Applying an osteopathic intervention to improve mild to moderate mental health symptoms: a mixed-methods feasibility study protocol.

INTRODUCTION: Mental health services are stretched in the UK and are in need of support. One approach that could improve mental health symptoms is osteopathy. Research suggests that osteopathy influences psychophysiological factors, which could lead to improvements in mental health. The first objective of this protocol is to investigate the feasibility and acceptability of four osteopathic interventions. A secondary aim is to evaluate the interventions' effectiveness for improving psychophysiological and mental health outcomes. METHODS AND ANALYSIS: This study will be an explanatory mixed-methods design. Participants will be 30 adults who have mild to moderate mental health symptoms and not experiencing any issues with pain. The feasibility and acceptability of the interventions will be the primary outcomes. Secondary outcomes will be physiological measures including heart rate variability, interoceptive accuracy and blood pressure. Psychological outcomes, collected preintervention and postintervention, will also be measured by five standardised questionnaires, which include: (1) the Depression, Anxiety and Stress Scale (DASS); (2) the International Positive and Negative Affect Schedule-Short-Form; (3) Acceptance and Action Questionnaire-II; (4) the Self as Context Scale and (5) and the Multidimensional Assessment of Interoceptive Awareness Version 2. Participants will be randomised to one of four intervention groups and receive a single intervention treatment session. These intervention groups are: (1) high-velocity and articulation techniques, (2) soft-tissue massage, (3) craniosacral techniques, and (4) a combination of these three approaches. Mixed design two (preintervention and postintervention) by the four interventions analysis of covariance models will be used to analyse the quantitative data for each quantitative measure. Participants will also be interviewed about their experiences of the study and interventions and a thematic analysis will be used to analyse this qualitative data. This will aid the assessment of the feasibility and acceptability of the study design. ETHICS AND DISSEMINATION: The protocol for this feasibility study has received ethical approval from the Department of Psychology Ethics Committee at Swansea University, ethical review reference number: 2022-5603-4810. Feasibility results from this protocol will be published in a peer review journal and presented at both national and international conferences. DISCUSSION: This study will assess the feasibility and acceptability of conducting osteopathic interventions for improving mental health outcomes. The results from this will help to inform the development of a future randomised controlled trial. The study will also produce original data which could provide preliminary evidence of whether osteopathic approaches are of benefit to individual's mental health in the form of effect sizes, even if they are pain-free. TRIAL REGISTRATION NUMBER: NCT05674071.

Corrigendum: The Immediate Effect of Therapeutic Touch and Deep Touch Pressure on Range of Motion, Interoceptive Accuracy and Heart Rate Variability: A Randomized Controlled Trial With Moderation Analysis.

[This corrects the article DOI: 10.3389/fnint.2018.00041.].

Immediate effects and associations between interoceptive accuracy and range of motion after a HVLA thrust on the thoracolumbar junction: A randomised controlled trial.

BACKGROUND: There is paucity in the literature regarding the role of interoceptive accuracy (IAc) at predicting the effectiveness of osteopathic techniques which increase spinal mobility when directed specifically at the thoracolumbar junction (TLJ). AIMS: The study aimed to explore whether a high velocity, low amplitude (HVLA) thrust of the TLJ would increase spinal mobility (measured through Range of Motion; ROM) and change IAc. Also, whether baseline IAc correlated with the post-ROM measures and change in ROM. METHOD: 21 asymptomatic participants were allocated into three conditions in a randomised order. These were; (1) a high velocity low amplitude manipulation of the TLJ; (2) sham (basic touch); and (3) a control (laying supine on a plinth). Before and following each intervention, the participants' spinal ROM was measured using an Acumar digital inclinometer. In addition to this an ECG was used to measure their pre and post condition IAc. RESULTS: There were significant increases in ROM for all condition, however, the HVLA thrust led to a significantly greater increase in ROM (p < 0.001) when compared to the control and sham. Baseline IAc was inversely associated with post-ROM but there was no association with change in ROM. The HVLA thrust did not significantly change IAc scores from pre to post intervention. CONCLUSIONS: HVLA thrust over the TLJ is a useful intervention for increasing spinal ROM. IAc maybe a useful predictor for intervention effectiveness of this technique and spinal area which could in the future be utilised by osteopaths as part of their diagnostics.

Age, Pain Intensity, Values-Discrepancy, and Mindfulness as Predictors for Mental Health and Cognitive Fusion: Hierarchical Regressions With Mediation Analysis.

