PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Randomized controlled trials”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 883 records · Page 49Linked to original sources
PubMed2005

Trunk muscle stabilization training plus general exercise versus general exercise only: randomized controlled trial of patients with recurrent low back pain.

BACKGROUND AND PURPOSE: The purpose of this randomized controlled trial was to examine the usefulness of the addition of specific stabilization exercises to a general back and abdominal muscle exercise approach for patients with subacute or chronic nonspecific back pain by comparing a specific muscle stabilization-enhanced general exercise approach with a general exercise-only approach. SUBJECTS: Fifty-five patients with recurrent, nonspecific back pain (stabilization-enhanced exercise group: n=29, general exercise-only group: n=26) and no clinical signs suggesting spinal instability were recruited. METHODS: Both groups received an 8-week exercise intervention and written advice (The Back Book). Outcome was based on self-reported pain (Short-Form McGill Pain Questionnaire), disability (Roland-Morris Disability Questionnaire), and cognitive status (Pain Self-Efficacy Questionnaire, Tampa Scale of Kinesiophobia, Pain Locus of Control Scale) measured immediately before and after intervention and 3 months after the end of the intervention period. RESULTS: Outcome measures for both groups improved. Furthermore, self-reported disability improved more in the general exercise-only group immediately after intervention but not at the 3-month follow-up. There were generally no differences between the 2 exercise approaches for any of the other outcomes. DISCUSSION AND CONCLUSION: A general exercise program reduced disability in the short term to a greater extent than a stabilization-enhanced exercise approach in patients with recurrent nonspecific low back pain. Stabilization exercises do not appear to provide additional benefit to patients with subacute or chronic low back pain who have no clinical signs suggesting the presence of spinal instability.

Abdominal Muscles↗
PubMed1992

A randomized controlled trial comparing octreotide and vasopressin in the control of acute esophageal variceal bleeding.

This randomized controlled trial was conducted to compare the efficacy of intravenous infusion of octreotide (a synthetic long-acting somatostatin analogue) with vasopressin in 48 cirrhotic patients with endoscopically proven bleeding esophageal varices. Twenty-four patients received a continuous infusion of octreotide 25 micrograms/h for 24 h after an initial bolus of 100 micrograms and another 24 patients received a continuous infusion of vasopressin 0.4 U/min for 24 h. Bleeding was initially controlled after 6 h of drug infusion in 88% (21/24) and 54% (13/24) of the patients treated with octreotide and vasopressin respectively (p = 0.03). Complete control of bleeding after 24 h of drug infusion was achieved in 15 (63%) patients receiving octreotide and in 11 (46%) patients receiving vasopressin (p > 0.05). Side effects during drug infusion such as headache, chest pain and abdominal pain were significantly lower in the octreotide group (3/24) than in the vasopressin group (11/24). Serum gastrin and insulin levels fell significantly following octreotide infusion, but plasma glucose levels remained unchanged. Mortality related to bleeding esophageal varices was no different between the two groups. This report showed that octreotide infusion was more effective and had fewer side effects than vasopressin in initial controlling of acute esophageal variceal bleeding until an elective endoscopic sclerotherapy could be performed.

Aged↗
PubMed1998

A randomized, controlled trial of computerized physiologic trend monitoring in an intensive care unit.

