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Chiropractic for Hypertension in Patients (CHiP)

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ClinicalTrials.gov Identifier: NCT01020435
Recruitment Status : Completed
First Posted : November 25, 2009
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Palmer College of Chiropractic

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Other: Spinal Manipulation
Other: Sham Spinal Manipulation

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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 the 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.

Spinal Manipulation is 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, 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).

Sham Spinal Manipulation

The sham assessment procedures will be similar to the active group. It has been developed and validated by Vernon et al.

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.


Participant Flow:   Overall Study
    Spinal Manipulation High Velocity   Sham Spinal Manipulation
STARTED   24   27 
COMPLETED   24   26 
NOT COMPLETED   0   1 
Lost to Follow-up                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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 the 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.

Spinal Manipulation is 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, 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).

Sham Spinal Manipulation

The sham assessment procedures will be similar to the active group. It has been developed and validated by Vernon et al.

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.

Total Total of all reporting groups

Baseline Measures
   Spinal Manipulation High Velocity   Sham Spinal Manipulation   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   27   51 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.6  (8.5)   54.9  (12.1)   56.2  (10.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  37.5%      12  44.4%      21  41.2% 
Male      15  62.5%      15  55.6%      30  58.8% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White   22   20   42 
Black   2   5   7 
Other   0   2   2 


  Outcome Measures

1.  Primary:   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 ]

2.  Other Pre-specified:   Number of Participants Who Were Recruited, Consented, Enrolled/Randomized, and Retained for the Duration of the Study   [ Time Frame: 19 months ]

3.  Other Pre-specified:   Study Duration From Launch Date to Final Outcomes   [ Time Frame: 19 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Christine M Goertz, DC, PhD (Study Principal Investigator)
Organization: Palmer College of Chiropractic
phone: 563-884-5150
e-mail: christine.goertz@palmer.edu


Publications of Results:
Other Publications:

Responsible Party: Palmer College of Chiropractic
ClinicalTrials.gov Identifier: NCT01020435     History of Changes
Obsolete Identifiers: NCT01230372
Other Study ID Numbers: CHiP
First Submitted: November 24, 2009
First Posted: November 25, 2009
Results First Submitted: April 18, 2017
Results First Posted: February 7, 2018
Last Update Posted: February 7, 2018