Effectiveness of osteopathic manipulative applications on hypothalamic-pituitary-adrenal (HPA) axis in youth with major depressive disorder: a randomized double-blind, placebo-controlled trial.

CONTEXT: Osteopathic treatments regulate the neurovegetative system through joint mobilizations and manipulations, and myofascial and craniosacral techniques. Despite the growing body of research, the precise impact of osteopathic medicine on the autonomic nervous system (ANS) is not yet fully elucidated. As to Kuchera's techniques, the stimulation of the sympathetic trunk and prevertebral ganglia contributed to harmonization of the sympathetic activity. However, potential relationships between the harmonization of the sympathetic nervous system (SNS) and the hypothalamic-pituitary-adrenal (HPA) axis largely remain uncertain and warrant further exploration. OBJECTIVES: This study was designed to evaluate the effectiveness of the osteopathic sympathetic harmonization (OSH) on the SNS and the HPA axis in youth with major depressive disorder (MDD). METHODS: The study included 39 youths aged 15-21 years and diagnosed with MDD. The participants were randomly assigned into either the OSH or the placebo group. Stimulation was performed on the sympathetic truncus and prevertebral ganglia in the OSH group. The stimulation of the placebo group was performed with a lighter touch and a shorter duration in similar areas. Each participant completed the Beck Depression Inventory (BDI) and the State and Trait Anxiety Inventory (SAI and TAI) before the application. Blood pressure (BP) and pulse measurements were made, and saliva samples were taken before, immediately after, and 20 min after application. RESULTS: The baseline BDI (p=0.617) and TAI (p=0.322) scores were similar in both groups. Although the SAI scores decreased in both groups postintervention, no statistically significant difference was found between the two groups. Subjects who received OSH had a decrease in α-amylase level (p=0.028) and an increase in cortisol level (p=0.009) 20 min after the procedure. CONCLUSIONS: Following OSH application in depressed youth, SNS activity may decrease, whereas HPA axis activity may increase. Future studies may examine the therapeutic efficacy of repeated OSH applications in depressed individuals.

Gentle Touch Therapy, Pain Relief and Neuroplasticity at Baseline in Fibromyalgia Syndrome: A Randomized, Multicenter Trial with Six-Month Follow-Up.

BACKGROUND: Fibromyalgia (FM) is considered a stress-related disorder characterized mainly by chronic widespread pain. Its pathogenesis is unknown, but cumulative evidence points at dysfunctional transmitter systems and inflammatory biomarkers that may underlie the major symptoms of the condition. This study aimed to evaluate pain scores (primary outcome), quality of life, inflammatory biomarkers and neurotransmitter systems in women with FM (secondary outcomes) subjected to gentle touch therapy (GTT) or placebo. METHODS: A total of 64 female patients with FM were randomly assigned to two groups, namely GTT (n = 32) or Placebo (n = 32). Clinical assessments were conducted at baseline and post-intervention with six-month follow-up. We measured serum catecholamines (dopamine), indolamines and intermediary metabolites (serotonin or 5-hydroxyindolacetic acid (5-HIAA)), as well as tetrahydrobiopterin (BH4), which is a cofactor for the synthesis of neurotransmitters and inflammatory biomarkers in women with FM. A group of healthy individuals with no intervention (control group) was used to compare biochemical measurements. Intervention effects were analyzed using repeated measures (RM) two-way ANOVA followed by Bonferroni post hoc test and mixed ANCOVA model with intention to treat. RESULTS: Compared to placebo, the GTT group presented lower pain scores and brain-derived neurotrophic factor (BDNF) levels without altering the quality of life of women with FM. Changes in BDNF had a mediating role in pain. Higher baseline serum BDNF and 5-HIAA or those with a history of anxiety disorder showed a higher reduction in pain scores across time. However, women with higher serum dopamine levels at baseline showed a lower effect of the intervention across the observation period revealed by an ANCOVA mixed model. CONCLUSIONS: In conclusion, lower pain scores were observed in the GTT group compared to the placebo group without altering the quality of life in women with FM. Reductions in BDNF levels could be a mechanism of FM pain status improvement. In this sense, the present study encourages the use of these GTT techniques as an integrative and complementary treatment of FM.

