The effect of two weeks of spinal manipulative therapy and home stretching exercises on pain and disability in patients with persistent or recurrent neck pain; a randomized controlled trial

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/)

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The effect of spinal manipulative therapy on heart rate variability and pain in patients with chronic neck pain: a randomized controlled trial

Trials ◽

10.1186/s13063-019-3678-8 ◽

2019 ◽

Vol 20 (1) ◽

Author(s):

Anders Galaasen Bakken ◽

Iben Axén ◽

Andreas Eklund ◽

Søren O’Neill

Keyword(s):

Heart Rate ◽

Heart Rate Variability ◽

Neck Pain ◽

Treatment Response ◽

Spinal Manipulative Therapy ◽

Pain Modulation ◽

Manipulative Therapy ◽

Randomized Controlled ◽

Second Pain ◽

Stretching Exercises

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.

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

10.21203/rs.2.9454/v1 ◽

2019 ◽

Author(s):

Anders Galaasen Bakken ◽

Iben Axén ◽

Andreas Eklund ◽

Sören O'neill

Keyword(s):

Heart Rate ◽

Heart Rate Variability ◽

Neck Pain ◽

Treatment Response ◽

Spinal Manipulative Therapy ◽

Pain Modulation ◽

Manipulative Therapy ◽

Randomized Controlled ◽

Second Pain ◽

Stretching Exercises

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.

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

10.21203/rs.2.9454/v3 ◽

2019 ◽

Author(s):

Anders Galaasen Bakken ◽

Andreas Eklund ◽

Sören O'neill ◽

Iben Axén

Keyword(s):

Heart Rate ◽

Heart Rate Variability ◽

Neck Pain ◽

Treatment Response ◽

Spinal Manipulative Therapy ◽

Pain Modulation ◽

Manipulative Therapy ◽

Randomized Controlled ◽

Second Pain ◽

Stretching Exercises

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.

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

10.21203/rs.2.9454/v2 ◽

2019 ◽

Author(s):

Anders Galaasen Bakken ◽

Andreas Eklund ◽

Sören O'neill ◽

Iben Axén

Keyword(s):

Heart Rate ◽

Heart Rate Variability ◽

Neck Pain ◽

Treatment Response ◽

Spinal Manipulative Therapy ◽

Pain Modulation ◽

Manipulative Therapy ◽

Randomized Controlled ◽

Second Pain ◽

Stretching Exercises

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.

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Asthma in Adolescents: A Randomized, Controlled Trial of an Asthma Program for Adolescents and Young Adults with Severe Asthma

Canadian Respiratory Journal ◽

10.1155/2002/106262 ◽

2002 ◽

Vol 9 (4) ◽

pp. 253-259 ◽

Cited By ~ 21

Author(s):

Robert L Cowie ◽

Margot F Underwood ◽

Cinde B Little ◽

Ian Mitchell ◽

Sheldon Spier ◽

...

Keyword(s):

Quality Of Life ◽

Emergency Department ◽

Randomized Controlled Trial ◽

Asthma Control ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Disease Specific

BACKGROUND: Asthma is common and is often poorly controlled in adolescent subjects.OBJECTIVE: To determine the impact of an age-specific asthma program on asthma control, particularly on exacerbations of asthma requiring emergency department treatment, and on the quality of life of adolescents with asthma.METHODS: The present randomized, controlled trial included patients who were 15 to 20 years of age and had visited emergency departments for management of their asthma. The interventional group attended an age-specific asthma program that included assessment, education and management by a team of asthma educators, respiratory therapists and respiratory physicians. In the control group, spirometry was performed, and the patients continued to receive usual care from their regular physicians. The outcomes were assessed by a questionnaire six months after entry into the study.RESULTS: Ninety-three subjects entered the study and were randomly assigned to the intervention or control group. Of these, only 62 patients were available for review after six months. Subjects in both the control and the intervention groups showed a marked improvement in their level of asthma control, reflected primarily by a 73% reduction in the rate of emergency department attendance for asthma. Other indexes of disease control, including disease-specific quality of life, as assessed by questionnaires, were improved. There was, however, no discernible difference between the subjects in the two groups, with the exception of an improvement in favour of the intervention group in the symptom (actual difference 0.7, P=0.048) and emotional (actual difference 0.8, P=0.028) domains of the asthma quality of life questionnaire. The overall quality of life score favoured the intervention group by a clinically relevant difference of 0.6, but this difference did not reach statistical significance (P=0.06).CONCLUSIONS: Although all subjects demonstrated a significant improvement in asthma control and quality of life, the improvement attributable to this intervention was limited to two domains in disease-specific quality of life.

