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NCT Number: NCT05649397

Effects of Cervical Spine Manipulation in Patients With Mechanical Neck Pain

Mechanical neck pain is known as one of the most common disorders in musculoskeletal system. In elderly population, prevalence of neck pain ranges up to 38% while point prevalence and lifetime prevalence ranges from 6% to 22% and 14.2% to 71% respectively . Neck pain is defined by the international association for the study of pain as: "Pain perceived as arising from anywhere within the region bounded superiorly by superior nuchal line, inferior by transverse line through the tip of first thoracic spinous process, and laterally by sagittal plane tangential to the lateral border of neck" . There are variable causes of neck pain like trauma, infections, inflammatory conditions, musculoskeletal conditions, rheumatic diseases, and congenital diseases . There are varying degrees of disability and activity limitation caused by neck pain, like work productivity reduction and decrease quality of life . People who have a sedentary lifestyle, poor occupational postures, students with poor posture, people involved in occupation like computer programming, clerical job workers and desk job works are more likely to suffer from mechanical neck pain . Most common cause of mechanical neck pain is muscle tightness, Upper trapezius and levator scapulae are the most involved muscles

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah international hospital Sihala

Islamabad, Punjab Province, Pakistan

About this study

Neck pain can over time negatively affect the central processing of any afferent input received because it can create a disturbance in the proprioceptive input to the Central Nervous System. Vuillerme stated that cervical muscle proprioceptors are stimulated by painful electrical stimuli. Therefore, joint proprioception can be affected in patients with mechanical neck pain .

The conservative management of mechanical neck pain includes many treatment options like electrotherapy which includes moist heat, Transcutaneous Electrical Nerve Stimulation therapy and different manual therapy options like cervical and thoracic mobilization and manipulation, Natural Apophyseal Glides and Sustained Natural Apophyseal Glides, Cyriax technique, manual pressure release, ischemic compression and proprioceptive neuromuscular facilitation. Postural reeducation and strength training of weak muscle group has beneficial effects. Joint mobilization and manipulation are widely used as a treatment for mechanical neck pain, as cervical mobilizations which are low velocity passive oscillatory movements are used by 90% of physiotherapist and chiropractors to treat people with neck pain.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with non-radiating neck pain of moderate intensity scoring 4-8 on the numeric pain rating scale (NPRS)
  • Have a Neck Disability Index (NDI) score of 20% or greater (10 points or greater on a 0-to-50 scale)
  • Patients who have cervical joint position error greater than 7.1 cm or 4.5 degrees

Exclusion criteria

  • Patients with a positive history of trauma, fracture or surgery of the cervical spine .
  • anatomical cervical spine abnormality
  • presented with any neurological signs
  • history of benign paroxysmal positional vertigo
  • Neck pain with radiation to the arm and upper extremity .
  • Diagnosed cases of torticollis, and scoliosis
  • History of osteoporosis, Any cardiac disorder
  • had participated in a neck exercise program in the past 6 months .

Treatment and study plan

Cervical Manipulation

Other

provide a high velocity, low-amplitude manipulation to each subject's cervical spine.

Conventional Therapy

Other

15 mins moist hot pack Neck Isometric exercise hold for 5-8 seconds and repeat 10 times Cervical range of motion 10 repetitions of movement in rotation within pain free range

Primary outcomes

  1. Joint position sense test

    Time frame: four weeks

    A target is placed on a wall 90cm away from the patient, at the patient's head height in sitting. The target is typically 40cm in diameter with concentric circles in 1cm increments. A laser pointer or similar targeting device is mounted onto a lightweight headband is then placed on the patient's head. The patient is then asked to focus on finding natural resting head position so that the laser pointer is in line with the center or "bullseye" of the target. With eyes closed, the patient will actively move their head in one plane of motion and attempt to return to the starting position as accurately as possible.

  2. Digital sphygmomanometer

    Time frame: four weeks

    It is the most technologically advanced sphygmomanometer. It consists of an electronic sensor to measure the blood pressure and the readings are displayed on the digital monitor. To measure the blood pressure, the instrument measures the fluctuations of arteries

  3. Respiratory rate measurement

    Time frame: four weeks

    To measure the respiratory rate of a person, ask the person to rest quietly for a moment. Start a timer for 60 seconds and count every time they breathe. Use the second hand on your watch or a timer on your phone to keep track of the person's breathing for exactly 1 minute. Once the minute starts, count every time you see their chest rise .

  4. NPRS (Numeric Pain Rating Scale).

    Time frame: four weeks

    The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain. The NPRS is an eleven-point scale from 0 to 10. "0" = no pain and "10" = the most intense pain imaginable while the NPRS exhibited moderate reliability

  5. NDI (U) (Neck Disability Index)

    Time frame: four weeks

    The neck disability index is a ten-item self-reported questionnaire that assesses pain and associated disability, with a total max score of 50 points. An Urdu version of neck disability index will be used in this study. An intra-class correlation coefficient (ICC) revealed excellent test-retest reliability for all items (ICC = 0.86-0.98) and total scores (ICC = 0.99) of the NDI-U

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Cervical Spine Manipulation on Proprioception, Blood Pressure and Respiratory Rate in Patients With Mechanical Neck Pain

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 14, 2022
Registry last updated
Jul 27, 2023

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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