The ACAMTO study-impact of add-on osteopathic treatment on adolescent patients with anorexia nervosa: study protocol for a randomized controlled trial.

BACKGROUND: Anorexia nervosa (AN) mainly affects women (sex ratio 1/10) and most often starts during adolescence. The prognosis of AN remains poor (10% of deaths and high risk of chronicity). Body dissatisfaction, disturbances in recognition and identification of body sensations are some of the key symptoms of AN. However, there is a contrast between this consensual observation of body image disorders in AN, and the relative deficit of specifically targeted body treatments. Our proposal for a body approach specifically dedicated to AN is based on the understanding that posture, breathing, muscle tension and body perception are closely linked to our psychological and emotional state and are therefore disturbed in patients with AN. The purpose of this monocentric randomized controlled trial is to evaluate if a targeted osteopathic protocol treatment for AN in addition to treatment as usual (TAU) is significantly more effective than TAU alone. METHODS: In total, 72 patients meeting the inclusion criteria will be randomly assigned to one of the two treatment groups: one receiving the specific osteopathic treatment targeted for AN in addition to the TAU (group A) and the other one, receiving TAU only (group B). The patients in group A will receive 5 30-min osteopathic treatment sessions. Soft specific palpatory techniques on the diaphragm, digestive system and cervical region will be performed. The TAU is defined by the multidisciplinary approach recommended by the French health high authority. The primary outcome is the evaluation of interoceptive sensibility and secondary outcomes include clinical and psychopathology-related symptoms with assessment of somatic dysfunctions' evolution. A qualitative study will also be carried out, applying the Interpretative Phenomenological Analysis method. Patients will be included for a maximum of 14 weeks between the inclusion time and the last evaluation. DISCUSSION: If the results of the study are positive (statistically significant efficacy of this osteopathic treatment protocol), the study will provide arguments in favor of osteopathic sessions as a possible non-invasive additional treatment option in the multidisciplinary care approach for patients with AN. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04666415 , Release Date: December 11, 2020; N° ID-RCB: 2019-A02613-54.

Osteopathic medicine for fibromyalgia: a sham-controlled randomized clinical trial.

BACKGROUND: Patients with fibromyalgia (FM) frequently resort to osteopathic or chiropractic treatment, despite very weak supporting evidence. We aimed to assess the efficacy of osteopathic manipulation in FM in a properly controlled and powered randomized clinical trial. METHODS: Patients were randomized to osteopathic or sham treatment. Treatment was administered by experienced physical medicine physicians, and consisted of six sessions per patient, over 6 weeks. Treatment credibility and expectancy were repeatedly evaluated. Patients completed standardized questionnaires at baseline, during treatment, and at 6, 12, 24, and 52 weeks after randomization. The primary outcome was pain intensity (100-mm visual analog scale) during the treatment period. Secondary outcomes included fatigue, functioning, and health-related quality of life. We performed primarily intention-to-treat analyses adjusted for credibility, using multiple imputation for missing data. RESULTS: In total, 101 patients (94% women) were included. Osteopathic treatment did not significantly decrease pain relative to sham treatment (mean difference during treatment: -2.2 mm; 95% confidence interval, -9.1 to 4.6 mm). No significant differences were observed for secondary outcomes. No serious adverse events were observed, despite a likely rebound in pain and altered functioning at week 12 in patients treated by osteopathy. Patient expectancy was predictive of pain during treatment, with a decrease of 12.9 mm (4.4-21.5 mm) per 10 points on the 0-30 scale. Treatment credibility and expectancy were also predictive of several secondary outcomes. CONCLUSION: Osteopathy conferred no benefit over sham treatment for pain, fatigue, functioning, and quality of life in patients with FM. These findings do not support the use of osteopathy to treat these patients. More attention should be paid to the expectancy of patients in FM management.