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Effectiveness of Hydrogalvanic Bath on Improving Pain, Disability, and Quality of Life in Individuals with Chronic Nonspecific Neck Pain: A Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/7974816 ◽

2020 ◽

Vol 2020 ◽

pp. 1-7

Author(s):

Mastour Saeed Alshahrani ◽

Jaya Shanker Tedla ◽

Ravi Shankar Reddy ◽

Faisal Asiri

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Pain Disability ◽

Sf 36 ◽

Neck Disability ◽

Experimental Group

Background. Neck pain is one of the world’s leading factors in years lived with disability. Ambiguity in the effect of electrotherapy modalities for the treatment of chronic nonspecific neck pains (CNSNP) needs to be examined further. This study sought to elucidate the effectiveness of hydrogalvanic bath on improving pain, disability, and quality of life among individuals with CNSNP. Methods. Thirty-four individuals with a diagnosis of CNSNP were selected through convenient sampling and randomly divided into two groups by block randomization. The control group treatment underwent low Transcutaneous Electrical Nerve Stimulation (TENS) and exercise, and the experimental group was subjected to hydrogalvanic bath therapy (HGBT) and exercise. Individuals were evaluated for pain using a visual analog scale (VAS), disability with the Neck Disability Index (NDI), and quality of life with Short Form-36 (SF-36). These measures were applied at baseline and after 12 weeks of treatment. Results. The pretreatment and posttreatment results for VAS, NDI, and SF-36 were compared for both control and experimental groups. We found that all the three variables showed significant differences between the two time points with p < 0.05 in both the groups but the experimental group improvements were more significant than the control group with p < 0.05 . Conclusion. Twelve weeks of low TENS or HGBT along with exercises can decrease pain and neck disability and increase the quality of life in individuals with CNSNP. However, HGBT along with exercise has superior effects relative to low TENS along with exercise. This randomized controlled trial was registered in the International Standard Randomized Controlled Trials Number-ISRCTN29695190 and registered on 05/02/2020. This study is a retrospective registration.

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Effect of a Smartphone-Based App on the Quality of Life of Patients With Heart Failure: Randomized Controlled Trial

JMIR Nursing ◽

10.2196/20747 ◽

2020 ◽

Vol 3 (1) ◽

pp. e20747

Author(s):

Mahboube Davoudi ◽

Tahereh Najafi Ghezeljeh ◽

Farveh Vakilian Aghouee

Keyword(s):

Quality Of Life ◽

Heart Failure ◽

Clinical Symptoms ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled ◽

Patients With Heart Failure

Background Patients with heart failure have low quality of life because of physical impairments and advanced clinical symptoms. One of the main goals of caring for patients with heart failure is to improve their quality of life. Objective The aim of this study was to investigate the effect of the use of a smartphone-based app on the quality of life of patients with heart failure. Methods This randomized controlled clinical trial with a control group was conducted from June to October 2018 in an urban hospital. In this study, 120 patients with heart failure hospitalized in cardiac care units were randomly allocated to control and intervention groups. Besides routine care, patients in the intervention group received a smartphone-based app and used it every day for 3 months. Both the groups completed the Minnesota Living with Heart Failure Questionnaire before entering the study and at 3 months after entering the study. Data were analyzed using the SPSS software V.16. Results The groups showed statistically significant differences in the mean scores of quality of life and its dimensions after the intervention, thereby indicating a better quality of life in the intervention group (P<.001). The effect size of the intervention on the quality of life was 1.85 (95% CI 1.41-2.3). Moreover, the groups showed statistically significant differences in the changes in the quality of life scores and its dimensions (P<.001). Conclusions Use of a smartphone-based app can improve the quality of life in patients with heart failure. The results of our study recommend that digital apps be used for improving the management of patients with heart failure. Trial Registration Iranian Registry of Clinical Trials IRCT2017061934647N1; https://www.irct.ir/trial/26434

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Health Education Through a Campaign and mHealth to Enhance Knowledge and Quality of Life Among Patients With Chronic Kidney Disease in Bangladesh: Protocol for a Randomized Controlled Trial (Preprint)

10.2196/preprints.30191 ◽

2021 ◽

Author(s):

Mohammad Habibur Rahman Sarker ◽

Michiko Moriyama ◽

Harun Ur Rashid ◽

Md Moshiur Rahman ◽

Mohammod Jobayer Chisti ◽

...