Background: Several studies have confirmed that higher levels of psychological flexibility predict better functioning for those suffering with chronic pain. However, few studies have investigated the role of the individual components of psychological flexibility within a chronic pain population in relation to aging specifically and the related indirect mediational processes. Aim: The present study aimed to compare how age, pain intensity, mindfulness, and values-discrepancy predicted mental health and cognitive fusion separately. It also explored the indirect process relations through the use of a mediated analysis. Methods: Two hundred and thirty three participants completed an online survey which included demographical questions as well as the following questionnaires; Short Form McGill Pain Questionnaire (SF-MPQ); General Health Questionnaire 12; Cognitive Fusion 7-Item Questionnaire (CFQ-7); Mindfulness Attention Awareness Scale (MAAS); and the Chronic Pain Values Inventory (CPVI). The relationships from the responses of the questionnaires and demographics were then analyzed through two hierarchical regression models followed by further mediation analysis. Results: In the first model, values-discrepancy, pain intensity, and mindfulness all predicted mental health, but age did not. However, age did account for a significant portion of the variance in the second model when cognitive fusion was used as the dependent measure. It was also found that cognitive fusion mediated the relationship between age and mental health. Conclusion: These results are discussed within the context of using indirect process relations of psychological flexibility and third wave therapies such as acceptance and commitment therapy for a chronic pain population.

Immediate biomechanical, systemic, and interoceptive effects of myofascial release on the thoracic spine: A randomised controlled trial.

BACKGROUND: Myofascial release (MFR) is used to restore tissue extensibility of the fascia tissue and is considered to be useful in a number of clinical settings such as low back pain, ankle injuries, fibromyalgia, and headaches. There is, however, despite the popularity of MFR in manual therapy, little consensus on whether it leads to biomechanical, systemic or interoceptive outcomes. AIMS: This study aimed to explore the immediate biomechanical (increased elasticity for increased range of motion), systemic (local vs. distal areas of pain threshold) and bodily awareness effects (interoception) of a myofascial release technique on the thoracic spine. METHOD: Twelve healthy participants took part in this triple-bind, repeated measures, cross-over design study, and were randomised into counterbalanced sequences of three conditions; a control, a sham, and the MFR condition. The outcome measures used were; range of motion (ROM), pain pressure thresholds (PPT), and interoceptive sensitivity (IS) to assess biomechanical, systemic, and interoceptive effects of MFR. RESULTS: There were significant increases in ROM and PPT (both local and distal) post MFR intervention. There was also a positive correlation between baseline interoceptive sensitivity and post-MFR ROM and a negative correlation for baseline interoceptive sensitivity and post-MRF PPT. Interoceptive sensitivity did increase post-MFR but this was non-significant. CONCLUSIONS: The increase in ROM suggests that the MFR may have caused a biomechanical change in tissue elasticity creating an increase in tissue flexibility. The increase in both local and distal sites of the PPT suggest an overall systemic response to the therapy. The correlation between baseline IS and post-MFR ROM and PPT suggest that IS may be usefully applied as a predictor for ROM and PPT post-MFR.

Protocol for a feasibility and acceptability study using a brief ACT-based intervention for people from Southwest Wales who live with persistent pain.

INTRODUCTION: Persistent pain affects a large percentage of the UK population and its burden has wide ramifications that affect physical, psychological, socioeconomic and occupational status. Pain has a significant impact on people's well-being and quality of life. Some of the most common comorbidities found in this population are depression and anxiety and also maladaptive behaviours such as fear avoidance and catastrophising. METHODS AND ANALYSIS: This is a protocol for a study assessing the feasibility and acceptability of a novel Acceptance and Commitment Therapy (ACT)-based intervention for people from Southwest Wales who live with persistent pain. A group of 12 participants will be recruited through the Health and Wellbeing Academy (Swansea University). After being referred by an Osteopath, and attending a brief meeting with the researcher, the participants will take part in six sessions over six consecutive weeks. 'A Mindful Act' is an ACT-based group programme aiming to teach people how to develop more acceptance and self-compassion, be more mindful and clarify personal values in order to live a more rich and meaningful life. The main outcomes will include the feasibility of the recruitment process and the measurement tools, the acceptability of the intervention for both the participants and the Osteopaths and the adherence to the programme. In order to measure acceptability of the intervention, qualitative interviews will be conducted to provide an insight into peoples' experiences of taking part. Data will be analysed using Thematic Analysis, with the use of NVIVO 10. In addition, quantitative data will be collected at baseline, on completion of the programme and at 1 month and 3 months follow-up to reveal any differences in psychological flexibility, depression, anxiety, fear avoidance and general health status. The findings will help enhance the intervention by making appropriate modifications to the processes and procedures involved, following the recommendations made by the Medical Research Council framework. A larger scale study is envisaged to follow, in order to investigate the full effectiveness and cost-effectiveness of 'A Mindful Act'. ETHICS AND DISSEMINATION: This study was approved by the College of Human and Health Sciences Research Ethics Committee at Swansea University in December 2017. The findings will be disseminated through various means including: the first author's PhD thesis, peer-reviewed journals as well as well as national and international conferences and public events.

