43 research outputs found
Validation of Placebo in a Manual Therapy Randomized Controlled Trial
No full textAt present, no consensus exists among clinical and academic experts regarding an appropriate placebo for randomized controlled trials (RCTs) of spinal manipulative therapy (SMT). Therefore, we investigated whether it was possible to conduct a chiropractic manual-therapy RCT with placebo. Seventy migraineurs were randomized to a single-blinded placebo-controlled clinical trial that consisted of 12 treatment sessions over 3 months. The participants were randomized to chiropractic SMT or placebo (sham manipulation). After each session, the participants were surveyed on whether they thought they had undergone active treatment (“yes” or “no”) and how strongly they believed that active treatment was received (numeric rating scale 0–10). The outcome measures included the rate of successful blinding and the certitude of the participants’ beliefs in both treatment groups. At each treatment session, more than 80% of the participants believed that they had undergone active treatment, regardless of group allocation. The odds ratio for believing that active treatment was received was >10 for all treatment sessions in both groups (all p < 0.001). The blinding was maintained throughout the RCT. Our results strongly demonstrate that it is possible to conduct a single-blinded manual-therapy RCT with placebo and to maintain the blinding throughout 12 treatment sessions given over 3 months
Adverse events in a chiropractic spinal manipulative therapy single-blinded, placebo, randomized controlled trial for migraineurs
No full textBackground Unlike pharmacological randomized controlled trials (RCTs), manual-therapy RCTs do not always report adverse events (AEs). The few manual-therapy RCTs that provide information on AEs are frequently without details, such as the type and-, severity of the AE and reason for withdrawal.
Objective To prospectively report all AEs in a chiropractic spinal manipulative therapy (CSMT) RCT.
Design A prospective 3-armed, single-blinded, placebo, RCT.
Methods Seventy migraineurs were randomized to the CSMT or a placebo, with 12 intervention sessions over three months. The recommendations by CONSORT and the International Headache Society's Task Force on AEs in migraine RCTs were followed. A standardized reporting scheme designed for pharmacological RCTs was used, and the AEs were described as frequencies and percentages within each group. The 95% confidence intervals (CIs) for the percentages (absolute risk) of AEs in each group were calculated when possible. Attributable risk (%) and relative risk were calculated with the corresponding 95% CIs.
Results AEs were assessed in 703 sessions, with 355 in the CSMT group and 348 in the placebo group. Local tenderness was the most common AE, reported by 11.3% and 6.9% of the CSMT group and the placebo group, respectively, and tiredness on the intervention day was reported by 8.5% and 1.4% of CSMT group and the placebo group, respectively. The highest attributable risk was for tiredness on the treatment day, 7.0% (CI 3.9–10.2%) which presented a relative risk of 5.9 (CI 2.3–15.0).
Conclusions AEs were mild and transient, and severe or serious AEs were not observed
Chiropractic spinal manipulative therapy for migraine: a three-armed, single-blinded, placebo, randomized controlled trial
No full textBackground and purpose To investigate the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraineurs.
Methods This was a prospective three-armed, single-blinded, placebo, randomized controlled trial (RCT) of 17 months duration including 104 migraineurs with at least one migraine attack per month. The RCT was conducted at Akershus University Hospital, Oslo, Norway. Active treatment consisted of CSMT, whereas placebo was a sham push manoeuvre of the lateral edge of the scapula and/or the gluteal region. The control group continued their usual pharmacological management. The RCT consisted of a 1-month run-in, 3 months intervention and outcome measures at the end of the intervention and at 3, 6 and 12 months follow-up. The primary end-point was the number of migraine days per month, whereas secondary end-points were migraine duration, migraine intensity and headache index, and medicine consumption.
Results Migraine days were significantly reduced within all three groups from baseline to post-treatment (P 0.025 for interaction). Migraine duration and headache index were reduced significantly more in the CSMT than the control group towards the end of follow-up (P = 0.02 and P = 0.04 for interaction, respectively). Adverse events were few, mild and transient. Blinding was strongly sustained throughout the RCT.