OBJECTIVE: To assess whether the provision of computerized physiologic trend data could improve outcome in newborn infants requiring intensive care. DESIGN: Randomized, controlled trial, with subsidiary questionnaire studies. SETTING: Tertiary neonatal intensive care unit with 12 intensive care cots. PATIENTS: All infants admitted between January 1991 and September 1993 who were < or =32 wks gestation or >32 wks gestation, and ventilated for >4 hrs or asphyxiated. INTERVENTIONS: Randomization to one of four groups for first 7 days of life: A) no display of trend data; B) continuous display of trend data; C1) alternating 24-hr display of trend data, starting with display in first 24 hrs; and C2) alternating 24-hr display of trend data, starting with no display in first 24 hrs. MEASUREMENTS AND MAIN RESULTS: The short-term effects of monitoring on patient outcome was judged by volume of colloid given, number of blood gases taken, and by measurement taken from cranial Doppler ultrasound. Medium-term measures included time ventilated, time given supplemental oxygen, death, time to death or discharge, and cranial ultrasound at discharge. Long-term outcome was assessed by neurodevelopmental status at age 1 to 4 yrs of age. Staff and parent questionnaires assessed their respective attitudes to the introduction of this technology. None of the patient outcome measures, short-, medium-, or long-term, demonstrated any significant benefit from the provision of computerized physiologic trend monitoring. Staff questionnaires demonstrated an acceptance of the system and an improved understanding of neonatal physiology as a result of computerized physiologic trends. Parent questionnaires demonstrated increased anxiety caused by the system in 11% of parents, although only 1% of parents continued to have concerns if the system were able to help their child. CONCLUSIONS: A randomized, controlled trial was unable to demonstrate any benefit to patients resulting from the introduction of a computerized physiologic trend monitoring system. Benefits of the system have been recognized, however, in subsidiary studies, staff education, and research studies.

Attitude of Health Personnel↗
PubMed2003

Oral misoprostol for the third stage of labor: a randomized controlled trial.

OBJECTIVE: To compare oral misoprostol with conventional oxytocics in the management of the third stage of labor. In a controlled trial, 1574 women were randomized into four groups, as follows: Group 1 received intravenous infusion of oxytocin 10 IU plus oral misoprostol 400 micro g, followed by two doses of oral misoprostol 100 micro g 4 hours apart; group 2 received oral misoprostol 400 micro g, followed by two doses of oral misoprostol 100 micro g 4 hours apart; group 3 received intravenous infusion of oxytocin 10 IU; and group 4 received intravenous infusion of oxytocin 10 IU plus intramuscular administration of methylergonovine maleate (Methergine) 0.2 mg. The incidence of postpartum hemorrhage and decrease in hemoglobin concentration from before delivery to 24 hours postpartum were the main outcome measures. RESULTS: The primary outcome measures were similar in groups 2 and 3. The incidence of postpartum hemorrhage was 9% in group 2, compared with 3.2% in group 1 and 3.5% in group 4 (P <.01, and P =.01, respectively). There were no significant differences among the four groups regarding hemoglobin concentrations. Significantly more women needed additional oxytocin in group 2, when compared with group 4 (5.9% versus 2.2%; P =.01). The proportion of women requiring additional methylergonovine maleate was 4.8% in group 2, compared with 0.7% in group 1 and 1% in group 4 (P <.01 and P =.01, respectively). CONCLUSION: Oral misoprostol alone is as effective as oxytocin alone for the prevention of postpartum hemorrhage; it is less effective than oxytocin plus methylergonovine maleate and oral misoprostol plus oxytocin.

Administration, Oral↗
PubMed2004

Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials.

AIMS: To systematically review the published literature on data monitoring committees (DMCs) for randomized controlled trials (RCT) and summarize information and opinions on best practice. This was part of the DAMOCLES project. METHODS: A systematic and comprehensive search of five online bibliographic databases was performed, identifying 4007 potentially relevant articles. These were assessed in two stages by the authors. The 84 most relevant articles were agreed and were supplemented with extracts from 16 books: ultimately, 100 sources were reviewed. A series of 23 questions plus subquestions were developed to structure the data extraction and interpretation process. RESULTS: Much has been written about DMCs but by a rather small community of authors. The papers included some results of surveys, but were mainly opinion pieces based on the authors' beliefs, practices and experiences. There is a lack of empirical evidence for many aspects of DMCs. There was a great range of detail in the literature relating to the prespecified questions. It was generally agreed that interim monitoring of accumulating data was necessary in some form for most trials. Questions such as membership of the DMC featured widely in the literature with opinions and practice ranging from 3-20 members, of whom between none and all should be independent. There was a consensus that formal statistical methods should be used as tools to guide decision making rather than as hard rules. Conversely, topics such as the training and experience required for DMC membership were discussed in very few papers. CONCLUSIONS: There is a consensus in the published literature in a number of areas, although there are many different models for structure and functions of a DMC. While uncertainty remains about some issues, it is strongly recommended that an explicit set of guidelines (Charter) is prepared for each DMC prior to the start of the trial specifying clearly how it will operate.

