The effect of spinal manipulation on pain and prostaglandin levels in women with primary dysmenorrhea. Spinal manipulation vs. amitriptyline for the treatment of chronic tension-type headaches: a randomized clinical trial. Chronic spinal pain syndromes: a clinical pilot trial comparing acupuncture, a nonsteroidal anti-inflammatory drug, and spinal manipulation. Two-year follow-up of a randomized clinical trial of spinal manipulation and two types of exercise for patients with chronic neck pain. Assessment of diclofenac or spinal manipulative therapy, or both, in addition to recommended first-line treatment for acute low back pain: a randomised controlled trial. Chronic asthma and chiropractic spinal manipulation: a randomized clinical trial. Long-term follow-up of a randomized clinical trial assessing the efficacy of medication, acupuncture, and spinal manipulation for chronic mechanical spinal pain syndromes. Chiropractic adjustive manipulation on subjects with acute low back pain: visual analog pain scores and plasma beta-endorphin levels. The efficacy of spinal manipulation, amitriptyline and the combination of both therapies for the prophylaxis of migraine headache. Lumbar spinal manipulation on trial. Part I--clinical assessment. A clinical prediction rule to identify patients with low back pain most likely to benefit from spinal manipulation: a validation study.
The primary objectives of this study were to compare the effect of spinal manipulation vs. sham manipulation on a) circulating plasma levels of the prostaglandin F2a metabolite, 15-keto-13,14-dihydroprostaglandin (KDPGF2a), b) perceived abdominal and back pain and c) perceived menstrual distress in women with primary dysmenorrhea.
                This randomized clinical pilot study investigated the outcome measures before and after either a spinal manipulation treatment (SMT) or a sham manipulation.
                All subjects were treated at the National College Chiropractic clinic, a private chiropractic clinic in the suburban Chicago area.
                Forty-five women with a history of primary dysmenorrhea were recruited from the local community. The volunteers ranged in age from 20-49 (mean age = 30.3 yr), and were entered into the study between April 1990 and January 1991. Twenty-four were randomly assigned to the spinal manipulation group and 21 were assigned to the sham group.
                Subjects treated with spinal manipulation were placed in a side-lying position with the bottom leg straight and the top leg flexed at the knee and hip. They received a high-velocity, short lever, low-amplitude thrust to all clinically relevant vertebral levels within T10 and L5-S1 and the sacroiliac joints. In the sham manipulation, subjects were placed in a side-lying position with both hips and knees flexed. Their manipulation consisted of a similar thrust administered to the midline base of the sacrum.
                Perceived abdominal and back pain were measured with a visual analog scale, and menstrual distress was measured with the Menstrual Distress Questionnaire. Both were administered 15 min before and 60 min after treatment. Blood samples were collected by venipuncture for the determination of plasma levels of KDPGF2a at the same times. The plasma was then assayed for KDPGF2a by radioimmunoassay.
                Analysis of covariance and paired Student's t tests were used for the statistical evaluation. Immediately after treatment, the perception of pain and the level of menstrual distress were significantly reduced by SMT. This reduction was associated with a significant reduction in plasma levels of KDGPF2a in the SMT group. A significant and similar reduction in plasma KDPGF2a also occurred in the sham group, indicating that a placebo effect was associated with a single sham intervention.
                This randomized pilot study suggests that SMT may be an effective and safe nonpharmacological alternative for relieving the pain and distress of primary dysmenorrhea. However, the large change in KDPGF2a observed in both treatment groups clearly indicates that further studies with more subjects, studied over a longer time frame, are needed to resolve the question of a placebo effect. To compare the effectiveness of spinal manipulation and pharmaceutical treatment (amitriptyline) for chronic tension-type headache.
                Randomized controlled trial using two parallel groups. The study consisted of a 2-wk baseline period, a 6-wk treatment period and a 4-wk posttreatment, follow-up period.
                Chiropractic college outpatient clinic.
                One hundred and fifty patients between the ages of 18 and 70 with a diagnosis of tension-type headaches of at least 3 months' duration at a frequency of at least once per wk.
                6 wk of spinal manipulative therapy provided by chiropractors or 6 wk of amitriptyline treatment managed by a medical physician.
                Change in patient-reported daily headache intensity, weekly headache frequency, over-the-counter medication usage and functional health status (SF-36).
