The following publications in MEDLINE-listed journals have been developed from German Osteopaths and out of Thesis under the supervision of the German Academy of Osteopathy (listed according to the year of publication)
(Die folgenden Publikationen in MEDLINE-gelisteten Journalen sind von deutschen Osteopathen und auf der Grundlage deutscher wissenschaftlicher Thesen unter der Supervision der AFO – Akademie für Osteopathie entstanden (geordnet nach Erscheinungsjahr))

J Am Osteopath Assoc. 2015;115(7):416-425
Osteopathic Manipulative Therapy in Women With Postpartum Low Back and Pelvic Girdle Pain and Disability: A Pragmatic Randomized Controlled Trial 
Florian Schwerla, Katrin Rother, Denis Rother, Michaela Ruetz, Karl-Ludwig Resch

CONTEXT: Persistent low back pain (LBP) is a common complaint among women during and after pregnancy, and its effects on quality of life can be disabling.
OBJECTIVE: To evaluate the effectiveness of osteopathic manipulative therapy (OMTh; manipulative care provided by foreign-trained osteopaths) in women with persistent LBP and functional disability after childbirth.
METHODS: A pragmatic randomized controlled trial was conducted among a sample of women with a history of pregnancy-related LBP for at least 3 months after delivery. Participants were identified from the general population in Germany. By means of external randomization, women were allocated to an OMTh group and a waitlist control group. Osteopathic manipulative therapy was provided 4 times at intervals of 2 weeks, with a follow-up after 12 weeks. The OMTh was tailored to each participant and based on osteopathic principles. The participants allocated to the control group did not receive OMTh during the 8-week study; rather, they were put on a waiting list to receive OMTh on completion of the study. Further, they were not allowed to receive any additional treatment (ie, medication, physical therapy, or other sources of pain relief) during the study period. The main outcome measures were pain intensity as measured by a visual analog scale and the effect of LBP on daily activities as assessed by the Oswestry Disability Index (ODI).
RESULTS: A total of 80 women aged between 23 and 42 years (mean [SD], 33.6 [4.5] years) were included in the study, with 40 in the OMTh group and 40 in the control group. Pain intensity decreased in the OMTh group from 7.3 to 2.0 (95% CI, 4.8-5.9; P<.001) and in the control group from 7.0 to 6.5 (95% CI, −0.2 to −0.9; P=.005). The between-group comparison of changes revealed a statistically significant improvement in pain intensity in the OMTh group (between-group difference of means, 4.8; 95% CI, 4.1-5.4; P<.001) and level of disability (between-group difference of means, 10.6; 95% CI, 9.9-13.2; P<.005). The follow-up assessment in the OMTh group (n=38) showed further improvement.
CONCLUSION: During 8 weeks, OMTh applied 4 times led to clinically relevant positive changes in pain intensity and functional disability in women with postpartum LBP. Further studies that include prolonged follow-up periods are warranted.

BMC Musculoskeletal Disorders 2014, 15:286
Osteopathic manipulative treatment for nonspecific low back pain: a systematic review and meta-analysis
Helge Franke, Jan-David Franke, Gary Fryer

BACKGROUND: Nonspecific back pain is common, disabling, and costly. Therefore, we assessed effectiveness of osteopathic manipulative treatment (OMT) in the management of nonspecific low back pain (LBP) regarding pain and functional status.
METHODS: A systematic literature search unrestricted by language was performed in October 2013 in electronic and ongoing trials databases. Searches of reference lists and personal communications identified additional studies. Only randomized clinical trials were included; specific back pain or single treatment techniques studies were excluded. Outcomes were pain and functional status. Studies were independently reviewed using a standardized form. The mean difference (MD) or standard mean difference (SMD) with 95% confidence intervals (CIs) and overall effect size were calculated at 3 months posttreatment. GRADE was used to assess quality of evidence.
RESULTS: We identified 307 studies. Thirty-one were evaluated and 16 excluded. Of the 15 studies reviewed, 10 investigated effectiveness of OMT for nonspecific LBP, 3 effect of OMT for LBP in pregnant women, and 2 effect of OMT for LBP in postpartum women. Twelve had a low risk of bias. Moderate-quality evidence suggested OMT had a significant effect on pain relief (MD, -12.91; 95% CI, -20.00 to -5.82) and functional status (SMD, -0.36; 95% CI, -0.58 to -0.14) in acute and chronic nonspecific LBP. In chronic nonspecific LBP, moderate-quality evidence suggested a significant difference in favour of OMT regarding pain (MD, -14.93; 95% CI, -25.18 to -4.68) and functional status (SMD, -0.32; 95% CI, -0.58 to -0.07). For nonspecific LBP in pregnancy, low-quality evidence suggested a significant difference in favour of OMT for pain (MD, -23.01; 95% CI, -44.13 to -1.88) and functional status (SMD, -0.80; 95% CI, -1.36 to -0.23), whereas moderate-quality evidence suggested a significant difference in favour of OMT for pain (MD, -41.85; 95% CI, -49.43 to -34.27) and functional status (SMD, -1.78; 95% CI, -2.21 to -1.35) in nonspecific LBP postpartum.
CONCLUSION: Clinically relevant effects of OMT were found for reducing pain and improving functional status in patients with acute and chronic nonspecific LBP and for LBP in pregnant and postpartum women at 3 months post-treatment. However, larger, high-quality randomized controlled trials with robust comparison groups are recommended.