Osteopathic treatment leads to significantly greater reductions in chronic thoracic pain after CABG surgery: A randomised controlled trial.

BACKGROUND: There are a number of long-term postoperative complications after coronary artery bypass graft (CABG) surgery. Pulmonary function is decreased by 12% and 30%-50% of the patients have chronic thoracic pain. METHODS: This randomised controlled trial with two parallel groups aimed to explore the effectiveness of osteopathic treatments (OTs) on these conditions. The standard care (SC) group and the and OT group received a 12-week standard cardiac rehabilitation programme, which was supplemented with four OTs for the OT group only. The outcome assessors were blinded to the patients' allocation. RESULTS: Eighty-two patients with median sternotomy after CABG surgery were randomly allocated in a 1:1 ratio (SC: n = 42, OT: n = 42). Slow vital capacity and pain intensity were measured at baseline and at 12 weeks and 52 weeks after surgery. Pain intensity was significantly lower in the OT group 12 weeks after surgery (3.6-0.80 vs. 2.6 to 1.2, p = 0.030). One year after surgery, there still was a significantly lower pain intensity in the OT group (3.6-0.56, vs. 2.6 to 1.2, p = 0.014). No significant changes between groups were found in pulmonary function. There were no adverse events reported. CONCLUSIONS: From this study, it can be concluded that the addition of OT to exercise-based cardiac rehabilitation may lead to significantly greater reductions in thoracic pain after CABG surgery. TRIAL REGISTRATION: This study was registered on ClinicalTrials.gov (NCT01714791).

Assessment of cervical stiffness in axial rotation among chronic neck pain patients: A trial in the framework of a non-manipulative osteopathic management.

BACKGROUND: Cervical stiffness is a clinical feature commonly appraised during the functional examination of cervical spine. Measurements of cervical stiffness in axial rotation have not been reported for patients with neck pain. The purpose of this study was to investigate cervical spine stiffness in axial rotation among neck pain patients and asymptomatic subjects, and to analyze the impact of osteopathic management. METHODS: Thirty-five individuals (17 patients) were enrolled. Measurements were carried out for left-right axial rotation using a torque meter device, prior and after intervention. Passive range of motion, stiffness, and elastic-and neutral zone magnitudes were analyzed. Pain intensity was also collected for patients. The intervention consisted in one single session of non-manipulative osteopathic treatment performed in both groups. FINDINGS: A significant main effect of intervention was found for total range of motion and neutral zone. Also, treatment by group interaction was demonstrated for neutral-, elastic zone, stiffness in right axial rotation, and for total neutral zone. Significant changes were observed in the clinical group after intervention, indicating elastic zone decrease and neutral zone increase. In contrast, no significant alteration was detected for the control group. INTERPRETATIONS: Stiffness characteristics of the cervical spine in axial rotation are prone to be altered in patients with neck pain, but seem to be relieved after a session of non-manipulative manual therapeutic techniques. Further investigations, including randomized clinical trials with various clinical populations and therapeutic modalities, are needed to confirm these preliminary findings.

Conservative management of a traumatic meniscal injury utilising osteopathy and exercise rehabilitation: A case report.

Meniscal injury is one of the most common knee soft tissue injuries, commonly affecting young athletes and an older, degenerative population. Treatment largely depends on the type and extent of the injury with arthroscopic repair or meniscectomy being mainstays. Although non-surgical approaches have been described, there is no published literature regarding a combination of indirect osteopathic techniques and rehabilitation in the management of these injuries. The current case report follows a 20-year-old male presenting with a 5-day history of acute knee pain, following trauma during an Australian Rules Football (AFL) match. An 8-week management plan of indirect osteopathic techniques and a tailored rehabilitation program was implemented. The Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Lower Extremity Functional Scale (LEFS) questionnaires were utilised to measure outcomes. After the 8-week treatment and rehabilitation program, the patient had exceeded the minimum detectable change score for all outcome measures. This case report suggests that osteopathic manipulative treatment and rehabilitation may be an alternative, non-surgical approach in the management of post-traumatic meniscal injuries.