The Immediate Effect of Therapeutic Touch and Deep Touch Pressure on Range of Motion, Interoceptive Accuracy and Heart Rate Variability: A Randomized Controlled Trial With Moderation Analysis.

Background: There is paucity in the literature regarding the role of the interoceptive pathway through the insular cortex (IC), as well as heart rate variability (HRV) in relation to Osteopathic Manipulative Therapy (OMT) and deep-touch. Aims: The present study investigated whether both OMT treatment and deep-touch (a newly hypothesized treatment option) was effective at altering the interoceptive pathway and HRV, whilst OMT was only expected to be effective for increasing Range of Motion (ROM). Methods: Thirty-five healthy volunteers were randomly allocated into three conditions in a repeated measures crossover design; a control (laying supine on a plinth); deep-touch (head cradling); and an osteopathic mobilization therapeutic technique on the temporomandibular joint (TMJ). Interoceptive accuracy (IAc), HRV, as well as range of motion (ROM) for the TMJ area as well as the cervical spine (Csp) right and left measures were taken pre and post each condition setting. Results: Significant condition effects emerged from the deep-touch and mobilization interventions for IAc where increases were identified through planned comparisons. For the HRV measure (RMSSD), a significant effect emerged in the deep-touch condition (increase) but not in the mobilization or control conditions. ROM did not increase for any condition. IAc correlated with post-ROM outcomes in many cases and HRV moderated some of these relations. Conclusion: These results are discussed in the context of clinical practice, where cranial deep-touch maybe an effective treatment and modulator of the parasympathetic nervous systems, as well as the interoceptive system.

The immediate effect of osteopathic cervical spine mobilization on median nerve mechanosensitivity: A triple-blind, randomized, placebo-controlled trial.

BACKGROUND: Neurodynamics is a clinical medium for testing the mechanical sensitivity of peripheral nerves which innervate the tissues of both the upper and lower limb. Currently, there is paucity in the literature of neurodynamic testing in osteopathic research, and where there is research, these are often methodologically flawed, without the appropriate comparators, blinding and reliability testing. AIMS: This study aimed to assess the physiological effects (measured through Range of Motion; ROM), of a commonly utilized cervical mobilization treatment during a neurodynamic test, with the appropriate methodology, i.e., compared against a control and sham. Specifically, this was to test whether cervical mobilization could reduce upper limb neural mechanical sensitivity. METHODOLOGY: Thirty asymptomatic participants were assessed and randomly allocated to either a control, sham or mobilization group, where they were all given a neurodynamic test and ROM was assessed. RESULTS: The results showed that the mobilization group had the greatest and most significant increase in ROM with Change-Left p < 0.05 and Change-Right p < 0.05 compared against the control group, and Change-Left p < 0.01 and Change-Right p < 0.05 compared against the sham group. CONCLUSIONS: This study has highlighted that, as expected, cervical mobilization has an effect at reducing upper limb neural mechanical sensitivity. However, there may be other factors interacting with neural mechanosensitivity outside of somatic influences such as psychological expectation bias. Further research could utilize the methodology employed here, but with other treatment areas to help develop neural tissue research. In addition to this, further exploration of psychological factors should be made such as utilizing complex top-down cognitive processing theories such as the neuromatrix or categorization theories to help further understand cognitive biases such as the placebo effect, which is commonly ignored in osteopathic research, as well as other areas of science, and which would further complete a holistic perspective.

An evaluation of osteopathic treatment on psychological outcomes with patients suffering from chronic pain: A prospective observational cohort study collected through a health and well-being academy.

Co-morbid mental health conditions such as anxiety, depression and fear avoidance are often associated with chronic pain. This novel study aimed to explore the impact of osteopathic treatment on several psychological outcome measures relating to anxiety, depression, mental health and fear avoidance for a chronic pain population receiving osteopathic treatment over a 2-week period. The findings show that there were significant reductions in anxiety, pain, mental health dysfunction and improvements in self-care. These results are promising, and it is suggested that now a full-scale randomised controlled trial should be conducted.