                A total of 448 people responded to the recruitment advertisements; 298 were excluded during the screening process. Of the 150 patients who were enrolled in the study, 24 (16%) dropped out: 5 (6.6%) from the spinal manipulative therapy and 19 (27.1%) from the amitriptyline therapy group. During the treatment period, both groups improved at very similar rates in all primary outcomes. In relation to baseline values at 4 wk after cessation of treatment, the spinal manipulation group showed a reduction of 32% in headache intensity, 42% in headache frequency, 30% in over-the-counter medication usage and an improvement of 16% in functional health status. By comparison, the amitriptyline therapy group showed no improvement or a slight worsening from baseline values in the same four major outcome measures. Controlling for baseline differences, all group differences at 4 wk after cessation of therapy were considered to be clinically important and were statistically significant. Of the patients who finished the study, 46 (82.1%) in the amitriptyline therapy group reported side effects that included drowsiness, dry mouth and weight gain. Three patients (4.3%) in the spinal manipulation group reported neck soreness and stiffness.
                The results of this study show that spinal manipulative therapy is an effective treatment for tension headaches. Amitriptyline therapy was slightly more effective in reducing pain at the end of the treatment period but was associated with more side effects. Four weeks after the cessation of treatment, however, the patients who received spinal manipulative therapy experienced a sustained therapeutic benefit in all major outcomes in contrast to the patients that received amitriptyline therapy, who reverted to baseline values. The sustained therapeutic benefit associated with spinal manipulation seemed to result in a decreased need for over-the-counter medication. There is a need to assess the effectiveness of spinal manipulative therapy beyond four weeks and to compare spinal manipulative therapy to an appropriate placebo such as sham manipulation in future clinical trials. To compare needle acupuncture, medication (tenoxicam with ranitidine), and spinal manipulation for managing chronic (>13 weeks duration) spinal pain syndromes.
                Prospective, randomized, independently assessed preintervention and postintervention clinical pilot trial.
                Specialized spinal pain syndrome out-patient unit at Townsville General Hospital, Queensland, Australia.
                Seventy-seven patients (without contraindication to manipulation or medication) were recruited.
                One of three separate, clearly defined intervention protocols: needle acupuncture, nonsteroidal anti-inflammatory medication, or chiropractic spinal manipulation.
                Main outcome measures were changes (4 weeks vs. initial visit) in the scores of the (1) Oswestry Back Pain Disability Index, (2) Neck Disability Index, and (3) three visual analogue scales of local pain intensity.
                Randomization was successful. After a median intervention period of 30 days, spinal manipulation was the only intervention that achieved statistically significant improvements (all expressed as percentages of the original scores) with (1) a reduction of 30.7% on the Oswestry scale, (2) an improvement of 25% on the neck disability index, and (3) reductions on the visual analogue scale of 50% for low back pain, 46% for upper back pain, and 33% for neck pain (all P<.001). Neither of the other interventions showed any significant improvement on any of the outcome measures.
                The consistency of the results provides, in spite of several discussed shortcomings of this pilot study, evidence that in patients with chronic spinal pain syndromes spinal manipulation, if not contraindicated, results in greater improvement than acupuncture and medicine. Randomized clinical trial.
                To compare the effects of spinal manipulation combined with low-tech rehabilitative exercise, MedX rehabilitative exercise, or spinal manipulation alone in patient self-reported outcomes over a two-year follow-up period.
                There have been few randomized clinical trials of spinal manipulation and rehabilitative exercise for patients with neck pain, and most have only reported short-term outcomes.
                One hundred ninety-one patients with chronic neck pain were randomized to 11 weeks of one of the three treatments. Patient self-report questionnaires measuring pain, disability, general health status, improvement, satisfaction, and OTC medication use were collected after 5 and 11 weeks of treatment and 3, 6, 12, and 24 months after treatment. Data were analyzed taking into account all time points using repeated measures analyses.
                Ninety-three percent (178) of randomized patients completed the 11-week intervention phase, and 76% (145) provided data at all evaluation time points over the two-year follow-up period. A difference in patient-rated pain with no group-time interaction was observed in favor of the two exercise groups [F(2141) = 3.2; P= 0.04]. There was also a group difference in satisfaction with care [F(2143) = 7.7; P= 0.001], with spinal manipulation combined with low-tech rehabilitative exercise superior to MedX rehabilitative exercise (P = 0.02) and spinal manipulation alone (P < 0.001). No significant group differences were found for neck disability, general health status, improvement, and OTC medication use, although the trend over time was in favor of the two exercise groups.