Clinical Trials Data Monitoring Committees↗
PubMed2006

Travoprost compared with other prostaglandin analogues or timolol in patients with open-angle glaucoma or ocular hypertension: meta-analysis of randomized controlled trials.

BACKGROUND: It is still uncertain whether travoprost has comparable or better efficacy compared with other prostaglandin analogues or timolol in patients with open-angle glaucoma or ocular hypertension. The authors performed a meta-analysis of randomized controlled trials to evaluate the incidence of reported side-effects and intraocular pressure (IOP)-lowering effect of travoprost versus other prostaglandin analogues (latanaprost, bimatoprost, unoprostone) or timolol. METHODS: Systematic literature retrieval was conducted in Pubmed, EMBASE, Chinese Bio-medicine Database and Cochrane Controlled Trials Register to identify the potentially relevant randomized controlled trials. The statistical analysis was performed by RevMan 4.1 software that was provided by the Cochrane Collaboration. The outcome measures were the incidence of reported side-effects (hyperaemia, iris pigmentation, eyelash changes) and mean IOP pooled over treatment visits. RESULTS: In total, 12 articles involving 3048 patients with open-angle glaucoma or ocular hypertension were included in this meta-analysis. The combined results showed that travoprost 0.004% was more effective than timolol or travoprost 0.0015% in lowering IOP, but not more effective than bimatoprost or latanoprost. Travoprost 0.004% caused a higher percentage of hyperaemia than timolol, latanoprost, or travoprost 0.0015%. There was an increased incidence of pigmentation with travoprost than timolol. Travoprost 0.004% caused a higher percentage of eyelash changes than timolol, latanoprost, or travoprost 0.0015%. CONCLUSION: According to data available, travoprost is more effective than timolol in lowering IOP in patients with open-angle glaucoma or ocular hypertension. Compared with other prostaglandin analogues, travoprost appears to be equivalent to bimatoprost and latanoprost. Although a limited number of local side-effects were reported, no serious treatment-related side-effects were reported.

Aged↗
PubMed1994

Chelation therapy for intermittent claudication. A double-blind, randomized, controlled trial.

BACKGROUND: The use of repeated intravenous infusions of EDTA, which has become known as "chelation therapy," has been promoted for treating intermittent claudication as well as a wide range of other disorders. Multiple reports of excellent results in large numbers of patients have encouraged the use of this regimen. The lack of well-controlled studies substantiating the benefits of this treatment has limited its use mainly to private clinics. The aim of the study was to assess the benefits of chelation therapy in patients with intermittent claudication. METHODS AND RESULTS: A double-blind, randomized, controlled trial included 32 patients with intermittent claudication who were randomized to a treatment group (15) and a control group (17). Main outcome measures were subjective and measured walking distances and ankle/brachial pulse indices. Other outcome measures included lifestyle and subjective parameters of improvement, cardiac function, ECG, renal function, hematology, blood glucose, and lipid biochemistry. No clinically significant differences in main outcome measures between chelation therapy and placebo groups were detected up to 3 months after treatment. Measures of mood state, activities of daily living, and quality of life factors were not consistently affected by chelation therapy. An equal proportion (13%) of each group thought that they had received the active agent. The proportion of patients showing an improvement in walking distance was not significantly different between the chelation group (60%) and the control group (59%). CONCLUSIONS: Chelation therapy has no significant beneficial effects over placebo in patients with intermittent claudication.

Activities of Daily Living↗
PubMed2004

Physicians' reasons for not entering their patients in a randomized controlled trial in Japan.

Physicians' not entering their patients can jeopardize the success of a randomized controlled trial (RCT). We used a survey to investigate the possible reasons why physicians who initially agreed to collaborate did not recruit any patients for an RCT being conducted in Japan. A total of 167 questionnaires were sent out and 122 responses were received. Main reasons for not entering patients were: concern about the detrimental effects on the doctor-patient relationship (51.8%), patients' refusal (47.5%), complicated registration and follow-up procedures (34.9%), and not feeling comfortable recruiting their own patients (32.4%). Multivariate logistic regression made it clear that physicians who thought that registering their own patients would damage the doctor-patient relationship and who expected the RCT would fail were more likely to be uncomfortable entering their own patients. Moreover, physicians aged 50 years or older, who felt uncomfortable recruiting their own patients, and saw no advantage in participating in the trial, were more likely to view the enrolment and follow-up procedures as cumbersome. We conclude that training and a manual for obtaining informed consent and a face-to-face demonstration of patient registration/follow-up procedures for the potential participants are prerequisites for increasing physician participation in RCTs in Japan.

Adult↗
PubMed2004

Soy isoflavone intake lowers serum LDL cholesterol: a meta-analysis of 8 randomized controlled trials in humans.

Clinical trials have noted hypocholesterolemic effects of soy protein intake, but the components responsible are not known. This meta-analysis of 8 randomized controlled trials was conducted to more precisely evaluate the effects of isoflavones on blood LDL cholesterol concentration independently of soy protein level. PubMed was searched for English-language "randomized controlled trial" articles published from 1966 to 2003 that described the effects of soy protein isolate (SPI) intake with measured isoflavone levels on blood lipids in humans using the search terms "soy protein," "isoflavones," and "cholesterol." From 31 articles identified by the search, 8 articles (with 10 low vs. high isoflavone comparisons) were selected for the meta-analysis. Subjects in each comparison consumed similar dietary fat, cholesterol, and fiber; the reported body weight of subjects did not change significantly during treatment. Serum LDL cholesterol concentration in subjects who consumed SPI (mean 50 g/d) with high isoflavone content (mean intake 96 mg/d) decreased by 0.15 mmol/L (95% CI: 0.08 to 0.23 mmol/L; P < 0.0001) compared with those who consumed the same SPI level with low isoflavone content (mean intake 6 mg/d). Decreases in serum LDL cholesterol concentration in hypercholesterolemic and normocholesterolemic subjects were 0.18 mmol/L (95% CI: 0.01 to 0.35 mmol/L; P = 0.03) and 0.14 mmol/L (95% CI: 0.06, 0.23 mmol/L; P = 0.0008), respectively. With identical soy protein intake, high isoflavone intake led to significantly greater decreases in serum LDL cholesterol than low isoflavone intake, demonstrating that isoflavones have LDL cholesterol-lowering effects independent of soy protein.

Cholesterol, LDL↗
PubMed2003

Noninvasive ventilation during persistent weaning failure: a randomized controlled trial.

To assess the efficacy of noninvasive ventilation (NIV) in patients with persistent weaning failure, we conducted a prospective, randomized, controlled trial in 43 mechanically ventilated patients who had failed a weaning trial for 3 consecutive days. This trial was stopped after a planned interim analysis. Patients were randomly extubated, receiving NIV (n = 21), or remained intubated following a conventional-weaning approach consisting of daily weaning attempts (n = 22). Compared with the conventional-weaning group, the noninvasive-ventilation group had shorter periods of invasive ventilation (through tracheal intubation) (9.5 +/- 8.3 vs. 20.1 +/- 13.1 days, p = 0.003) and intensive care unit (ICU) (14.1 +/- 9.2 vs. 25.0 +/- 12.5 days, p = 0.002) and hospital stays (27.8 +/- 14.6 vs. 40.8 +/- 21.4 days, p = 0.026), less need for tracheotomy to withdraw ventilation (1, 5% vs. 13, 59%, p < 0.001), lower incidence of nosocomial pneumonia (5, 24% vs. 13, 59%, p = 0.042) and septic shock (2, 10% vs. 9, 41%, p = 0.045), and increased ICU (19, 90% vs. 13, 59%, p = 0.045) and 90-day survival (p = 0.044). The conventional-weaning approach was an independent risk factor of decreased ICU (odds ratio: 6.6; p = 0.035) and 90-day survival (odds ratio: 3.5; p = 0.018). Earlier extubation with NIV results in shorter mechanical ventilation and length of stay, less need for tracheotomy, lower incidence of complications, and improved survival in these patients.

