Clinical trial NCT05246826: Comparison of Pilates and Conventional Treatment in Addition to Pilates in Patients With Chronic Neck Pain
Official title: The Effect of Conventional Treatment In Addition to Clinical Pilates Exercises in Chronic Neck Pain on Pain Level, Physical, Functional and Psychosocial Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Neck Pain
Keywords: pilates
convantional therapy
chronic neck pain
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of clinical pilates exercises and electrotherapy on pain level, physical condition, functional status and psychosocial status in patients with chronic neck pain.In the study, individuals will be divided into two groups. Pilates will be applied to one group for 6 weeks, pilates and conventional therapy will be applied to one group. Individuals will be evaluated before and after treatment. In the evaluation, pain, disability, anxiety and depression status, quality of life of individuals will be questioned. In addition, cervical joint range of motion and endurance will be evaluated.

Detailed description: Neck pain is often described by pain and/or stiffness dorsal to the region between the occipital condyles and the C7 vertebra. Pain and/or disability for more than 12 weeks is defined as chronic neck pain. Neck pain is one of the major musculoskeletal disorders in the adult population. Neck pain, which is increasingly prevalent all over the world, significantly affects individuals, families, society, health care systems and businesses. This situation causes serious disability and economic costs. Two-thirds of the entire population faces neck pain at some point in their lives. Its lifetime prevalence ranges from 40% to 70%. The prevalence of neck pain increases with age. It is more common in women approximately in the 5th decade of their life.

In various studies, various changes have been observed in the activation of the superficial and deep neck flexor (DBF) muscles of individuals experiencing neck pain. In studies conducted with electroneuromyography, it was determined that neuromuscular muscle activation increased more in superficial muscles, and decreased undesirably in DBF muscles. DBF muscles provide a fundamental contribution to the preservation of physiological cervical lordosis and the maintenance of spine stability in cranio-vertebral junction movements. For this reason, exercise methods for gaining strength and endurance of these muscles have become very important recently.

The neck region contains deep suboccipital muscles with dense muscle spindles, nerve connections to the vestibular and visual systems. Especially the high muscle spindle density in the superior and inferior oblique muscles and the rectus capitis posterior major and minor muscles is important in terms of proprioceptive input in coordinated head-eye movements. In a disorder in the neck region, muscle dysfunction occurs as a result of pain, disruption of sensory-motor input, and the transfer of deep muscles to superficial muscles. All these problems can cause asymmetrical, tight, position and movement of the neck to be perceived abnormally.

Fear avoidance beliefs are significantly associated with the experience of pain, especially when the pain becomes chronic. The anticipated threat of intense pain often causes constant alertness of pain dermatomes. This can cause even low-intensity pain sensations to be unbearable for the person. Only the increased expectation of pain or re-injury can further encourage avoidance behaviors. Increased pain or fear of re-injury interferes with many activities. Studies have shown that fear of movement in chronic neck pain increases pain and disability, worsens functional status, and negatively affects physical performance.

Studies associate individuals who experience persistent neck pain with psychological factors, including cognitive stress, anxiety, and depressed mood. In addition, it has been reported that sleep disorders are seen in parallel with the severity of pain in patients with chronic neck pain. These psychological factors may play a role in the chronicity of symptoms and cause increased pain, disability or fear-avoidance.

Studies have shown that chronic neck pain is associated with low quality of life. It has been stated that the quality of life of patients with chronic neck pain is worse than normal individuals, and that many of these individuals face mental problems and may also experience psychosocial disorders such as anxiety and depression.

Clinical Pilates exercises are a set of exercises that emphasize mind-body unity. Pilates strengthens the deep stabilizing muscles of the spine, gives flexibility to the spine, develops mind-body awareness and improves posture. Pilates also promotes the activation of the deep neck flexor muscles by promoting a neutral position of the cervical spine with mild upper cervical flexion at the cranio-cervical junction. Studies investigating the effect of clinical pilates on pain and disability in patients with chronic neck pain have shown that clinical pilates is effective in these parameters. Although it has been shown that neck perception is associated with factors such as pain, disability, anxiety and quality of life, no study has been found in the literature examining the effects of exercise and electrotherapy methods on neck awareness. In addition, there was no study examining the effect of electrotherapy on fear of movement and fear avoidance beliefs in individuals with chronic neck pain, and the effects of clinical pilates exercises on body awareness, fear of movement, and biopsychosocial factors.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* Individuals with neck pain lasting longer than 3 months
* Individuals with a score of 3 or more according to VAS

Exclusion Criteria:

* Those with a history of surgery
* Those who have received physical therapy for the neck region in the last 6 months
* With pregnancy status
* Cancer, infectious disease
* With inflammatory disease
* With neurological disease
* Joint injection in the last 3 months
* Individuals using analgesics, myorelaxants, or antidepressants

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: 6 weeks
Secondary outcomes:
measure: Cervical Normal Joint Movement
timeFrame: 6 weeks
measure: Cervical Flexor Muscle Endurance Test
timeFrame: 6 weeks
measure: Cervikal Extensor Muscle Endurance Test
timeFrame: 6 weeks
measure: Strength and Endurance of Deep Cervical Flexors
timeFrame: 6 weeks
measure: Functional Status-Neck Disability Index
timeFrame: 6 weeks
measure: Functional Status-Fremantle Neck Awareness Questionnaire:
timeFrame: 6 weeks
measure: Psychosocial Factors-Neckpix Scale:
timeFrame: 6 weeks
measure: Psychosocial Factors-Fear Avoidance Beliefs Questionnaire (KKIA)
timeFrame: 6 weeks
measure: Psychosocial Factors-Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 weeks
measure: Psychosocial Factors-Cognitive Exercise Therapy Method Scale (BETY Scale)
timeFrame: 6 weeks
measure: Quality of Life-Short form -36
timeFrame: 6 weeks
measure: Patient Satisfaction
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Gizem Vaiz Haklıgil
Study officials:
affiliation: Eastern Mediterranean University
name: SEVİM ÖKSÜZ, Asst. Prof.
role: STUDY_DIRECTOR
affiliation: Eastern Mediterranean University
name: Ender Angın, Assoc. Prof.
role: STUDY_DIRECTOR
References: