An open study of diflunisal, conservative and manipulative therapy in the management of acute mechanical low back pain. Cyclobenzaprine and naproxen versus naproxen alone in the treatment of acute low back pain and muscle spasm. Cyclobenzaprine hydrochloride effect on skeletal muscle spasm in the lumbar region and neck: two double-blind controlled clinical and laboratory studies. Lower back pain is reduced and range of motion increased after massage therapy. Acute back pain and spasm. A controlled multicenter trial of combined analgesic and antispasm agents. A prospective, randomized, double-blind evaluation of trigger-point injection therapy for low-back pain. A randomized clinical trial comparing chiropractic adjustments to muscle relaxants for subacute low back pain. A randomized, placebo-controlled trial of exercise therapy in patients with acute low back pain. Injection of steroids and local anaesthetics as therapy for low-back pain. [Neuro-reflexotherapy intervention in the treatment of non specified low back pain: a randomized, controlled, double-blind clinical trial]. Acute low-back pain. An objective analysis of conservative therapy. Controlled trial of balneotherapy in treatment of low back pain. Treatment of low back pain with a herbal or synthetic anti-rheumatic: a randomized controlled study. Willow bark extract for low back pain. Comparison of carisoprodol, butabarbital, and placebo in treatment of the low back syndrome.
One hundred and twelve patients with acute mechanical low back pain were randomly divided into three treatment groups. All patients received ergonomic advice and then either a non-steroidal anti-inflammatory drug or conservative or manipulative types of physiotherapy. Serial assessments of pain and spinal mobility showed similar response rates in all three treatment groups and no significant difference between therapies. The overall improvement ratings, time off work, and economic cost favoured the group treated with the nonsteroidal anti-inflammatory drug, but this group had a better range of spinal flexion at the onset so firm conclusions regarding the preferred management of these patients in general practice cannot be drawn. Treatment failures occurred in all groups highlighting the need for a variety of therapeutic approaches in managing the patient with low back pain. Two groups of 20 patients each, with mild to moderate acute low back pain with associated muscle spasm of ten days' duration or less, were treated with a combination of cyclobenzaprine and naproxen or naproxen alone in a randomized, 14-day open-label trial. Cyclobenzaprine was added to the naproxen regimen as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful, musculoskeletal conditions. The clinical characteristics of each study group, including the number of worker's compensation patients, were comparable. Combination therapy was associated with less objective muscle spasm and tenderness and greater motion of the lumbosacral spine (P less than 0.05). There were trends toward faster resolution of functional deficits and pain with combined therapy. Combination therapy was associated with more side effects, due primarily to drowsiness from the cyclobenzaprine. The results of this study demonstrated that patients with muscle spasm associated with acute low back strain benefited from the use of combination therapy consisting of a nonsteroidal anti-inflammatory agent (naproxen) and a muscle relaxant (cyclobenzaprine). A new drug, Cyclobenzaprine hydrochloride (Flexeril), was compared with diazepam (Valium) and placebo in double-blind trials for efficacy in treating spasms and pain in the neck and low back. Complex recording methods involving clinical evaluations (graded), patient self-ratings, goniometry, motion analysis by computer, electromyography of controlled motions and detailed statistical analysis were used. Clinical improvement over two weeks was statistically significant in all treatment groups with a statistically significant preference for Cyclobenzaprine hydrochloride. The most striking improvements recorded were in the electromyographic findings, which showed statistically significant changes for the Cyclobenzaprine group. Clinical muscle spasms are not accompanied by increased myoelectric activity; the reverse is true. With improvement, myoelectric activity in back muscles is augmented during prescribed stressful movements as measured by electromyography and computer analysis combined with complex electrogoniometry. A randomized between-groups design evaluated massage therapy versus relaxation for chronic low back pain.
                Treatment effects were evaluated for reducing pain, depression, anxiety and stress hormones, and sleeplessness and for improving trunk range of motion associated with chronic low back pain. SUMMARY of
                Twenty-four adults (M age=39.6 years) with low back pain of nociceptive origin with a duration of at least 6 months participated in the study. The groups did not differ on age, socioeconomic status, ethnicity or gender.
                Twenty-four adults (12 women) with lower back pain were randomly assigned to a massage therapy or a progressive muscle relaxation group. Sessions were 30 minutes long twice a week for five weeks. On the first and last day of the 5-week study participants completed questionnaires, provided a urine sample and were assessed for range of motion.
                By the end of the study, the massage therapy group, as compared to the relaxation group, reported experiencing less pain, depression, anxiety and improved sleep. They also showed improved trunk and pain flexion performance, and their serotonin and dopamine levels were higher.
                Massage therapy is effective in reducing pain, stress hormones and symptoms associated with chronic low back pain.