Aged↗
PubMed2005

An integrated approach to consumer representation and involvement in a multicentre randomized controlled trial.

Although, consumer involvement in individual studies is often limited, their involvement in guiding health research is generally considered to be beneficial. This paper outlines our experiences of an integrated relationship between the organisers of a clinical trial and a consumer organisation. The PRISM trial is a UK multicentre, randomized controlled trial comparing treatment strategies for Paget's disease of the bone. The National Association for the Relief of Paget's Disease (NARPD) is the only UK support group for sufferers of Paget's disease and has worked closely with the PRISM team from the outset. NARPD involvement is integral to the conduct of the trial and specific roles have included: peer-review; trial steering committee membership; provision of advice to participants, and promotion of the trial amongst Paget's disease patients. The integrated relationship has yielded benefits to both the trial and the consumer organisation. The benefits for the trial have included: recruitment of participants via NARPD contacts; well-informed participants; unsolicited patient advocacy of the trial; and interested and pro-active collaborators. For the NARPD and Paget's disease sufferers, benefits have included: increased awareness of Paget's disease; increased access to relevant health research; increased awareness of the NARPD services; and wider transfer of diagnosis and management knowledge to/from health care professionals. Our experience has shown that an integrated approach between a trial team and a consumer organisation is worthwhile. Adoption of such an approach in other trials may yield significant improvements in recruitment and quality of participant information flow. There are, however, resource implications for both parties.

Consumer Organizations↗
PubMed1986

A double-blind randomized controlled trial of the effect of a low- versus a middle-tar cigarette on respiratory symptoms--a feasibility study.

A feasibility study of a double-blind, randomized controlled trial of the effect of a low-versus a middle-tar cigarette on respiratory symptoms is described. A smoking questionnaire was sent to 19,366 households. Returned questionnaires (64%) yielded 604 middle-tar cigarette smokers aged 20-44 years; 342 replied to a health warning stating that they did not want to or had failed to stop smoking and of these 183 volunteered for the trial. Thus about every 100 households originally mailed yielded one volunteer. Of the volunteers, 95 men were randomly allocated to be sold a middle-tar cigarette and 88 to be sold a low-tar cigarette of identical appearance. The cigarettes were sold at three different reduced prices and the men were asked to smoke them for five weeks. There was a 22% drop-out and this was unrelated to type of cigarette smoked. A reduction in price of 20% was sufficient incentive for volunteers to participate. Cigarette butts were collected weekly or fortnightly and urine samples were collected initially and after three and five weeks. Compliance with the trial cigarettes was good. The excretion of nicotine metabolites, number of cigarettes smoked and average butt weight for men allocated the low-tar cigarette was not significantly different from that of those allocated the middle-tar cigarette. This suggested that the former compensated for the 37% reduction in the nicotine yield of their cigarette by taking more frequent or deeper puffs from their cigarette. The implications of these results for a large-scale, randomized controlled trial are discussed.

Adult↗
PubMed2002

Conversion of recent-onset atrial fibrillation with intravenous amiodarone: a meta-analysis of randomized controlled trials.

