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This study evaluates the effect of high-velocity low-amplitude thrust (HVLAT) manipulation to the cervical spine on neuropeptide expression as determined by the plasma concentration of oxytocin, neurotensin, orexin A and cortisol; and Examine the effect of HVLAT manipulation on pain perception in symptomatic females with non-specific mechanical cervical spine pain
A high-velocity low-amplitude thrust (HVLAT) manipulation or commonly known as a spinal manipulation, is an intervention frequently used by physical therapists and other healthcare practitioners as an alternative treatment to help relieve spinal pain The mechanism by which HVLAT manipulation modulates pain remains undefined, although this does not contradict the clinical effects from HVLAT manipulation. Furthermore, there is evidence that suggests analgesia after HVLAT manipulation. There is a variety of observed and proposed phenomena that can explain the mechanisms for the psychological, mechanical, or neurophysiological responses from a HVLAT manipulation associated with alterations in pain processing or sympathetic and motor systems' excitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HVLAT manipulation | Experimental | An HVLAT manipulation is applied to the site of pain or restriction with the patient in supine. This technique uses both primary levers (pre-manipulation rotation - away (30 ° - 45 °) from the side of pain or limitation) and secondary levers (Side bending - towards coupled with lateral shift - away, and posterior-anterior (PA) shift (extension). This is a bimanual technique. For the applicator hand, the anterolateral portion of the first or second phalanx of the second ray was positioned on the superior joint partner of the target vertebrae using a cradle hold. The other hand is placed on the posterolateral aspect of the occiput (above the ear). While maintaining these positions the clinician performed the thrust with the arc of rotation dependent on the level of the target vertebrae. |
|
| Sham HVLAT manipulation | Sham Comparator | Subjects in the control group were instructed to lay on a table in the same position as the HVLAT manipulation group. The clinician went through the same basic steps as the HVLAT manipulation, localizing the appropriate vertebral landmarks but without carrying out the final HVLA thrust procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HVLAT manipulation | Procedure | HVLAT will be performed 10 minutes after the first blood draw. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Oxytocin | Samples were analyzed for Human Oxytocin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Blood will be drawn 10 minutes prior to HVLAT procedure. |
| Plasma Concentration of Oxytocin | Samples were analyzed for Human Oxytocin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Blood will be drawn immediately after HVLAT procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Neurotensin | Samples were analyzed for Human Neurotensin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Within 10 minutes after consent signature completion |
| Plasma Concentration of Neurotensin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Everett Lohman, D.Sc. | Loma Linda University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92350 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20510644 | Background | Gross A, Miller J, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Bronfort G, Hoving JL; COG. Manipulation or mobilisation for neck pain: a Cochrane Review. Man Ther. 2010 Aug;15(4):315-33. doi: 10.1016/j.math.2010.04.002. Epub 2010 May 26. | |
| 20184717 | Background | Bronfort G, Haas M, Evans R, Leininger B, Triano J. Effectiveness of manual therapies: the UK evidence report. Chiropr Osteopat. 2010 Feb 25;18:3. doi: 10.1186/1746-1340-18-3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | HVLAT Manipulation | An HVLAT manipulation is applied to the site of pain or restriction with the patient in supine. This technique uses both primary levers (pre-manipulation rotation - away (30 ° - 45 °) from the side of pain or limitation) and secondary levers (Side bending - towards coupled with lateral shift - away, and posterior-anterior (PA) shift (extension). This is a bimanual technique. For the applicator hand, the anterolateral portion of the first or second phalanx of the second ray was positioned on the superior joint partner of the target vertebrae using a cradle hold. The other hand is placed on the posterolateral aspect of the occiput (above the ear). While maintaining these positions the clinician performed the thrust with the arc of rotation dependent on the level of the target vertebrae. HVLAT manipulation: HVLAT will be performed 10 minutes after the first blood draw. |
| FG001 | Sham HVLAT Manipulation | Subjects in the control group were instructed to lay on a table in the same position as the HVLAT manipulation group. The clinician went through the same basic steps as the HVLAT manipulation, localizing the appropriate vertebral landmarks but without carrying out the final HVLA thrust procedure. Sham HVLAT manipulation: Sham HVLAT will be performed 10 minutes after the first blood draw. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT).
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| ID | Title | Description |
|---|---|---|
| BG000 | HVLAT Manipulation | An HVLAT manipulation is applied to the site of pain or restriction with the patient in supine. This technique uses both primary levers (pre-manipulation rotation - away (30 ° - 45 °) from the side of pain or limitation) and secondary levers (Side bending - towards coupled with lateral shift - away, and posterior-anterior (PA) shift (extension). This is a bimanual technique. For the applicator hand, the anterolateral portion of the first or second phalanx of the second ray was positioned on the superior joint partner of the target vertebrae using a cradle hold. The other hand is placed on the posterolateral aspect of the occiput (above the ear). While maintaining these positions the clinician performed the thrust with the arc of rotation dependent on the level of the target vertebrae. HVLAT manipulation: HVLAT will be performed 10 minutes after the first blood draw. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Twenty-eight female subjects between the ages of 20 and 45 years with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT). |
| 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 | Plasma Concentration of Oxytocin | Samples were analyzed for Human Oxytocin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT). | Posted | Mean | Standard Deviation | ug/ml | Blood will be drawn 10 minutes prior to HVLAT procedure. |
|
Subjects received a total of 1 intervention. The data collection period lasted 3 months total.
