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NCT Number: NCT04605510

Acute Effect of Passive Joint Mobilization 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.

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Key information

Age range

24 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University School of Physical Therapy and Rehabilitation

Denizli, 20000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Maitland Mobilization

Primary outcomes

  1. Cervical Range of Motion

    Time frame: Cervical Range of Motion assessment will take maximum of 5 minutes.

    Cervical Range of Motion will be assessed by Baselşne Bubble Inclinometer as degree of flexion-extension, rotation and lateral flexion and will be recorded.

  2. Pain Pressure Threshold

    Time frame: Pain Pressure Threshold assessment will take maximum of 5 minutes.

    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.

  3. Neuropeptide Measurement

    Time frame: Blood Sample Collection for Neuropeptide Measurement will take maximum of 5 minutes.

    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 outcomes

  1. Pain Intensity Measurement

    Time frame: Pain Intensity Measurement will take maximum of 1 minute.

    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.

  2. Neck Disability

    Time frame: Neck Disability measurement will take maximum of 1 minute.

    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.

Sponsors and collaborators

Lead sponsor

Mücahit ÖZTOP

Other

Collaborators

  • Pamukkale University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Oct 28, 2020
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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