Chiropractic for Hypertension in Patients (CHiP)
|ClinicalTrials.gov Identifier: NCT01020435|
Recruitment Status : Completed
First Posted : November 25, 2009
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Other: Spinal Manipulation Other: Sham Spinal Manipulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Upper Cervical Manipulation for Patients With Stage 1 Hypertension|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||May 2012|
Active Comparator: Spinal Manipulation High Velocity
This non-rotary upper cervical procedure uses an impulse thrust with a controlled depth (high velocity). The participant's head is supported by a specially designed cushion and the doctor usually approaches the participant from in front of his or her head to contact soft tissue over the atlas transverse process, posterior to the lateral mass or occasionally on the C2 lamina or spinous process, with the pisiform process of one hand. The thrust is delivered by a contraction of the triceps muscles of both arms, which straightens the arms and applies the thrust to the participant.
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).
Placebo Comparator: Sham Spinal Manipulation
The sham assessment procedures will be similar to the active group. It has been developed and validated by Vernon et al.
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.
Other Name: Sham
- Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 [ Time Frame: Baseline after 1, 3, and 6 Weeks of treatment ]
To estimate the effect size and variability of change in systolic (SBP) and/or diastolic blood pressure (DBP) over a six week treatment period to use in planning a full-scale randomized controlled trial and to assess the believability of the placebo manipulation.
The table shows the unadjusted and adjusted mean change in SBP and DBP from baseline to after Treatment 1 (Tx 1), 3 (Wk 3), and 6 (Wk 6) Weeks.
Adjusted values were adjusted for age, sex, BMI, and respective baseline blood pressure.
Wk 3 and Wk 6 DBP were also adjusted for stage of blood pressure (prehypertension or Stage 1 hypertension).
- Number of Participants Who Were Recruited, Consented, Enrolled/Randomized, and Retained for the Duration of the Study [ Time Frame: 19 months ]To assess the feasibility of conducting a full-scale randomized controlled trial to evaluate the efficacy of Toggle Recoil chiropractic manipulation for patients with stage I hypertension. Feasibility measured by: patient recruitment, enrollment, and retention, and duration of study from launch date to final outcomes.
- Study Duration From Launch Date to Final Outcomes [ Time Frame: 19 months ]To assess the feasibility of conducting a full-scale randomized controlled trial to evaluate the efficacy of Toggle Recoil chiropractic manipulation for patients with stage I hypertension. Feasibility measured by and duration of study from launch date to final outcomes.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020435
|United States, Iowa|
|Palmer College of Chirpractic|
|Davenport, Iowa, United States, 52803|
|Principal Investigator:||Christine M Goertz, DC, PhD||Palmer College of Chiropractic|