Efficacy of an Osteopathic Treatment Coupled With Lactation Consultations for Infants' Biomechanical Sucking Difficulties.

BACKGROUND: Despite well-known recommendations from national and international bodies including the World Health Organization, few mothers achieve the goal of breastfeeding exclusively for 6 months. Half of mothers stop breastfeeding due to biomechanical issues in the first month, despite increasing support from lactation consultants. Osteopaths worldwide work with these babies, but there is little empirical evidence for this type of treatment. Research aim: This study aimed to determine the efficacy of an osteopathic treatment coupled with usual lactation consultations on infants' ability to latch. Secondary objectives included assessment of nipple pain and mothers' perceptions of the effect of treatment. METHODS: We conducted a single blind, randomized controlled trial at a mother-to-mother support group between January and December 2015. Data were collected at four different times over a 10-day period (T0-T10) from 97 mother-infant dyads using the LATCH assessment tool, a visual analog scale (VAS) to document mothers' nipple pain, and a de novo questionnaire for breastfeeding management and potential treatment side effects. RESULTS: There were consistent statistical and clinical differences in the mean LATCH scores between the treatment and the control groups ( p < .001). However, no significant differences in the VAS scores were reported over time ( p = .713). Mothers reported no serious or unexpected side effects during the follow-up period. CONCLUSION: This study is one of the first to bring together lactation consultants and osteopaths to address infants with biomechanical sucking difficulties. Findings support the hypothesis that the addition of osteopathy to regular lactation consultations is beneficial and safe.

Effects of osteopathic treatment on pulmonary function and chronic thoracic pain after coronary artery bypass graft surgery (OstinCaRe): study protocol for a randomised controlled trial.

BACKGROUND: Coronary artery bypass graft surgery (CABG) is an effective and widespread coronary revascularisation technique, nevertheless there are a number of long-term postoperative complications from which patients can suffer. One year after CABG surgery pulmonary function is decreased by 12% and 30% of the patients suffer from chronic thoracic pain. To date and to our knowledge there are no effective treatments for these conditions. The aim of the present clinical trial is to explore the effectiveness of osteopathic treatment on these conditions. METHODS: The study is designed as a randomised controlled trial with two parallel groups. Group A will receive a standard cardiac rehabilitation programme during 12 weeks and group B will receive the same standard cardiac rehabilitation programme supplemented with four osteopathic treatments (OT). OT will be performed at week 4, 5, 8 and 12 after surgery. Three hundred and eight patients (Group A: n = 154, Group B: n = 154) will be enrolled from the cardiothoracic surgery department of the Jessa Hospital Hasselt. Blinding will be assured for the staff of the cardiac rehabilitation centre and outcome assessors. Primary outcome measure will be the mean difference in change from baseline in slow vital capacity (SVC) at 12 weeks after surgery between groups. Secondary outcome measures will be the change from baseline in quality of life, pain, thoracic stiffness and maximal aerobic capacity at 12 weeks after surgery. A follow-up is planned 52 weeks after surgery for SVC, quality of life, pain and thoracic stiffness. Intention to treat analysis will be executed. DISCUSSION: The OstinCare study has been designed to explore the potential long-term added value of osteopathic treatment in the management of decreased pulmonary function, chronic thoracic pain and diminished thoracic mobility after CABG surgery. TRIAL REGISTRATION: The protocol has been retrospectively registered on ClinicalTrials.gov ( NCT01714791 ).

