- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04732338
The Effectiveness of Osteopathic Manipulative Medicine in the Management of Headaches Associated With Post Concussion Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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New Jersey
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Edison, New Jersey, United States, 08817
- Hackensack Meridian Health - JFK Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Study arm - Osteopathic Manipulative Therapy
Standard of care including physical therapy, occupational therapy and over the counter medication AND OMT as described below:
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 (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.
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NO_INTERVENTION: Control - Standard of care
Standard of care including physical therapy, occupational therapy and over the counter medication.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immediate Change in Headache Scores With a Visual Analog Scale (VAS)
Time Frame: Same day with treatment on visit 1
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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). |
Same day with treatment on visit 1
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Change in the 6-item Headache Impact Test (HIT-6) Between Baseline and Follow-up Visit.
Time Frame: 4 weeks post treatment (Follow-up visit 1)
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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. |
4 weeks post treatment (Follow-up visit 1)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alphonsa Thomas, DO, HMH-JFK
Publications and helpful links
General 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00001814
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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