Yoga for Chronic Neck Pain: A Pilot Randomized Controlled Clinical Trial

Yoga has been found effective in the treatment of chronic low back pain. We aimed to evaluate the effectiveness of Iyengar yoga in chronic neck pain by means of a randomized clinical trial. Seventy-seven patients (aged 47.9 ± 7.9, 67 female) with chronic neck pain who scored >40 mm on a 100-mm visual analog scale (VAS) were randomized to a 9-week Iyengar yoga program with weekly 90-minute classes (n = 38) or to a self-care/exercise program (n = 38). Patients were examined at baseline and after 4 and 10 weeks. The primary outcome measure was change of mean pain at rest (VAS) from baseline to week 10. Secondary outcomes included pain at motion, functional disability, quality of life (QOL), and psychological outcomes. Twelve patients in the yoga group and 11 patients in the self-care/exercise group were lost to follow-up, with higher study nonadherence in the self-care group (5 versus 10 patients). Mean pain at rest was reduced from 44.3 ± 20.1 to 13.0 ± 11.6 at week 10 by yoga and from 41.9 ± 21.9 to 34.4 ± 21.1 by self-care/exercise (group difference: −20.1, 95% confidence interval: −30.0, −10.1; P < .001). Pain at motion was reduced from 53.4 ± 18.5 to 22.4 ± 18.7 at week 10 by yoga and from 49.4 ± 22.8 to 39.9 ± 21.5 by self-care/exercise (group difference: −18.7, 95% confidence interval: −29.3, −8.1; P < .001). Significant treatment effects of yoga were also found for pain-related apprehension, disability, QOL, and psychological outcomes. Sensitivity analyses suggested minimal influence of dropout rates. Both programs were well tolerated. In this preliminary trial, yoga appears to be an effective treatment in chronic neck pain with possible additional effects on psychological well-being and QOL. The effectiveness of yoga in chronic neck pain should be further tested by comparative effectiveness studies with longer observation periods.     

Robotic-Assisted Shoulder Rehabilitation Therapy Effectively Improved Poststroke Hemiplegic Shoulder Pain: A Randomized Controlled Trial

ObjectiveThe purpose of this study was to investigate the therapeutic effects of a newly developed shoulder robot on poststroke hemiplegic shoulder pain.DesignProspective, single-blind randomized controlled trial.SettingInpatient department of a tertiary university hospital.ParticipantsHemiplegic shoulder pain patients (N=38) were consecutively recruited and randomly assigned to an intervention or control group.InterventionsA newly developed robot was designed to perform joint mobilization and stretching exercises with patients lying in the supine position. Conventional physical therapy directed at both improving upper extremity mechanics and reducing neurologic injury was performed twice per day in both groups. In the intervention group, additional robotic-assisted shoulder rehabilitation therapy was administered for 30 minutes per day, 5 times per week for 4 weeks.Main Outcome MeasuresThe visual analog scale was the primary outcome, and the pain-free passive range of motion of the shoulder joint, the Korean version of the Shoulder Disability Questionnaire, and ultrasonographic grades were the secondary outcomes. The outcomes were evaluated at baseline (T0), postintervention (T1), and a 4-week follow-up (T2).ResultsSignificant time and group interaction effects were found on the visual analog scale, in the abduction passive range of motion, and on the Shoulder Disability Questionnaire (F_2,33=16.384, P=.002; F_2,33=10.609, P=.012; F_2,33=32.650, P=.008, respectively). Significantly higher improvements in these outcome measures were observed in the intervention group than in the control group at T1 after post hoc analysis (P<0.05, all). These improvements were sustained at T2 when the intervention group was compared with the control group (P<.05, all).ConclusionsA prototype shoulder rehabilitation robot as an adjuvant therapy improves hemiplegic shoulder pain and self-reported shoulder-related disability.     

