The Effectiveness of Osteopathic Manipulative Medicine in the Management of Headaches Associated With Post Concussion Syndrome

• Sponsor: Hackensack Meridian Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT04732338
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 2
• Actual Duration (Months): 30.4
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Pilot study looking at the Osteopathic Manipulative Treatment (OMT) for various headache types in patients with post-concussion syndrome (PCS). Twenty-six subjects with symptoms lasting >3 months were enrolled and were randomly assigned to a treatment group (n = 13) and a control group (n = 13).

Condition or Disease	Intervention/Treatment	Phase
Headache; Post-Concussion Syndrome	Other: Osteopathic Manipulative Therapy	Early Phase 1

Detailed Description

Evidence shows the effectiveness of Osteopathic Manipulative Treatment (OMT) for various headache types, with limited evidence of its use for headaches related to mild traumatic brain injury (MTBI). No studies were found regarding OMT for headaches in patients with post-concussion syndrome (PCS), defined as symptom persistence >3 months after MTBI.

Objective: To evaluate OMT for headaches in patients with PCS. Methods: A controlled pilot study was conducted of patients with PCS who presented to an outpatient interdisciplinary rehabilitation clinic. Twenty-six subjects with symptoms lasting >3 months were enrolled and were randomly assigned to a treatment group (n = 13) and a control group (n = 13). Primary outcome measures were 1) immediate change in headache scores with a visual analog scale (VAS) and 2) change in the 6-item Headache Impact Test (HIT-6) between baseline and follow-up visits. 10 control participants completed HIT-6 between baseline and follow-up visits but did not receive OMT and did not complete VAS. After OMT, immediate VAS changes in treatment group and the improvements in HIT-6 scores for both groups between baseline and follow-up were analyzed for statistical significance.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Effectiveness of Osteopathic Manipulative Medicine in the Management of Headaches Associated With Post Concussion Syndrome
• Actual Study Start Date: Aug 1, 2017
• Actual Primary Completion Date: Mar 31, 2019
• Actual Study Completion Date: Feb 11, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study arm - Osteopathic Manipulative Therapy Standard of care including physical therapy, occupational therapy and over the counter medication AND OMT as described below: Musculoskeletal examination of the cervical spine. Testing will be comprised of : Range of motion testing involving cervical rotation, lateral side bending, flexion and extension. Muscular palpation of the cervical paraspinals for hypertonicity of the muscles and/or tenderness. Patient placed supine on the examination table. 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.	Other: 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.
No Intervention: Control - Standard of care Standard of care including physical therapy, occupational therapy and over the counter medication.

Outcome Measures

Primary Outcome Measures

1. Immediate Change in Headache Scores With a Visual Analog Scale (VAS) [Same day with treatment on visit 1]

   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).

2. Change in the 6-item Headache Impact Test (HIT-6) Between Baseline and Follow-up Visit. [4 weeks post treatment (Follow-up visit 1)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• diagnosis of mild traumatic brain injury (MTBI),

• age 18 years or older

• injury occurring >3 months prior, and

• headache as a primary symptomatic concern.

Exclusion Criteria:

• history of moderate to severe traumatic brain injury (TBI),

• documented intracranial injury,

• chronic headache or migraine headache before the injury,

• treatment with a headache specialist at the time of injury, or receipt of IV infusion for medication for headache at the time of treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hackensack Meridian Health - JFK Medical Center	Edison	New Jersey	United States	08817

