Trial Outcomes & Findings for Effects of Chiropractic Care on Cytokine Levels in Multiple Sclerosis (NCT NCT04972929)
NCT ID: NCT04972929
Last Updated: 2026-07-20
Results Overview
Determine changes in serum inflammatory cytokine levels from baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
From baseline to after 8th treatment at 4 weeks
Results posted on
2026-07-20
Participant Flow
People with RRMS were recruited through advertisements distributed on the UAB campus, the local chapter of the National Multiple Sclerosis Society as well via clinicians at the UAB Multiple Sclerosis Center. Recruitment began in September 2023 and data collection ended in February 2025. Sixty-six people with MS were screened for eligibility, 26 met the inclusion criteria and provided informed consent.
Three participants withdrew before the baseline visit and two were excluded due to the physical exam/x-ray findings. All of the 21 participants that were included in the study completed the study.
Participant milestones
| Measure |
Thoracic Spinal Manipulation/Trigger Point Therapy Group
Participants in the chiropractic thoracic SM intervention group received thoracic spine palpation, soft tissue relaxation (trigger point therapy) and a manually delivered posterior-to-anterior high-velocity, low-amplitude (HVLA) spinal manipulation restricted to the thoracic spine while in a prone position
|
Sham-spinal Manipulation Group
Participants in the sham-SM group received thoracic spine palpation without soft tissue relaxation techniques and a simulated sham thoracic spinal manipulation designed to mimic the physical contact and clinician interaction of chiropractic treatment without delivering a therapeutic thrust. For the sham-SM, an Activator II device (Activator Methods®, Phoenix AZ) was used and set to zero force output) and placed onto the dorsal surface of the clinician's thumb, without direct instrument contact with the participant. A sham-SM was delivered at multiple non-vertebral trunk anatomical sites. The Activator II device is a spring-activated device that produces an audible clicking sound upon application but applies force at a zero setting. This method of sham-SM has been used in previous studies with slight variation, and serves as a control of participant-clinician physical contact, verbal interaction, and contextual factors during the office visit.
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|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Chiropractic Care on Cytokine Levels in Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Thoracic Spinal Manipulation/Trigger Point Therapy Group
n=11 Participants
Participants in the chiropractic thoracic SM intervention group received thoracic spine palpation, soft tissue relaxation (trigger point therapy) and a manually delivered posterior-to-anterior high-velocity, low-amplitude (HVLA) spinal manipulation restricted to the thoracic spine while in a prone position
|
Sham-spinal Manipulation Group
n=10 Participants
Participants in the sham-SM group received thoracic spine palpation without soft tissue relaxation techniques and a simulated sham thoracic spinal manipulation designed to mimic the physical contact and clinician interaction of chiropractic treatment without delivering a therapeutic thrust. For the sham-SM, an Activator II device (Activator Methods®, Phoenix AZ) was used and set to zero force output) and placed onto the dorsal surface of the clinician's thumb, without direct instrument contact with the participant. A sham-SM was delivered at multiple non-vertebral trunk anatomical sites. The Activator II device is a spring-activated device that produces an audible clicking sound upon application but applies force at a zero setting. This method of sham-SM has been used in previous studies with slight variation, and serves as a control of participant-clinician physical contact, verbal interaction, and contextual factors during the office visit.
|
Total
n=21 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 8.9 • n=20 Participants
|
41 years
STANDARD_DEVIATION 6.7 • n=20 Participants
|
42 years
STANDARD_DEVIATION 7.8 • n=40 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · white
|
6 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · black
|
5 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: From baseline to after 8th treatment at 4 weeksDetermined mean changes in serum inflammatory cytokine levels from baseline for each group
Outcome measures
| Measure |
Thoracic Spinal Manipulation/Trigger Point Therapy
n=11 Participants
Participants in the chiropractic thoracic SM intervention group received thoracic spine palpation, soft tissue relaxation (trigger point therapy) and a manually delivered posterior-to-anterior high-velocity, low-amplitude (HVLA) spinal manipulation restricted to the thoracic spine while in a prone position
|
Sham-spinal Manipulation
n=10 Participants
Participants in the sham-SM group received thoracic spine palpation without soft tissue relaxation techniques and a simulated sham thoracic spinal manipulation designed to mimic the physical contact and clinician interaction of chiropractic treatment without delivering a therapeutic thrust. For the sham-SM, an Activator II device (Activator Methods®, Phoenix AZ) was used and set to zero force output) and placed onto the dorsal surface of the clinician's thumb, without direct instrument contact with the participant. A sham-SM was delivered at multiple non-vertebral trunk anatomical sites. The Activator II device is a spring-activated device that produces an audible clicking sound upon application but applies force at a zero setting. This method of sham-SM has been used in previous studies with slight variation (48,49), and serves as a control of participant-clinician physical contact, verbal interaction, and contextual factors during the office visit.
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|---|---|---|
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IL-6 Serum Inflammatory Cytokine Levels
|
3.85 pg/mL
Standard Deviation 6.01
|
2.76 pg/mL
Standard Deviation 4.77
|
PRIMARY outcome
Timeframe: From baseline to after 8th treatment at 4 weeksDetermine changes in serum inflammatory cytokine levels from baseline
Outcome measures
| Measure |
Thoracic Spinal Manipulation/Trigger Point Therapy
n=11 Participants
Participants in the chiropractic thoracic SM intervention group received thoracic spine palpation, soft tissue relaxation (trigger point therapy) and a manually delivered posterior-to-anterior high-velocity, low-amplitude (HVLA) spinal manipulation restricted to the thoracic spine while in a prone position
|
Sham-spinal Manipulation
n=10 Participants
Participants in the sham-SM group received thoracic spine palpation without soft tissue relaxation techniques and a simulated sham thoracic spinal manipulation designed to mimic the physical contact and clinician interaction of chiropractic treatment without delivering a therapeutic thrust. For the sham-SM, an Activator II device (Activator Methods®, Phoenix AZ) was used and set to zero force output) and placed onto the dorsal surface of the clinician's thumb, without direct instrument contact with the participant. A sham-SM was delivered at multiple non-vertebral trunk anatomical sites. The Activator II device is a spring-activated device that produces an audible clicking sound upon application but applies force at a zero setting. This method of sham-SM has been used in previous studies with slight variation (48,49), and serves as a control of participant-clinician physical contact, verbal interaction, and contextual factors during the office visit.
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|---|---|---|
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IL-4 Serum Inflammatory Cytokine Levels
|
83.85 pg/ML
Standard Deviation 187.51
|
73.36 pg/ML
Standard Deviation 198.60
|
PRIMARY outcome
Timeframe: From baseline to after 8th treatment at 4 weeksDetermine changes in serum inflammatory cytokine levels from baseline
Outcome measures
| Measure |
Thoracic Spinal Manipulation/Trigger Point Therapy
n=11 Participants
Participants in the chiropractic thoracic SM intervention group received thoracic spine palpation, soft tissue relaxation (trigger point therapy) and a manually delivered posterior-to-anterior high-velocity, low-amplitude (HVLA) spinal manipulation restricted to the thoracic spine while in a prone position
|
Sham-spinal Manipulation
n=10 Participants
Participants in the sham-SM group received thoracic spine palpation without soft tissue relaxation techniques and a simulated sham thoracic spinal manipulation designed to mimic the physical contact and clinician interaction of chiropractic treatment without delivering a therapeutic thrust. For the sham-SM, an Activator II device (Activator Methods®, Phoenix AZ) was used and set to zero force output) and placed onto the dorsal surface of the clinician's thumb, without direct instrument contact with the participant. A sham-SM was delivered at multiple non-vertebral trunk anatomical sites. The Activator II device is a spring-activated device that produces an audible clicking sound upon application but applies force at a zero setting. This method of sham-SM has been used in previous studies with slight variation (48,49), and serves as a control of participant-clinician physical contact, verbal interaction, and contextual factors during the office visit.
