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Efficacy and safety of guaifenesin for upper back, neck, and shoulder pain: a Phase II proof-of-concept, multicenter, placebo-controlled, repeat-dose, parallel-group study.

ABSTRACT: BACKGROUND/OBJECTIVE:Guaifenesin, an over-the-counter (OTC) expectorant, has exhibited muscle relaxant effects preclinically and clinically. This proof-of-principle study explored whether OTC doses of guaifenesin can provide relief from acute upper back, neck, or shoulder muscle spasm and pain. METHODS:This multicenter, placebo-controlled, repeat-dose, parallel study randomly assigned adults experiencing acute pain and muscle spasm in their upper back, neck, or shoulder to guaifenesin 600 or 1200 mg or matched placebo twice daily (BID) in a 2:2:1:1 ratio for 7 days. The primary end point was the change from baseline in muscle spasm relief, measured using an 11-point numeric rating scale (0=not present to 10=unbearable) recorded twice daily and averaged over the 7-day treatment period. Analyses were performed using a linear mixed model that included treatment as a fixed effect and site as a random effect. RESULTS:A total of 77 subjects were included in the 4 treatment groups. Least squares mean muscle spasm score over 7 days was 1.77 with guaifenesin 1200 mg, 1.42 with its matched placebo, 1.53 with guaifenesin 600 mg, and 1.74 with its matched placebo. Treatment with guaifenesin 1200 mg BID provided 25% greater reduction in mean muscle spasm over its matched placebo and 16% greater reduction than guaifenesin 600 mg BID. These differences were not statistically significant. Based on comparisons of absolute mean values, a consistent directional change in effect was observed, suggesting some benefit from placebo to lower-to-upper doses of guaifenesin with regard to muscle spasm, tension, pain, discomfort, and relaxation. No severe or serious adverse events were reported. CONCLUSION:Results suggest the potential for OTC dose of guaifenesin 1200 mg BID to provide symptomatic relief of upper back musculoskeletal pain and spasm. Confirmation of this preliminary result in a larger, adequately powered study is needed.

SUBMITTER: Collaku A

PROVIDER: S-EPMC5367561 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Efficacy and safety of guaifenesin for upper back, neck, and shoulder pain: a Phase II proof-of-concept, multicenter, placebo-controlled, repeat-dose, parallel-group study.

Collaku Agron A Yue Yong Y Reed Kenneth K

Journal of pain research 20170321

<h4>Background/objective</h4>Guaifenesin, an over-the-counter (OTC) expectorant, has exhibited muscle relaxant effects preclinically and clinically. This proof-of-principle study explored whether OTC doses of guaifenesin can provide relief from acute upper back, neck, or shoulder muscle spasm and pain.<h4>Methods</h4>This multicenter, placebo-controlled, repeat-dose, parallel study randomly assigned adults experiencing acute pain and muscle spasm in their upper back, neck, or shoulder to guaifen ...[more]

PMID: 28356767

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Project description:BackgroundFunctional shoulder instability (polar type III) is caused by underactivity of rotator cuff and periscapular muscles, which leads to subluxation or dislocation during shoulder movement. While surgical treatment has shown no benefits, aggravates pain, and frequently diminishes function even further, conservative treatment is often ineffective as well.ObjectivesThe aim was to investigate the effectiveness of a "shoulder pacemaker" device that stimulates underactive muscles in patients with functional instability during shoulder movement in order to re-establish glenohumeral stability.Patients and methodsThree patients with unsuccessfully treated functional shoulder instability causing pain, emotional stress, as well as limitations during daily activities and sports participation were enrolled in this pilot project. The device was used to stimulate the external rotators of the shoulder and retractors of the scapula. Pain level, subjective shoulder instability, range of motion, visible aberrant muscle activation, and signs of dislocation were compared when the device was switched on and off.ResultsNo changes were observed when the device was attached but switched off. When the device was switched on, all patients were able to move their arms freely without pain, discomfort, or subjective or objective signs of instability. All patients rated this as an excellent experience and volunteered to train further with the device. No complications were observed.ConclusionThe electric stimulation of hypoactive rotator cuff and periscapular muscles by means of the shoulder pacemaker successfully re-establishes stability in patients with functional shoulder instability during the time of application. video onlineThe online version of this article (doi: 10.1007/s11678-017-0399-z) contains the video: "The Shoulder-Pacemaker: treatment of functional shoulder instability with pathological muscle activation pattern". Video by courtesy of P. Moroder, M. Minkus, E. Böhm, V. Danzinger, C. Gerhardt and M. Scheibel, Charité Universitätsmedizin Berlin 2017, all rights reserved.