J Am Osteopath Assoc. 2014 Jun;114(6):470-9.
Effectiveness of Osteopathic Manipulative Therapy for Managing Symptoms of Irritable Bowel Syndrome: A Systematic Review
Axel Müller, Helge Franke, Karl-Ludwig Resch, Gary Fryer

CONTEXT: Irritable bowel syndrome (IBS) is a common and often lifelong functional gastrointestinal disorder. There is a scarcity of effective management options for IBS.
OBJECTIVE: To assess the effectiveness of osteopathic manipulative therapy (OMTh) for managing the symptoms of IBS.
DATA SOURCES: Articles without language or publication-date restriction were searched in PubMed, Embase, Cochrane Library, PEDro, OSTMED.DR, and Osteopathic Research Web. Search terms included irritable bowel syndrome, IBS, functional colonic disease, colon irritable, osteopath*, osteopathic manipulation, osteopathic medicine, clinical trial, and randomized clinical trial. Experts in the field of visceral osteopathy were also contacted to identify additional studies.
STUDY SELECTION: The authors evaluated randomized controlled trials (RCTs) of OMTh for IBS in adults in whom IBS was diagnosed using Rome (I-III) criteria. If OMTh was not the sole intervention in the intervention group and if the same additional interventions were not applied to the control group, the study was excluded.
DATA EXTRACTION: Citation identification, study selection, and data extraction were independently undertaken by 2 reviewers with a data extraction form from the Cochrane Collaboration. A consensus method was used to resolve disagreements concerning the assessment of the methodologic quality of the RCTs that were reviewed.
RESULTS: The search identified 10 studies that examined OMTh for patients with IBS; 5 studies (204 patients) met the inclusion criteria. All studies were assessed as having low risk of bias according to the Cochrane Collaboration criteria, although there was heterogeneity in the outcome measures and control interventions. Three studies used visual analog scales for abdominal pain, whereas others used the IBS severity score and the Functional Bowel Disorder Severity Index. A variety of secondary outcomes were used. All studies reported more pronounced short-term improvements with OMTh compared with sham therapy or standard care only. These differences remained statistically significant after variable lengths of follow-up in 3 studies.
CONCLUSION: The present systematic review provides preliminary evidence that OMTh may be beneficial in the treatment of patients with IBS. However, caution is required in the interpretation of these findings because of the limited number of studies available and the small sample sizes.

International Journal of Osteopathic Medicine (2014) 17, 222-231
Osteopathic treatment in patients with primary dysmenorrhoea: A randomised controlled trial 
Florian Schwerla, Petra Wirthwein, Michaela Ruetz, Karl-Ludwig Resch

