[Neuro-reflexotherapy intervention in the treatment of non specified low back pain: a randomized, controlled, double-blind clinical trial]. Effects of treatment intensity in upper limb robot-assisted therapy for chronic stroke: a pilot randomized controlled trial. Tetrahydrocannabinol (THC) for cramps in amyotrophic lateral sclerosis: a randomised, double-blind crossover trial. Modified constraint-induced therapy in acute stroke: a randomized controlled pilot study. Local and remote sustained trigger point therapy for exacerbations of chronic low back pain. A randomized, double-blind, controlled, multicenter trial. An open study of diflunisal, conservative and manipulative therapy in the management of acute mechanical low back pain. Effects of conventional physical therapy and functional strength training on upper limb motor recovery after stroke: a randomized phase II study. Modified constraint induced therapy: a randomized feasibility and efficacy study. Manipulative therapy and clinical prediction criteria in treatment of acute nonspecific low back pain.
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. Robot-assisted therapy (RT) is a current promising intervention in stroke rehabilitation, but more research is warranted for examining its efficacy and the dose-benefit relation. The authors investigated the effects of higher intensity versus lower intensity RT on movements of forearm pronation-supination and wrist flexion-extension relative to conventional rehabilitation (CR) in patients poststroke for a mean of 21 months.
                In this pilot study, 18 patients with initial mean Fugl-Meyer Assessment (FMA) of 37 to 44 for the upper extremity were randomized to higher intensity RT, lower intensity RT, or CR intervention for 4 weeks. The dose of the higher intensity RT was twice the number of repetitions in the lower intensity RT. Outcome measures at pretreatment and posttreatment were administered to patients to evaluate beneficial and adverse effects of interventions. Primary outcomes were the FMA and Medical Research Council scale.
                There were significant differences in motor function (P = .04) and daily performance (P = .03) among the 3 groups. The higher intensity RT group showed better improvement in motor function, muscle strength, performance of daily activities, and bimanual ability than the other 2 groups. The intensive RT intervention did not induce higher levels of an oxidative DNA biomarker.
                Higher intensity of RT that assists forearm and wrist movements may lead to greater improvement in motor ability and functional performance in stroke patients. A sample size of only 20 to 25 in each arm of a larger randomized controlled trial is needed to confirm the findings for similar subjects. Many patients with amyotrophic lateral sclerosis (ALS) experience cramps during the course of the disease but so far, none of the medications used has been of proven benefit. The objective was to determine the effect of orally administered tetrahydrocannabinol (THC) on cramps in ALS patients.
                The authors conducted a randomised, double-blind, placebo-controlled crossover trial in 27 ALS patients suffering from moderate to severe (visual analogue scale (VAS); VAS≥4) daily cramps. There were 7 women and 20 men with a mean age of 57 years and a mean functional ALS score (ALSFRS-R) of 38.4. Patients were randomly assigned to receive 5 mg THC twice daily followed by placebo or vice versa. Each treatment period lasted for 2 weeks and was preceded by a 2-week drug-free observation period (run-in, wash-out period respectively). The primary outcome measure was change in cramp intensity as assessed by a VAS. Secondary outcome measures included the number of cramps per day, number of cramps during daytime and bedtime, intensity of fasciculations (VAS) as well as validated measures of quality of life (ALSAQ-40), quality of sleep (SDQ), appetite (FAACT) and depression (HADS).
                Complete data were available from 22 patients. THC was well tolerated. There was no evidence for a treatment effect on cramp intensity, number of cramps, fasciculation intensity or any of the other secondary outcome measures.
                This interventional study with orally administered THC 5 mg twice daily did not demonstrate subjective improvement of cramp intensity in ALS patients. To determine modified constraint-induced therapy (mCIT) feasibility and compare its efficacy to traditional rehabilitation (TR) in acute stroke patients exhibiting upper limb hemiparesis.
                Before-after, multiple baseline, randomized controlled pilot study.
                Rehabilitation hospital.
                Ten stroke patients < 14 d poststroke and exhibiting upper limb hemiparesis and affected limb nonuse.
                Five patients were administered mCIT, consisting of structured therapy emphasizing more affected arm use in valued activities 3 d/week for 10 weeks and less affected arm restraint 5 d/week for 5 h. Five other patients received 1/2 sessions of traditional motor rehabilitation for the affected arm, which included affected limb manual dexterity exercises and stretching, as well as compensatory strategies with the unaffected limb. The TR regimens occurred 3 d/week for 10 weeks.
                The Fugl-Meyer Assessment of Motor Recovery (Fugl-Meyer), Action Research Arm Test (ARA), and Motor Activity Log (MAL).
                Before intervention, all patients exhibited stable motor deficits and more affected arm nonuse. After intervention, mCIT patients displayed increased affected arm use (+ 2.43 on the MAL amount of use scale), uniformly exhibited increases on the Fugl-Meyer and ARA (mean change scores = + 18.7 and + 21.7, respectively), and were able to again perform valued activities. TR patients exhibited nominal change in affected limb use (+ 0.07 on the MAL amount of use scale) and modest changes on the Fugl-Meyer and ARA (+ 4.4 and + 4.8, respectively). Fugl-Meyer and ARA changes were significant for the mCIT group only (P < 0.01).
                mCIT is a promising regimen for improving more affected limb use and function in acute cerebrovascular accident. However, larger confirmatory studies need to be performed. A randomized, double-blind, controlled, multicenter trial was conducted.
