scholarly journals The effect of Spinal Manipulative Therapy on Heart Rate Variability and pain in patients with chronic neck pain: A Randomized Controlled trial

2019 ◽  
Author(s):  
Anders Galaasen Bakken ◽  
Iben Axén ◽  
Andreas Eklund ◽  
Sören O'neill

Abstract Background Recent experimental research has suggested that Spinal Manipulative Therapy (SMT) may reduce pain through modulation of the ascending pain signals and/or the central pain regulating mechanisms. People with persistent neck pain (NP) have also been found to have disturbances in Autonomic Nervous System (ANS) regulation. A common way to study ANS is to measure heart rate variability (HRV). It is not known if deviations in HRV are related to changes in pain perception or to the treatment response to SMT. Commonly, an individual in pain will experience pain reduction when exposed to a second pain stimulus, a mechanism known as Conditioning Pain Modulation (CPM). Patients with persistent pain have been found to have a reduced CPM reaction. It is not known if this is predictive of treatment response to SMT. The aim of the study is to examine the effects of SMT on HRV and pain and to test if a CPM test can be used to predict treatment response, in a population of patients with recurrent and persistent NP. Method/Design A multicentre randomized controlled clinical trial will be carried out in multidisciplinary primary care clinics. This setting is chosen to minimize bias resulting from patient preference to treatment modality and provider. The subjects are either self-referred or referred from other health care practitioners locally. The treatment modalities are two well-known interventions for NP; SMT and stretching exercises compared to stretching exercises alone. The subjective pain experience will be investigated by assessing pain intensity and the affective quality of pain. HRV will be measured using a portable heart monitor and CPM will be measured with a standardized cold-pressor-test. Measurements will be performed at baseline, prior to the third treatment and after the fourth treatment. Discussion The study will utilize normal clinical procedures, which should aid transferability and external validity of the results. The study will provide knowledge regarding the underlying mechanisms of the effects of SMT. Furthermore, the study will examine if a CPM test is predictive of treatment outcome in a population of patients with recurrent and persistent NP.

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Anders Galaasen Bakken ◽  
Iben Axén ◽  
Andreas Eklund ◽  
Søren O’Neill

Abstract Background Recent experimental research has suggested that spinal manipulative therapy (SMT) may reduce pain through modulation of the ascending pain signals and/or the central pain-regulating mechanisms. People with persistent neck pain (NP) have also been found to have disturbances in autonomic nervous system (ANS) regulation. A common way to study the ANS is to measure heart rate variability (HRV). It is not known whether deviations in HRV are related to changes in pain perception or to the treatment response to SMT. Commonly, an individual in pain will experience pain reduction when exposed to a second pain stimulus, a mechanism known as conditioned pain modulation (CPM). Patients with persistent pain have been found to have a reduced CPM reaction. It is not known whether this is predictive of treatment response to SMT. The aim of the study is to examine the effects of SMT on HRV and pain. Further, a secondary aim is to test whether a CPM test can be used to predict treatment response in a population of patients with recurrent and persistent NP. Method/design A multicentre randomized controlled clinical trial will be carried out in multidisciplinary primary care clinics. This setting is chosen to minimize bias resulting from patient preference for the treatment modality and provider. The subjects are either self-referred or referred from other health care practitioners locally. The treatment modalities are two well-known interventions for NP; SMT and stretching exercises compared to stretching exercises alone. HRV will be measured using a portable heart monitor. The subjective pain experience will be investigated by assessing pain intensity and the affective quality of pain. CPM will be measured with a standardized cold pressor test. Measurements will be performed three times during a 2-week treatment series. Discussion The study will utilize normal clinical procedures, which should aid the transferability and external validity of the results. The study will provide knowledge regarding the underlying mechanisms of the effects of SMT. Furthermore, the study will examine whether a CPM test is predictive of treatment outcome in a population of patients with recurrent and persistent NP. Trial registration ClinicalTrials.gov, NCT03576846. Registered on 3 July 2018.


