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Acute Effect of Passive Joint Mobilization in Non-Specific Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Passive Cervical Joint Mobilization
Sponsored by
Mücahit ÖZTOP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring non-specific neck pain, passive joint mobilization, blood markers, neck range of motion

Eligibility Criteria

24 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

For Intervention Group;

  • Having neck pain lasting more than 30 days and being diagnosed with non-specific neck pain
  • Having obtained 14/50 points and above in Neck Disability Index
  • Expressing neck pain at least 34/100 points and above on a Visual Analog Scale
  • Being 20-45 years old and female

For Healthy Control Group;

- Healthy volunteers without a chronic illness and musculoskeletal pain

Exclusion Criteria:

  • Congenital anomalies
  • Previously diagnosed orthopedic diseases related to the spine
  • Pregnancy and having just given birth
  • Within the last 3 months; use of corticosteroids, cytotoxic drugs, or immunosuppressants
  • Liver or kidney failure
  • Acute or chronic infections (including HIV)
  • Serious pathologies (such as cancer, spondylolisthesis, rheumatoid arthritis or ankylosing spondylitis)
  • Symptoms of cervical spinal stenosis (such as incoordination of hands, arms and legs, bowel and bladder incontinence)
  • Radix compression (such as sensory changes, muscle weakness or decreased reflexes)
  • Whiplash or a history of cervical surgery

Sites / Locations

  • Pamukkale University School of Physical Therapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Healthy Control Group

Arm Description

24 female participants with non-specific neck pain included in the mobilization group will undergo detailed manual cervical examination. In the evaluation, the most painful segment with dysfunction will be selected and mobilization application and algometric measurements will be performed on this segment. Grade 3 Central Posterior-Anterior (CPA) passive joint mobilization with Maitland method will be applied in 3 sets, 30 seconds, to the segment with the detected dysfunction.

Healthy volunteer participants included in the control group will only be applied an evaluation protocol and blood samples will be taken without any application.

Outcomes

Primary Outcome Measures

Cervical Range of Motion
Cervical Range of Motion will be assessed by Baselşne Bubble Inclinometer as degree of flexion-extension, rotation and lateral flexion and will be recorded.
Pain Pressure Threshold
Pressure Pain Threshold will be measured with the JTech Commander Algometer at the level of the right and left zygapophyseal joint of the dysfunctional cervical segment detected during physical examination. During the evaluation, the participants will be asked to lie in a prone position. By placing the probe of the algometer vertically on the skin, the pressure applied will be gradually increased and the participant will be asked to report at the first moment of pain. The measurement will be made once and the result will be recorded in kilograms.
Neuropeptide Measurement
Neuropeptide Measurement will be performed as a result of evaluating the blood samples taken from the participants with the appropriate ELISA kits. Orexin A and Neurotensin levels are planned to be evaluated with Human Orexin A (Competitive EIA) ELISA Kit and Human NTS / NT / Neurotensin (Competitive EIA) ELISA Kit which are specific for these neuropeptides.

Secondary Outcome Measures

Pain Intensity Measurement
Pain intensity will be evaluated with the Visual Analogue Scale. The Visual Analogue Scale is a horizontal scale in the range of 0-100 mm, where 0 is the lowest pain and 100 the highest pain. The patient will be asked to mark the pain felt in the neck area on this line and the point marked will be measured with a ruler and recorded in mm.
Neck Disability
Neck Disability will be measured by Neck Disability Index. The Neck Disability Index is a frequently used scale to evaluate the level of disability due to neck pain. It consists of 10 items and 6 options under each item. Options are scored between 0-5 points. An increasing score indicates a higher level of disability. The minimum score that can be obtained from the scale is 0, and the highest score is 50. 14 points are used as cut-off points for the minimal level of disability.

Full Information

First Posted
October 22, 2020
Last Updated
May 24, 2022
Sponsor
Mücahit ÖZTOP
Collaborators
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT04605510
Brief Title
Acute Effect of Passive Joint Mobilization in Non-Specific Neck Pain
Official Title
Acute Effect of Passive Joint Mobilization on Joint Motion And Pain Perception in Non-Specific Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
July 20, 2021 (Actual)
Study Completion Date
May 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mücahit ÖZTOP
Collaborators
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Aim of present study is investigating the acute effects of passive joint mobilization on pain perception and range of motion. Study protocol includes passive joint mobilization application to study group with neck pain and blood sample collection of study and healthy control group.
Detailed Description
Our purpose of planning this study is to examine the acute effect of passive joint mobilization application on pain perception and range of motion in women with non-specific neck pain. The hypotheses we will test for this purpose; H1- Passive joint mobilization application increases the range of motion of the cervical joint in women with non-specific neck pain. H2- Passive joint mobilization application increases the pressure pain threshold in women with non-specific neck pain. H3- Passive joint mobilization increases serum Orexin A and Neurotensin levels in women with non-specific neck pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
non-specific neck pain, passive joint mobilization, blood markers, neck range of motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study includes two groups. Intervention group including women with non-specific neck pain will applied cervical passive joint mobilization and assessment protocol. Control group including healthy women without pain will applied only assessment protocol.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
24 female participants with non-specific neck pain included in the mobilization group will undergo detailed manual cervical examination. In the evaluation, the most painful segment with dysfunction will be selected and mobilization application and algometric measurements will be performed on this segment. Grade 3 Central Posterior-Anterior (CPA) passive joint mobilization with Maitland method will be applied in 3 sets, 30 seconds, to the segment with the detected dysfunction.
Arm Title
Healthy Control Group
Arm Type
No Intervention
Arm Description
Healthy volunteer participants included in the control group will only be applied an evaluation protocol and blood samples will be taken without any application.
Intervention Type
Other
Intervention Name(s)
Passive Cervical Joint Mobilization
Other Intervention Name(s)
Maitland Mobilization
Intervention Description
It will be applied to the cervical spine, whose dysfunction is detected as a result of the evaluation. The participant will be in the prone position and Grade 3 Central Posterior-Anterior (CPA) passive joint mobilization with Maitland method will be applied for 3 sets, 30 seconds, to the segment to be treated.
Primary Outcome Measure Information:
Title
Cervical Range of Motion
Description
Cervical Range of Motion will be assessed by Baselşne Bubble Inclinometer as degree of flexion-extension, rotation and lateral flexion and will be recorded.
Time Frame
Cervical Range of Motion assessment will take maximum of 5 minutes.
Title
Pain Pressure Threshold
Description
Pressure Pain Threshold will be measured with the JTech Commander Algometer at the level of the right and left zygapophyseal joint of the dysfunctional cervical segment detected during physical examination. During the evaluation, the participants will be asked to lie in a prone position. By placing the probe of the algometer vertically on the skin, the pressure applied will be gradually increased and the participant will be asked to report at the first moment of pain. The measurement will be made once and the result will be recorded in kilograms.
Time Frame
Pain Pressure Threshold assessment will take maximum of 5 minutes.
Title
Neuropeptide Measurement
Description
Neuropeptide Measurement will be performed as a result of evaluating the blood samples taken from the participants with the appropriate ELISA kits. Orexin A and Neurotensin levels are planned to be evaluated with Human Orexin A (Competitive EIA) ELISA Kit and Human NTS / NT / Neurotensin (Competitive EIA) ELISA Kit which are specific for these neuropeptides.
Time Frame
Blood Sample Collection for Neuropeptide Measurement will take maximum of 5 minutes.
Secondary Outcome Measure Information:
Title
Pain Intensity Measurement
Description
Pain intensity will be evaluated with the Visual Analogue Scale. The Visual Analogue Scale is a horizontal scale in the range of 0-100 mm, where 0 is the lowest pain and 100 the highest pain. The patient will be asked to mark the pain felt in the neck area on this line and the point marked will be measured with a ruler and recorded in mm.
Time Frame
Pain Intensity Measurement will take maximum of 1 minute.
Title
Neck Disability
Description
Neck Disability will be measured by Neck Disability Index. The Neck Disability Index is a frequently used scale to evaluate the level of disability due to neck pain. It consists of 10 items and 6 options under each item. Options are scored between 0-5 points. An increasing score indicates a higher level of disability. The minimum score that can be obtained from the scale is 0, and the highest score is 50. 14 points are used as cut-off points for the minimal level of disability.
Time Frame
Neck Disability measurement will take maximum of 1 minute.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For Intervention Group; Having neck pain lasting more than 30 days and being diagnosed with non-specific neck pain Having obtained 14/50 points and above in Neck Disability Index Expressing neck pain at least 34/100 points and above on a Visual Analog Scale Being 20-45 years old and female For Healthy Control Group; - Healthy volunteers without a chronic illness and musculoskeletal pain Exclusion Criteria: Congenital anomalies Previously diagnosed orthopedic diseases related to the spine Pregnancy and having just given birth Within the last 3 months; use of corticosteroids, cytotoxic drugs, or immunosuppressants Liver or kidney failure Acute or chronic infections (including HIV) Serious pathologies (such as cancer, spondylolisthesis, rheumatoid arthritis or ankylosing spondylitis) Symptoms of cervical spinal stenosis (such as incoordination of hands, arms and legs, bowel and bladder incontinence) Radix compression (such as sensory changes, muscle weakness or decreased reflexes) Whiplash or a history of cervical surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nesrin YAĞCI, Professor
Organizational Affiliation
Pamukkale University School of Physical Therapy and Rehabilitation
Official's Role
Study Director
Facility Information:
Facility Name
Pamukkale University School of Physical Therapy and Rehabilitation
City
Denizli
ZIP/Postal Code
20000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24450367
Citation
Plaza-Manzano G, Molina-Ortega F, Lomas-Vega R, Martinez-Amat A, Achalandabaso A, Hita-Contreras F. Changes in biochemical markers of pain perception and stress response after spinal manipulation. J Orthop Sports Phys Ther. 2014 Apr;44(4):231-9. doi: 10.2519/jospt.2014.4996. Epub 2014 Jan 22.
Results Reference
background
PubMed Identifier
24674816
Citation
Molina-Ortega F, Lomas-Vega R, Hita-Contreras F, Plaza Manzano G, Achalandabaso A, Ramos-Morcillo AJ, Martinez-Amat A. Immediate effects of spinal manipulation on nitric oxide, substance P and pain perception. Man Ther. 2014 Oct;19(5):411-7. doi: 10.1016/j.math.2014.02.007. Epub 2014 Mar 5.
Results Reference
background
PubMed Identifier
30935335
Citation
Lohman EB, Pacheco GR, Gharibvand L, Daher N, Devore K, Bains G, AlAmeri M, Berk LS. The immediate effects of cervical spine manipulation on pain and biochemical markers in females with acute non-specific mechanical neck pain: a randomized clinical trial. J Man Manip Ther. 2019 Sep;27(4):186-196. doi: 10.1080/10669817.2018.1553696. Epub 2018 Dec 11.
Results Reference
background
Citation
Maitland GD. Maitland's Vertebral Manipulation. Seventh Ed. (Hengeveld E, Banks K, eds.). Edinburgh; New York: Churchill Livingstone; 2013. https://www.elsevier.com/books/maitlands-vertebral-manipulation/hengeveld/978-0-7020-4066-5.
Results Reference
background

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Acute Effect of Passive Joint Mobilization in Non-Specific Neck Pain

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