Keyword(s):

Quality Of Life ◽

Chronic Kidney Disease ◽

Randomized Controlled Trial ◽

Kidney Disease ◽

Health Education ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled

BACKGROUND Despite the growing burden of chronic kidney disease (CKD), disease knowledge and understanding are still lacking, especially in Bangladesh. OBJECTIVE The aim of this study was to evaluate the outcome of a health education intervention in order to enhance knowledge, health-related quality of life (QOL), and motivation regarding healthy lifestyles among rural and periurban adults suffering from CKD. METHODS A parallel-group (1:1) randomized controlled trial is ongoing in the Mirzapur subdistrict, Bangladesh, where two groups of patients with CKD are being compared. Patients aged 18 years and over with CKD (stages 1-3) were enrolled in November 2020. Patients were randomly allocated into either the intervention group (n=63) or the control group (n=63). The control group received usual treatment, while the intervention group received health education through a CKD campaign facilitated by a nephrologist and via mHealth (ie, periodic mobile phone calls) from community health workers. Both groups were followed up for a period of 6 months. The primary endpoint is patients’ increased knowledge measured using the Chronic Kidney Disease Knowledge Questionnaire. The secondary endpoints are improved QOL measured using the standardized EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire as well as improvements in the levels of blood pressure, BMI, serum creatinine, fasting blood sugar, hemoglobin, cholesterol, high-density lipoprotein cholesterol, triglyceride, serum uric acid, blood urea nitrogen, and albumin to creatinine ratio. RESULTS Enrollment of participants began in November 2020; the intervention and follow-up were completed in May 2021. We enrolled 126 patients in the study. Patients’ mean ages were 57.97 (SD 15.03) years in the control group and 57.32 (SD 14.37) years in the intervention group. There were 45 out of 63 (71%) females in the control group and 38 out of 63 (60%) females in the intervention group. In addition, there were 38 out of 63 (60%) literate patients in the control group and 33 out of 63 (52%) literate patients in the intervention group. CONCLUSIONS It is expected that a combined approach, incorporating both a CKD campaign and mHealth, for health education may be an effective tool for increasing knowledge and improving QOL among patients with CKD. CLINICALTRIAL ClinicalTrials.gov NCT04094831; https://clinicaltrials.gov/ct2/show/NCT04094831 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/30191

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Efficacy and cost-utility of the eHealth application ‘Oncokompas’, supporting patients with incurable cancer in finding optimal palliative care, tailored to their quality of life and personal preferences: a study protocol of a randomized controlled trial

BMC Palliative Care ◽

10.1186/s12904-019-0468-8 ◽

2019 ◽

Vol 18 (1) ◽

Cited By ~ 4

Author(s):

Anouk S. Schuit ◽

Karen Holtmaat ◽

Nienke Hooghiemstra ◽

Femke Jansen ◽

Birgit I. Lissenberg-Witte ◽

...

Keyword(s):

Quality Of Life ◽

Palliative Care ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Cost Utility ◽

Control Group ◽

Incurable Cancer ◽

Randomized Controlled

Abstract Background Patients with incurable cancer have to deal with a wide range of symptoms due to their disease and treatment, influencing their quality of life. Nowadays, patients are expected to adopt an active role in managing their own health and healthcare. Oncokompas is an eHealth self-management application developed to support patients in finding optimal palliative care, tailored to their quality of life and personal preferences. A randomized controlled trial will be carried out to determine the efficacy and cost-utility of Oncokompas compared to care as usual. Methods 136 adult patients with incurable lung, breast, colorectal and head and neck cancer, lymphoma and glioma, will be included. Eligible patients have no curative treatment options and a prognosis of at least three months. Patients will be randomly assigned to the intervention group or the control group. The intervention group directly has access to Oncokompas alongside care as usual, while the waiting list control group receives care as usual and will have access to Oncokompas after three months. The primary outcome measure is patient activation, which can be described as a patient’s knowledge, skills and confidence to manage his or her own health and healthcare. Secondary outcome measures comprise self-efficacy, health-related quality of life, and costs. Measures will be assessed at baseline, two weeks after randomization, and three months after the baseline measurement. Discussion This study will result in knowledge on the efficacy and cost-utility of Oncokompas among patients with incurable cancer. Also, more knowledge will be generated into the need for and costs of palliative care from a societal and healthcare perspective. Trial registration Netherlands Trial Register identifier: NTR 7494. Registered on 24 September 2018.

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