2019 ◽  
Author(s):  
Anders Galaasen Bakken ◽  
Andreas Eklund ◽  
Sören O'neill ◽  
Iben Axén

Abstract Background Recent experimental research has suggested that Spinal Manipulative Therapy (SMT) may reduce pain through modulation of the ascending pain signals and/or the central pain regulating mechanisms. People with persistent neck pain (NP) have also been found to have disturbances in Autonomic Nervous System (ANS) regulation. A common way to study ANS is to measure heart rate variability (HRV). It is not known if deviations in HRV are related to changes in pain perception or to the treatment response to SMT. Commonly, an individual in pain will experience pain reduction when exposed to a second pain stimulus, a mechanism known as Conditioning Pain Modulation (CPM). Patients with persistent pain have been found to have a reduced CPM reaction. It is not known if this is predictive of treatment response to SMT. The aim of the study is to examine the effects of SMT on HRV and pain and to test if a CPM test can be used to predict treatment response, in a population of patients with recurrent and persistent NP. Method/Design A multicentre randomized controlled clinical trial will be carried out in multidisciplinary primary care clinics. This setting is chosen to minimize bias resulting from patient preference to treatment modality and provider. The subjects are either self-referred or referred from other health care practitioners locally. The treatment modalities are two well-known interventions for NP; SMT and stretching exercises compared to stretching exercises alone. The subjective pain experience will be investigated by assessing pain intensity and the affective quality of pain. HRV will be measured using a portable heart monitor and CPM will be measured with a standardized cold-pressor-test. Measurements will be performed at baseline, prior to the third treatment and after the fourth treatment. Discussion The study will utilize normal clinical procedures, which should aid transferability and external validity of the results. The study will provide knowledge regarding the underlying mechanisms of the effects of SMT. Furthermore, the study will examine if a CPM test is predictive of treatment outcome in a population of patients with recurrent and persistent NP.


2019 ◽  
Author(s):  
Anders Galaasen Bakken ◽  
Andreas Eklund ◽  
Sören O'neill ◽  
Iben Axén

Abstract Background Recent experimental research has suggested that Spinal Manipulative Therapy (SMT) may reduce pain through modulation of the ascending pain signals and/or the central pain regulating mechanisms. People with persistent neck pain (NP) have also been found to have disturbances in Autonomic Nervous System (ANS) regulation. A common way to study ANS is to measure heart rate variability (HRV). It is not known if deviations in HRV are related to changes in pain perception or to the treatment response to SMT. Commonly, an individual in pain will experience pain reduction when exposed to a second pain stimulus, a mechanism known as Conditioning Pain Modulation (CPM). Patients with persistent pain have been found to have a reduced CPM reaction. It is not known if this is predictive of treatment response to SMT. The aim of the study is to examine the effects of SMT on HRV and pain and to test if a CPM test can be used to predict treatment response, in a population of patients with recurrent and persistent NP. Method/Design A multicentre randomized controlled clinical trial will be carried out in multidisciplinary primary care clinics. This setting is chosen to minimize bias resulting from patient preference to treatment modality and provider. The subjects are either self-referred or referred from other health care practitioners locally. The treatment modalities are two well-known interventions for NP; SMT and stretching exercises compared to stretching exercises alone. The subjective pain experience will be investigated by assessing pain intensity and the affective quality of pain. HRV will be measured using a portable heart monitor and CPM will be measured with a standardized cold-pressor-test. Measurements will be performed at baseline, prior to the third treatment and after the fourth treatment. Discussion The study will utilize normal clinical procedures, which should aid transferability and external validity of the results. The study will provide knowledge regarding the underlying mechanisms of the effects of SMT. Furthermore, the study will examine if a CPM test is predictive of treatment outcome in a population of patients with recurrent and persistent NP.


2021 ◽  
Vol 29 (1) ◽  
Author(s):  
Anders Galaasen Bakken ◽  
Andreas Eklund ◽  
David M. Hallman ◽  
Iben Axén

