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

Acute Effect of Passive Joint Mobilization on Joint Motion And Pain Perception in Non-Specific Neck Pain

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Other: Passive Cervical Joint Mobilization

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey, 20000
    • Pamukkale University School of Physical Therapy and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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.	Other: Passive Cervical Joint Mobilization; 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.; Other Names: Maitland Mobilization
No Intervention: Healthy Control Group; Healthy volunteer participants included in the control group will only be applied an evaluation protocol and blood samples will be taken without any application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Cervical Range of Motion assessment will take maximum of 5 minutes.
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.	Pain Pressure Threshold assessment will take maximum of 5 minutes.
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.	Blood Sample Collection for Neuropeptide Measurement will take maximum of 5 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pain Intensity Measurement will take maximum of 1 minute.
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.	Neck Disability measurement will take maximum of 1 minute.

Collaborators and Investigators

• Sponsor: Mücahit ÖZTOP
• Collaborators: Pamukkale University
• Investigators: Study Director: Nesrin YAĞCI, Professor, Pamukkale University School of Physical Therapy and Rehabilitation

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): July 20, 2021
• Study Completion (Actual): May 23, 2022

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: non-specific neck pain; passive joint mobilization; blood markers; neck range of motion
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 60116787-020/46072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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