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|---|---|---|
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IL-10 Serum Inflammatory Cytokine Levels
|
12.01 pg/ML
Standard Deviation 25.01
|
8.82 pg/ML
Standard Deviation 17.14
|
PRIMARY outcome
Timeframe: From baseline to after 8th treatment at 4 weeksDetermine changes in serum inflammatory cytokine levels from baseline
Outcome measures
| Measure |
Thoracic Spinal Manipulation/Trigger Point Therapy
n=11 Participants
Participants in the chiropractic thoracic SM intervention group received thoracic spine palpation, soft tissue relaxation (trigger point therapy) and a manually delivered posterior-to-anterior high-velocity, low-amplitude (HVLA) spinal manipulation restricted to the thoracic spine while in a prone position
|
Sham-spinal Manipulation
n=10 Participants
Participants in the sham-SM group received thoracic spine palpation without soft tissue relaxation techniques and a simulated sham thoracic spinal manipulation designed to mimic the physical contact and clinician interaction of chiropractic treatment without delivering a therapeutic thrust. For the sham-SM, an Activator II device (Activator Methods®, Phoenix AZ) was used and set to zero force output) and placed onto the dorsal surface of the clinician's thumb, without direct instrument contact with the participant. A sham-SM was delivered at multiple non-vertebral trunk anatomical sites. The Activator II device is a spring-activated device that produces an audible clicking sound upon application but applies force at a zero setting. This method of sham-SM has been used in previous studies with slight variation (48,49), and serves as a control of participant-clinician physical contact, verbal interaction, and contextual factors during the office visit.
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|---|---|---|
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IL-2 Serum Inflammatory Cytokine Levels
|
0.13 pg/mL
Standard Deviation 0.43
|
0.01 pg/mL
Standard Deviation 1.12
|
PRIMARY outcome
Timeframe: baseline to after 8th treatment at 4 weeksDetermine changes in serum inflammatory cytokine levels from baseline
Outcome measures
| Measure |
Thoracic Spinal Manipulation/Trigger Point Therapy
n=11 Participants
Participants in the chiropractic thoracic SM intervention group received thoracic spine palpation, soft tissue relaxation (trigger point therapy) and a manually delivered posterior-to-anterior high-velocity, low-amplitude (HVLA) spinal manipulation restricted to the thoracic spine while in a prone position
|
Sham-spinal Manipulation
n=10 Participants
Participants in the sham-SM group received thoracic spine palpation without soft tissue relaxation techniques and a simulated sham thoracic spinal manipulation designed to mimic the physical contact and clinician interaction of chiropractic treatment without delivering a therapeutic thrust. For the sham-SM, an Activator II device (Activator Methods®, Phoenix AZ) was used and set to zero force output) and placed onto the dorsal surface of the clinician's thumb, without direct instrument contact with the participant. A sham-SM was delivered at multiple non-vertebral trunk anatomical sites. The Activator II device is a spring-activated device that produces an audible clicking sound upon application but applies force at a zero setting. This method of sham-SM has been used in previous studies with slight variation (48,49), and serves as a control of participant-clinician physical contact, verbal interaction, and contextual factors during the office visit.
