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Completed

NCT Number: NCT04455048

The Effectiveness of Manipulation Treatment in Cervical Region

Neck pain is the second most common musculoskeletal pain after lumbar pain. Prevalence is 27.2% female and 17.4% in male population (1, 2). Approximately 1/3 of acute onset neck aches become chronic. It causes increasing the cost of treatment and also the loss of labor (3, 4).

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abant Izzet Baysal University, Bolu, Merkez, Turkey (Türkiye)

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About this study

Acute neck pain is often caused by mechanical causes and can be classified as rheumatic diseases, infectious and tumoral pathologies, metabolic bone diseases such as osteoporosis and osteomalacia, pain reflected the cervical region. A-V malformation and syringomyelia are the causes of chronic cervical pain (5). Mechanical neck pain is a non-radicular pain caused by local musculoskeletal structures and is characterized by a spasm of the cervical muscles. (6, 7). Posture, emotional stress, cold and fatigue are etiologic causes, and pain is also reflected in the cervical, occipital and scapular regions depending on the severity of muscle spasm and the presence of trigger point in myofascial pain syndrome (9, 10). Many authors have suggested that facet joints are associated with mechanical dysfunction as a common cause of cervical pain (8-10).

The pain in the head and neck region affects the quality of life, cognitive and functional status of the person. The most important difficulty and failure in the treatment of such pain arise from the inability to diagnose the disease correctly. Good anatomical and biomechanical properties of the region, comprehensive anamnesis, physical examination under static and dynamic conditions, laboratory and radiological examinations are the most important milestones of diagnosis (12). In most cases, medical treatment and physical therapy modalities (superficial and deep heat, electrotherapy, laser, traction, massage, spa) are sufficient for pain relief and recovery of function, but interventional procedures and surgical procedures are needed for the fewer patient. Recently, spinal mobilization and manipulation techniques can be used to relieve pain and restore function in the early stages. Although it is a safe method, in order to prevent the rare complications it is necessary to determine the indications of treatment correctly, to exclude contiguous cases and to apply the manipulation by experts (12).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis Nonspecific neck pain (NSNP)
  • Symptoms should last longer than 2 weeks

Exclusion criteria

  • Any known cause such as radiculopathy or neurological diseases,
  • History of neck surgery,
  • History of vertebral fracture,
  • Osteoporosis,
  • Tumor or a mass in the vertebral column,
  • Any spinal thrust manipulation contraindication,
  • Medication usage such as antiinflammatory or analgesic which might effect outcome assessments,
  • History of spinal manipulation

Treatment and study plan

Cervicothoracic thrust manipulation

Other

The patient will be positioned in a supine position with arms crossed over over the trunk and holding the shoulders. The therapist will place a stabilizing hand over transverse process of T1 in pistol grip and contacted patients elbow with sternum and patient will be asked do a hip bridge while taking a deep breath than exhale. Thrust manipulation will be applied at the end of exhale.

Cervicothoracic thrust manipulation sham

Other

The patient will be positioned in a supine position with arms crossed over over the trunk and holding the shoulders. The therapist will place a stabilizing hand over transverse process of T1 in pistol grip and contacted patients elbow with sternum and patient will be asked do a hip bridge while taking a deep breath than exhale. A soft compression will be applied at the end of exhale without a thrust.

Primary outcomes

  1. Pain pressure threshold

    Time frame: two weeks

    Pain pressure threshold (PPT). was assessed with an algometer (JTECH Medical, Salt Lake City, UT) with 1 cm2 rubber tip was used to measure the pain pressure threshold. Algometer perpendicularly placed over spinous process of T1 on prone position and pressure progressively increased 1 kg/s until patients verbally reported pain under the tip of algometer or referring pain. Measurement repeated three times and average score recorded.

Secondary outcomes

  1. Visual analog scale

    Time frame: two weeks

    The patient was asked to mark the severity of his or her pain with active motion on a horizontal line 100 millimeters in length. The intensity of the pain was calculated by measuring the area in which the individual marked between 0 (no pain) and 10 (the most severe pain I felt in my life).

  2. Cervical range of motion

    Time frame: two weeks

    Cervical Range of Motion (ROM) of flexion,extension, lateral flexion and rotation were measured with basic cervical ROM device (Performance Attainment, Associates, St Paul, MN, USA) in seated position without back support.

  3. Neck Disability Index

    Time frame: two weeks

    Perceived disability of patients was assessed with 10-item item Neck Disability Index (NDI),which a modified from Oswestry Low Back Pain Disability Index to assess with a score range of 0 to 50.

  4. Global Perceived Effect Scale

    Time frame: two weeks

    Change in the perception of the symptoms after the treatment was measured by a Global Perceived Effect Scale. Patients were asked to rate change between 1 completely recovered, 4 unchanged, 7 vastly worse on a horizontal likert scale.

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

The Effectiveness of Manipulation Treatment in Acute Cervical Region Pain

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 2, 2020
Registry last updated
Jun 23, 2026

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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