The study has concluded an no subjects had any adverse events.
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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 | HVLAT Manipulation | An HVLAT manipulation is applied to the site of pain or restriction with the patient in supine. This technique uses both primary levers (pre-manipulation rotation - away (30 ° - 45 °) from the side of pain or limitation) and secondary levers (Side bending - towards coupled with lateral shift - away, and posterior-anterior (PA) shift (extension). This is a bimanual technique. For the applicator hand, the anterolateral portion of the first or second phalanx of the second ray was positioned on the superior joint partner of the target vertebrae using a cradle hold. The other hand is placed on the posterolateral aspect of the occiput (above the ear). While maintaining these positions the clinician performed the thrust with the arc of rotation dependent on the level of the target vertebrae. HVLAT manipulation: HVLAT will be performed 10 minutes after the first blood draw. |
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One limitation of this study may be the lack of a control group with no touch contact. There may be an increase in oxytocin in both groups as a consequence of the touch and pressure applied to the subject's cervical spine.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Everett Lohman, PhD. Professor | Loma Linda University Health | 83171 | elohman@llu.edu |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Experimental Group (HVLAT manipulation) Control Group (sham HVLAT manipulation)
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| Sham HVLAT manipulation | Procedure | Sham HVLAT will be performed 10 minutes after the first blood draw. |
|
Samples were analyzed for Human Neurotensin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).
| Blood will be drawn immediately after HVLAT procedure. |
| Plasma Concentration of Orexin A | Samples were analyzed for Human Orexin A, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Within 10 minutes after consent signature completion |
| Plasma Concentration of Orexin A | Samples were analyzed for Human Orexin A, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Blood will be drawn immediately after HVLAT procedure. |
| Plasma Concentration of Cortisol | Samples were analyzed for Human Cortisol, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Within 10 minutes after consent signature completion |
| Plasma Concentration of Cortisol | Samples were analyzed for Human Cortisol, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Blood will be drawn immediately after HVLAT procedure. |
| BG001 | Sham HVLAT Manipulation | Subjects in the control group were instructed to lay on a table in the same position as the HVLAT manipulation group. The clinician went through the same basic steps as the HVLAT manipulation, localizing the appropriate vertebral landmarks but without carrying out the final HVLA thrust procedure. Sham HVLAT manipulation: Sham HVLAT will be performed 10 minutes after the first blood draw. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| years |
|
| Sex/Gender, Customized | Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT). | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Sham HVLAT Manipulation | Subjects in the control group were instructed to lay on a table in the same position as the HVLAT manipulation group. The clinician went through the same basic steps as the HVLAT manipulation, localizing the appropriate vertebral landmarks but without carrying out the final HVLA thrust procedure. Sham HVLAT manipulation: Sham HVLAT will be performed 10 minutes after the first blood draw. |
|
|
| Primary | Plasma Concentration of Oxytocin | Samples were analyzed for Human Oxytocin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT). | Posted | Mean | Standard Deviation | ug/ml | Blood will be drawn immediately after HVLAT procedure. |
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|
|
| Secondary | Plasma Concentration of Neurotensin | Samples were analyzed for Human Neurotensin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT). | Posted | Mean | Standard Deviation | ug/ml | Within 10 minutes after consent signature completion |
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| Secondary | Plasma Concentration of Neurotensin | Samples were analyzed for Human Neurotensin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT). | Posted | Mean | Standard Deviation | ug/ml | Blood will be drawn immediately after HVLAT procedure. |
|
|
|
| Secondary | Plasma Concentration of Orexin A | Samples were analyzed for Human Orexin A, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT). | Posted | Mean | Standard Deviation | ug/ml | Within 10 minutes after consent signature completion |
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| Secondary | Plasma Concentration of Orexin A | Samples were analyzed for Human Orexin A, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT). | Posted | Mean | Standard Deviation | ug/ml | Blood will be drawn immediately after HVLAT procedure. |
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| Secondary | Plasma Concentration of Cortisol | Samples were analyzed for Human Cortisol, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT). | Posted | Mean | Standard Deviation | ug/ml | Within 10 minutes after consent signature completion |
|
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| Secondary | Plasma Concentration of Cortisol | Samples were analyzed for Human Cortisol, using the Multiplex Luminex-100 platform (Luminex, Inc., USA). | Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT). | Posted | Mean | Standard Deviation | ug/ml | Blood will be drawn immediately after HVLAT procedure. |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Sham HVLAT Manipulation | Subjects in the control group were instructed to lay on a table in the same position as the HVLAT manipulation group. The clinician went through the same basic steps as the HVLAT manipulation, localizing the appropriate vertebral landmarks but without carrying out the final HVLA thrust procedure. Sham HVLAT manipulation: Sham HVLAT will be performed 10 minutes after the first blood draw. | 0 | 15 | 0 | 15 | 0 | 15 |
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