                Adults (M age=39.6 years) with low back pain with a duration of at least 6 months received two 30-min massage or relaxation therapy sessions per week for 5 weeks. Participants receiving massage therapy reported experiencing less pain, depression, anxiety and their sleep had improved. They also showed improved trunk and pain flexion performance, and their serotonin and dopamine levels were higher. A double-blind, 18-center, balanced trial of diflunisal vs. cyclobenzaprine HCl vs. these two drugs combined vs. placebo produced complete results from 175 patients. They had sought treatment at the cooperating centers for acute painful spasms of the back within a day or two of trauma or strain. Global results over the 7 to 10 days of observations revealed a clinically and statistically significant superiority of the combined therapy by Day 4 (P = 0.006) and almost all patients recovered within a week to 10 days. A combination therapy with an effective safe analgesic and a true muscle relaxant for less than a week appears to be an excellent relief measure for acute back problems. The efficacy of trigger-point injection therapy in treatment of low-back strain was evaluated in a prospective, randomized, double-blind study. The patient population consisted of 63 individuals with low-back strain. Patients with this diagnosis had nonradiating low-back pain, normal neurologic examination, absence of tension signs, and lumbosacral roentgenograms interpreted as being within normal limits. They were treated conservatively for 4 weeks before entering the study. Injection therapy was of four different types: lidocaine, lidocaine combined with a steroid, acupuncture, and vapocoolant spray with acupressure. Results indicated that therapy without injected medication (63% improvement rate) was at least as effective as therapy with drug injection (42% improvement rate), at a P value of 0.09. Trigger-point therapy seems to be a useful adjunct in treatment of low-back strain. The injected substance apparently is not the critical factor, since direct mechanical stimulus to the trigger-point seems to give symptomatic relief equal to that of treatment with various types of injected medication. The adult lifetime incidence for low back pain is 75% to 85% in the United States. Investigating appropriate care has proven difficult, since, in general, acute pain subsides spontaneously and chronic pain is resistant to intervention. Subacute back pain has been rarely studied.
                To compare the relative efficacy of chiropractic adjustments with muscle relaxants and placebo/sham for subacute low back pain.
                A randomized, double-blind clinical trial.
                Subjects (N = 192) experiencing low back pain of 2 to 6 weeks' duration were randomly allocated to 3 groups with interventions applied over 2 weeks. Interventions were either chiropractic adjustments with placebo medicine, muscle relaxants with sham adjustments, or placebo medicine with sham adjustments. Visual Analog Scale for Pain, Oswestry Disability Questionnaire, and Modified Zung Depression Scale were assessed at baseline, 2 weeks, and 4 weeks. Schober's flexibility test, acetaminophen usage, and Global Impression of Severity Scale (GIS), a physician's clinical impression used as a secondary outcome, were assessed at baseline and 2 weeks.
                Baseline values, except GIS, were similar for all groups. When all subjects completing the protocol were combined (N = 146), the data revealed pain, disability, depression, and GIS decreased significantly (P <.0001); lumbar flexibility did not change. Statistical differences across groups were seen for pain, a primary outcome, (chiropractic group improved more than control group) and GIS (chiropractic group improved more than other groups). No significant differences were seen for disability, depression, flexibility, or acetaminophen usage across groups.
                Chiropractic was more beneficial than placebo in reducing pain and more beneficial than either placebo or muscle relaxants in reducing GIS. To assess the efficacy of exercise therapy for acute low back pain, a randomized, placebo-controlled trial was performed in 40 Dutch general practices. Patients received either exercise instruction with advice for daily life by a physiotherapist; placebo ultrasound therapy by a physiotherapist; or usual care by the general practitioner. All patients received analgesic agents and information on low back pain before randomization. Four hundred seventy-three patients were included. No differences in number of recurrences, functional health status, or medical care usage could be found among the three groups. In the exercise group, duration of recurrences was shorter and patients were less tired during the first 3 months than in the usual care group, but no differences were found between the exercise and placebo groups. It was concluded that exercise therapy for patients with acute low back pain has no advantage over usual care from the general practitioner. Thirty patients with low-back pain of at least one month's duration were included in a double-blind controlled study with third-party administration and treated with either methylprednisolone acetate mixed with lignocaine or isotonic saline, injected at the site of the iliolumbar ligament. The treatment was evaluated by a visual analogue scale, range of spinal flexion ad modum Wright & Moll and of the patients' self-assessments. In the methylprednisolone group, significant decreases in pain score and in patients' self-assessments were found. The range of spinal flexion did not undergo any significant change. No significant changes were found in the control group. No side effects were observed during the study. Nonspecific low back pain is a very common disorder for which no completely satisfactory treatment has been established. A randomized, double-blind, controlled clinical trial was design to assess the efficacy of neuro-reflexotherapic intervention in the treatment of this condition.
