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

Gregory Plaugher, Cynthia R. Long, Joel Alcantara, Alyssa D. Silveus, Herbert Wood, Kapildeo Lotun, J. Michael Menke, William C. Meeker, Stephen H. Rowe

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

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. Design: Randomized controlled-comparison trial with 3 parallel groups. Setting: Private practice outpatient chiropractic clinic. Patients: Twenty-three subjects, aged 24 to 50 years with systolic or diastolic essential hypertension. Interventions: 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. Main Outcome Measures: 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.

Original languageEnglish (US)
Pages (from-to)221-239
Number of pages19
JournalJournal of Manipulative and Physiological Therapeutics
Volume25
Issue number4
DOIs
StatePublished - May 2002
Externally publishedYes

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Chiropractic Manipulation
Massage
Chiropractic
Randomized Controlled Trials
Confidence Intervals
Private Practice
Control Groups
Blood Pressure
Spine
Therapeutics
Outcome Assessment (Health Care)
Sphygmomanometers
Costs and Cost Analysis
Random Allocation
Ambulatory Care Facilities
Health Status
Essential Hypertension
Clinical Trials
Weights and Measures

Keywords

  • Cervical Vertebrae
  • Chiropractic
  • Hypertension
  • Lumbar Vertebrae
  • Pelvis
  • Pilot Study
  • Randomized Clinical Trial

ASJC Scopus subject areas

  • Physical Therapy, Sports Therapy and Rehabilitation
  • Health Professions(all)
  • Nursing(all)

Cite this

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. / Plaugher, Gregory; Long, Cynthia R.; Alcantara, Joel; Silveus, Alyssa D.; Wood, Herbert; Lotun, Kapildeo; Menke, J. Michael; Meeker, William C.; Rowe, Stephen H.

In: Journal of Manipulative and Physiological Therapeutics, Vol. 25, No. 4, 05.2002, p. 221-239.

Research output: Contribution to journalArticle

Plaugher, Gregory ; Long, Cynthia R. ; Alcantara, Joel ; Silveus, Alyssa D. ; Wood, Herbert ; Lotun, Kapildeo ; Menke, J. Michael ; Meeker, William C. ; Rowe, Stephen H. / 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. In: Journal of Manipulative and Physiological Therapeutics. 2002 ; Vol. 25, No. 4. pp. 221-239.
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T1 - Practice-based randomized controlled-comparison clinical trial of chiropractic adjustments and brief massage treatment at sites of subluxation in subjects with essential hypertension

T2 - Pilot study

AU - Plaugher, Gregory

AU - Long, Cynthia R.

AU - Alcantara, Joel

AU - Silveus, Alyssa D.

AU - Wood, Herbert

AU - Lotun, Kapildeo

AU - Menke, J. Michael

AU - Meeker, William C.

AU - Rowe, Stephen H.

PY - 2002/5

Y1 - 2002/5

N2 - 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. Design: Randomized controlled-comparison trial with 3 parallel groups. Setting: Private practice outpatient chiropractic clinic. Patients: Twenty-three subjects, aged 24 to 50 years with systolic or diastolic essential hypertension. Interventions: 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. Main Outcome Measures: 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.

AB - 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. Design: Randomized controlled-comparison trial with 3 parallel groups. Setting: Private practice outpatient chiropractic clinic. Patients: Twenty-three subjects, aged 24 to 50 years with systolic or diastolic essential hypertension. Interventions: 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. Main Outcome Measures: 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.

KW - Cervical Vertebrae

KW - Chiropractic

KW - Hypertension

KW - Lumbar Vertebrae

KW - Pelvis

KW - Pilot Study

KW - Randomized Clinical Trial

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