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|---|---|---|
|
TNFalpha Serum Inflammatory Cytokine
|
7.25 pg/ML
Standard Deviation 5.52
|
4.81 pg/ML
Standard Deviation 4.83
|
PRIMARY outcome
Timeframe: baseline and 8th treatment after 4 weeksMean change in serum from baseline and after 8 treatments
Outcome measures
| Measure |
Thoracic Spinal Manipulation/Trigger Point Therapy
n=11 Participants
Participants in the chiropractic thoracic SM intervention group received thoracic spine palpation, soft tissue relaxation (trigger point therapy) and a manually delivered posterior-to-anterior high-velocity, low-amplitude (HVLA) spinal manipulation restricted to the thoracic spine while in a prone position
|
Sham-spinal Manipulation
n=10 Participants
Participants in the sham-SM group received thoracic spine palpation without soft tissue relaxation techniques and a simulated sham thoracic spinal manipulation designed to mimic the physical contact and clinician interaction of chiropractic treatment without delivering a therapeutic thrust. For the sham-SM, an Activator II device (Activator Methods®, Phoenix AZ) was used and set to zero force output) and placed onto the dorsal surface of the clinician's thumb, without direct instrument contact with the participant. A sham-SM was delivered at multiple non-vertebral trunk anatomical sites. The Activator II device is a spring-activated device that produces an audible clicking sound upon application but applies force at a zero setting. This method of sham-SM has been used in previous studies with slight variation (48,49), and serves as a control of participant-clinician physical contact, verbal interaction, and contextual factors during the office visit.
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|---|---|---|
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IL-B Serum Cytokine Levels
|
3.11 pg/mL
Standard Deviation 3.59
|
2.15 pg/mL
Standard Deviation 3.00
|
SECONDARY outcome
Timeframe: From Baseline to after 8th treatment at 4 weeksDetermine changes in fatigue from baseline. It is a 9 item scale determining fatigue severity and its effect on a person's activities. The 9-item Fatigue Severity Scale (FSS) is a self-report questionnaire designed to measure the severity of fatigue and its impact on daily functioning over the past week. Respondents rate nine statements on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree). The scores for the nine statements are averaged to compute a total score ranging from 1 to 7, with higher average scores indicating greater fatigue severity.
Outcome measures
| Measure |
Thoracic Spinal Manipulation/Trigger Point Therapy
n=11 Participants
Participants in the chiropractic thoracic SM intervention group received thoracic spine palpation, soft tissue relaxation (trigger point therapy) and a manually delivered posterior-to-anterior high-velocity, low-amplitude (HVLA) spinal manipulation restricted to the thoracic spine while in a prone position
|
Sham-spinal Manipulation
n=10 Participants
Participants in the sham-SM group received thoracic spine palpation without soft tissue relaxation techniques and a simulated sham thoracic spinal manipulation designed to mimic the physical contact and clinician interaction of chiropractic treatment without delivering a therapeutic thrust. For the sham-SM, an Activator II device (Activator Methods®, Phoenix AZ) was used and set to zero force output) and placed onto the dorsal surface of the clinician's thumb, without direct instrument contact with the participant. A sham-SM was delivered at multiple non-vertebral trunk anatomical sites. The Activator II device is a spring-activated device that produces an audible clicking sound upon application but applies force at a zero setting. This method of sham-SM has been used in previous studies with slight variation (48,49), and serves as a control of participant-clinician physical contact, verbal interaction, and contextual factors during the office visit.
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|---|---|---|
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Fatigue Severity Scale (FSS)
|
4.19 units on a scale
Standard Deviation 1.42
|
4.16 units on a scale
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: From baseline to after 8th treatment at 4 weeksDetermine changes in fatigue and tiredness from baseline. It is a 21 item scale that provides a more in-depth look at the impact of fatigue and lack of energy might have on mental alertness and daily activities. It evaluates three domains: physical, cognitive, and psychosocial functioning, typically over the past 4 weeks, with a total score range of 0-84 (higher number indicate greater fatigue)
Outcome measures
| Measure |
Thoracic Spinal Manipulation/Trigger Point Therapy
n=11 Participants
Participants in the chiropractic thoracic SM intervention group received thoracic spine palpation, soft tissue relaxation (trigger point therapy) and a manually delivered posterior-to-anterior high-velocity, low-amplitude (HVLA) spinal manipulation restricted to the thoracic spine while in a prone position
|
Sham-spinal Manipulation
n=10 Participants
Participants in the sham-SM group received thoracic spine palpation without soft tissue relaxation techniques and a simulated sham thoracic spinal manipulation designed to mimic the physical contact and clinician interaction of chiropractic treatment without delivering a therapeutic thrust. For the sham-SM, an Activator II device (Activator Methods®, Phoenix AZ) was used and set to zero force output) and placed onto the dorsal surface of the clinician's thumb, without direct instrument contact with the participant. A sham-SM was delivered at multiple non-vertebral trunk anatomical sites. The Activator II device is a spring-activated device that produces an audible clicking sound upon application but applies force at a zero setting. This method of sham-SM has been used in previous studies with slight variation (48,49), and serves as a control of participant-clinician physical contact, verbal interaction, and contextual factors during the office visit.