                To assess the efficacy of neuroreflexotherapy in the management of low back pain.
                Neuroreflexotherapy consists of temporary implantation of epidermal devices in trigger points in the back and referred tender points in the ear.
                The rheumatology and rehabilitation departments of three teaching hospitals in Madrid recruited 78 patients with chronic low back pain. These patients were randomly assigned to the control group (37 patients) or to the treatment group (41 patients). Patients in the treatment group underwent one neuroreflexotherapeutic intervention. The control group received sham treatment consisting of placement of the same number of epidermal devices within a 5-cm radius of the target zones. Patients from both groups were allowed to continue drug treatment as previously prescribed. The use of medications during the trial was recorded.
                Patients underwent clinical evaluations on three occasions: within 5 minutes before intervention, within 5 minutes after intervention, and 45 days later. The preintervention assessment was carried out by the physician from each hospital department who included the patient in the study. Each of the two follow-up assessments were carried out independently by two of three physicians who had no connection with the research team. Patients in the treatment group showed immediate lessening of pain compared with the results in patients in the control group. The pain relief was clinically relevant and statistically significant, and it persisted up to the end of the trial.
                Neuroreflexotherapy intervention seems to be a simple and effective treatment for rapid amelioration of pain episodes in patients with chronic low back pain. At this time, the duration of pain relief beyond 45 days has not been evaluated. 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. Functional training and muscle strength training may improve upper limb motor recovery after stroke. Combining these as functional strength training (FST) might enhance the benefit, but it is unclear whether this is better than conventional physical therapy (CPT). Comparing FST with CPT is not straightforward.
                This study aimed at assessing the feasibility of conducting a phase III trial comparing CPT with FST for upper limb recovery.
                Randomized, observer-blind, phase II trial. Subjects had upper limb weakness within 3 months of anterior circulation infarction. Subjects were randomized to CPT (no extra therapy), CPT + CPT, and CPT + FST. Intervention lasted 6 weeks. Primary outcome measure was the Action Research Arm Test (ARAT). Measurements were taken before treatment began, after 6 weeks of intervention, and 12 weeks thereafter. Attrition rate was calculated and differences between groups were interpreted using descriptive statistics. ARAT data were used to inform a power calculation.
                Thirty subjects were recruited (8% of people screened). Attrition rate was 6.7% at outcome and 40% at follow-up. At outcome the CPT + FST group showed the largest increase in ARAT score and this was above the clinically important level of 5.7 points. Median (interquartile range) increases were 11.5 (21.0) for CPT; 8.0 (13.3) for CPT + CPT; and 19.5 (22.0) for CPT + FST. The estimated sample size for an adequately powered subsequent phase III trial was 279 subjects at outcome.
                Further work toward a phase III clinical trial appears justifiable. This case series examined the feasibility and efficacy of a modified constraint induced therapy (CIT) protocol administered on an outpatient basis. The Fugl-Meyer Assessment of Motor Recovery After Stroke (Fugl), Action Research Arm Test (ARA), Wolf Motor Function Test (WMFT), and Motor Activity Log (MAL) were administered to six patients between 2 and 6 months poststroke (CVA) exhibiting stable motor deficits and learned nonuse of the affected limb. Two patients then participated in half-hour physical and occupational therapy sessions three times/week for 10 weeks. During the same period, their unaffected arms and hands were restrained 5 days/week during 5 hours identified as times of frequent use. Two other patients received regular therapy and two control patients received no therapy. The ARA, Fugl, WMFT, and MAL were again administered after 10 weeks. Patients receiving modified CIT exhibited substantial improvements on the Fugl, ARA, and WMFT, as well as increases in amount and quality of use of the limb using the MAL. Patients receiving traditional or no therapy exhibited no improvements. Results suggest that modified CIT may be an efficacious method of improving function and use of the affected arms of patients exhibiting learned nonuse. Manipulative therapy as part of a multidimensional approach may be more effective than standard physical therapy in treating Acute Nonspecific Low Back Pain. 64 participants, 29 women and 35 men, with Acute Nonspecific Low Back Pain and a mean age of 40 yr. (SD=9.6) were randomly assigned to two groups: an experimental group (manipulative therapy plus physical therapy) and a control group (only physical therapy). A multicentre, nonblinded, randomised clinical trial was conducted. Pain relief was the main performance criteria measured together with secondary criteria which included functional status and mobility of the lower back. Fritz, Childs, and Flynn's clinical prediction rule--a duration of symptoms less than 16 days, no pain distal of the knee--was used to analyse the results. In combination with an age >35 years, results showed a statistical significant effect for disability, but no statistically significant benefit of additional manipulative therapy over physical therapy found for pain and mobility within 4 treatments. Controlled for the applied clinical prediction rule, there were statistically significant interaction effects with low effect size for disability and sex, but no significant effects were found for pain of mobility.
There is limited evidence on which to base clinical decisions regarding the use of non-drug therapies for the treatment of lower limb muscle cramp. Serious methodological limitations in the existing evidence hinder clinical application. There is an urgent need to carefully evaluate many of the commonly recommended and emerging non-drug therapies in well designed randomised controlled trials.