Multimodal chiropractic care for migraine: A pilot randomized controlled trial

Cephalalgia ◽  
2020 ◽  
pp. 033310242096384
Author(s):  
Pamela M Rist ◽  
Carolyn Bernstein ◽  
Matthew Kowalski ◽  
Kamila Osypiuk ◽  
Julie P Connor ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Episodic Migraine ◽  
Chiropractic Care ◽  
Adult Women ◽  
Serious Adverse Events ◽  
Randomized Controlled ◽  
Migraine Frequency ◽  
Pilot Randomized Controlled Trial

Background Spinal manipulation may reduce migraine frequency, but effects of multimodal chiropractic care on migraine frequency have not been evaluated. Methods We conducted a pilot randomized controlled trial comparing multimodal chiropractic care + enhanced usual care (MCC+) versus enhanced usual care alone (EUC) among adult women with episodic migraine. EUC was comprised of usual medical care and migraine education literature. MCC+ participants received 10 sessions of chiropractic care over 14 weeks. Primary aims evaluated feasibility of recruitment, retention, protocol adherence, and safety. Change in migraine days was a secondary aim. Results Of 422 patients screened, 61 were randomized over 20 months. Fifty-seven (93%) completed daily migraine logs during the intervention, 51 (84%) completed final follow-up, and 45 (74%) completed all assessments. Twenty-four of 29 MCC+ participants (83%) attended > 75% of the chiropractic sessions. Ninety-eight non-serious adverse events were reported by 26 participants (43%) with 39 events among 11 EUC participants and 59 events among 15 MCC+ participants. MCC+ participants experienced greater reductions in migraine days (−2.9 days for MCC+ vs. −1.0 days for EUC, difference = −1.9; 95% confidence interval: −3.5, −0.4). Conclusions Pre-specified feasibility criteria were not met, but deficits were remediable. Preliminary data support a definitive trial of MCC+ for migraine. Trial Registration This study is registered at Clinicaltrials.gov (NCT03177616).

scholarly journals Protocolized Sedative Weaning vs Usual Care in Pediatric Critically Ill Patients: A Pilot Randomized Controlled Trial

2020 ◽  
Vol 24 (6) ◽  
pp. 451-458
Author(s):  
Duangtip Tiacharoen ◽  
Rojjanee Lertbunrian ◽  
Jarin Veawpanich ◽  
Nattanicha Suppalarkbunlue ◽  
Nattachai Anantasit
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Wristband Accelerometers to motiVate arm Exercises after Stroke (WAVES): a pilot randomized controlled trial

2019 ◽  
Vol 33 (8) ◽  
pp. 1391-1403 ◽  
Author(s):  
Ruth H Da-Silva ◽  
Sarah A Moore ◽  
Helen Rodgers ◽  
Lisa Shaw ◽  
Louise Sutcliffe ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Total Sample ◽  
Control Group ◽  
Intervention Participant ◽  
Serious Adverse Events ◽  
Post Stroke ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Objective: To evaluate the feasibility of a multicentre, observer-blind, pilot randomized controlled trial (RCT) of a wristband accelerometer with activity-dependent vibration alerts to prompt impaired arm use after stroke. Design: Parallel-group pilot RCT. Setting: Four English stroke services. Participants: Patients 0–3 months post stroke with a new arm deficit. Intervention: Participants were randomized to wear a prompting or ‘sham’ wristband during a four-week self-directed therapy programme with twice-weekly therapy review. Main outcomes: Recruitment, retention and adherence rates, safety and completion of assessments were reported. Arm recovery was measured by Action Research Arm Test (ARAT) and Motor Activity Log (MAL) without statistical comparison. Results: In total, 33 patients were recruited (0.6 per month/site; median time post stroke: 26 days (interquartile range (IQR):15.5–45)). Baseline, four-week and eight-week median (IQR) ARAT for the control group ( n = 19) were 15 (2–35), 35 (15–26) and 31 (21–55) and those for the intervention group (n = 14) were 37 (16–45), 57 (29–57) and 57 (37–57), respectively; for MAL Amount of Use, the corresponding values in the control group were 0.2 (0.0–1.2), 1.1 (0.3–2.9) and 1.2 (0.7–2.9) and in the intervention group were 1.4 (0.5–2.6), 3.8 (1.9–4.5) and 3.7 (2.1–4.3). Four participants withdrew from the study. Wristbands were worn for 79% of the recommended time. The intervention and control group participants received a median of 6.0 (IQR: 4.3–8.0) and 7.5 (IQR: 6.8–8.0) therapy reviews. A median of 8 (IQR: 6–10) prompts were delivered per intervention participant/day. Research assessments were completed for 28/29 and 25/28 patients at four and eight weeks. Eight serious adverse events were reported, all unrelated to the intervention. Conclusion: A multicentre RCT of wristband accelerometers to prompt arm activity early after stroke is feasible. A total sample of 108 participants would be required.

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