Sponsors and Collaborators

• Hackensack Meridian Health

Investigators

• Principal Investigator: Alphonsa Thomas, DO, HMH-JFK

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 11, 2019

More Information

Publications

• 1. McCrory, P. Consensus Statement on Concussion in Sport, 3 rd International Conference on Concussion in Sport. Clinical Journal of Sport Medicine 2010, 20(4), 332. 2. Ellis, M. J.; Leddy, J. J.; Willer, B. Physiological, vestibule-ocular and cervicogenic post-concussion disorders: An evidence-based classification system with directions for treatment.Brain Injury 2014, 29(2), 238-248. 3. Langlois, J. A.; Rutland-Brown, W.; Wald, M. M. The epidemiology and impact of traumatic brain injury: a brief overview. Journal of Head Trauma Rehabilitation2006, 21(5), 375-378. 4. Willer, B.; Leddy, J. J. Management of Concussion and Post-Concussion Syndrome. Current Treatment Options in Neurology2006, 8(5), 415-426. 5. Anderson, T.; Heitger, M.; Macleod, A. D. Concussion and mild head injury. Practical Neurology2006, 6(6), 342-357. 6. Kushner, D. Mild Traumatic brain injury: toward understanding manifestations and treatment. Archives of Internal Medicine1998, 158(15), 1617. 7. Alexander, M. P. Mild traumatic brain injury: pathophysiology, natural history, and clinical management. Neurology1995, 45(7), 1253-1260. 8. Zasler, N. D., Katz, D. I., & Zafonte, R. D. (2007). Brain injury medicine: Principles and practice. New York: Demos 9. Hiploylee, C.; Dufort, P. A.; Davis, H. S.; Wennberg, R. A.; Tartaglia, M. C.; Mikulis, D.; Hazrati, L.-N.; Tator, C. H. Longitudinal Study of Postconcussion Syndrome: Not Everyone Recovers. Journal of Neurotrauma2017, 34(8), 1511-1523. 10. Cerritelli, Francesco et al. "Osteopathy for Primary Headache Patients: A Systematic Review." Journal of Pain Research 10 (2017): 601-611. PMC. Web. 20 Dec. 2017. 11. Espi-lopez, G.V, et al. "Do Manual Therapy techniques have a positive effect on quality of life in people with tension-type headache? A randomized controlled trial." European Journal of Physical Medicine and Rehabilitation2016, 52(4), 447-56. 12. Cerritelli, Francesco et al. "Osteopathy for Primary Headache Patients: A Systematic Review." Journal of Pain Research 2017: (15)601-611. PMC. Web. 20 Dec. 2017. 13. Castillo, I.; Wolf, K; Rakowsky, A. "Concussions and Osteopathic Manipulative Treatment: An Adolescent Case Presentation." J Am Osteopath Assoc 2016;116(3):178-181. doi: 10.7556/jaoa.2016.034. 14. Guernsey, D.; Leder, A.; Yao, S. "Resolution of Concussion Symptoms After Osteopathic Manipulative Treatment: A Case Report." J Am Osteopath Assoc 2016;116(3):e13-e17. doi: 10.7556/jaoa.2016.036. 15. Adragna et al. "Osteopathic manipulative treatment of headache in a polytrauma patient: case report." The Journal of Headache and Pain 2015, 16(Suppl 1):A181. 16. Savarese, R. G., Capobianco, J. D., & Cox, J. J., (2009). OMT Review 3rd edition.

• Responsible Party: Hackensack Meridian Health
• ClinicalTrials.gov Identifier: NCT04732338
• Other Study ID Numbers: IRB00001814
• First Posted: Feb 1, 2021
• Last Update Posted: May 25, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Post-Concussion Syndrome; Syndrome; Headache

Study Results

Participant Flow

Arm/Group Title	Study Arm - Osteopathic Manipulative Therapy	Control - Standard of Care
Arm/Group Description	Standard of care including physical therapy, occupational therapy and over the counter medication AND OMT as described below: Musculoskeletal examination of the cervical spine. Testing will be comprised of : Range of motion testing involving cervical rotation, lateral side bending, flexion and extension. Muscular palpation of the cervical paraspinals for hypertonicity of the muscles and/or tenderness. Patient placed supine on the examination table. 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.	Standard of care including physical therapy, occupational therapy and over the counter medication.
Period Title: Overall Study
STARTED	13	13
COMPLETED	10	10
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Study Arm - Osteopathic Manipulative Therapy	Control - Standard of Care	Total
Arm/Group Description	Standard of care including physical therapy, occupational therapy and over the counter medication AND OMT as described below: Musculoskeletal examination of the cervical spine. Testing will be comprised of : Range of motion testing involving cervical rotation, lateral side bending, flexion and extension. Muscular palpation of the cervical paraspinals for hypertonicity of the muscles and/or tenderness. Patient placed supine on the examination table. 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.	Standard of care including physical therapy, occupational therapy and over the counter medication.	Total of all reporting groups
Overall Participants	10	10	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	9 90%	10 100%	19 95%
>=65 years	1 10%	0 0%	1 5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45 (15)	42 (17)	43.5 (16)
Sex: Female, Male (Count of Participants)
Female	7 70%	6 60%	13 65%
Male	3 30%	4 40%	7 35%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	10 50%

Outcome Measures

1. Primary Outcome

Title	Immediate Change in Headache Scores With a Visual Analog Scale (VAS)
Description	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).
Time Frame	Same day with treatment on visit 1

Outcome Measure Data

Analysis Population Description

We captured the pre and post VAS score and the change between the two.

Arm/Group Title	Study Arm - Osteopathic Manipulative Therapy	Control - Standard of Care
Arm/Group Description	Standard of care including physical therapy, occupational therapy and over the counter medication AND OMT as described below: Musculoskeletal examination of the cervical spine. Testing will be comprised of : Range of motion testing involving cervical rotation, lateral side bending, flexion and extension. Muscular palpation of the cervical paraspinals for hypertonicity of the muscles and/or tenderness. Patient placed supine on the examination table. 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.	Standard of care including physical therapy, occupational therapy and over the counter medication.
Measure Participants	10	10
Initial VAS score	5.6 (1.7)	NA (NA)
Post intervention VAS score	3.5 (2.1)	NA (NA)
Change in VAS score	2 (1.8)	NA (NA)

2. Primary Outcome

Title	Change in the 6-item Headache Impact Test (HIT-6) Between Baseline and Follow-up Visit.
Description	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.
Time Frame	4 weeks post treatment (Follow-up visit 1)

Outcome Measure Data

Analysis Population Description

Pre and post intervention HIT-6 scores and change between the two.

Arm/Group Title	Study Arm - Osteopathic Manipulative Therapy	Control - Standard of Care
Arm/Group Description	Standard of care including physical therapy, occupational therapy and over the counter medication AND OMT as described below: Musculoskeletal examination of the cervical spine. Testing will be comprised of : Range of motion testing involving cervical rotation, lateral side bending, flexion and extension. Muscular palpation of the cervical paraspinals for hypertonicity of the muscles and/or tenderness. Patient placed supine on the examination table. 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.	Standard of care including physical therapy, occupational therapy and over the counter medication.
Measure Participants	10	10
Initial HIT-6 score	63.0	62.0
Post-intervention HIT-6 score	60.0	60.5
Change in HIT-6 score	3.5	2.0

Adverse Events

Time Frame	up to 6 weeks of post-treatment follow up
Arm/Group Title	Study Arm - Osteopathic Manipulative Therapy		Control - Standard of Care
Arm/Group Description	Standard of care including physical therapy, occupational therapy and over the counter medication AND OMT as described below: Musculoskeletal examination of the cervical spine. Testing will be comprised of : Range of motion testing involving cervical rotation, lateral side bending, flexion and extension. Muscular palpation of the cervical paraspinals for hypertonicity of the muscles and/or tenderness. Patient placed supine on the examination table. 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.		Standard of care including physical therapy, occupational therapy and over the counter medication.
All Cause Mortality
	Study Arm - Osteopathic Manipulative Therapy		Control - Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Study Arm - Osteopathic Manipulative Therapy		Control - Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Study Arm - Osteopathic Manipulative Therapy		Control - Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

We lost 3 patients in each group to follow-up as they did not come back although our team attempted to reach out to them. Limitation: no VAS was measured in the control group.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.