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

Primary Purpose

Headache, Post-Concussion Syndrome

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manipulative Therapy
Sponsored by
Hackensack Meridian Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hackensack Meridian Health - JFK Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study arm - Osteopathic Manipulative Therapy

Control - Standard of care

Arm 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.

Standard of care including physical therapy, occupational therapy and over the counter medication.

Outcomes

Primary Outcome Measures

Immediate Change in Headache Scores With a Visual Analog Scale (VAS)
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).
Change in the 6-item Headache Impact Test (HIT-6) Between Baseline and Follow-up Visit.
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.

Secondary Outcome Measures

Full Information

First Posted
January 11, 2021
Last Updated
May 3, 2021
Sponsor
Hackensack Meridian Health
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1. Study Identification

Unique Protocol Identification Number
NCT04732338
Brief Title
The Effectiveness of Osteopathic Manipulative Medicine in the Management of Headaches Associated With Post Concussion Syndrome
Official Title
The Effectiveness of Osteopathic Manipulative Medicine in the Management of Headaches Associated With Post Concussion Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
February 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hackensack Meridian Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Post-Concussion Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study arm - Osteopathic Manipulative Therapy
Arm Type
Experimental
Arm 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.
Arm Title
Control - Standard of care
Arm Type
No Intervention
Arm Description
Standard of care including physical therapy, occupational therapy and over the counter medication.
Intervention Type
Other
Intervention Name(s)
Osteopathic Manipulative Therapy
Intervention Description
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.
Primary Outcome Measure Information:
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
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alphonsa Thomas, DO
Organizational Affiliation
HMH-JFK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hackensack Meridian Health - JFK Medical Center
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
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The Effectiveness of Osteopathic Manipulative Medicine in the Management of Headaches Associated With Post Concussion Syndrome

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