Abstract Background Persistent or recurrent neck pain is, together with other chronic conditions, suggested to be associated with disturbances of the Autonomic Nervous System. Acute effects on the Autonomic Nervous System, commonly measured using Heart Rate Variability, have been observed with manual therapy. This study aimed to investigate the effect on Heart Rate Variability in (1) a combination of home stretching exercises and spinal manipulative therapy versus (2) home stretching exercises alone over 2 weeks in participants with persistent or recurrent neck pain. Methods A randomized controlled clinical trial was carried out in five multidisciplinary primary care clinics in Stockholm from January 2019 to April 2020. The study sample consisted of 131 participants with a history of persistent or recurrent neck. All participants performed home stretching exercises daily for 2 weeks and were scheduled for four treatments during this period, with the intervention group receiving spinal manipulative therapy in addition to the home exercises. Heart Rate Variability at rest was measured at baseline, after 1 week, and after 2 weeks, with RMSSD (Root mean square of successive RR interval differences) as the primary outcome. Both groups were blinded to the other group intervention. Thus, they were aware of the purpose of the trial but not the details of the “other” intervention. The researchers collecting data were blinded to treatment allocation, as was the statistician performing data analyses. The clinicians provided treatment for participants in both groups and could not be blinded. A linear mixed-effects model with continuous variables and person-specific random intercept was used to investigate the group-time interaction using an intention to treat analysis. Results Sixty-six participants were randomized to the intervention group and sixty-five to the control group. For RMSSD, a B coefficient of 0.4 (p value: 0.9) was found, indicating a non-significant difference in the regression slope for each time point with the control group as reference. No statistically significant differences were found between groups for any of the Heart Rate Variability indices. Conclusion Adding four treatments of spinal manipulation therapy to a 2-week program of daily stretching exercises gave no significant change in Heart Rate Variability. Trial Registration: The trial was registered 03/07/2018 at ClinicalTrials.gov, registration number: NCT03576846. (https://pubmed.ncbi.nlm.nih.gov/31606042/)


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anders Galaasen Bakken ◽  
Andreas Eklund ◽  
Anna Warnqvist ◽  
Søren O’Neill ◽  
Iben Axén

Abstract Background Recurrent or persistent neck pain affects a vast number of people globally, leading to reduced quality of life and high societal costs. Clinically, it is a difficult condition to manage, and treatment effect sizes are often moderate at best. Activity and manual therapy are first-line treatment options in current guidelines. We aimed to investigate the combination of home stretching exercises and spinal manipulative therapy in a multicentre randomized controlled clinical trial, carried out in multidiscipline ary primary care clinics. Methods The treatment modalities utilized were spinal manipulative therapy and home stretching exercises compared to home stretching exercises alone. Both groups received 4 treatments for 2 weeks. The primary outcome was pain, where the subjective pain experience was investigated by assessing pain intensity (NRS − 11) and the quality of pain (McGill Pain Questionnaire). Neck disability and health status were secondary outcomes, measured using the Neck Disability Indexthe EQ-5D, respectively. One hundred thirty-one adult subjects were randomized to one of the two treatment groups. All subjects had experienced persistent or recurrent neck pain the previous 6 months and were blinded to the other group intervention. The clinicians provided treatment for subjects in both group and could not be blinded. The researchers collecting data were blinded to treatment allocation, as was the statistician performing data analyses. An intention-to-treat analysis was used. Results Sixty-six subjects were randomized to the intervention group, and sixty-five to the control group. For NRS − 11, a B-coefficient of − 0,01 was seen, indication a 0,01 improvement for the intervention group in relation to the control group at each time point with a p-value of 0,305. There were no statistically significant differences between groups for any of the outcome measures. Conclusion Based on the current findings, there is no additional treatment effect from adding spinal manipulative therapy to neck stretching exercises over 2 weeks for patients with persistent or recurrent neck pain. Trial registration The trial was registered 03/07/2018 at ClinicalTrials.gov, registration number: NCT03576846.


2021 ◽  
Vol 29 (1) ◽  
Author(s):  
Pierre Côté ◽  
Jan Hartvigsen ◽  
Iben Axén ◽  
Charlotte Leboeuf-Yde ◽  
Melissa Corso ◽  
...  

