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

NCT04605510 | Completed

• 1 other identifier: 60116787-020/46072
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Keywords

non-specific neck pain; passive joint mobilization; blood markers; neck range of motion

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Pain Intensity Measurement

  Pain Intensity Measurement will take maximum of 1 minute.

• Neck Disability

  Neck Disability measurement will take maximum of 1 minute.

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Healthy Control Group

NO INTERVENTION

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

Interventions

Passive Cervical Joint Mobilization OTHER

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.

Also known as: Maitland Mobilization

Intervention Group

Eligibility Criteria

• Age: 24 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mücahit ÖZTOP: lead
• Pamukkale University: collaborator

Study Sites (1)

Pamukkale University School of Physical Therapy and Rehabilitation

Denizli, 20000, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 24450367 BACKGROUND

• 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.

  PMID: 24674816 BACKGROUND

• 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.

  PMID: 30935335 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nesrin YAĞCI, Professor

  Pamukkale University School of Physical Therapy and Rehabilitation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 28, 2020
• Study Start: January 1, 2021
• Primary Completion: July 20, 2021
• Study Completion: May 23, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)