Project description:BackgroundPreventing transition to chronic back pain (CBP) is a long-sought strategy that could rescue patients from prolonged suffering. Recent rodent and human brain imaging studies suggest involvement of sexually dimorphic, dopaminergic-motivational, mesolimbic circuits in the transition to chronic pain (tCBP), and hint that the combination of carbidopa/levodopa and naproxen (LDP + NPX) may block tCBP. Here we evaluated, in people with recent-onset back pain, whether a 3-month treatment with LDP + NPX is safe, blocks tCBP, and whether its efficacy is sex-dependent.MethodsA total of 72 participants were enrolled and stratified by risk for tCBP using brain-imaging biomarkers. Low-risk participants entered a no-treatment arm. Others were randomized to placebo + naproxen or LDP + NPX for 3 months.ResultsBoth treatments resulted in more than 50% pain relief for approximately 75% of participants. A strong sex by treatment interaction was observed for daily pain intensity (phone NRS, P = 0.007), replicated on 4-week average pain (Pain/4w, P = 0.00001), and in intent-to-treat analysis (Pain/4w, P = 0.000004). Nucleus accumbens functional connectivity with medial prefrontal cortex, a predefined objective biomarker, showed sex dependence at baseline (P = 0.03) and sex-by-treatment interaction effect 3 months after treatment cessation (P = 0.031). Treatment modified the psychological profile of participants, and disrupted brain modeling-based predicted back pain intensity trajectories. Forty participants were queried 3.3 years from trial start; back pain ratings were similar between end of treatment and at 3.3 years (P = 0.62), indicating persistence of relief for this duration.ConclusionsThese results provide the first evidence for preventing transition to chronic back pain using sex-specific pharmacotherapy. These provocative observations require confirmation in a larger study. ClinicalTrials.gov identifier: NCT01951105.

Project description:PurposeLow-intensity continuous ultrasound (LICUS) is an emerging high-dosimetry ultrasound-based therapy for accelerated tissue healing and the treatment of myofascial pain. In this study, LICUS treatment is clinically evaluated for chronic upper neck and shoulder pain in a randomized, multi-site, double-blind, placebo-controlled study.Patients and methodsCONSORT guidelines were followed in conducting and reporting the clinical trial. Thirty-three participants with upper trapezius myofascial pain were randomized for treatment with active (n=25) or placebo (n=8) devices. Investigators and subjects were blinded to treatment groups. Participants self-reported pain daily, rating from 0-10 on the numeric rating scale. If pain rating was more significant than or equal to 3, the LICUS (3MHz, 0.132W/cm2, 1.3W, 4 hours) was self-applied for total energy dosimetry of 18,720 Joules per treatment. During the 4-week study, daily pain rating was recorded. If LICUS treatment was delivered, pain before, during, and after treatment were recorded as well as the global rate of change (GROC). Independent t-tests were used to assess change from baseline and differences between treatment groups. ClinicalTrials.gov: NCT02135094.ResultsThere was a 100% completion rate for participants enrolled in the study and no significant differences between the groups regarding demographic variables or baseline outcome measures. Participants treated with active therapy observed a significant mean pain reduction from baseline of 2.61 points for active (p<0.001), compared to 1.58 points decrease from baseline for placebo (p=0.087), resulting in a 1.03 points significant decrease in the active group over placebo (p=0.003). The total GROC was significantly higher in the active group at 2.84 points compared to the placebo group at 0.46 points (p<0.001).ConclusionLow-intensity continuous ultrasound treatment significantly reduced pain in patients with upper trapezius myofascial pain of the neck and shoulder. LICUS treatment showed a clinically meaningful improvement in the GROC scores for patients. The results from this clinical trial indicate that the LICUS treatment of 18,720 Joules can effectively be used to treat clinical pain related to upper trapezius myofascial pain. Further research could investigate varying dosimetry to improve efficacy and/or reduce the dose.

Project description:BackgroundClinical tests for detecting central and peripheral shoulder fatigue are limited. The discrimination of these two types of fatigue is necessary to better adapt recovery intervention. The Kinematic Theory of Rapid Human Movements describes the neuromotor impulse response using lognormal functions and has many applications in pathology detection. The ideal motor control is modeled and a change in the neuromuscular system is reflected in parameters extracted according to this theory.ObjectiveThe objective of this study was to assess whether a shoulder neuromuscular fatigue could be detected through parameters describing the theory, if there is the possibility to discriminate central from peripheral fatigue, and which handwriting test gives the most relevant information on fatigue.MethodsTwenty healthy participants performed two sessions of fast stroke handwriting on a tablet, before and after a shoulder fatigue. The fatigue was in internal rotation for one session and in external rotation during the other session. The drawings consisted of simple strokes, triangles, horizontal, and vertical oscillations. Parameters of these strokes were extracted according to the Sigma-Lognormal model of the Kinematic Theory. The evolution of each participant was analyzed through a U-Mann-Whitney test for individual comparisons. A Hotelling's T 2-test and a U-Mann-Whitney test were also performed on all participants to assess the group evolution after fatigue. Moreover, a correlation among parameters was calculated through Spearman coefficients to assess intrinsic parameters properties of each handwriting test.ResultsCentral and peripheral parameters were statistically different before and after fatigue with a possibility to discriminate them. Participants had various responses to fatigue. However, when considering the group, parameters related to the motor program execution showed significant increase in the handwriting tests after shoulder fatigue. The test of simple strokes permits to know more specifically where the fatigue comes from, whereas the oscillations tests were the most sensitive to fatigue.ConclusionThe results of this study suggest that the Sigma-Lognormal model of the Kinematic Theory is an innovative approach for fatigue detection with discrimination between the central and peripheral systems. Overall, there is a possibility to implement the setting for clinics and sports personalized follow-up.

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Dataset Information

Efficacy and safety of guaifenesin for upper back, neck, and shoulder pain: a Phase II proof-of-concept, multicenter, placebo-controlled, repeat-dose, parallel-group study.

Publications

Efficacy and safety of guaifenesin for upper back, neck, and shoulder pain: a Phase II proof-of-concept, multicenter, placebo-controlled, repeat-dose, parallel-group study.

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