Conclusions It is possible to conduct a manual-therapy RCT with concealed placebo. The effect of CSMT observed in our study is probably due to a placebo response
Chiropractic spinal manipulative therapy for migraine: a study protocol of a single-blinded placebo-controlled randomised clinical trial
No full textIntroduction Migraine affects 15% of the population, and has substantial health and socioeconomic costs. Pharmacological management is first-line treatment. However, acute and/or prophylactic medicine might not be tolerated due to side effects or contraindications. Thus, we aim to assess the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraineurs in a single-blinded placebo-controlled randomised clinical trial (RCT).
Method and analysis According to the power calculations, 90 participants are needed in the RCT. Participants will be randomised into one of three groups: CSMT, placebo (sham manipulation) and control (usual non-manual management). The RCT consists of three stages: 1 month run-in, 3 months intervention and follow-up analyses at the end of the intervention and 3, 6 and 12 months. The primary end point is migraine frequency, while migraine duration, migraine intensity, headache index (frequency x duration x intensity) and medicine consumption are secondary end points. Primary analysis will assess a change in migraine frequency from baseline to the end of the intervention and follow-up, where the groups CSMT and placebo and CSMT and control will be compared. Owing to two group comparisons, p values below 0.025 will be considered statistically significant. For all secondary end points and analyses, a p value below 0.05 will be used. The results will be presented with the corresponding p values and 95% CIs.
Ethics and dissemination The RCT will follow the clinical trial guidelines from the International Headache Society. The Norwegian Regional Committee for Medical Research Ethics and the Norwegian Social Science Data Services have approved the project. Procedure will be conducted according to the declaration of Helsinki. The results will be published at scientific meetings and in peer-reviewed journals
Trophoniella radesiensis Chaibi & Antit & Bouhedi & Meca & Gillet & Azzouna & Martin 2019, n. sp.
No full textTrophoniella radesiensis n. sp. Chaibi and Gillet Figures 3–6 urn:lsid:zoobank.org:act: D7C85C70-87FF-4AF4-8599-A8462B3FB8B1 Material examined. Holotype: MNCN16.01 /18453, collected on 25 Nov 2015 in Radés Station, Gulf of Tunis (15°55′ N, 97°41′ W) by the first author. Paratypes: MNCN 16.01 /18454. 6 specimens, same data as for holotype; UCO T FLA 025.1specimen, same data as for holotype. Diagnosis. Body covered by sediments of different grain size (50–1000 µm of long axe) embedded on tunic, completely concealed except in posterior region. Tunic pale, dorsally smooth, ventrally rough, with large papillae, carrying sediment grains and particles. Body papillae arranged in two dorsal and four ventral rows. Branchial plate tongue-shaped. Unidentate anchylosed neurohooks from chaetiger 20. Description. Holotype with some chaetae broken, non-reproductive adult, unknown sex. 35 mm long, 4 mm wide, with 60 chaetigers; paratypes varying from 30–43 mm long and 1–4 mm wide for 43–74 chaetigers (Fig. 3 A– E). Anterior body sub-cylindrical in cross-section, tapering towards pygidium. Tunic transparent, dorsally smooth, ventrally rough with large papillae, carrying sediment grains and particles with long axes ranging from 50 to 1000 µm, totally embedded in tunic, completely concealing it dorsally and ventrally, absent in posterior region. Pale brown, slightly reddish anteriorly. Cephalic cage 12 mm long, with chaetae ca. 1.5 times longer than body width, formed by chaetigers 1–5; chaetiger 2 dorsolateral, chaetiger 3–4 lateral. Chaetal transition from cephalic cage to body chaetae gradual (Fig. 3A, 3 C–E). Body papillae similar in colour to body wall, mostly eroded, arising in two dorsal and four ventral longitudinal rows from first chaetiger to posterior end, better preserved anterior-most body region (Fig. 3A, 3 C–E). Parapodia well developed. Noto and neuropodia have four prechaetal papillae and five postchaetal papillae (Fig. 3C). Especially long papillae absent from anterior chaetigers. Gonopodial papillae not seen. Chaetiger 1 with about six notochaetae and eight neurochaetae; anterior dorsal margin with dorsal papillae, arising as a multifid cephalic veil (Fig. 4A). Chaetiger 5 widening posteriorly. Cephalic hood not exposed. Caruncle short and triangular (Fig. 4C, 4D). Branchiae cirriform, arising from tongue-shaped