                The results of this study demonstrate an advantage of spinal manipulation combined with low-tech rehabilitative exercise and MedX rehabilitative exercise versus spinal manipulation alone over two years and are similar in magnitude to those observed after one-year follow-up. These results suggest that treatments including supervised rehabilitative exercise should be considered for chronic neck pain sufferers. Further studies are needed to examine the cost effectiveness of these therapies and how spinal manipulation compares to no treatment or minimal intervention. We aimed to investigate whether the addition of non-steroidal anti-inflammatory drugs or spinal manipulative therapy, or both, would result in faster recovery for patients with acute low back pain receiving recommended first-line care.
                240 patients with acute low back pain who had seen their general practitioner and had been given advice and paracetamol were randomly allocated to one of four groups in our community-based study: diclofenac 50 mg twice daily and placebo manipulative therapy (n=60); spinal manipulative therapy and placebo drug (n=60); diclofenac 50 mg twice daily and spinal manipulative therapy (n=60); or double placebo (n=60). The primary outcome was days to recovery from pain assessed by survival curves (log-rank test) in an intention-to-treat analysis. This trial was registered with the Australian Clinical Trials Registry, ACTRN012605000036617.
                Neither diclofenac nor spinal manipulative therapy appreciably reduced the number of days until recovery compared with placebo drug or placebo manipulative therapy (diclofenac hazard ratio 1.09, 95% CI 0.84-1.42, p=0.516; spinal manipulative therapy hazard ratio 1.01, 95% CI 0.77-1.31, p=0.955). 237 patients (99%) either recovered or were censored 12 weeks after randomisation. 22 patients had possible adverse reactions including gastrointestinal disturbances, dizziness, and heart palpitations. Half of these patients were in the active diclofenac group, the other half were taking placebo. One patient taking active diclofenac had a suspected hypersensitivity reaction and ceased treatment.
                Patients with acute low back pain receiving recommended first-line care do not recover more quickly with the addition of diclofenac or spinal manipulative therapy. The purpose of this randomized patient- and observer-blinded cross-over trial was to evaluate the efficacy of chiropractic treatment in the management of chronic asthma when combined with pharmaceutical maintenance therapy. The trial was conducted at the National University Hospital's Out-patient Clinic in Copenhagen, Denmark. Thirty-one patients aged 18-44 years participated, all suffering from chronic asthma controlled by bronchodilators and/or inhaled steroids. Patients, or who had received chiropractic treatment for asthma within the last 5 years, who received oral steroids and immunotherapy, were not eligible. Patients were randomized to receive either active chiropractic spinal manipulative treatment or sham chiropractic spinal manipulative treatment twice weekly for 4 weeks, and then crossed over to the alternative treatment for another 4 weeks. Both phases were preceded and followed by a 2-week period without chiropractic treatment. The main outcome measurements were forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), daily use of inhaled bronchodilators, patient-rated asthma severity and non-specific bronchial reactivity (n-BR). Using the cross-over analysis, no clinically important or statistically significant differences were found between the active and sham chiropractic interventions on any of the main or secondary outcome measures. Objective lung function did not change during the study, but over the course of the study, non-specific bronchial hyperreactivity (n-BR) improved by 36% (P = 0.01) and patient-rated asthma severity decreased by 34% (P = 0.0002) compared with the baseline values.(ABSTRACT TRUNCATED AT 250 WORDS) To assess the long-term benefits of medication, needle acupuncture, and spinal manipulation as exclusive and standardized treatment regimens in patients with chronic (>13 weeks) spinal pain syndromes.
                Extended follow-up (>1 year) of a randomized clinical trial was conducted at the multidisciplinary spinal pain unit of Townsville's General Hospital between February 1999 and October 2001.
                Of the 115 patients originally randomized, 69 had exclusively been treated with the randomly allocated treatment during the 9-week treatment period (results at 9 weeks were reported earlier). These patients were followed up and assessed again 1 year after inception into the study reapplying the same instruments (ie, Oswestry Back Pain Index, Neck Disability Index, Short-Form-36, and Visual Analogue Scales). Questionnaires were obtained from 62 patients reflecting a retention proportion of 90%. The main analysis was restricted to 40 patients who had received exclusively the randomly allocated treatment for the whole observation period since randomization.
                Comparisons of initial and extended follow-up questionnaires to assess absolute efficacy showed that only the application of spinal manipulation revealed broad-based long-term benefit: 5 of the 7 main outcome measures showed significant improvements compared with only 1 item in each of the acupuncture and the medication groups.
