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NCT Number: NCT04420403

Investigation of the Effectiveness of Manual Therapy Plus Cervical Stabilization Exercise in Chronic Neck Pain

This study aims to investigate the effectiveness of manual therapy plus cervical stabilization exercise compared to manual therapy alone on balance, proprioception, and neck muscle morphology in chronic neck pain.

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Key information

Conditions

Neck Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Yildirim Beyazit University

Ankara, 06760, Turkey (Türkiye)

About this study

Neck pain is defined as pain and/or stiffness localized to the dorsal area of the area between the condyle of the occiput and the third thoracic vertebra. Chronic neck pain (CNP), defined as persistent pain lasting three or more mounts, causes disability and a reduction in life quality. Balance disorders or postural instability, a deficit in proprioception, changes in muscle recruitment, a decrease in dimension of deep cervical muscle, and an increase in stiffness of superficial neck muscle may lead to pain in patients with CNP. Both manual therapy and exercise have favorable effects on management with CNP. According to our knowledge, no study has investigated the effects of manual therapy plus cervical stabilization exercise on balance, proprioception, and neck muscle morphology in CNP, yet.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 20 to 55 years of age,
  • Having generalized neck pain for more than 3 months,
  • Being volunteer

Exclusion criteria

  • Being pregnant,
  • Malignancy,
  • Having cervical stenosis,
  • Severe cervical spondylosis,
  • Cervical fractures and tumor,
  • Osteoporosis,
  • Positive vertebrobasilar test
  • Positive Babinski reflex
  • Neurologic deficit related to compression of the spinal root or cord,
  • Having neurologic, dermatologic, infectious, inflammatory rheumatologic and endocrine diseases,
  • Being an inability to fulfill the questionnaires,
  • Any problems that will hinder exercise (advanced cardiopulmonary or orthopedic problems), having intervention including exercise program or physiotherapy in the three months

Treatment and study plan

Manual therapy

Other

Cyriax's mobilization techniques will be applied as manual therapy. Before the mobilization, soft tissue mobilization techniques will be applied to relieve muscular spasm and preventing the patient' s anxiety. Bringing, manual traction, manual traction with rotation, manual traction with anterior-posterior gliding and lateral gliding mobilization techniques will be applied. Appropriate mobility techniques will be selected according to the complaints and symptoms of the patients. Cervical mobilization applications will take an average of 15-20 minutes.

Cervical Stabilazation Exercise (CSE)

Other

The CSE program aims to maintain a neutral spine position and activate deep cervical muscles during exercises. It is performed in stages with gradual progression according to the stages of motor learning and sensory-motor integration, namely, static, dynamic, and functional. The program will start with postural training and then the cervical bracing technique with the activation of deep neck flexors for CSE was performed. The patients will be asked to maintain a neutral spine during the exercises and throughout the day as much as possible. The difficulty and variety of exercises will be increased weekly. It will be carried out 2 days a week for 6 weeks (12 sessions) by the supervisor physiotherapist.

Primary outcomes

  1. Balance

    Time frame: change from baseline at 6 weeks

    The balance will be evaluated with Biodex BioSwayTM Balance Evaluation System. It reliably measures the patient's ability to balance on soft and/or hard ground.

Secondary outcomes

  1. Proprioception

    Time frame: change from baseline at 6 weeks

    Proprioception will be assessed with dual digital inclinometer. The feet of the inclinometers will be placed as simultaneously as possible over the head of the patients and the cervical seventh vertebra. Firstly, patients will be asked to move their heads forward as possible as from the neutral position and then they will try to find neutral position from reached position. The angle on digital display of inclinometer will be recorded as degree. Each test will be repeated 3 times and the average deviation error score will be recorded.

  2. Muscle morphology

    Time frame: change from baseline at 6 weeks

    The thickness and stiffness of the neck muscles will be evaluated by a specialist radiologist with real-time ultrasonography. It is a reliable, valid and, non-invasive method that provides an assessment of muscle morphology. Measurements will be made by using the Logiq S7 / Expert ultrasound device. The cross-sectional area of deep neck muscle with sonography, the stiffness of the superficial muscles with elastography were assessed.

  3. Pain intensity

    Time frame: change from baseline at 6 weeks

    The pain intensity will be assessed with the Visual Analog Scale, which consists of a horizontal line of 10 cm in length. For pain level assessment, "0" defines "no pain" and "10" defines "unbearable pain''. The participants will be asked to mark the intensity of their pain level.

  4. Disability level

    Time frame: change from baseline at 6 weeks

    The disability level will be measured with the Turkish version of Neck Disability Index (NDI). It consists of 10 sections which include the severity of pain, personal care, lifting, reading, headache, concentration, work-life, driving, sleeping and leisure activities. There are 6 responses for each section, scored 0 (no pain and no functional limitation) and 5 (worst pain and maximum limitation). The total score ranges from 0 to 50. Patients will be asked to select the most appropriate option for each section.

Sponsors and collaborators

Lead sponsor

Ataturk Training and Research Hospital

Other

Registry information

Official study title

Investigation of the Effectiveness of Manual Therapy Plus Cervical Stabilization Exercise on Balance, Proprioception, and Neck Muscle Morphology in Chronic Neck Pain

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2020
Registry last updated
Jan 4, 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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