OBJECTIVE: To investigate the effectiveness of a series of osteopathic treatments in patients with pain due to primary dysmenorrhea.
DESIGN AND SETTINGS: Multi-centered randomized controlled trial with an osteopathic intervention group and an untreated (“waiting list”) control group.
SUBJECTS: Women aged 14 years and older with a regular menstrual cycle, diagnosed with primary dysmenorrhea.
INTERVENTION: Six osteopathic treatments over a period of three menstrual cycles or no osteopathic treatment. At each treatment session, dysfunctional structures were tested and treated based on osteopathic principles. In both groups, pain medication on demand was allowed, but was documented.
OUTCOME MEASURES: Primary outcome measures were average pain intensity (API) during menstruation, assessed by the Numeric Rating Scale (NRS), and days of dysmenorrheal pain exceeding 50% of NRS maximum (DDP). Main secondary outcome measure was health-related quality of life.
RESULTS: A total of 60 individuals (average age 33 years) were randomized, seven patients dropped out. API decreased in the intervention group from 4.6 to 1.9 (95%CI=-1.9 to -3.5), and from 4.3 to 4.2 in controls (95%CI=-0.7 to 0.5); between group difference of means (BGDoM): 2.6, 95%CI= 1.7 to 3.6; p< 0.005. DDP decreased from 2.2 to 0.2 days in the intervention group (95%CI=-2.5 to -1.3), and from 2.3 to 1.9 in controls (95%CI=-1.0 to 0.2); BGDoM 1.5; 95%CI= 0.6 to 2.3; p= 0.002. A positive impact on quality of life (physical component score) could be observed in the osteopathic treatment group only.
CONCLUSIONS: A series of osteopathic treatments might be beneficial for women suffering from primary dysmenorrhea.

The Journal of Alternative and Complementary Medicine 2013 Jun;19(6):543-9.
Osteopathic treatment of patients with long term sequelae of whiplash injury – effect on neck pain disability and quality of life
Florian Schwerla,  Albrecht K. Kaiser, Richard Gietz, Ralf Kastner

OBJECTIVE: The clinical sequelae and manifestation resulting from whiplash injury is defined as late whiplash syndrome (LWS). The objective of this study was to investigate whether a series of osteopathic treatments of patients with LWS may improve their symptoms.
DESIGN: The study was designed as a two-phase (pre-post) clinical intervention study. In phase one the patients received no treatment for six weeks; in phase two they received five test-dependent osteopathic treatments.
SETTING: 42 patients (mean age 39 years) suffering from late whiplash syndrome due to car rear-end collisions were included.
INTERVENTION: 5 individualized and custom-tailored osteopathic treatments at one-week intervals were performed.
MAIN OUTCOME MEASURES: Main outcome parameters were the neck-related pain and disability (determined by the Neck Pain and Disability Scale NPAD) and the quality of life (assessed on the SF-36). The presence of a post-traumatic stress disorder (PTSD) was diagnosed.
RESULTS: A direct comparison between the untreated period and the treatment period revealed clinically relevant and statistically significant improvements in the osteopathic treatment period for the NPAD. In the intervention phase the NPAD dropped from 41.5 to 26.0 points, which corresponds to an improvement of 37% (95% CI= 11.1 to 19.8; p < .0005). For the SF-36, both the physical and the mental component summary showed a significant and substantial improvement during treatment phase (p = .009 vs. p= .02). Previous to treatment, 17 patients (43.6 %) were diagnosed with a positive PTSD; this number fell to only 6 (15.4 %) during observation.
CONCLUSIONS: 5 osteopathic treatments had a marked beneficial effect on the physical as well as the mental aspects of late whiplash syndrome and lives up to its claim of being a complementary modality in the treatment regimen of this condition. Based on these preliminary findings, rigorous randomized controlled studies are warranted.

J Bodyw Mov Ther. 2013 Jan;17(1):11-8
Osteopathic manipulative treatment (OMT) for lower urinary tract symptoms (LUTS) in women. Systematic review and meta-analysis
Helge Franke, Klaus Hoesele

BACKGROUND: Because of its prevalence and impact on women’s well-being, and its high financial costs, female LUTS is an important health problem that requires serious atten- tion from health professionals.
OBJECTIVE: The objective of this review was to determine the clinical effects of osteopathic treatment on female lower urinary tract disorders.
DATA SOURCES: A systematic literature search was performed in May 2011 in the electronic data- bases Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, PEDro, OSTMED-DR, OSTEOPATHIC WEBRESEARCH and databases of ongoing trials. A manual search in reference lists and a personal communication with experts in the field of osteopathy was also conducted to identify additional studies.
STUDY SELECTION: Only randomized clinical studies (RCT) or controlled clinical studies (CCT) were included. Inclusion criteria of the participants were female, at least 18 years old and a diagnosed female urinary tract disorder. Exclusion criteria were neurologic disorders, tumors, urinary tract infections or antibiotic treatment, and pregnancy.
DATA EXTRACTION: Two review authors independently extracted the data of the studies using a standardized data extraction form. The updated Cochrane Risk of bias tool from 2011 was used to assess the methodological quality.
RESULTS: The quantitative analysis shows a statistically significant and clinically relevant improvement when the osteopathic intervention was compared to an untreated group. Two studies which compare OMT with the pelvic floor muscle training as a reference treatment document almost the same therapeutic effect.

Urologe A. 2009 Aug; 48:1339-45. [Article in German]
Chronic prostatitis/chronic pelvic pain syndrome : Influence of osteopathic treatment – a randomized controlled study.
Marx S, Cimniak U, Beckert R, Schwerla F, Resch KL.

BACKGROUND: Prostatitis is the most common urological disease in males over the age of 50 years old. As bacteria are detected in only <5% of cases the disease can mostly be classified as chronic nonbacterial prostatitis. The symptoms of this problem complex, often described as chronic prostatitis and chronic pelvic pain syndrome (CP-CPPS), seem to be multifactorial so that an improvement can only rarely be achieved with conventional forms of therapy.
MATERIALS AND METHODS: The aim of this study was to investigate whether osteopathic treatment can influence the symptoms of CP-CPPS (randomized controlled study, 5 sessions, follow-up after 6 weeks and 1.5 years without treatment). The study was carried out in a practice for osteopathy. Patients were recruited by referral from urologists, newspaper articles and lectures on the topic. A total of 35 males with medically diagnosed CP-CPPS aged 29-70 years old took part in the study. Of the patients 20 were allocated to the treatment group and 15 to the placebo group whereby 2 patients had to retire from the study prematurely. Patients in the treatment group received 5 osteopathic treatment sessions separated by 1 week at the beginning and by up to 3 weeks at the end (total period 8 weeks). The osteopathic dysfunctions of the patients were treated according to the principles of osteopathy. The placebo treatment in the control group consisted of a training program with simple gymnastic and physiotherapeutic exercises. Improvements of the complaints by urination (LUTS), chronic pelvic pain (CPPS) and quality of life (QOL) were measured using the questionnaires for international prostate symptom score (IPSS), the National Institutes of Health chronic prostatitis symptom index (NIH-CPSI) and the quality of life index (QOL).
RESULTS: Comparison of the results from the osteopathy and placebo groups revealed statistically significant differences in favor of the osteopathy group (p<0.0005). During the study period the average IPSS in the osteopathy group improved from 19.7 to 10.3 points (48%, p<0.0005), the NIH from 26.0 to 12.0 (54%; p<0.0005) and the QOL from 4.4 to 1.9 points (58%, p<0.0005). In contrast the corresponding values in the placebo group remained relatively constant. At the follow-up 6 weeks after the last session the improvements in the osteopathy group were found to be stabile and remained so at least up to the second follow-up after 1.5 years.
CONCLUSIONS: The positive results of this study indicate that osteopathic treatment can be considered a genuine alternative to the conventional treatment of CP-CPPS and a closer cooperation between urologists/internists and osteopaths would be desirable. Further studies with larger numbers of patients should be carried out to substantiate these results.

Forsch Komplement Med. 2008 Jun;15(3):138-45.
Osteopathic treatment of patients with chronic non-specific neck pain: a randomised controlled trial of efficacy.
Schwerla F, Bischoff A, Nurnberger A, Genter P, Guillaume JP, Resch KL.

OBJECTIVE: Chronic non-specific neck pain (CNP) is a common, often disabling condition which still lacks a reliable therapeutic standard. Empiric evidence suggests that osteopathic interventions might be effective in alleviating CNP symptoms. A randomized controlled clinical trial of efficacy was performed to test this hypothesis.
MATERIALS AND METHODS: 135 CNP sufferers were identified through advertisements, and 41 patients who met all relevant predefined criteria were recruited. All participants received a 12-min session of sham ultrasound once a week for an average of 10 weeks. In addition, a test-dependent osteopathic intervention of 45 min was given to 24 participants every other week. 40 participants could be followed up for 12 weeks after the end of therapy. The main outcome parameter was pain intensity measured on a numeric rating scale (NRS, range: 0-10).
RESULTS: There were 2 dropouts in the intervention group and 2 in the control group. Average pain intensity decreased from 4.7 to 2.2 in the osteopathic group (p < 0.0005), and from 4.8 to 4.0 in the control group (p = 0.09). The intergroup difference of longitudinal changes was clearly significant, too (p = 0.02). Further slight but comparable reductions were observed at follow-up (0.3 and 0.4 NRS points, respectively). These changes seem to have a positive impact on quality of life, as assessed by generic and specific instruments such as the MOS SF-36 and the Northwick Park Pain Questionnaire. CONCLUSIONS: A series of test-dependent osteopathic interventions may be a promising therapeutic regimen for CNP sufferers. Further studies will have to demonstrate a) whether these findings are reproducible, and b) whether positive long-term outcomes can be achieved.