STUDY OBJECTIVE: To evaluate efficacy and safety of intravenous amiodarone for conversion of recent-onset atrial fibrillation. DATA SOURCES: MEDLINE search of published, randomized, controlled trials assessing the efficacy and safety of intravenous amiodarone in recent-onset (< 7 days) atrial fibrillation, supplemented with searches of reference lists of identified articles and bibliographies of secondary and tertiary review articles. STUDY SELECTION: The identified trials were eligible for meta-analysis if they met the following criteria: patients had recent-onset atrial fibrillation; patients were randomized to intravenous amiodarone, placebo, or another antiarrhythmic agent; no other antiarrhythmic agent except digoxin was administered simultaneously with intravenous amiodarone or other active treatments; the number and percentage of conversions to sinus rhythm after treatment began were reported; and the number and type of adverse drug reactions occurring after treatment began were reported. RESULTS: Eighteen randomized controlled trials, including active control cohorts and placebo cohorts, met inclusion criteria. Atrial fibrillation was spontaneous in 13 trials, postoperative in 4, and combined spontaneous and postoperative in 1. A total of 550 patients received intravenous amiodarone, 451 received other antiarrhythmic therapy, and 202 received placebo. Unadjusted averages for cardioversion were as follows: intravenous amiodarone, 417 (76%) of 550 patients; other antiarrhythmics, 324 (72%) of 451 patients; and placebo, 121 (60%) of 202 patients. Pooled estimates of cardioversion for active cohort studies were 72.1% for intravenous amiodarone and 71.9% for other antiarrhythmics (p=0.84). Pooled estimates of cardioversion for placebo cohort studies were 82.4% for intravenous amiodarone and 59.7% for placebo (p=0.03). Unadjusted averages for adverse event rates were intravenous amiodarone, 94 (17%) of 550 patients; other antiarrhythmics, 63 (14%) of 451 patients; and placebo, 23 (11%) of 202 patients. Pooled estimates of adverse event rates for active cohort studies were 12.2% for intravenous amiodarone and 14.0% for other antiarrhythmics (p=0.64). Pooled estimates of adverse event rates for placebo cohort studies were 26.8% for intravenous amiodarone and 10.8% for placebo (p=0.02). The most common adverse drug reactions reported with intravenous amiodarone were infusion phlebitis, bradycardia, and hypotension. CONCLUSION: The efficacy and safety profile of intravenous amiodarone is similar to that of other antiarrhythmics for cardioversion of recent-onset atrial fibrillation. Intravenous amiodarone is significantly more effective than placebo but is associated with significantly higher frequency of adverse events, although most were not considered to be dose limiting.

Amiodarone↗
PubMed2004

A randomized controlled trial of a mutual support group for family caregivers of patients with schizophrenia.

This randomized controlled trial examined the effectiveness of a 12-session mutual support group conducted over 3-months for Chinese family caregivers of a relative with schizophrenia compared with routine family support services in Hong Kong. Forty-eight family caregivers from two psychiatric outpatient clinics were allocated randomly to an experimental (mutual support and usual outpatient care) group (n = 24) or a control (usual outpatient care only) group (n = 24). Data were collected prior to, 1 week and 3 months after the intervention. Families allocated to the mutual support group experienced decreased levels of family burden and increased family functioning and these changes were significantly greater than those of the controls at both post-intervention time points. The experimental group also showed a significant decrease in the duration of patient re-hospitalization (the total number of days of psychiatric hospitalization) at 3 months compared with the control group. This suggests that the mutual support group provided a more responsive service for patients than standard care. However, there was no significant difference in family service utilization between the two groups. The findings indicate that a mutual support group can provide benefits for family caregivers of people with schizophrenia that go beyond those provided by routine family support.

Adult↗
PubMed2002

The effect of independent practice of motor tasks by stroke patients: a pilot randomized controlled trial.

OBJECTIVE: To investigate the effect of independent practice of sitting balance as an addition to standard physiotherapy treatment for patients with stroke. DESIGN: Randomized controlled trial, using blocked randomization procedure with 2:1 ratio. SUBJECTS: Inpatients with diagnosis of stroke, having achieved one minute of independent sitting balance but not yet achieved 10 independent steps, and with no known previous disabilities, pathology or neurological deficit affecting mobility prior to stroke. INTERVENTION: A four-week regime of independent practice aimed at improving aspects of balance, as an addition to standard physiotherapy treatment based on the Bobath Approach. MAIN OUTCOME MEASURE: Proportion of patients achieving 'normal' symmetry of weight distribution during sitting, standing, rising to stand, sitting down, and reaching. RESULTS: Nineteen subjects were randomized to the control group; nine to the intervention group. There were no clinically significant differences in measured outcome between the groups. CONCLUSIONS: The regime of independent practice had no measured beneficial effect on the balance ability of patients with recently acquired stroke.