Hyperbaric Oxygen Therapy for Pain,Opioid Withdrawal,and Related Symptoms: A Pilot Randomized Controlled Trial

BackgroundPain, drug cravings, and opioid withdrawal symptoms can interfere with substance use disorder or opioid tapering treatment goals.AimThis pilot study investigated the feasibility of a protocol designed to test opioid withdrawal symptom relief relative to a sham condition after two consecutive days of hyperbaric oxygen therapy (HBOT) for adults prescribed daily methadone for opioid use disorder.MethodUsing a double-blind protocol, eight adults were randomized to receive either a full 90-minute HBOT dose in a pressurized chamber with 100% oxygen at 2.0 atmospheres absolute (ATA) or a sham condition receiving 21% oxygen (equivalent to room air within the chamber) at a minimal pressure of ≤1.3 ATA. Measures included study retention, treatment satisfaction, and pre- and post-intervention effects for opioid withdrawal symptoms, drug cravings, pain intensity and interference, sleep quality, and mood.ResultsStudy retention and treatment satisfaction was high. All measurements improved more, on average, for participants receiving full-dose HBOT treatment than among participants receiving sham treatments except for clinically observed withdrawal symptoms. The largest positive effects were observed in measurements of pain intensity and drug craving.ConclusionsThese pilot results provide evidence to support a fully powered study of HBOT as a potential treatment adjunct for adults receiving methadone for opioid use disorder. Trends towards symptom improvements were detected from pre- to post-HBOT in the full treatment arm versus sham condition. More research into novel non-pharmacologic options to relieve distressing symptoms related to pain and opioid use disorder is essential to improve clinical outcomes.     

Electroacupuncture for Poststroke Spasticity: Results of a Pilot Pragmatic Randomized Controlled Trial

ContextPeople with spasticity that occurred between 30 days and one year after stroke onset with a baseline Modified Ashworth Scale (MAS) ≥1.ObjectivesTo determine the practicality of a pragmatic parallel-group open-labeled randomized controlled trial and to collect preliminary data of effectiveness and safety of electroacupuncture (EA) for poststroke spasticity.MethodsEligible participants were randomly allocated to the intervention group (EA plus usual care) or the control group (usual care alone) at a 1:1 ratio with block sizes of six. Participants received EA three times a week for four weeks, then were followed up for another four weeks. Participants' retention and adherence in the trial were assessed to determine the practicality of trial design. Clinical outcome measures were the change scores of MAS, Fugl-Meyer Assessment of motor performance and Barthel Index, and adverse events.ResultsSeventy-two people were screened for eligibility, and 30 of them were recruited and randomized. At the end, 25 participants followed the trial protocol and were included in our final data analyses using an intention-to-treat approach. No significant between-group difference was detected for the change scores of MAS, Fugl-Meyer Assessment, or Barthel Index at the end of treatment or end of follow-up. Eighteen participants reported 37 adverse events, but none of the participants was deemed related to EA.ConclusionIt is feasible to conduct a full-scale trial to precisely evaluate the effectiveness and safety of EA for treating poststroke spasticity; however, longer treatment and follow-up phases should be considered in the full-scale trial.     

The Effects of Thoracic Manipulation Versus Mobilization for Chronic Neck Pain: a Randomized Controlled Trial Pilot Study

[Purpose] To investigate effects of thoracic manipulation versus mobilization on chronic neck pain. [Methods] Thirty-nine chronic neck pain subjects were randomly assigned to single level thoracic manipulation, single level thoracic mobilization, or a control group. The cervical range of motion (CROM) and pain ratings (using a visual analog scale: VAS) were measured before, immediately after and at a 24-hour follow-up. [Results] Thoracic manipulation significantly decreased VAS pain ratings and increased CROM in all directions in immediate and 24-hour follow-ups. The thoracic mobilization group significantly increased in CROM in most directions at immediate follow-up and right and left rotational directions at the 24-hour follow-up. Comparisons between groups revealed the CROM for the manipulation group to increase significantly more than for control subjects in most directions at immediate follow-up and flexion, left lateral flexion and left rotation at the 24-hour follow-up. The CROM for the thoracic mobilization group significantly increased in comparison to the control group in flexion at immediate follow-up and in flexion and left rotation at the 24-hour follow-up. [Conclusion] The study demonstrated reductions in VAS pain ratings and increases in CROM at immediate and 24-hour follow-ups from both single level thoracic spine manipulation and thoracic mobilization in chronic neck pain.Key words: Single level thoracic manipulation, Single level thoracic mobilization, Chronic neck pain     

Physiotherapy for Sleep Disturbance in People With Chronic Low Back Pain: Results of a Feasibility Randomized Controlled Trial

Objective

To determine the feasibility of a randomized controlled trial investigating the effectiveness of physiotherapy for sleep disturbance in chronic low back pain (CLBP) (≥12wks).

Design

Randomized controlled trial with evaluations at baseline, 3 months, and 6 months.

Setting

Outpatient physiotherapy department in an academic teaching hospital.

Participants

Participants with CLBP were randomly assigned to a walking program (n=20; mean age ± SD, 46.4±13.8y), supervised exercise class (n=20; mean age ± SD, 41.3±11.9y), or usual physiotherapy (n=20; mean age ± SD, 47.1±14.3y). The 3-month evaluation was completed by 44 participants (73%), and 42 (70%) participants completed the 6-month evaluation.

Interventions

Participants received a physiotherapy-delivered 8-week walking program, an 8-week group supervised exercise class (1 class/wk), or 1-to-1 usual physiotherapy (advice, manual therapy, and exercise).

Main Outcome Measures

Sleep was assessed by the self-reported Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Pittsburgh Sleep Diary, and objective actigraphy.

Results

Groups were comparable at baseline. Most (95%, n=57) of the participants had sleep disturbance. The acceptability of actigraphy was excellent at baseline (58 of 60 participants), but dropped at 3 months (26 of 44 participants). There were improvements on the PSQI and ISI in all groups at 3 and 6 months, with predominantly medium effect sizes (Cohen d=0.2–0.5).

Conclusions

The high prevalence of sleep disturbance indicated the feasibility of good recruitment in future trials. The PSQI would be a suitable screening tool and outcome measure alongside an objective nonobtrusive sleep outcome measure. The effectiveness of physiotherapy for sleep disturbance in CLBP warrants investigation in a fully powered randomized controlled trial.     

Randomized Controlled Trial of Nurse-Delivered Cognitive-Behavioral Therapy Versus Supportive Psychotherapy Telehealth Interventions for Chronic Back Pain

This study evaluated a nurse-delivered, telehealth intervention of cognitive-behavioral therapy (CBT) versus supportive psychotherapy for chronic back pain. Participants (N?=?61) had chronic back pain (pain “daily”?≥6 months at an intensity of ≥4 of 10 scale) and were randomized to an 8-week, 12-session, CBT or to supportive care (SC) matched for frequency, format, and time, with each treatment delivered by a primary care nurse. The primary outcome was the Roland Morris Disability Questionnaire (RMDQ). Secondary outcomes included the numeric rating scale (NRS) and the Patient Global Impressions Scale (CGI). CBT participants (n?=?30) showed significant improvements on the RMDQ (mean = 11.4 [SD = 5.9] vs 9.4 [SD = 6.1] at baseline and post-treatment, respectively, P?<?.05; d?=?.33), NRS (mean = 4.9 [SD = 2.1] vs 4.0 [SD = 1.9], respectively, P?<?.05; d?=?.45), and on the CGI (39.1% reporting “much improved” or “very much improved”). SC participants (n?=?31) also showed significant improvements on the RMDQ (mean = 11.1 [SD = 5.4] vs 9.1 [SD = 5.2], respectively, P?<?.05; d?=?.38), the NRS, (mean = 5.0 [SD = 1.9] vs 3.8 [SD = 2.1], respectively, P?<?.05; d?=?.60), and 26.7% reporting “much improved” or “very much improved” on the CGI. Between groups comparisons of CBT and SC showed no differences on the study outcomes (Ps > .10). The results suggest that telehealth, nurse-delivered CBT, and SC treatments for chronic back pain can offer significant and relatively comparable benefits.

