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Headaches have been listed as 1 of the 10 most disabling conditions worldwide. (Stovner et al., 2007) and cervicogenic headaches (CeHs) comprise 15% of the individuals with these complaints. (Nillsson, 1995); (Fernandez de-las-penas et al., 2005) The current best approach to the conservative care of this condition has yet to be determined. The primary aim of this study is to determine whether individuals with CeHs will respond to a program of thoracic spine thrust manipulation in isolation. This may further the current body of evidence by offering an alternative, potentially safer approach to the conservative care of individuals with this condition. Additionally, results of this study may serve to drive a larger scale Randomized Clinical Trial (RCT) by offering information regarding feasibility of recruitment of individuals with chronic CeHs as well as timing and dosing of the intervention.
Headaches have been listed as 1 of the 10 most disabling conditions worldwide. (Stovner et al., 2007) and cervicogenic headaches (CeHs) comprise 15% of the individuals with these complaints. (Nillsson, 1995); (Fernandez de-las-penas et al., 2005) The current best approach to the conservative care of this condition has yet to be determined. Evidence suggests that manipulative therapy aimed at the cervical spine in combination with exercise is helpful in alleviating these symptoms. (Jull et al., 2002) The risk of injury from cervical spine manipulative techniques has been documented to be remote (Haldeman et al., 2002; DiFabio 1999), however the potential consequences can be severe. Therefore with inherently lower risks, thoracic spine manipulations may be a suitable alternative as the evidence is accumulating for its influence on the cervical spine. (Mintken et al., 2010; Boyles et al., 2009; Cleland et al., 2005 & 2007 A & B, 2010; Flynn et al., 2001; Fernandez-de-las-penas et al., 2004; Piva et al., 2000; Browder et al., 2004) The primary aim of this study is to determine whether individuals with CeHs will respond to a program of thoracic spine thrust manipulation in isolation. This may further the current body of evidence by offering an alternative, potentially safer approach to the conservative care of individuals with this condition. Additionally, results of this study may serve to drive a larger scale RCT by offering information regarding feasibility of recruitment of individuals with chronic CeHs as well as timing and dosing of the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (thoracic manipulation) | Experimental | Patients in the initial manipulation group will attend physical therapy two sessions per week for 3 weeks for a total of 6 sessions. Each treatment session will last for a total of 15 minutes. After the initial manipulation group receives 3 weeks of treatment they will wait for 1-week, be retested, and then crossover into the other group. |
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| Wait-list (thoracic manipulation) | Active Comparator | When individuals are assigned to the wait-list control group they will serve as the control for 3 weeks while the initial manipulation group receives treatment. After serving as the wait-list control condition for 3 weeks, this group will then return for testing and will receive the manipulation package as described below at 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracic manipulation (Manipulation Group) | Procedure | Manipulation techniques will include: CT junction manipulation seated and supine, upper thoracic manipulation, middle thoracic spine manipulation in seated and supine, middle thoracic spine manipulation in prone, thoracic active range of motion exercise and instruction to maintain usual activity level within the limits of pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Headache Disability Index | Headache Disability Index (HDI): The HDI is a 25-item questionnaire used to assess the patient's perceived impact of the headaches on their daily life. | Baseline |
| Headache Disability Index | Headache Disability Index (HDI): The HDI is a 25-item questionnaire used to assess the patient's perceived impact of the headaches on their daily life. | 4 weeks |
| Headache Disability Index | Headache Disability Index (HDI): The HDI is a 25-item questionnaire used to assess the patient's perceived impact of the headaches on their daily life. | 8 weeks |
| Headache Disability Index | Headache Disability Index (HDI): The HDI is a 25-item questionnaire used to assess the patient's perceived impact of the headaches on their daily life. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating Scale | An 11-point NPRS will be used to measure pain intensity. Patients rate their current level of pain and their worse and least amount of pain in the last 24 hours. | Baseline |
| Numeric Pain Rating Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy W McDevitt, DPT | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12221344 | Background | Jull G, Trott P, Potter H, Zito G, Niere K, Shirley D, Emberson J, Marschner I, Richardson C. A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1835-43; discussion 1843. doi: 10.1097/00007632-200209010-00004. | |
| 34269160 | Derived |
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| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Thoracic Manipulation (Control wait-list) | Procedure | Manipulation techniques will include: CT junction manipulation seated and supine, upper thoracic manipulation, middle thoracic spine manipulation in seated and supine, middle thoracic spine manipulation in prone, thoracic active range of motion exercise and instruction to maintain usual activity level within the limits of pain. |
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An 11-point NPRS will be used to measure pain intensity. Patients rate their current level of pain and their worse and least amount of pain in the last 24 hours.
| 4 weeks |
| Numeric Pain Rating Scale | An 11-point NPRS will be used to measure pain intensity. Patients rate their current level of pain and their worse and least amount of pain in the last 24 hours. | 8 weeks |
| Numeric Pain Rating Scale | An 11-point NPRS will be used to measure pain intensity. Patients rate their current level of pain and their worse and least amount of pain in the last 24 hours. | 3 months |
| Pain Self Efficacy Questionnaire (PSEQ) | The 10 item questionnaire is used to assess the patient's confidence in performing specific activities despite pain. Items are listed on a 0 to 6 scale, with a maximum score of 60 points. | Baseline |
| Pain Self Efficacy Questionnaire (PSEQ) | The 10 item questionnaire is used to assess the patient's confidence in performing specific activities despite pain. Items are listed on a 0 to 6 scale, with a maximum score of 60 points. | 4 weeks |
| Pain Self Efficacy Questionnaire (PSEQ) | The 10 item questionnaire is used to assess the patient's confidence in performing specific activities despite pain. Items are listed on a 0 to 6 scale, with a maximum score of 60 points. | 8 weeks |
| Pain Self Efficacy Questionnaire (PSEQ) | The 10 item questionnaire is used to assess the patient's confidence in performing specific activities despite pain. Items are listed on a 0 to 6 scale, with a maximum score of 60 points. | 3 months |
| McDevitt AW, Cleland JA, Rhon DI, Altic RAK, Courtney DJ, Glynn PE, Mintken PE. Thoracic spine thrust manipulation for individuals with cervicogenic headache: a crossover randomized clinical trial. J Man Manip Ther. 2022 Apr;30(2):78-95. doi: 10.1080/10669817.2021.1947663. Epub 2021 Jul 16. |