                In patients with chronic spinal pain syndromes, spinal manipulation, if not contraindicated, may be the only treatment modality of the assessed regimens that provides broad and significant long-term benefit. The purpose of this study was to evaluate pain scores and plasma beta-endorphin levels following a single spinal adjustive manipulation in subjects with acute low back pain. Eighteen subjects were randomly assigned to either a control group, which received no treatment; a sham group, which received only light physical contact (touch); or an experimental group, which received an adjustive manipulation at a specific lumbar segment. Following a standard protocol, all subjects were administered visual analog pain scales and venous blood was drawn 5 min prior to, 5 min after, and 30 min after intervention. Analysis of the pain scores indicated that there was a slight, but significant, reduction of pain in the experimental group, but no similar reduction in the control or sham groups. Furthermore, this reduction of pain in the experimental group was not accompanied any significant change in the plasma beta-endorphin concentration. Migraine headache affects approximately 11 million adults in the United States. Spinal manipulation is a common alternative therapy for headaches, but its efficacy compared with standard medical therapies is unknown.
                To measure the relative efficacy of amitriptyline, spinal manipulation and the combination of both therapies for the prophylaxis of migraine headache.
                A prospective, randomized, parallel-group comparison. After a 4-wk baseline period, patients were randomly assigned to 8 wk of treatment, after which there was a 4-wk follow-up period.
                Chiropractic college outpatient clinic.
                A total of 218 patients with the diagnosis of migraine headache.
                An 8-wk course of therapy with spinal manipulation, amitriptyline or a combination of the two treatments.
                A headache index score derived from a daily headache pain diary during the last 4 wk of treatment and during the 4-wk follow-up period.
                Clinically important improvement was observed in both primary and secondary outcomes in all three study groups over time. The reduction in headache index scores during treatment compared with baseline was 49% for amitriptyline, 40% for spinal manipulation and 41% for the combined group; p = .66. During the posttreatment follow-up period the reduction from baseline was 24% for amitriptyline, 42% for spinal manipulation and 25% for the combined group; p = .05.
                There was no advantage to combining amitriptyline and spinal manipulation for the treatment of migraine headache. Spinal manipulation seemed to be as effective as a well-established and efficacious treatment (amitriptyline), and on the basis of a benign side effects profile, it should be considered a treatment option for patients with frequent migraine headaches. Thirty-two patients with chronic low back pain were treated three times at weekly intervals with rotational manipulation. Patients with femoral or sciatic root pain were included provided they did not exhibit root compression signs. Background therapy of codeine phosphate was administered throughout. There was a significant increase in spinal flexion measured clinically during the three-week period of manipulation followed by a significant decrease in the three-week period after manipulation. The first week of manipulative treatment was more painful than the corresponding week in the control group but in the second and third weeks there was less pain in the manipulated group. Pain scores were reduced to a significant degree within four weeks of starting treatment only in the group manipulated in the first treatment period. Patients benefitting subjectively from manipulation were more likely to be older and to have had symptoms for a shorter period than those not deriving benefit. The age of onset of symptoms was significantly later in the responders. Conflicting evidence exists about the effectiveness of spinal manipulation.
                To validate a manipulation clinical prediction rule.
                Multicenter randomized, controlled trial.
                Physical therapy clinics.
                131 consecutive patients with low back pain, 18 to 60 years of age, who were referred to physical therapy.
                Patients were randomly assigned to receive manipulation plus exercise or exercise alone by a physical therapist for 4 weeks.
                Patients were examined according to the clinical prediction rule criteria (symptom duration, symptom location, fear-avoidance beliefs, lumbar mobility, and hip rotation range of motion). Disability and pain at 1 and 4 weeks and 6 months were assessed.
                Outcome from spinal manipulation depends on a patient's status on the prediction rule. Treatment effects are greatest for the subgroup of patients who were positive on the rule (at least 4 of 5 criteria met); health care utilization among this subgroup was decreased at 6 months. Compared with patients who were negative on the rule and received exercise, the odds of a successful outcome among patients who were positive on the rule and received manipulation were 60.8 (95% CI, 5.2 to 704.7). The odds were 2.4 (CI, 0.83 to 6.9) among patients who were negative on the rule and received manipulation and 1.0 (CI, 0.28 to 3.6) among patients who were positive on the rule and received exercise. A patient who was positive on the rule and received manipulation has a 92% chance of a successful outcome, with an associated number needed to treat for benefit at 4 weeks of 1.9 (CI, 1.4 to 3.5).
                The response rate for the 6-month follow-up resulted in inadequate power to detect statistically significant differences for some comparisons.
                The spinal manipulation clinical prediction rule can be used to improve decision making for patients with low back pain.
There is no evidence to suggest that spinal manipulation is effective in the treatment of dysmenorrhoea. In the one trial reporting on adverse effects there was no greater risk of such events with spinal compared with sham manipulation.