Trial Outcomes & Findings for The Effectiveness of Osteopathic Manipulative Medicine in the Management of Headaches Associated With Post Concussion Syndrome (NCT NCT04732338)
NCT ID: NCT04732338
Last Updated: 2021-05-25
Results Overview
Change in the headache scores, defined as the different pain pre and post treatment using the visual analog scale (VAS). VAS is widely used to capture pain, the scale ranges from 0-10 with 0 (best outcome) being no pain and 10 being the worst pain possible (worst outcome).
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Same day with treatment on visit 1
Results posted on
2021-05-25
Participant Flow
Participant milestones
| Measure |
Study Arm - Osteopathic Manipulative Therapy
Standard of care including physical therapy, occupational therapy and over the counter medication AND OMT as described below:
1. Musculoskeletal examination of the cervical spine. Testing will be comprised of :
1. Range of motion testing involving cervical rotation, lateral side bending, flexion and extension.
2. Muscular palpation of the cervical paraspinals for hypertonicity of the muscles and/or tenderness.
2. Patient placed supine on the examination table.
3. Treatment sessions lasting 5-10 minutes each. OMT techniques: cervical muscle energy, myofascial release of the cervical paraspinals and a suboccipital release.
Assessment with Headache Impact Test (HIT-6) at baseline and follow-up visit and change in pain scores between baseline and post treatment.
Osteopathic Manipulative Therapy: Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, noninvasive form of manual medicine. Osteopathic practitioners use a wide variety of therapeutic manual techniques to improve physiological function and help restore homeostasis in the body. There is a structural assessment is to identify possible abnormalities of tissue texture. Areas of asymmetry and misalignment of bony landmarks are also evaluated, along with the quality of motion, balance, and organization. These asymmetries, also known as somatic dysfunctions, are then treated by a variety of manual treatments, administered by osteopaths.
|
Control - Standard of Care
Standard of care including physical therapy, occupational therapy and over the counter medication.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Study Arm - Osteopathic Manipulative Therapy
Standard of care including physical therapy, occupational therapy and over the counter medication AND OMT as described below:
1. Musculoskeletal examination of the cervical spine. Testing will be comprised of :
1. Range of motion testing involving cervical rotation, lateral side bending, flexion and extension.
2. Muscular palpation of the cervical paraspinals for hypertonicity of the muscles and/or tenderness.
2. Patient placed supine on the examination table.
3. Treatment sessions lasting 5-10 minutes each. OMT techniques: cervical muscle energy, myofascial release of the cervical paraspinals and a suboccipital release.
Assessment with Headache Impact Test (HIT-6) at baseline and follow-up visit and change in pain scores between baseline and post treatment.
Osteopathic Manipulative Therapy: Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, noninvasive form of manual medicine. Osteopathic practitioners use a wide variety of therapeutic manual techniques to improve physiological function and help restore homeostasis in the body. There is a structural assessment is to identify possible abnormalities of tissue texture. Areas of asymmetry and misalignment of bony landmarks are also evaluated, along with the quality of motion, balance, and organization. These asymmetries, also known as somatic dysfunctions, are then treated by a variety of manual treatments, administered by osteopaths.
|
Control - Standard of Care
Standard of care including physical therapy, occupational therapy and over the counter medication.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Study Arm - Osteopathic Manipulative Therapy
n=10 Participants
Standard of care including physical therapy, occupational therapy and over the counter medication AND OMT as described below:
1. Musculoskeletal examination of the cervical spine. Testing will be comprised of :
1. Range of motion testing involving cervical rotation, lateral side bending, flexion and extension.
2. Muscular palpation of the cervical paraspinals for hypertonicity of the muscles and/or tenderness.
2. Patient placed supine on the examination table.
3. Treatment sessions lasting 5-10 minutes each. OMT techniques: cervical muscle energy, myofascial release of the cervical paraspinals and a suboccipital release.
Assessment with Headache Impact Test (HIT-6) at baseline and follow-up visit and change in pain scores between baseline and post treatment.
Osteopathic Manipulative Therapy: Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, noninvasive form of manual medicine. Osteopathic practitioners use a wide variety of therapeutic manual techniques to improve physiological function and help restore homeostasis in the body. There is a structural assessment is to identify possible abnormalities of tissue texture. Areas of asymmetry and misalignment of bony landmarks are also evaluated, along with the quality of motion, balance, and organization. These asymmetries, also known as somatic dysfunctions, are then treated by a variety of manual treatments, administered by osteopaths.
|
Control - Standard of Care
n=10 Participants
Standard of care including physical therapy, occupational therapy and over the counter medication.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
19 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 15 • n=10 Participants
|
42 years
STANDARD_DEVIATION 17 • n=10 Participants
|
43.5 years
STANDARD_DEVIATION 16 • n=20 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
13 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
7 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
10 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Same day with treatment on visit 1Population: We captured the pre and post VAS score and the change between the two.
Change in the headache scores, defined as the different pain pre and post treatment using the visual analog scale (VAS). VAS is widely used to capture pain, the scale ranges from 0-10 with 0 (best outcome) being no pain and 10 being the worst pain possible (worst outcome).
Outcome measures
| Measure |
Study Arm - Osteopathic Manipulative Therapy
n=10 Participants
Standard of care including physical therapy, occupational therapy and over the counter medication AND OMT as described below:
1. Musculoskeletal examination of the cervical spine. Testing will be comprised of :
1. Range of motion testing involving cervical rotation, lateral side bending, flexion and extension.
2. Muscular palpation of the cervical paraspinals for hypertonicity of the muscles and/or tenderness.
2. Patient placed supine on the examination table.
3. Treatment sessions lasting 5-10 minutes each. OMT techniques: cervical muscle energy, myofascial release of the cervical paraspinals and a suboccipital release.
Assessment with Headache Impact Test (HIT-6) at baseline and follow-up visit and change in pain scores between baseline and post treatment.
Osteopathic Manipulative Therapy: Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, noninvasive form of manual medicine. Osteopathic practitioners use a wide variety of therapeutic manual techniques to improve physiological function and help restore homeostasis in the body. There is a structural assessment is to identify possible abnormalities of tissue texture. Areas of asymmetry and misalignment of bony landmarks are also evaluated, along with the quality of motion, balance, and organization. These asymmetries, also known as somatic dysfunctions, are then treated by a variety of manual treatments, administered by osteopaths.
|
Control - Standard of Care
n=10 Participants
Standard of care including physical therapy, occupational therapy and over the counter medication.
|
|---|---|---|
|
Immediate Change in Headache Scores With a Visual Analog Scale (VAS)
Initial VAS score
|
5.6 units on a scale
Standard Deviation 1.7
|
NA units on a scale
Standard Deviation NA
VAS was not measured in the control group
|
|
Immediate Change in Headache Scores With a Visual Analog Scale (VAS)
Post intervention VAS score
|
3.5 units on a scale
Standard Deviation 2.1
|
NA units on a scale
Standard Deviation NA
VAS was not measured in the control group
|
|
Immediate Change in Headache Scores With a Visual Analog Scale (VAS)
Change in VAS score
|
2 units on a scale
Standard Deviation 1.8
|
NA units on a scale
Standard Deviation NA
VAS was not measured in the control group
|
PRIMARY outcome
Timeframe: 4 weeks post treatment (Follow-up visit 1)Population: Pre and post intervention HIT-6 scores and change between the two.
HIT-6 was completed at baseline and competed to HIT-6 completed post treatment at follow up visit. Headache Impact Test (HIT-6) is a measure of headache severity and provides information regarding the effect of headache on other domains related to functional participation. The HIT-6 has six questions and the range goes from 36 (best outcome) to a maximum score of 78 (worst outcome). Higher HIT-6 scores indicate increased headache severity and greater functional limitations.
Outcome measures
| Measure |
Study Arm - Osteopathic Manipulative Therapy
n=10 Participants
Standard of care including physical therapy, occupational therapy and over the counter medication AND OMT as described below:
1. Musculoskeletal examination of the cervical spine. Testing will be comprised of :
1. Range of motion testing involving cervical rotation, lateral side bending, flexion and extension.
2. Muscular palpation of the cervical paraspinals for hypertonicity of the muscles and/or tenderness.
2. Patient placed supine on the examination table.
3. Treatment sessions lasting 5-10 minutes each. OMT techniques: cervical muscle energy, myofascial release of the cervical paraspinals and a suboccipital release.
Assessment with Headache Impact Test (HIT-6) at baseline and follow-up visit and change in pain scores between baseline and post treatment.
Osteopathic Manipulative Therapy: Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, noninvasive form of manual medicine. Osteopathic practitioners use a wide variety of therapeutic manual techniques to improve physiological function and help restore homeostasis in the body. There is a structural assessment is to identify possible abnormalities of tissue texture. Areas of asymmetry and misalignment of bony landmarks are also evaluated, along with the quality of motion, balance, and organization. These asymmetries, also known as somatic dysfunctions, are then treated by a variety of manual treatments, administered by osteopaths.
|
Control - Standard of Care
n=10 Participants
Standard of care including physical therapy, occupational therapy and over the counter medication.
|
|---|---|---|
|
Change in the 6-item Headache Impact Test (HIT-6) Between Baseline and Follow-up Visit.
Initial HIT-6 score
|
63.0 units on a scale
Interval 57.8 to 70.0
|
62.0 units on a scale
Interval 49.5 to 65.5
|
|
Change in the 6-item Headache Impact Test (HIT-6) Between Baseline and Follow-up Visit.
Post-intervention HIT-6 score
|
60.0 units on a scale
Interval 55.0 to 65.0
|
60.5 units on a scale
Interval 49.5 to 64.3
|
|
Change in the 6-item Headache Impact Test (HIT-6) Between Baseline and Follow-up Visit.
Change in HIT-6 score
|
3.5 units on a scale
Interval 0.8 to 7.3
|
2.0 units on a scale
Interval -2.5 to 3.5
|
Adverse Events
Study Arm - Osteopathic Manipulative Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control - Standard of Care
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place