The Effectiveness of Manipulation Treatment in Cervical Region

Not Applicable

Completed

• Conditions: Neck Pain
• Interventions: Other: Cervicothoracic thrust manipulation sham; Other: Cervicothoracic thrust manipulation

• Registration Number: NCT04455048
• Lead Sponsor: Abant Izzet Baysal University

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).

Study Timeline

• Study Start: 2019-02-02
• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-02
• Primary Completion: 2022-03-16
• Study Completion: 2022-04-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Cervicothoracic thrust manipulation sham	A sham manipulation without a high-speed low-amplitude thrust technique in the cervicothoracic transition region will be applied.
Intervention Group	Cervicothoracic thrust manipulation	A single-session manipulation with a high-speed low-amplitude thrust technique in the cervicothoracic transition region will be applied each week for two weeks.

Primary Outcome Measures

Name	Time	Method
Pain pressure threshold	two weeks	Pain pressure threshold (PPT). was assessed with an analogue algometry (Baseline, FEl Inc. White Plains, NY,USA) 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 Outcome Measures

Name	Time	Method
Cervical range of motion	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.
Visual analog scale	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).
Global Perceived Effect Scale	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.
Neck Disability Index	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.

Trial Locations

Locations (2)

Health Sciences Faculty Bolu Abant Izzet Baysal University; 🇹🇷 Bolu, Merkez, Turkey

Abant Izzet Baysal University; 🇹🇷 Bolu, Merkez, Turkey