branchial plate, arranged in two lateral lobes (Fig. 4A, 4D), thin, long (0.5–3mm), whitish once preserved in ethanol, with ca. 60 filaments. Palp, long, corrugated, pale, as long as largest branchiae, 6 mm long (Fig. 4B, 4C). Prostomium lowcone, with two large and two small black eyes (Fig. 3D, 3E). Lateral lip expanded; dorsal and ventral lips not well developed (Fig. 3D, 3E). Notochaetae all multiarticulated capillaries; articles progressively longer towards falcate tips; medial ones in short longitudinal series, 4–7 per bundle; some yellowish some dark brown; unidentate tips (Fig. 5 A–5D). Multiarticulated capillary neurochaeta from chaetiger 2 to 5, then short unidentate neurohooks from chaetiger 6 to 19 (Fig. 6A) and anchylosed hooks from chaetiger 20 to body end (Fig. 6B), darker than preceding ones, arranged in transverse series of 4–6 units per bundle, similarly wide along their length, subdistally not or slightly expanded, with short rings continued up to a subdistal, non-annulated hyaline region, hooked, tapering to roughly pointed, unidentate tips (Fig. 5A, 6B). Pygidium simple, with single anal cirrus. No intra-specific variability in morphological characters was observed, except for lacking sediment gains in some specimens. Distribution. Known only from the type locality, Radés Station (Gulf of Tunisia, Mediterranean Sea). Collected from both soft and rocky bottoms, from 3–4 m to 10 m depth. Etymology. The species name radesiensis refers to the type locality, Radés Station.Published as part of Chaibi, Marwa, Antit, Mouna, Bouhedi, Marwa, Meca, Miguel A., Gillet, Patrick, Azzouna, Atf & Martin, Daniel, 2019, A new species of Flabelligeridae (Annelida), Trophoniella radesiensis n. sp., from Tunisia, pp. 551-561 in Zootaxa 4571 (4) on pages 554-556, DOI: 10.11646/zootaxa.4571.4.7, http://zenodo.org/record/261426
Manual therapies for cervicogenic headache: a systematic review
No full textThis paper systematically reviewed randomized clinical trials (RCT) assessing the efficacy of manual therapies for cervicogenic headache (CEH). A total of seven RCTs were identified, i.e. one study applied physiotherapy ± temporomadibular mobilization techniques and six studies applied cervical spinal manipulative therapy (SMT). The RCTs suggest that physiotherapy and SMT might be an effective treatment in the management of CEH, but the results are difficult to evaluate, since only one study included a control group that did not receive treatment. Furthermore, the RCTs mostly included participant with infrequent CEH. Future challenges regarding CEH are substantial both from a diagnostic and management point of view.
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Chiropractic spinal manipulative treatment of migraine headache of 40-year duration using Gonstead method: a case study
No full textChiropractic spinal manipulative treatment of cervicogenic dizziness using Gonstead method: a case study
No full textManual therapies for primary chronic headaches: a systematic review of randomized controlled trials
No full textThis is to our knowledge the first systematic review regarding the efficacy of manual therapy randomized clinical trials (RCT) for primary chronic headaches. A comprehensive English literature search on CINHAL, Cochrane, Medline, Ovid and PubMed identified 6 RCTs all investigating chronic tension-type headache (CTTH). One study applied massage therapy and five studies applied physiotherapy. Four studies were considered to be of good methodological quality by the PEDro scale. All studies were pragmatic or used no treatment as a control group, and only two studies avoided co-intervention, which may lead to possible bias and makes interpretation of the results more difficult. The RCTs suggest that massage and physiotherapy are effective treatment options in the management of CTTH. One of the RCTs showed that physiotherapy reduced headache frequency and intensity statistical significant better than usual care by the general practitioner. The efficacy of physiotherapy at post-treatment and at 6 months follow-up equals the efficacy of tricyclic antidepressants. Effect size of physiotherapy was up to 0.62. Future manual therapy RCTs are requested addressing the efficacy in chronic migraine with and without medication overuse. Future RCTs on headache should adhere to the International Headache Society’s guidelines for clinical trials, i.e. frequency as primary end-point, while duration and intensity should be secondary end-point, avoid co-intervention, includes sufficient sample size and follow-up period for at least 6 months