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|---|---|---|
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Modified Fatigue Impact Scale
|
33.27 unit on a scale
Standard Deviation 23.19
|
45.4 unit on a scale
Standard Deviation 12.61
|
SECONDARY outcome
Timeframe: From Baseline to after 8th treatment at 4 weeksDetermine changes in cognitive (rapid) processing speed from baseline. Assesses the time it takes to complete a mental task and is related to the speed at which a person can understand and react to a set of information that they receive.
Outcome measures
| Measure |
Thoracic Spinal Manipulation/Trigger Point Therapy
n=11 Participants
Participants in the chiropractic thoracic SM intervention group received thoracic spine palpation, soft tissue relaxation (trigger point therapy) and a manually delivered posterior-to-anterior high-velocity, low-amplitude (HVLA) spinal manipulation restricted to the thoracic spine while in a prone position
|
Sham-spinal Manipulation
n=10 Participants
Participants in the sham-SM group received thoracic spine palpation without soft tissue relaxation techniques and a simulated sham thoracic spinal manipulation designed to mimic the physical contact and clinician interaction of chiropractic treatment without delivering a therapeutic thrust. For the sham-SM, an Activator II device (Activator Methods®, Phoenix AZ) was used and set to zero force output) and placed onto the dorsal surface of the clinician's thumb, without direct instrument contact with the participant. A sham-SM was delivered at multiple non-vertebral trunk anatomical sites. The Activator II device is a spring-activated device that produces an audible clicking sound upon application but applies force at a zero setting. This method of sham-SM has been used in previous studies with slight variation (48,49), and serves as a control of participant-clinician physical contact, verbal interaction, and contextual factors during the office visit.
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|---|---|---|
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Cognitive Processing Speed
|
57 milliseconds
Standard Deviation 20.21
|
54 milliseconds
Standard Deviation 7.61
|
SECONDARY outcome
Timeframe: From Baseline to after 8th treatment at 4 weeksThe McGill Pain Questionnaire (MPQ) is a multidimensional self-report tool used to evaluate the quality, location, and intensity of a patient's pain. The mean change in pain scores will be totaled on a scale of 0-3, where 3 equals more severe pain on 15 separate items totaled to compute a total minimum score of 0 and maximum score of 45.
Outcome measures
| Measure |
Thoracic Spinal Manipulation/Trigger Point Therapy
n=11 Participants
Participants in the chiropractic thoracic SM intervention group received thoracic spine palpation, soft tissue relaxation (trigger point therapy) and a manually delivered posterior-to-anterior high-velocity, low-amplitude (HVLA) spinal manipulation restricted to the thoracic spine while in a prone position
|
Sham-spinal Manipulation
n=10 Participants
Participants in the sham-SM group received thoracic spine palpation without soft tissue relaxation techniques and a simulated sham thoracic spinal manipulation designed to mimic the physical contact and clinician interaction of chiropractic treatment without delivering a therapeutic thrust. For the sham-SM, an Activator II device (Activator Methods®, Phoenix AZ) was used and set to zero force output) and placed onto the dorsal surface of the clinician's thumb, without direct instrument contact with the participant. A sham-SM was delivered at multiple non-vertebral trunk anatomical sites. The Activator II device is a spring-activated device that produces an audible clicking sound upon application but applies force at a zero setting. This method of sham-SM has been used in previous studies with slight variation (48,49), and serves as a control of participant-clinician physical contact, verbal interaction, and contextual factors during the office visit.