Aged↗
PubMed2005

Decompression and transposition of the pudendal nerve in pudendal neuralgia: a randomized controlled trial and long-term evaluation.

BACKGROUND: We assess that pudendal neuralgia is a tunnel syndrome due to a ligamentous entrapment of the pudendal nerve and have treated 400 patients surgically since 1987. We have had no major complication. We conducted a randomized controlled trial to evaluate our procedure. METHODS: A sequential, randomized controlled trial to compare decompression of the pudendal nerve with non-surgical treatment. Patients aged 18-70, had chronic, uni/bilateral perineal pain, positive temporary response to blocks at the ischial spine and in Alcock's canal. They were randomly assigned to surgery (n=16) and control (n=16) groups. Primary end point was improvement at 3 months following surgery or assignment to the non-surgery group. Secondary end points were improvement at 12 months and at 4 years following surgical intervention. RESULTS: A significantly higher proportion of the surgery group was improved at 3 months. On intention-to-treat analysis 50% of the surgery group reported improvement in pain at 3 months versus 6.2% of the non-surgery group (p=.0155); in the analysis by treatment protocol the figures were 57.1% versus 6.7% (p=.0052). At 12 months, 71.4% of the surgery group compared with 13.3% of the non-surgery group were improved, analyzing by treatment protocol (p=.0025). Only those randomized to surgery were evaluated at 4 years: 8 remained improved at 4 years. No complications were encountered. CONCLUSIONS: In this study we demonstrate that decompression of the pudendal nerve is an effective and safe treatment for cases of chronic pudendal neuralgia that have been unresponsive to analgesia and nerve blocks. Following surgery, other medical interventions may be necessary.

Adolescent↗
PubMed2002

A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache.

STUDY DESIGN: A multicenter, randomized controlled trial with unblinded treatment and blinded outcome assessment was conducted. The treatment period was 6 weeks with follow-up assessment after treatment, then at 3, 6, and 12 months. OBJECTIVES: To determine the effectiveness of manipulative therapy and a low-load exercise program for cervicogenic headache when used alone and in combination, as compared with a control group. SUMMARY OF BACKGROUND DATA: Headaches arising from cervical musculoskeletal disorders are common. Conservative therapies are recommended as the first treatment of choice. Evidence for the effectiveness of manipulative therapy is inconclusive and available only for the short term. There is no evidence for exercise, and no study has investigated the effect of combined therapies for cervicogenic headache. METHODS: In this study, 200 participants who met the diagnostic criteria for cervicogenic headache were randomized into four groups: manipulative therapy group, exercise therapy group, combined therapy group, and a control group. The primary outcome was a change in headache frequency. Other outcomes included changes in headache intensity and duration, the Northwick Park Neck Pain Index, medication intake, and patient satisfaction. Physical outcomes included pain on neck movement, upper cervical joint tenderness, a craniocervical flexion muscle test, and a photographic measure of posture. RESULTS: There were no differences in headache-related and demographic characteristics between the groups at baseline. The loss to follow-up evaluation was 3.5%. At the 12-month follow-up assessment, both manipulative therapy and specific exercise had significantly reduced headache frequency and intensity, and the neck pain and effects were maintained (P < 0.05 for all). The combined therapies was not significantly superior to either therapy alone, but 10% more patients gained relief with the combination. Effect sizes were at least moderate and clinically relevant. CONCLUSION: Manipulative therapy and exercise can reduce the symptoms of cervicogenic headache, and the effects are maintained.

Adult↗