Repeat-measures longitudinal study evaluating behavioural and gastrointestinal symptoms in children with autism before, during and after visceral osteopathic technique (VOT).

UNLABELLED: This study investigated the influence of visceral osteopathic technique (VOT) on the behaviour and gastrointestinal (GI) symptoms of children with autism using a validated questionnaire to measure outcome. METHODS: The 49 recruited autistic children suffered GI symptoms and impaired social interaction and communication, but were otherwise healthy. Thirty minute VOT sessions were applied to the abdomens of the children over a 6 week period whilst their GI and behavioural parameters were recorded. Outcomes were measured using a modified Autism Research Institute Secretin Outcomes Survey Form, the 'S.O.S Form'. Four questionnaires were completed by parents before treatment (control period), four completed during treatment (treatment period) and one completed six weeks after the last treatment (post treatment period). Subjects acted as their own controls. RESULTS: Results from repeat ANOVA demonstrated a positive, overall significant, symptomatic improvement (p < 0.05) in 'social behaviour and communication' and 'digestive signs' subscales of the questionnaire comparing before and after VOT. Significant improvement in vomiting (p = 0.00029), poor appetite (p = 0.039) and eye contact (p = 0.035) was also demonstrated after VOT application. DISCUSSION AND CONCLUSION: The experimental hypothesis has been supported indicating a positive effect of VOT on some of the measured GI symptoms and behavioural patterns in this group of children with autism. This data indicates that the application of VOT may be of benefit to children with autism and GI disturbance.

A randomized control trial on the effectiveness of osteopathic manipulative treatment in reducing pain and improving the quality of life in elderly patients affected by osteoporosis.

INTRODUCTION: In the elderly population, a decrease in bone mineral density (osteoporosis) is often associated with a decrease in quality of life and an increase in self reported body pain. This pain originates from the musculoskeletal system and can potentially affect different areas of the body. AIM: The aim of this study was to investigate the effect of osteopathic manipulative treatment (OMT) on self reported pain and quality of life in an elderly population. DESIGN: Randomized placebo controlled trial. METHODS: Patients were recruited from the Geriatric Department, Bassini Hospital (Milan, Italy). Patients were randomly assigned to either 6 sessions of OMT (n = 37 patients) or an equivalent number of sham manipulative treatment (SMT) (n = 35 patients). The main outcome variables were QOL measured by QUALEFFO -41 and overall bodily pain measured using a visual analog scale (VAS). Data were analyzed using a two factor ANOVA (treatment × time) for repeated measurements with an α level set at p ≤ 0.05. RESULTS: Main result of this study was that OMT compared to SMT showed a significant decreased of disability. This effect was demonstrated by a significant interaction in the overall disability score (p =0.001) and the Mental wellbeing (p =0.058), Health perception (p =0.005) and Pain (p =0.003) QUALEFFO -41 subscales, while no significant difference (no interaction) for pain as measured by VAS and for the Daily activities, Walking, Household cleaning and Leisure time activities QUALEFFO -41 subscales (p > 0.05) was found. No adverse effects were recorded during the study. DISCUSSION: This study demonstrated that, in a group of elderly subjects affected by osteoporosis OMT was able to increase self reported QOL while the effect on body pain perception is unclear. This overall improvement in QOL appears to be caused by an improvement in psychological factors (i.e Mental wellbeing and Health perception) rather than physical factors. In fact, all QUALEFFO -41 subscales related to physical function demonstrated no significant interaction. The effect of OMT on Pain perception is less clear. In fact, there was no effect on pain as assessed by VAS while a significant improvement was observed when the QUALEFFO -41 subscale was used. This could be due to the metric properties of the two pain measurement methods; an alternative explanation could be that VAS measures mainly pain quantity while QUA-LEFFO -41 subscales measures mainly pain quality. The lack of effect of OMT on physical function needs to be confirmed by more direct measurements of this variable.