|
|---|---|---|
|
Total Change in Pain Short-form McGill Pain Questionnaire
|
0.91 units on a scale
Full Range 3.56 • Interval 0.0 to 45.0
|
2.4 units on a scale
Full Range 3.29 • Interval 0.0 to 45.0
|
SECONDARY outcome
Timeframe: From Baseline to after 8th treatment at 4 weeksDetermine changes in anxiety/depression from baseline. This is a 14 item instrument that you respond to inquires related about you have felt during the last week.The total score is out of 0-42, (0-21 per subscale). Total Scores are derived by summing responses for each of the two subscales or for the scale as a whole. Higher scores indicate greater levels of anxiety or depression.
Outcome measures
| Measure |
Thoracic Spinal Manipulation/Trigger Point Therapy
n=11 Participants
Participants in the chiropractic thoracic SM intervention group received thoracic spine palpation, soft tissue relaxation (trigger point therapy) and a manually delivered posterior-to-anterior high-velocity, low-amplitude (HVLA) spinal manipulation restricted to the thoracic spine while in a prone position
|
Sham-spinal Manipulation
n=10 Participants
Participants in the sham-SM group received thoracic spine palpation without soft tissue relaxation techniques and a simulated sham thoracic spinal manipulation designed to mimic the physical contact and clinician interaction of chiropractic treatment without delivering a therapeutic thrust. For the sham-SM, an Activator II device (Activator Methods®, Phoenix AZ) was used and set to zero force output) and placed onto the dorsal surface of the clinician's thumb, without direct instrument contact with the participant. A sham-SM was delivered at multiple non-vertebral trunk anatomical sites. The Activator II device is a spring-activated device that produces an audible clicking sound upon application but applies force at a zero setting. This method of sham-SM has been used in previous studies with slight variation (48,49), and serves as a control of participant-clinician physical contact, verbal interaction, and contextual factors during the office visit.
|
|---|---|---|
|
Total Change in Hospital Anxiety Depression Scale
|
6.18 units on a scale
Standard Deviation 4.69
|
8.7 units on a scale
Standard Deviation 4.81
|
SECONDARY outcome
Timeframe: From Baseline to after 8th treatment at 4 weeksDetermine changes in sleep quality from baseline. This is a 7 item instrument to assess components of nighttime and daytime insomnia. The Insomnia Severity Index (ISI) is a 7-item, self-report questionnaire used to assess the severity of insomnia, with a total score ranging from 0-28. A score of 15 or higher is typically used to indicate moderate-to-severe clinical insomnia, with 8-14 indicating subthreshold insomnia.
Outcome measures
| Measure |
Thoracic Spinal Manipulation/Trigger Point Therapy
n=11 Participants
Participants in the chiropractic thoracic SM intervention group received thoracic spine palpation, soft tissue relaxation (trigger point therapy) and a manually delivered posterior-to-anterior high-velocity, low-amplitude (HVLA) spinal manipulation restricted to the thoracic spine while in a prone position
|
Sham-spinal Manipulation
n=10 Participants
Participants in the sham-SM group received thoracic spine palpation without soft tissue relaxation techniques and a simulated sham thoracic spinal manipulation designed to mimic the physical contact and clinician interaction of chiropractic treatment without delivering a therapeutic thrust. For the sham-SM, an Activator II device (Activator Methods®, Phoenix AZ) was used and set to zero force output) and placed onto the dorsal surface of the clinician's thumb, without direct instrument contact with the participant. A sham-SM was delivered at multiple non-vertebral trunk anatomical sites. The Activator II device is a spring-activated device that produces an audible clicking sound upon application but applies force at a zero setting. This method of sham-SM has been used in previous studies with slight variation (48,49), and serves as a control of participant-clinician physical contact, verbal interaction, and contextual factors during the office visit.