Dev Med Child Neurol. 2006 Jan;48(1):5-9.
Infantile postural asymmetry and osteopathic treatment: a randomized therapeutic trial.
Philippi H, Faldum A, Schleupen A, Pabst B, Jung T, Bergmann H, Bieber I, Kaemmerer I, Dijs P, Reitter B.

The aim of this study was to assess the therapeutic efficacy of osteopathic treatment in infants with postural asymmetry. A randomized clinical trial of efficacy with blinded videoscoring was performed. Sixty-one infants with postural asymmetry aged 6 to 12 weeks (mean 9wks) were recruited. Thirty-two infants (18 males, 14 females) with a gestational age of at least 36 weeks were found to be eligible and randomly assigned to the intervention groups, 16 receiving osteopathic treatment and 16 sham therapy. After a treatment period of 4 weeks the outcome was measured using a standardized scale (4-24 points). With sham therapy, five infants improved (at least 3 points), eight infants were unchanged (within 3 points), and three infants deteriorated (not more than -3 points); the mean improvement was 1.2 points (SD 3.5). In the osteopathic group, 13 infants improved and three remained unchanged; the mean improvement was 5.9 points (SD 3.8). The difference was significant (p=0.001). We conclude that osteopathic treatment in the first months of life improves the degree of asymmetry in infants with postural asymmetry.

Forsch Komplement Med. 2004 Apr;11(2):93-97.  [Article in German]
Osteopathic versus orthopedic treatments for chronic epicondylopathia humeri radialis: a randomized controlled trial
Geldschläger S.

BACKGROUND: The Epicondylopathia humeri radialis is mainly caused by an overload of the extensor muscles of the hand, the afflicted side is generally the dominant hand. There is a multitude of treatment methods, none of them, however, can guarantee success. OBJECTIVE: Can an osteopathic treatment of the chronic Epicondylopathia humeri radialis reduce the pain more effectively than an orthopedic treatment? STUDY DESIGN: Randomized controlled clinical study.
MATERIAL AND METHODS: 53 patients were randomly distributed among examination and control group. They were treated for 8 weeks. The osteopathic treatment was done exclusively manually, with parietal, visceral, and craniosacral techniques, individually chosen for each patient. The orthopedic treatment was performed with chiropractic techniques, antiphlogistics, and mostly with injections of cortison. Four common tests were used, all 4 valuing pain and development of power: pressure pain test, Thomsen test, middle finger extension test, and test for strength. Additionally a questionnaire about the attendant circumstances of the chronic Epicondylopathia humeri radialis was raised. RESULTS: Subjective pain sensation reduced from 50% to 33% (p < 0.01) in the intervention group and from 48% to 32% (p = 0.03) in the orthopedic group. A reduction of pain as well as an increase of power could be measured. The difference between the two treatment methods, however, was not statistically significant.
CONCLUSIONS: In this study it was possible to successfully treat the chronic Epicondylopathia humeri radialis with an osteopathic approach. A significant difference to an orthopedic treatment could not be proved.

Forsch Komplement Med. 1999 Dec;6(6):302-10.  [Article in German]
Evaluation and critical review published in the European literature on osteopathic studies in the clinical field and in the area of fundamental research
Schwerla F, Hass-Degg K, Schwerla B.

OBJECTIVE: Identification of studies of osteopathic treatment in defined countries. Evaluation of methods and results of the studies and assessment of the available evidence concerning the effectiveness of osteopathy.
STUDY DESIGN: Systematic review. Assessment of the quality of the studies, with respect to the osteopathic concept and current methodological criteria according to predefined keys.
DATA SOURCES: Clinical trials and fundamental studies originating from Germany, England, Austria, The Netherlands, Scandinavia +/- published or unpublished.
RESULTS: Out of a total of 30 studies retrieved, 9 reached the predetermined minimum number of points to be rated into quality categories. In 2 of these studies the osteopathic treatment was more effective than the control intervention (p < 0.05).
CONCLUSIONS: No definitive conclusions about the effectiveness of osteopathy can be drawn so far because of the low number of evaluated studies. It seems necessary to scrutinize the relevance of osteopathy through further methodologically adequate studies. Additionally, criteria for evaluation are proposed which correspond to the highest international standards in order to ensure a valid (and commonly accepted) evaluation of the osteopathic literature.