Trial Outcomes & Findings for Chiropractic for Hypertension in Patients (NCT NCT01020435)
NCT ID: NCT01020435
Last Updated: 2018-02-07
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
Baseline after 1, 3, and 6 Weeks of treatment
Results posted on
2018-02-07
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
27
|
|
Overall Study
COMPLETED
|
24
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Chiropractic for Hypertension in Patients
Baseline characteristics by cohort
| Measure |
Spinal Manipulation High Velocity
n=24 Participants
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
n=27 Participants
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
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
56.2 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline after 1, 3, and 6 Weeks of treatmentTo 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).
Outcome measures
| Measure |
Spinal Manipulation High Velocity
n=24 Participants
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
n=27 Participants
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.
|
|---|---|---|
|
Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6
Tx 1 - SBP (Adjusted)
|
-0.9 mmHg
Interval -4.5 to 2.8
|
-5.5 mmHg
Interval -9.0 to -2.1
|
|
Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6
Tx 1 - SBP (Unadjusted)
|
-1.2 mmHg
Interval -4.8 to 2.5
|
-5.3 mmHg
Interval -8.7 to -1.8
|
|
Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6
Tx 1 - DBP (Unadjusted)
|
0.8 mmHg
Interval -1.3 to 2.9
|
-1.7 mmHg
Interval -3.7 to 0.3
|
|
Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6
Wk 3 - SBP (Unadjusted)
|
-3.6 mmHg
Interval -7.8 to 0.7
|
-3.3 mmHg
Interval -7.4 to 0.8
|
|
Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6
Wk 3 - DBP (Unadjusted)
|
-2.4 mmHg
Interval -5.2 to 0.3
|
-2.2 mmHg
Interval -4.8 to 0.4
|
|
Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6
Wk 6 - SBP (Unadjusted)
|
-0.1 mmHg
Interval -4.0 to 3.8
|
-3.6 mmHg
Interval -7.3 to 0.2
|
|
Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6
Wk 6 - DBP (Unadjusted)
|
0.3 mmHg
Interval -2.2 to 2.9
|
-1.2 mmHg
Interval -3.6 to 1.3
|
|
Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6
Tx 1 - DBP (Adjusted)
|
1.4 mmHg
Interval -0.7 to 3.4
|
-2.2 mmHg
Interval -4.2 to -0.3
|
|
Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6
Wk 3 - SBP (Adjusted)
|
-3.0 mmHg
Interval -7.2 to 1.3
|
-3.9 mmHg
Interval -8.0 to 0.2
|
|
Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6
Wk 3 - DBP (Adjusted)
|
-1.8 mmHg
Interval -4.5 to 0.9
|
-2.8 mmHg
Interval -5.4 to -0.2
|
|
Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6
Wk 6 - SBP (Adjusted)
|
0.6 mmHg
Interval -3.1 to 4.3
|
-4.2 mmHg
Interval -7.8 to -0.6
|
|
Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6
Wk 6 - DBP (Adjusted)
|
0.7 mmHg
Interval -1.7 to 3.2
|
-1.6 mmHg
Interval -3.9 to 0.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 19 monthsPopulation: In this study, participants are not allocated to a treatment arm until they have met all eligibility criteria through the Final Case Review. Because of this it is not possible to report feasibility outcomes by treatment arm.
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.
Outcome measures
| Measure |
Spinal Manipulation High Velocity
n=681 Participants
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.
|
|---|---|---|
|
Number of Participants Who Were Recruited, Consented, Enrolled/Randomized, and Retained for the Duration of the Study
# Participants completed follow-up
|
50 # participants
|
—
|
|
Number of Participants Who Were Recruited, Consented, Enrolled/Randomized, and Retained for the Duration of the Study
# Participants screened via phone interview
|
681 # participants
|
—
|
|
Number of Participants Who Were Recruited, Consented, Enrolled/Randomized, and Retained for the Duration of the Study
# Participants consented at Baseline Visit 1
|
372 # participants
|
—
|
|
Number of Participants Who Were Recruited, Consented, Enrolled/Randomized, and Retained for the Duration of the Study
# Participants eligible for final case review
|
63 # participants
|
—
|
|
Number of Participants Who Were Recruited, Consented, Enrolled/Randomized, and Retained for the Duration of the Study
# Participants Enrolled/Randomized
|
51 # participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 19 monthsPopulation: 51 participants were enrolled; however, the table below shows the number enrolled and consented before the 51 were enrolled. The final row of data shows, 19, signifying the study duration in MONTHS (October 2010 - April 2012).
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.
Outcome measures
| Measure |
Spinal Manipulation High Velocity
n=681 Participants
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.
|
|---|---|---|
|
Study Duration From Launch Date to Final Outcomes
|
19 months
|
—
|
Adverse Events
Spinal Manipulation High Velocity*
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Sham Spinal Manipulation*
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Spinal Manipulation High Velocity*
n=24 participants at risk
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*
n=27 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
4.2%
1/24 • 6 weeks
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
3.7%
1/27 • 6 weeks
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Musculoskeletal and connective tissue disorders
Headache
|
8.3%
2/24 • 6 weeks
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/27 • 6 weeks
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Musculoskeletal and connective tissue disorders
Migraine
|
4.2%
1/24 • 6 weeks
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/27 • 6 weeks
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Musculoskeletal and connective tissue disorders
Headache and tenderness
|
4.2%
1/24 • 6 weeks
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/27 • 6 weeks
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck and back pain and fracture
|
4.2%
1/24 • 6 weeks
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/27 • 6 weeks
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
General disorders
Radiating symptoms
|
0.00%
0/24 • 6 weeks
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
7.4%
2/27 • 6 weeks
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
General disorders
Dizziness/imbalance/vertigo
|
0.00%
0/24 • 6 weeks
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
3.7%
1/27 • 6 weeks
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
General disorders
Hypertension
|
0.00%
0/24 • 6 weeks
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
3.7%
1/27 • 6 weeks
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
General disorders
Hypotension
|
4.2%
1/24 • 6 weeks
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/27 • 6 weeks
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
Additional Information
Christine M Goertz, DC, PhD (Study Principal Investigator)
Palmer College of Chiropractic
Phone: 563-884-5150
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place