|
|---|---|---|
|
Insomnia Severity Index
|
21.31 units on a scale
Standard Deviation 6.63
|
21.47 units on a scale
Standard Deviation 3.64
|
SECONDARY outcome
Timeframe: From Baseline to after 8th treatment at 4 weeksDetermine changes in upper limb coordination from baseline. This is a standardized timed assessment to assess finger dexterity in which 9 wooden pegs are placed into predrilled holes in a block of wood.
Outcome measures
| Measure |
Thoracic Spinal Manipulation/Trigger Point Therapy
n=11 Participants
Participants in the chiropractic thoracic SM intervention group received thoracic spine palpation, soft tissue relaxation (trigger point therapy) and a manually delivered posterior-to-anterior high-velocity, low-amplitude (HVLA) spinal manipulation restricted to the thoracic spine while in a prone position
|
Sham-spinal Manipulation
n=10 Participants
Participants in the sham-SM group received thoracic spine palpation without soft tissue relaxation techniques and a simulated sham thoracic spinal manipulation designed to mimic the physical contact and clinician interaction of chiropractic treatment without delivering a therapeutic thrust. For the sham-SM, an Activator II device (Activator Methods®, Phoenix AZ) was used and set to zero force output) and placed onto the dorsal surface of the clinician's thumb, without direct instrument contact with the participant. A sham-SM was delivered at multiple non-vertebral trunk anatomical sites. The Activator II device is a spring-activated device that produces an audible clicking sound upon application but applies force at a zero setting. This method of sham-SM has been used in previous studies with slight variation (48,49), and serves as a control of participant-clinician physical contact, verbal interaction, and contextual factors during the office visit.
|
|---|---|---|
|
Nine-Hole Peg Test
|
0.65 seconds
Standard Deviation 2.64
|
-0.71 seconds
Standard Deviation 2.28
|
SECONDARY outcome
Timeframe: From Baseline to after 8th treatment at 4 weeksDetermine changes in lower limb mobility from baseline. Evaluates leg function and quantitative mobility in a timed 25 foot walk.
Outcome measures
| Measure |
Thoracic Spinal Manipulation/Trigger Point Therapy
n=11 Participants
Participants in the chiropractic thoracic SM intervention group received thoracic spine palpation, soft tissue relaxation (trigger point therapy) and a manually delivered posterior-to-anterior high-velocity, low-amplitude (HVLA) spinal manipulation restricted to the thoracic spine while in a prone position
|
Sham-spinal Manipulation
n=10 Participants
Participants in the sham-SM group received thoracic spine palpation without soft tissue relaxation techniques and a simulated sham thoracic spinal manipulation designed to mimic the physical contact and clinician interaction of chiropractic treatment without delivering a therapeutic thrust. For the sham-SM, an Activator II device (Activator Methods®, Phoenix AZ) was used and set to zero force output) and placed onto the dorsal surface of the clinician's thumb, without direct instrument contact with the participant. A sham-SM was delivered at multiple non-vertebral trunk anatomical sites. The Activator II device is a spring-activated device that produces an audible clicking sound upon application but applies force at a zero setting. This method of sham-SM has been used in previous studies with slight variation (48,49), and serves as a control of participant-clinician physical contact, verbal interaction, and contextual factors during the office visit.
|
|---|---|---|
|
Timed 25 Foot Walk Test
|
4.99 minutes
Standard Deviation 1.74
|
5.34 minutes
Standard Deviation 1.11
|
Adverse Events
Thoracic Spinal Manipulation/Trigger Point Therapy Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham-spinal Manipulation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. William R. Reed (professor)
University of Alabama at Birmingham
Phone: 2059343261
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place