Preliminary evidence of Regional Interdependent Inhibition, using a 'Diaphragm Release' to specifically induce an immediate hypoalgesic effect in the cervical spine.

In clinical practice, Osteopaths and Manual Therapists commonly direct treatment towards the diaphragm by the use of a 'Diaphragm Release'. Currently, there is paucity within the literature to support the use of this technique, specifically in pain outcomes. This research aims to support a neurophysiological mechanism based upon the osteopathic principle "The body is a unit". Demonstrating that directing treatment to distal tissue which is neurologically related can reduce pain in the originating spinal segments. This study investigated the immediate hypoalgesic effects of a 'Diaphragm Release' on pain pressure thresholds in the cervical spine. A single-blind, randomised, sham-controlled, repeated measures within subject, crossover design was conducted on 17 asymptomatic subjects. Pain pressure thresholds were measured bilaterally in the C4 paraspinal musculature, lateral end of the clavicle and upper third of the tibialis anterior before and after a 'Diaphragm Release'. Results demonstrated a statistically significant hypoalgesic effect was only found in the spinal segment C4 in both the right (p = 0.016) and left (p = 0.004) sides. Averaging the hypoalgesic effect from both sides equates to a 17.17% change which is considered clinically significant, the effect magnitude was calculated to be small but educationally significant for the right (d = 0.26) and left (d = 0.40) sides. This study supports a novel neurophysiological mechanism, Regional Interdependent Inhibition, to induce a hypoalgesic state at segmentally related spinal segments, specifically C4. Suggesting that directing treatment towards the diaphragm, using a 'Diaphragm Release', could induce an immediate clinically and statistically significant hypoalgesic effect local to the fourth cervical segment due to its relationship with the phrenic nerve.

The Impact of Mindfulness and Perspective-Taking on Implicit Associations Toward the Elderly: a Relational Frame Theory Account.

Perspective-taking interventions have been shown to improve attitudes toward social outgroups. In contrast, similar interventions have produced opposite effects (i.e., enhanced negativity) in the context of attitudes toward elderly groups. The current study investigated whether a brief perspective-taking intervention enhanced with mindfulness would be associated with less negativity than perspective-taking alone. One hundred five participants were randomly assigned to 1 of 4 conditions which comprised of an active or control perspective-taking component and an active or control mindfulness component. Participants were then administered an Implicit Associated Test to assess implicit biases toward the elderly. Results supported previous findings in that the condition in which perspective-taking was active but mindfulness was inactive was associated with greater negative implicit bias toward the elderly; however, some of this negativity decreased in the active perspective-taking and active mindfulness condition. The current findings and other mixed effects that have emerged from perspective-taking interventions are discussed from a Relational Frame Theory perspective.

Discovery of potent, soluble and orally active TRPV1 antagonists. Structure-activity relationships of a series of isoxazoles.

Systematic optimisation of a poorly soluble lead series of isoxazole-3-carboxamides was conducted. Substitution of the 4-position with specific polar functionality afforded the requisite balance of potency, solubility and physicochemical properties. Compound 21a was found to be efficacious in the rat Capsaicin Hargreaves assay following oral administration.

Design, synthesis and structure-activity relationships of (indo-3-yl) heterocyclic derivatives as agonists of the CB1 receptor. Discovery of a clinical candidate.

We report an expansion of the structure-activity relationship (SAR) of a novel series of indole-3-heterocyclic CB1 receptor agonists. Starting from the potent but poorly soluble lead, 1, a rational approach was taken in order to balance solubility, hERG activity and potency while retaining the desired long duration of action within the mouse tail flick test. This led to the discovery of compound 38 which successfully progressed into clinical development.

Structure-activity studies of a novel series of isoxazole-3-carboxamide derivatives as TRPV1 antagonists.

Optimisation of a screening hit incorporating both TRPV1 activity and solubility was conducted. Substitution of the isoxazole-3-carboxamide with the bespoke 1S, 3R-3-aminocyclohexanol motif afforded the requisite balance of potency and solubility. Compounds 32 and 40 were found to have antihyperalgesic effects in the rat CFA Hg assay and induce a mechanism based hyperthermia.

The discovery of novel indole-2-carboxamides as cannabinoid CB(1) receptor antagonists.

The discovery and structure-activity relationship of a novel series of indole-2-carboxamide antagonists of the cannabinoid CB(1) receptor is disclosed. Compound 26i was found to be a high potency, selective cannabinoid CB(1) antagonist.