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| Name | Class |
|---|---|
| Minnesota Office of Higher Education | OTHER_GOV |
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The purpose of the study is to determine the effect of a low vs. high dose of acupuncture treatment in individuals with chronic post-traumatic headache (CPTH). A total of 36 people with mild traumatic brain injury (mTBI) suffering from CPTH will be enrolled in this study to receive acupuncture treatment for 5 weeks. Participants will be randomized into two groups: 1) Low Acupuncture group (5 treatments) and 2) High Acupuncture group (10 treatments). It is hypothesized that both treatment groups will have decreased headaches, but that 10 treatments will greater alleviate headaches when compared to 5 treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed. |
|
| High Dose | Experimental | Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Headache Days | The number of self-reported headache days over a 4 week period. Range: 0-28 days. More headache total days indicates a worse outcome. | baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | The total number of adverse events (AE) or serious adverse events (SAE) over the course of the study. A higher number of AE/SAEs indicates a less safe treatment. | 16 weeks |
| Compliance With Overall Protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | The PSQI contains questions about participant's sleeping habits. Range: 0-21. Sum of 7 subscores. Higher score indicates worse sleep quality | 3 months |
| Traumatic Brain Injury-Quality of Life Headache Pain (TBI-QOL-Headache) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda A Herrmann, PhD | HealthPartners Neuroscience Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners Neuroscience Center | Saint Paul | Minnesota | 55130 | United States |
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One participant was withdrawn for eligibility reasons prior to randomization to study group. This participant was not included in analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose | Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed. Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes. |
| FG001 | High Dose | Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed. Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose | Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed. Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Number of Headache Days | The number of self-reported headache days over a 4 week period. Range: 0-28 days. More headache total days indicates a worse outcome. | Posted | Mean | Standard Deviation | headache days | baseline to 3 months |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose | Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed. Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lightheaded/Syncope | Ear and labyrinth disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Herrmann, PhD | HealthPartners Institute | 6514956565 | amanda.a.herrmann@healthpartners.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2023 | Nov 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
Completion of treatment sessions. Percent of target treatments. Range: 0-100. A higher percentage indicates more compliance.
| 3 months |
The TBI-QOL-Headache contains questions about participant's headache pain. Raw Score Range: 10-50. Raw scores converted to T-score (mean = 50, standard deviation = 10). Higher T-score indicates more headache pain. |
| 3 months |
| Change in Headache Pain Intensity | The headache pain intensity is self reported for each headache day. Pain intensity will be averaged for the 4 week period measured. Pain intensity scale range is 0 (no pain) to 10 (worst pain imaginable). Higher pain intensity score indicates more intense headaches. | baseline to 3 months |
| BG001 | High Dose | Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed. Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Time to diagnosis of TBI | Mean | Inter-Quartile Range | months |
|
Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed. Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes. |
|
|
| Secondary | Adverse Events | The total number of adverse events (AE) or serious adverse events (SAE) over the course of the study. A higher number of AE/SAEs indicates a less safe treatment. | Posted | Number | total number of AEs | 16 weeks |
|
|
|
| Secondary | Compliance With Overall Protocol | Completion of treatment sessions. Percent of target treatments. Range: 0-100. A higher percentage indicates more compliance. | Posted | Mean | Standard Deviation | percentage of treatments completed | 3 months |
|
|
|
| Other Pre-specified | Pittsburgh Sleep Quality Index (PSQI) | The PSQI contains questions about participant's sleeping habits. Range: 0-21. Sum of 7 subscores. Higher score indicates worse sleep quality | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Other Pre-specified | Traumatic Brain Injury-Quality of Life Headache Pain (TBI-QOL-Headache) | The TBI-QOL-Headache contains questions about participant's headache pain. Raw Score Range: 10-50. Raw scores converted to T-score (mean = 50, standard deviation = 10). Higher T-score indicates more headache pain. | Posted | Mean | Standard Deviation | T-score | 3 months |
|
|
|
| Other Pre-specified | Change in Headache Pain Intensity | The headache pain intensity is self reported for each headache day. Pain intensity will be averaged for the 4 week period measured. Pain intensity scale range is 0 (no pain) to 10 (worst pain imaginable). Higher pain intensity score indicates more intense headaches. | Posted | Mean | Standard Deviation | score on a scale | baseline to 3 months |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 14 |
| 18 |
| EG001 | High Dose | Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed. Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes. | 0 | 20 | 0 | 20 | 17 | 20 |
| Skin Reaction at site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin or other issues away from site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Breathing issues | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Heart issues | Cardiac disorders | Non-systematic Assessment |
|
| Flu | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fatigue | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Acute Illness | Infections and infestations | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |