Trial Outcomes & Findings for The Effect of Manipulation of the Cervical Spine on Pain Biomarkers (NCT NCT03176654)

NCT ID: NCT03176654

Last Updated: 2019-08-01

Results Overview

Samples were analyzed for Human Oxytocin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 28 participants
• Primary outcome timeframe: Blood will be drawn 10 minutes prior to HVLAT procedure.
• Results posted on: 2019-08-01

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	13	15
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	HVLAT Manipulation n=13 Participants 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.	Sham HVLAT Manipulation n=15 Participants 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.	Total n=28 Participants Total of all reporting groups
Age, Customized Mean age of participants	37 years n=13 Participants	30 years n=15 Participants	37 years n=28 Participants
Sex/Gender, Customized	13 Participants n=13 Participants	15 Participants n=15 Participants	28 Participants n=28 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Blood will be drawn 10 minutes prior to HVLAT procedure.

Population: Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT).

Samples were analyzed for Human Oxytocin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).

Outcome measures

Measure	HVLAT Manipulation n=13 Participants 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.	Sham HVLAT Manipulation n=15 Participants 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.
Plasma Concentration of Oxytocin	154.5 ug/ml Standard Deviation 0.9	158.8 ug/ml Standard Deviation 0.5

PRIMARY outcome

Timeframe: Blood will be drawn immediately after HVLAT procedure.

Population: Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT).

Samples were analyzed for Human Oxytocin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).

Outcome measures

Measure	HVLAT Manipulation n=13 Participants 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.	Sham HVLAT Manipulation n=15 Participants 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.
Plasma Concentration of Oxytocin	185.1 ug/ml Standard Deviation 0.9	189.1 ug/ml Standard Deviation 0.5

SECONDARY outcome

Timeframe: Within 10 minutes after consent signature completion

Population: Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT).

Samples were analyzed for Human Neurotensin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).

Outcome measures

Measure	HVLAT Manipulation n=13 Participants 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.	Sham HVLAT Manipulation n=15 Participants 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.
Plasma Concentration of Neurotensin	116.0 ug/ml Standard Deviation 1.6	125.6 ug/ml Standard Deviation 0.2

SECONDARY outcome

Timeframe: Blood will be drawn immediately after HVLAT procedure.

Population: Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT).

Samples were analyzed for Human Neurotensin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).

Outcome measures

Measure	HVLAT Manipulation n=13 Participants 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.	Sham HVLAT Manipulation n=15 Participants 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.
Plasma Concentration of Neurotensin	136.4 ug/ml Standard Deviation 1.6	131.6 ug/ml Standard Deviation 0.2

SECONDARY outcome

Timeframe: Within 10 minutes after consent signature completion

Population: Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT).

Samples were analyzed for Human Orexin A, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).

Outcome measures

Measure	HVLAT Manipulation n=13 Participants 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.	Sham HVLAT Manipulation n=15 Participants 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.
Plasma Concentration of Orexin A	52.2 ug/ml Standard Deviation 1.0	62.9 ug/ml Standard Deviation 0.2

SECONDARY outcome

Timeframe: Blood will be drawn immediately after HVLAT procedure.

Population: Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT).

Samples were analyzed for Human Orexin A, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).

Outcome measures

Measure	HVLAT Manipulation n=13 Participants 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.	Sham HVLAT Manipulation n=15 Participants 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.
Plasma Concentration of Orexin A	73.8 ug/ml Standard Deviation 1.0	67.3 ug/ml Standard Deviation 0.2

SECONDARY outcome

Timeframe: Within 10 minutes after consent signature completion

Population: Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT).

Samples were analyzed for Human Cortisol, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).

Outcome measures

Measure	HVLAT Manipulation n=13 Participants 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.	Sham HVLAT Manipulation n=15 Participants 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.
Plasma Concentration of Cortisol	95.8 ug/ml Standard Deviation 0.8	127.4 ug/ml Standard Deviation 0.5

SECONDARY outcome

Timeframe: Blood will be drawn immediately after HVLAT procedure.

Population: Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT).

Samples were analyzed for Human Cortisol, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).

Outcome measures

Measure	HVLAT Manipulation n=13 Participants 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.	Sham HVLAT Manipulation n=15 Participants 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.
Plasma Concentration of Cortisol	108.1 ug/ml Standard Deviation 0.8	139.7 ug/ml Standard Deviation 0.5

Adverse Events

HVLAT Manipulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham HVLAT Manipulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Everett Lohman, PhD. Professor

Loma Linda University Health

Email: elohman@llu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place