Christine M Goertz1, Stacie A Salsbury2, Robert D Vining3, Cynthia R Long4, Katherine A Pohlman5, William B Weeks6, Gervasio A Lamas7. 1. Vice Chancellor for Research & Health Policy, Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, IA. Electronic address: christine.goertz@palmer.edu. 2. Assistant Professor, Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, IA. 3. Associate Professor and Senior Research Clinician, Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, IA. 4. Professor, Director of Research, Davenport Campus, Director, Office of Data Management & Biostatistics, Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, IA. 5. Assistant Professor and Clinical Research Scientist, Parker University, Dallas, TX. 6. Professor, Geisel School of Medicine at Dartmouth College, Hanover, NH; Professor, The Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH; Chair, Clinical and Health Services Research, Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, IA. 7. Chairman of Medicine, Chief of Cardiology, Professor of Medicine, Mount Sinai Medical Center, Miami Beach, FL, USA; Columbia University Medical Center, New York, NY.
Abstract
OBJECTIVE: The purpose of this pilot sham-controlled clinical trial was to estimate the treatment effect and safety of toggle recoil spinal manipulation for blood pressure management. METHODS:Fifty-one participants with prehypertension or stage 1 hypertension (systolic blood pressure ranging from 135 to 159 mmHg or diastolic blood pressure ranging from 85 to 99 mm Hg) were allocated by an adaptive design to 2 treatments: toggle recoil spinal manipulation or a sham procedure. Participants were seen by a doctor of chiropractic twice weekly for 6 weeks and remained on their antihypertensive medications, as prescribed, throughout the trial. Blood pressure was assessed at baseline and after study visits 1, 6 (week 3), and 12 (week 6), with the primary end point at week 6. Analysis of covariance was used to compare mean blood pressure changes from baseline between groups at each end point, controlling for sex, age, body mass index, and baseline blood pressure. RESULTS: Adjusted mean change from baseline to week 6 was greater in the sham group (systolic, -4.2 mm Hg; diastolic, -1.6 mm Hg) than in the spinal manipulation group (systolic, 0.6 mm Hg; diastolic, 0.7 mm Hg), but the difference was not statistically significant. No serious and few adverse events were noted. CONCLUSIONS: Six weeks of toggle recoil spinal manipulation did not lower systolic or diastolic blood pressure when compared with a sham procedure. No serious adverse events from either treatment were reported. Our results do not support a larger clinical trial. Further research to understand the potential mechanisms of action involving upper cervical manipulation on blood pressure is warranted before additional clinical investigations are conducted.
RCT Entities:
OBJECTIVE: The purpose of this pilot sham-controlled clinical trial was to estimate the treatment effect and safety of toggle recoil spinal manipulation for blood pressure management. METHODS: Fifty-one participants with prehypertension or stage 1 hypertension (systolic blood pressure ranging from 135 to 159 mm Hg or diastolic blood pressure ranging from 85 to 99 mm Hg) were allocated by an adaptive design to 2 treatments: toggle recoil spinal manipulation or a sham procedure. Participants were seen by a doctor of chiropractic twice weekly for 6 weeks and remained on their antihypertensive medications, as prescribed, throughout the trial. Blood pressure was assessed at baseline and after study visits 1, 6 (week 3), and 12 (week 6), with the primary end point at week 6. Analysis of covariance was used to compare mean blood pressure changes from baseline between groups at each end point, controlling for sex, age, body mass index, and baseline blood pressure. RESULTS: Adjusted mean change from baseline to week 6 was greater in the sham group (systolic, -4.2 mm Hg; diastolic, -1.6 mm Hg) than in the spinal manipulation group (systolic, 0.6 mm Hg; diastolic, 0.7 mm Hg), but the difference was not statistically significant. No serious and few adverse events were noted. CONCLUSIONS: Six weeks of toggle recoil spinal manipulation did not lower systolic or diastolic blood pressure when compared with a sham procedure. No serious adverse events from either treatment were reported. Our results do not support a larger clinical trial. Further research to understand the potential mechanisms of action involving upper cervical manipulation on blood pressure is warranted before additional clinical investigations are conducted.
Authors: Matthew Fernandez; Craig Moore; Wenbo Peng; Katie de Luca; Katherine A Pohlman; Michael Swain; Jon Adams Journal: Chiropr Man Therap Date: 2019-04-17