Clinical trial NCT04455048: The Effectiveness of Manipulation Treatment in Cervical Region
Official title: The Effectiveness of Manipulation Treatment in Acute Cervical Region Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Tape
Pain
Rehabilitation
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with a sham control. Assessments will be performed before manipulation, immediately after first session, in the second week, and two months after the last session.
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Pain pressure threshold
timeFrame: two weeks
Secondary outcomes:
measure: Visual analog scale
timeFrame: two weeks
measure: Cervical range of motion
timeFrame: two weeks
measure: Neck Disability Index
timeFrame: two weeks
measure: Global Perceived Effect Scale
timeFrame: two weeks
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University
state: Merkez
city: Bolu
country: Turkey
facility: Health Sciences Faculty Bolu Abant Izzet Baysal University
state: Merkez
Study officials:
affiliation: Bolu Abant Izzet Baylsa University
name: Erdal Dilekçi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bolu Abant Izzet Baylsa University
name: Ramazan KURUL, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: