HeadacheEarly Phase 1NCT04732338
The Effectiveness of Osteopathic Manipulative Medicine in the Management of Headaches Associated With Post Concussion Syndrome
A Early Phase 1 study testing Osteopathic Manipulative Therapy in people with Headache and Post-Concussion Syndrome, run by Hackensack Meridian Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache, Post-Concussion Syndrome
- What is being tested?
- Osteopathic Manipulative Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 11 Feb 2020
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of mild traumatic brain injury (MTBI),
- age 18 years or older
- injury occurring >3 months prior, and
- headache as a primary symptomatic concern.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack Meridian Health - JFK Medical Center
Edison, New Jersey, 08817
About this study
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).
Read the 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.
- Conditions
- Headache, Post-Concussion Syndrome
- Being tested
- Osteopathic Manipulative Therapy
- Medical subject headings
- Headache, Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study arm - Osteopathic Manipulative Therapy | Experimental | 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. Receives: Other: Osteopathic Manipulative Therapy |
| Control - Standard of care | No intervention | Standard of care including physical therapy, occupational therapy and over the counter medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Same day with treatment on visit 1
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.
Measured: 4 weeks post treatment (Follow-up visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start1 Aug 2017
- Primary completion31 Mar 2019
- Study completion11 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alphonsa Thomas, DO, Principal investigator, HMH-JFK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732338
- Sponsor's protocol ID
- IRB00001814
- Status last verified
- May 2021
- First submitted
- 11 Jan 2021
- Last updated
- 25 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Osteopathic Manipulative Medicine in the Management of Headaches Associated With Post Concussion Syndrome
- ClinicalTrials.gov ID
- NCT04732338
- Acronym / sponsor ID
- IRB00001814
- Conditions
- Headache, Post-Concussion Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 1 Feb 2021 (actual)
- Results
- Posted 25 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study arm - Osteopathic Manipulative Therapy | Experimental | Other: Osteopathic Manipulative TherapyStandard 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. |
| Control - Standard of care | No intervention | –Standard of care including physical therapy, occupational therapy and over the counter medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of mild traumatic brain injury (MTBI),
- age 18 years or older
- injury occurring >3 months prior, and
- headache as a primary symptomatic concern.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative TherapyOsteopathic 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. | Other | Study arm - Osteopathic Manipulative Therapy |
Primary outcome
Immediate Change in Headache Scores With a Visual Analog Scale (VAS)
Time frame: 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).
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)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background1. 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alphonsa Thomas, DO principal investigator
HMH-JFK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Osteopathic Manipulative Therapy in people with Headache and Post-Concussion Syndrome, run by Hackensack Meridian Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate Change in Headache Scores With a Visual Analog Scale (VAS) (time frame: Same day with treatment on visit 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04732338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.