Perioperative Pregabalin and Intraoperative Lidocaine Infusion to Reduce Persistent Neuropathic Pain After Breast Cancer Surgery: A Multicenter,Factorial, Randomized,Controlled Pilot Trial

Persistent postsurgical pain is defined as pain localized to the area of surgery of a duration of ≥2 months and is, unfortunately, a common complication after breast cancer surgery. Although there is insufficient evidence to support any preventative strategy, prior literature suggests the possible efficacy of intravenous lidocaine and perioperative pregabalin in preventing persistent pain after surgery. To determine feasibility of conducting a larger definitive trial, we conducted a multicenter 2 × 2 factorial, randomized, placebo-controlled pilot trial of 100 female patients undergoing breast cancer surgery. Patients were randomized to receive an intraoperative lidocaine infusion (1.5 mg/kg bolus followed by 2 mg/kg/h) or placebo and perioperative pregabalin (300 mg preoperatively, 75 mg twice daily for 9 days) or placebo. All feasibility criteria were surpassed; recruitment of 100 patients was accomplished within 42 weeks, with a follow-up rate of 100% and study drug compliance of ≥80%. At 3 months, 53% of patients reported persistent neuropathic pain. Although there was no interaction between lidocaine and pregabalin, lidocaine decreased the development of persistent neuropathic pain (43.1% vs 63.3%; relative risk = .68; 95% confidence interval = .47–1.0). Pregabalin did not reduce persistent pain (60% vs 46%; relative risk = 1.3; 95% confidence interval = .90–1.90) and neither pregabalin nor lidocaine impacted acute postoperative pain, opioid consumption, pain interference, or quality of life. Our pilot trial successfully demonstrated feasibility and provided promising data for conducting further trials of intraoperative lidocaine infusions during breast cancer surgeries.Clinical trial number: NCT02240199PerspectiveThis article reports the findings of a pilot randomized, controlled trial evaluating the effects of perioperative pregabalin and intraoperative lidocaine infusions in patients undergoing breast cancer surgery. This trial demonstrated the feasibility of conducting a larger trial and provided promising data that these interventions may decrease the development of persistent pain.     

Music Therapy Reduces Pain in Palliative Care Patients: A Randomized Controlled Trial

ContextTreatment of pain in palliative care patients is challenging. Adjunctive methods of pain management are desirable. Music therapy offers a nonpharmacologic and safe alternative.ObjectivesTo determine the efficacy of a single music therapy session to reduce pain in palliative care patients.MethodsTwo hundred inpatients at University Hospitals Case Medical Center were enrolled in the study from 2009 to 2011. Patients were randomly assigned to one of two groups: standard care alone (medical and nursing care that included scheduled analgesics) or standard care with music therapy. A clinical nurse specialist administered pre- and post-tests to assess the level of pain using a numeric rating scale as the primary outcome, and the Face, Legs, Activity, Cry, Consolability Scale and the Functional Pain Scale as secondary outcomes. The intervention incorporated music therapist-guided autogenic relaxation and live music.ResultsA significantly greater decrease in numeric rating scale pain scores was seen in the music therapy group (difference in means [95% CI] ?1.4 [?2.0, ?0.8]; P < 0.0001). Mean changes in Face, Legs, Activity, Cry, Consolability scores did not differ between study groups (mean difference ?0.3, [95% CI] ?0.8, 0.1; P > 0.05). Mean change in Functional Pain Scale scores was significantly greater in the music therapy group (difference in means ?0.5 ([95% CI] ?0.8, 0.3; P < 0.0001).ConclusionA single music therapy intervention incorporating therapist-guided autogenic relaxation and live music was effective in lowering pain in palliative care patients.     