Abstract Background A small proportion of chiropractors, osteopaths, and other manual medicine providers use spinal manipulative therapy (SMT) to manage non-musculoskeletal disorders. However, the efficacy and effectiveness of these interventions to prevent or treat non-musculoskeletal disorders remain controversial. Objectives We convened a Global Summit of international scientists to conduct a systematic review of the literature to determine the efficacy and effectiveness of SMT for the primary, secondary and tertiary prevention of non-musculoskeletal disorders. Global summit The Global Summit took place on September 14–15, 2019 in Toronto, Canada. It was attended by 50 researchers from 8 countries and 28 observers from 18 chiropractic organizations. At the summit, participants critically appraised the literature and synthesized the evidence. Systematic review of the literature We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, the Cumulative Index to Nursing and Allied Health, and the Index to Chiropractic Literature from inception to May 15, 2019 using subject headings specific to each database and free text words relevant to manipulation/manual therapy, effectiveness, prevention, treatment, and non-musculoskeletal disorders. Eligible for review were randomized controlled trials published in English. The methodological quality of eligible studies was assessed independently by reviewers using the Scottish Intercollegiate Guidelines Network (SIGN) criteria for randomized controlled trials. We synthesized the evidence from articles with high or acceptable methodological quality according to the Synthesis without Meta-Analysis (SWiM) Guideline. The final risk of bias and evidence tables were reviewed by researchers who attended the Global Summit and 75% (38/50) had to approve the content to reach consensus. Results We retrieved 4997 citations, removed 1123 duplicates and screened 3874 citations. Of those, the eligibility of 32 articles was evaluated at the Global Summit and 16 articles were included in our systematic review. Our synthesis included six randomized controlled trials with acceptable or high methodological quality (reported in seven articles). These trials investigated the efficacy or effectiveness of SMT for the management of infantile colic, childhood asthma, hypertension, primary dysmenorrhea, and migraine. None of the trials evaluated the effectiveness of SMT in preventing the occurrence of non-musculoskeletal disorders. Consensus was reached on the content of all risk of bias and evidence tables. All randomized controlled trials with high or acceptable quality found that SMT was not superior to sham interventions for the treatment of these non-musculoskeletal disorders. Six of 50 participants (12%) in the Global Summit did not approve the final report. Conclusion Our systematic review included six randomized clinical trials (534 participants) of acceptable or high quality investigating the efficacy or effectiveness of SMT for the treatment of non-musculoskeletal disorders. We found no evidence of an effect of SMT for the management of non-musculoskeletal disorders including infantile colic, childhood asthma, hypertension, primary dysmenorrhea, and migraine. This finding challenges the validity of the theory that treating spinal dysfunctions with SMT has a physiological effect on organs and their function. Governments, payers, regulators, educators, and clinicians should consider this evidence when developing policies about the use and reimbursement of SMT for non-musculoskeletal disorders.


2021 ◽  
Vol 29 (1) ◽  
Author(s):  
Julita A. Teodorczyk-Injeyan ◽  
John J. Triano ◽  
Robert Gringmuth ◽  
Christopher DeGraauw ◽  
Adrian Chow ◽  
...  

Abstract Background The inflammatory profiles of patients with acute and chronic nonspecific low back pain (LBP) patients are distinct. Spinal manipulative therapy (SMT) has been shown to modulate the production of nociceptive chemokines differently in these patient cohorts. The present study further investigates the effect(s) of SMT on other inflammatory mediators in the same LBP patient cohorts. Methods Acute (n = 22) and chronic (n = 25) LBP patients with minimum pain scores of 3 on a 10-point numeric scale, and asymptomatic controls (n = 24) were recruited according to stringent exclusion criteria. Blood samples were obtained at baseline and after 2 weeks during which patients received 6 SMTs in the lumbar or lumbosacral region. The in vitro production of tumor necrosis factor (TNFα), interleukin-1 β (IL-1β), IL-6, IL-2, interferon ɣ (IFNɣ), IL-1 receptor antagonist (IL-1RA), TNF soluble receptor type 2 (sTNFR2) and IL-10 was determined by specific immunoassays. Parametric as well as non-parametric statistics (PAST 3.18 beta software) was used to determine significance of differences between and within study groups prior and post-SMT. Effect size (ES) estimates were obtained using Cohen’s d. Results Compared with asymptomatic controls, SMT-related change scores were significant (P = 0.03–0.01) in reducing the production levels of TNFα in both patient cohorts and those of IL-6, IFNɣ and sTNFR2 (P = 0.001–0.02) in patients with chronic LBP. Above-moderate to large ES (d > 0.6–1.4) was observed for these mediators. Compared with respective baselines, a significant post-SMT reduction (P = 0.01) of IL-6 production was detected only in patients with chronic LBP while a significant increase of IL-2 production (P = 0.001 vs. control, and P = 0.004 vs. chronic LBP group) and a large ES (d = 0.87) were observed in patients with acute LBP. Pain and disability scores declined significantly (P < 0.001) in all LBP patients, and were positively correlated (P = 0.03) with IFNɣ and IL-2 levels in the acute LBP cohort. Conclusion The short course of SMT treatments of non-specific LBP patients resulted in significant albeit limited and diverse alterations in the production of several of the mediators investigated in this study. This exploratory study highlights the potential of SMT to modulate the production of inflammatory components in acute and chronic non-specific LBP patients and suggests a need for further, randomized controlled clinical trials in this area. Trial registration This study was prospectively registered April 2012 with Clinical Trials.gov (#NCT01766141). https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0003ZIL&selectaction=Edit&uid=U0001V74&ts=2&cx=-axvqtg


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