Practice-based randomized controlled-comparison clinical trial of chiropractic adjustments and brief massage treatment at sites of subluxation in subjects with essential hypertension: pilot study.
OBJECTIVE
To determine the feasibility of conducting a randomized clinical trial in the private practice setting examining short- and long-term effects of chiropractic adjustments for subjects with essential hypertension compared with a brief soft tissue massage, as well as a nontreatment control group.


METHODS
Randomized controlled-comparison trial with 3 parallel groups.


METHODS
Private practice outpatient chiropractic clinic.


METHODS
Twenty-three subjects, aged 24 to 50 years with systolic or diastolic essential hypertension.


METHODS
Two months of full-spine chiropractic care (ie, Gonstead) consisting primarily of specific-contact, short-lever-arm adjustments delivered at motion segments exhibiting signs of subluxation. The massage group had a brief effleurage procedure delivered at localized regions of the spine believed to be exhibiting signs of subluxation. The nontreatment control group rested alone for a period of approximately 5 minutes in an adjustment room.


METHODS
Cost per enrolled subject, as well as systolic and diastolic blood pressure (BP) measured with a random-0 sphygmomanometer and patient reported health status (SF-36). Pilot study outcome measures also included an assessment of cooperation of subjects to randomization procedures and drop-out rates, recruitment effectiveness, analysis of temporal stability of BPs at the beginning of care, and the effects of inclusion/exclusion criteria on the subject pool.


RESULTS
Thirty subjects enrolled, yielding a cost of $161 per enrolled subject. One subject was later determined to be ineligible, and 6 others dropped out. In both the chiropractic and massage therapy groups, all subjects were classified as either overweight or obese; in the control group there were only 2 classified as such. SF-36 profiles for the groups were similar to that of a normal population. The mean change in diastolic BP was -4 (95% confidence interval [CI]: -8.6, 0.5) in the chiropractic care group, 0.5 (95% CI: -3.5, 4.5) in the brief massage treatment group, and -4.9 (95% CI: -9.7, -0.1) in the no treatment control group. At the end of the study period, this change was -6.3 (95% CI: 13.1, 0.4), -1.0 (95% CI: -7.5, 15.6), -7.2 (95% CI: -13.3, -1.1) in the 3 study groups. The mean improvements in the chiropractic care and no treatment control groups remained consistent over the follow-up period.


CONCLUSIONS
This pilot study elucidated several procedural issues that should be addressed before undertaking a full-scale clinical trial on the effects of chiropractic adjustments in patients with essential hypertension. A multidisciplinary approach to recruitment may need to be used in any future efforts because of the limited subject pool of patients who have hypertensive disease but are not taking medications for its control. Measures need to be used to assure comparable groups regarding prognostic variables such as weight. Studies such as these demonstrate the feasibility of conducting a full-scale 3-group randomized clinical trial in the private practice setting.
Plaugher
Gregory
G
Director of Research, Life Chiropractic College West, 25001 Industrial Boulevard, Hayward, CA 94545, USA.
Long
Cynthia R
CR
Alcantara
Joel
J
Silveus
Alyssa D
AD
Wood
Herbert
H
Lotun
Kapildeo
K
Menke
J Michael
JM
Meeker
William C
WC
Rowe
Stephen H
SH
D000328:Adult; D000959:Antihypertensive Agents / Q000009:adverse effects; D003971:Diastole; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy / Q000209:etiology* / Q000503:physiopathology / Q000628:therapy*; D004204:Joint Dislocations / Q000150:complications / Q000628:therapy; D008297:Male; D026882:Manipulation, Chiropractic / Q000191:economics / Q000379:methods; D008405:Massage / Q000379:methods; D008875:Middle Aged; D010865:Pilot Projects; D011788:Quality of Life; D012107:Research Design; D012720:Severity of Illness Index; D019722:Sphygmomanometers; D013122:Spinal Diseases / Q000150:complications* / Q000628:therapy*; D013599:Systole; D016896:Treatment Outcome
D000959:Antihypertensive Agents