Widespread Pressure Delivered by a Weighted Blanket Reduces Chronic Pain: A Randomized Controlled Trial

Pleasant sensation is an underexplored avenue for modulation of chronic pain. Deeper pressure is perceived as pleasant and calming, and can improve sleep. Although pressure can reduce acute pain, its effect on chronic pain is poorly characterized. The current remote, double-blind, randomized controlled trial tested the hypothesis that wearing a heavy weighted blanket – providing widespread pressure to the body – relative to a light weighted blanket would reduce ratings of chronic pain, mediated by improvements in anxiety and sleep. Ninety-four adults with chronic pain were randomized to wear a 15-lb. (heavy) or 5-lb. (light) weighted blanket during a brief trial and overnight for one week. Measures of anxiety and chronic pain were collected pre- and post-intervention, and ratings of pain intensity, anxiety, and sleep were collected daily. After controlling for expectations and trait anxiety, the heavy weighted blanket produced significantly greater reductions in broad perceptions of chronic pain than the light weighted blanket (Cohen's f = .19, CI [-1.97, -.91]). This effect was stronger in individuals with high trait anxiety (P = .02). However, weighted blankets did not alter pain intensity ratings. Pain reductions were not mediated by anxiety or sleep. Given that the heavy weighted blanket was associated with greater modulation of affective versus sensory aspects of chronic pain, we propose that the observed reductions are due to interoceptive and social/affective effects of deeper pressure. Overall, we demonstrate that widespread pressure from a weighted blanket can reduce the severity of chronic pain, offering an accessible, home-based tool for chronic pain.The study purpose, targeted condition, study design, and primary and secondary outcomes were pre-registered in ClinicalTrials.gov (NCT04447885: “Weighted Blankets and Chronic Pain”).PerspectiveThis randomized-controlled trial showed that a 15-lb weighted blanket produced significantly greater reductions in broad perceptions of chronic pain relative to a 5-lb weighted blanket, particularly in highly anxious individuals. These findings are relevant to patients and providers seeking home-based, nondrug therapies for chronic pain relief.     

Cost-Effectiveness and Cost-Utility of Internet-Delivered Exposure Therapy for Fibromyalgia: Results From a Randomized,Controlled Trial

Fibromyalgia (FM) is a prevalent and debilitating chronic pain disorder associated with a substantial economic burden. Although there are several studies investigating the effectiveness of psychological treatments such as cognitive-behavioral therapy for FM, studies on cost-effectiveness are scarce. The aim of the present study was to investigate the cost-effectiveness of Internet-delivered exposure therapy (iExp) for FM. We used health economic data from a recently conducted randomized, controlled trial, where 140 participants were randomized to either iExp or a waitlist control (WLC) condition. Economic data were collected at pre-treatment, post-treatment, and at the 1-year follow-up. Treatment effectiveness in relation to costs were analyzed using both a societal perspective (including all direct and indirect costs) and a health care unit perspective (including only the direct treatment costs). Bootstrapped net benefit regression analyses were also conducted, comparing the difference in costs and effects between iExp and WLC, within different willingness-to-pay scenarios. Results showed that the incremental cost-effectiveness ratio was –$15,295, indicating that iExp was highly cost-effective as each successfully treated case (treatment responder) was associated with a substantial net reduction in costs. The robustness of the results was tested in 2 different sensitivity analyses, where iExp remained cost-effective, even in a willingness-to-pay-scenario of $0. We conclude that iExp is a cost-effective treatment that generates large societal cost savings.

Cost Analysis Related to Dose-Response of Spinal Manipulative Therapy for Chronic Low Back Pain: Outcomes From a Randomized Controlled Trial

Objective

The purpose of this analysis is to report the incremental costs and benefits of different doses of spinal manipulative therapy (SMT) in patients with chronic low back pain (LBP).

Methods

We randomized 400 patients with chronic LBP to receive a dose of 0, 6, 12, or 18 sessions of SMT. Participants were scheduled for 18 visits for 6 weeks and received SMT or light massage control from a doctor of chiropractic. Societal costs in the year after study enrollment were estimated using patient reports of health care use and lost productivity. The main health outcomes were the number of pain-free days and disability-free days. Multiple regression was performed on outcomes and log-transformed cost data.

