trial.
                To compare the effect of 3 early intervention strategies following whiplash injury.
                Long-lasting pain and disability, known as chronic whiplash-associated disorder (WAD), may develop after a forced flexion-extension trauma to the cervical spine. It is unclear whether this, in some cases disabling, condition can be prevented by early intervention. Active interventions have been recommended but have not been compared with information only.
                Participants were recruited from emergency units and general practitioners within 10 days after a whiplash injury and randomized to: 1) immobilization of the cervical spine in a rigid collar followed by active mobilization, 2) advice to "act-as-usual," or 3) an active mobilization program (Mechanical Diagnosis and Therapy). Follow-up was carried out after 3, 6, and 12 months postinjury. Treatment effect was measured in terms of headache and neck pain intensity (0-10), disability, and work capability.
                A total of 458 participants were included. At the 1-year follow-up, 48% of participants reported considerable neck pain, 53% disability, and 14% were still sick listed at 1 year follow-up. No significant differences were observed between the 3 interventions group.
                Immobilization, "act-as-usual," and mobilization had similar effects regarding prevention of pain, disability, and work capability 1 year after a whiplash injury. Adequate and intensive rehabilitation is an important requirement for successful total knee arthroplasty. Although research suggests that Continuous Passive Motion (CPM) should be implemented in the first rehabilitation phase after surgery, there is substantial debate about the duration of each session and the total period of CPM application. A Cochrane review on this topic concluded that short-term use of CPM leads to greater short-term range of motion. It also suggested, however, that future research should concentrate on the treatment period during which CPM should be administered.
                In a randomised controlled trial we investigated the effectiveness of prolonged CPM use in the home situation as an adjunct to standardised PT. Efficacy was assessed in terms of faster improvements in range of motion (RoM) and functional recovery, measured at the end of the active treatment period, 17 days after surgery. Sixty patients with knee osteoarthritis undergoing TKA and experiencing early postoperative flexion impairment were randomised over two treatment groups. The experimental group received CPM + PT for 17 consecutive days after surgery, whereas the usual care group received the same treatment during the in-hospital phase (i.e. about four days), followed by PT alone (usual care) in the first two weeks after hospital discharge. From 18 days to three months after surgery, both groups received standardised PT. The primary focus of rehabilitation was functional recovery (e.g. ambulation) and regaining RoM in the knee.
                Prolonged use of CPM slightly improved short-term RoM in patients with limited RoM at the time of discharge after total knee arthroplasty when added to a semi-standard PT programme. Assessment at 6 weeks and three months after surgery found no long-term effects of this intervention Neither did we detect functional benefits of the improved RoM at any of the outcome assessments.
                Although results indicate that prolonged CPM use might have a small short-term effect on RoM, routine use of prolonged CPM in patients with limited RoM at hospital discharge should be reconsidered, since neither long-term effects nor transfer to better functional performance was detected.
                ISRCTN85759656. A randomized controlled design superimposed on treatment as usual was used to compare the effects of a cognitive-behavior intervention aimed at preventing chronicity with two different forms of information.
                To develop a coping-oriented preventive intervention applicable in primary care, and to compare its impact with educational information.
                Preventing long-term disability resulting from spinal pain has proved difficult. The information provided by health care professions and early interventions aimed at preventing long-term disability may be important, but little scientific evidence exists concerning their use.
                A protocol for a six-session cognitive-behavior group intervention was developed on the basis of earlier research. The main focus was to prevent long-term disability by changing patients' behaviors and beliefs so they can cope better with their problems. Comparison groups received either a pamphlet shown earlier to have an effect, or a more extensive information package consisting of six installments. All the groups continued to receive treatment as usual in primary care. There were 243 patients with acute or subacute spinal pain who perceived that they were at risk for developing a chronic problem. These patients were randomized to the cognitive-behavioral intervention or one of the two information groups. Because the aim was to prevent long-term disability, the key outcome variables at the 1-year follow-up assessment were sick absenteeism and health care use. Other variables were pain, function, fear-avoidance beliefs, and cognitions.
                The comparison groups reported benefits. However, the risk for a long-term sick absence developing was lowered ninefold for the cognitive-behavior intervention group as compared with the risk for the information groups (relative risk, 9.3). Participants in the cognitive-behavior group also reported a significant decrease in perceived risk. In addition, the cognitive-behavior group demonstrated a significant decrease in physician and physical therapy use as compared with two groups receiving information, in which such use increased. All three groups tended to improve on the variables of pain, fear-avoidance, and cognitions.
                This study demonstrates that a cognitive-behavior group intervention can lower the risk of a long-term disability developing. These findings underscore the significance of early interventions that specifically aim to prevent chronic problems. This approach might be applied to primary care settings.
Both small trials had significant risks of bias and do not provide reliable evidence on the effects of surgery for cervical spondylotic radiculopathy or myelopathy. It is unclear whether the short-term risks of surgery are offset by long-term benefits. Further research is very likely to have an impact on the estimate of effect and our confidence in it.
There is low quality evidence that surgery may provide pain relief faster than physiotherapy or hard collar immobilization in patients with cervical radiculopathy; but there is little or no difference in the long-term.
There is very low quality evidence that patients with mild myelopathy feel subjectively better shortly after surgery, but there is little or no difference in the long-term.