                Ninety-one patients with a confirmed diagnosis of nonspecific low back pain were referred for treatment from primary health care facilities in the Spanish National Health System. A total of 43 patients were assigned to the control group and 48 to the treatment group. Patients in the treatment group received a single neuro-reflexotherapic intervention. Patients in the control group underwent a similar procedure, although inappropriate zones were stimulated. Patients in both groups were allowed to continue drug and physiotherapy treatments prescribed by their general practitioners. According to the design the study was ended when statistically significant and clinically evaluable results were obtained in an analysis carried out half way through the study.
                Participants underwent clinical evaluations on three occasions: immediately prior to intervention, immediately after and on day 30 afterwards. Patients in the treatment group showed immediate clinically and statistically significant improvements (p < 0.0001) in pain, muscular contracture and mobility, allowing them to discontinue pharmacological treatment and keeping them free of symptoms during the study period.
                According to results of this study, neuro-reflexotherapic intervention has proved to be an effective method for treating low back pain. The roles of bedrest, antiinflammatory medication, and analgesic medication in the treatment of acute back strain were objectively analyzed to determine whether they have a measurable effect on the return of patients to full daily activities as well as on the relief of pain. Two hundred patients were studied prospectively. Each patient had the diagnosis of acute back strain, which was defined as nonradiating low-back pain. The results of the patient's neurologic examination, straight leg raising test, and lumbosacral spine roentgenograms had to be within normal limits for the patient to be included in the study. The results showed that bedrest, as compared with ambulation, will decrease the amount of time lost from work by 50%. Bedrest will also decrease the amount of discomfort by 60%. Analgesic medication, when combined with bedrest, will further decrease the amount of pain incurred, particularly when used in the first three days of the healing process. However, analgesic medication will not allow a more prompt return to work. Antiinflammatory medication, when added to bedrest in the treatment of lumbago, does not provide an advantage over bedrest alone. Three treatments for non-specific lumbar pain--balneotherapy, underwater traction bath, and underwater massage--were assessed in a randomised prospective controlled trial in 158 outpatients. Each group was treated for four weeks and patients were reviewed at the end of this period and at 12 months after entry to the trial. The prescription of analgesics and the pain score were significantly reduced in all three treated groups, but there was no difference between the three groups. No significant change occurred in spinal motion and the straight leg raising test. After one year only the analgesic consumption was significantly lower than in the control group. To compare the effects of a proprietary extract of willow bark (Assalix) and a selective inhibitor (rofecoxib) of the enzyme cyclo-oxygenase-2 (COX-2).
                An open, randomized, post-marketing study was carried out in an out-patients clinic on two groups of patients aged 18 to 80 yr presenting over a 6-month period with acute exacerbations of low back pain. Using computer-generated random list, 114 patients were allocated to receive a daily dose of herbal extract containing 240 mg of salicin [PAID (phyto-anti-inflammatory drug) group] and 114 were allocated to receive 12.5 mg of the synthetic COX-2 inhibitor rofecoxib [NSAID (non-steroidal anti-inflammatory drug) group]. The doses were chosen according to existing recommendations. All patients were free to use whatever additional conventional treatments were thought necessary. The outcome measures were a modified Arhus index, its pain component and the Total Pain Index.
                Groups were well matched. After 4 weeks of treatment, the Arhus index had improved by about 20%, its pain component by about 30% and the Total Pain Index by about 35%. The number of pain-free patients (visual analogue scale score <2) was about 20 in each group. About 60% of the patients in each group responded well to the treatment (as judged by an improvement of >/=30% in the Total Pain Index relative to its baseline). The improvement was also reflected reasonably well in the physicians' and patients' judgements of the effectiveness of treatment, which were largely concordant. Few patients of either group resorted to the additional conventional treatment options. The incidence of adverse events was similar in the two groups. Treatment with rofecoxib was about 40% more expensive than that with Assalix.
                There was no significant difference in effectiveness between the two treatments at the doses chosen. Treatment with Assalix was less expensive. A double-blind study was carried out to determine the effectiveness of a muscle relaxant, carisoprodol, in the treatment of the low back syndrome, and to test whether this drug would produce any greater effect than an active sedative control. Forty-eight Mexican migrant farm laborers with acute lumbar strain and spasm were given either carisoprodol 350 mg, butabarbital 15 mg, or placebo, four times daily for four days, and then were rated on pertinent symptoms, the degree of limitation of motion (by an objective finger-to-floor test), and overall improvement. In the 43 patients who could be statistically analyzed, carisoprodol was shown to be significantly more effective than butabarbital or placebo in producing improvement of all factors rated. This result suggests that the effects of carisoprodol are not due solely to sedative action, but are also related to its muscle relaxant activity.
Muscle relaxants are effective in the management of non-specific low back pain, but the adverse effects require that they be used with caution. Trials are needed that evaluate if muscle relaxants are more effective than analgesics or non-steroidal anti-inflammatory drugs.