Results

Lost productivity accounts for most societal costs of chronic LBP. Cost of treatment and lost productivity ranged from $3398 for 12 SMT sessions to $3815 for 0 SMT sessions with no statistically significant differences between groups. Baseline patient characteristics related to increase in costs were greater age (P = .03), greater disability (P = .01), lower quality-adjusted life year scores (P = .01), and higher costs in the period preceding enrollment (P < .01). Pain-free and disability-free days were greater for all SMT doses compared with control, but only SMT 12 yielded a statistically significant benefit of 22.9 pain-free days (P = .03) and19.8 disability-free days (P = .04). No statistically significant group differences in quality-adjusted life years were noted.

Conclusions

A dose of 12 SMT sessions yielded a modest benefit in pain-free and disability-free days. Care of chronic LBP with SMT did not increase the costs of treatment plus lost productivity.     

A Trial of Scrambler Therapy in the Treatment of Cancer Pain Syndromes and Chronic Chemotherapy-Induced Peripheral Neuropathy

ABSTRACT

Neuropathic pain is common among cancer patients and often difficult to treat. This study used Scrambler therapy, a patient-specific electrocutaneous nerve stimulation device, to treat cancer patients with pain. Patients received Scrambler therapy for 10 sessions (one daily) over a two-week period. The primary outcome was changed in pain numerical rating scale (NRS) at one month; secondary outcomes were changes in the Brief Pain Inventory and European Organization for Treatment and Cancer QLC-CIPN-20(EORTC CIPN-20), over time. Thirty-nine patients, mean age 56.5 yr, 16 men and 23 women, were treated over an 18-month period for an average of 9.3 days each. The “now” pain scores reduced from 6.6 before treatment to 4.5 at 14 days, 4.6, 4.8, and 4.6 at 1, 2, and 3 months, respectively (?p < 0.001). Clinically important and statistically significant improvements were seen in average, least, and worst pain; BPI interference with life scores, and motor and sensory scales on the EORTC CIPN-20. No adverse effects were observed. In this single arm trial, Scrambler therapy appeared to relieve cancer-associated chronic neuropathic pain both acutely and chronically, and provided sustained improvements in many indicators of quality of life.     

Pulsed Electromagnetic Fields to Reduce Diabetic Neuropathic Pain and Stimulate Neuronal Repair: A Randomized Controlled Trial

Weintraub MI, Herrmann DN, Smith AG, Backonja MM, Cole SP. Pulsed electromagnetic fields to reduce diabetic neuropathic pain and stimulate neuronal repair: a randomized controlled trial.

Objective

To determine whether repetitive and cumulative exposure to low-frequency pulsed electromagnetic fields (PEMF) targeting painful feet can reduce neuropathic pain (NP), influence sleep in symptomatic diabetic peripheral neuropathy (DPN), and influence nerve regeneration.

Design

Randomized, double-blind, placebo-controlled parallel study.

Setting

Sixteen academic and clinical sites in 13 states.

Participants

Subjects (N=225) with DPN stage II or III were randomly assigned to use identical devices generating PEMF or sham (placebo) 2 h/d to feet for 3 months.

Interventions

Nerve conduction testing was performed serially.

Main Outcome Measures

Pain reduction scores using a visual analog scale (VAS), the Neuropathy Pain Scale (NPS), and the Patient's Global Impression of Change (PGIC). A subset of subjects underwent serial 3-mm punch skin biopsies from 3 standard lower limb sites for epidermal nerve fiber density (ENFD) quantification.

Results

Subjects (N=225) were randomized with a dropout rate of 13.8%. There was a trend toward reductions in DPN symptoms on the PGIC, favoring the PEMF group (44% vs 31%; P=.04). There were no significant differences between PEMF and sham groups in the NP intensity on NPS or VAS. Twenty-seven subjects completed serial biopsies. Twenty-nine percent of PEMF subjects had an increase in distal leg ENFD of at least 0.5 SDs, while none did in the sham group (P=.04). Increases in distal thigh ENFD were significantly correlated with decreases in pain scores.

Conclusions

PEMF at this dosimetry was noneffective in reducing NP. However neurobiological effects on ENFD, PGIC and reduced itching scores suggest future studies are indicated with higher dosimetry (3000-5000 G), longer duration of exposure, and larger biopsy cohort.