NCT01020435

Chiropractic for Hypertension in Patients

Upper Cervical Manipulation for Patients With Stage 1 Hypertension

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Palmer College of Chiropractic · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose a prospective randomized 2 arm parallel observer-blinded phase II clinical study comparing a distinct method of upper cervical chiropractic manipulation to a sham technique in 50 individuals with stage I hypertension (systolic blood pressure (SBP): 140-159 mm Hg; diastolic blood pressure (DBP):90-99 mm Hg).

Detailed description

More than 50 million Americans suffer from hypertension, a disease with far-reaching public health impact causing or contributing to 7.1 million deaths yearly at an estimated annual incremental direct cost of $54 billion per year. Common treatments include antihypertensive medications and lifestyle modifications. While these treatments have been shown to be effective, only about 30% of hypertensive patients achieve blood pressure goals. Based on a recently published study (Bakris et al, 2007), one unique non-pharmaceutical approach may be a non-rotary type of upper cervical spinal manipulation to align the first cervical vertebra (atlas) performed by a doctor of chiropractic. We propose to conduct a similar study with a more commonly known chiropractic technique called Toggle Recoil. We propose a prospective randomized 2 arm parallel observer-blinded phase II clinical study comparing a distinct method of upper cervical chiropractic manipulation to a sham technique in 50 (25 in each group) individuals with Stage I hypertension (systolic blood pressure (SBP); 140-159 mm Hg or diastolic blood pressure (DBP):90-99 mm Hg). Patients will be seen by doctors of chiropractic twice each week for 6 weeks and outcomes will be collected at baseline, 3 weeks, and 6 weeks after enrollment. The primary outcome measure will be change in SBP and the primary endpoint will be at the week 6 assessment.

Conditions

• Hypertension

Interventions

Type	Name	Description
OTHER	Spinal Manipulation	The procedure in its broadest definition describes the application of a load (force or displacement) to specific body tissues (usually vertebral joints) with therapeutic intent. The mechanical characteristics of SM can vary in terms of its duration and amplitude, (hence, the rate at which it is applied), as well as its anatomical location, choice of levers, direction of force application, and the vehicle used to apply the force (manually or mechanically assisted).
OTHER	Sham Spinal Manipulation	The sham assessment procedures will be the same as those in the high velocity treatment group. The sham intervention is identical to this treatment protocol except for the placement of the treating clinicians pisiform contact. The force and vector applied will be the same.

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-04-01
• Completion: 2012-05-01
• First posted: 2009-11-25
• Last updated: 2018-02-07
• Results posted: 2018-02-07

Locations

1 site across 1 country: United States