NCT05496127

Brief Summary

Neck pain is an important public health problem with a high lifetime prevalence and frequently occurring in all industrialized countries. Clinical practice guidelines for chronic neck pain recommend conservative management. Conservative treatment includes many approaches such as endurance, stretching and strengthening exercises, manual therapy, proprioceptive exercises, pilates and yoga. In patients with chronic neck pain, atrophy of deep neck muscles, deterioration in fiber type ratio, muscle tenderness and decreased range of motion are observed. These problems cause poor cervical postural control system and thus impaired sense of proprioception, loss of balance, decreased eye movement and cervical muscle activity. Sensorimotor control of upright posture and head-eye movement relies on information from the vestibular, visual, and proprioceptive systems that assemble throughout the central nervous system.The cervical spine has an important role in providing proprioceptive input. This role is associated with an abundance of cervical mechanoreceptors. Recent studies have shown that proprioceptive training is associated with cervical joint position sense, joint range of motion, pain and disability. Also yoga combines physical exercises with breathing techniques and meditation and yoga is one of the most commonly used complementary treatments for neck pain.The aim of study is to determine the effectiveness of exercises for sensorimotor structure and yoga exercises with physical and meditative effects in individuals with chronic neck pain.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

1.7 years

First QC Date

July 19, 2022

Last Update Submit

August 11, 2022

Conditions

Outcome Measures

Primary Outcomes (6)

  • Short Form 36 Quality of Life Scale

    SF-36 assesses quality of life by focusing on the physical, social and spiritual components of health. It consists of 36 items. Each item is scored between 0-100. 100 points indicate good health, 0 points poor health.

    Change in quality of life at 8 weeks

  • The Neck Disability Index

    The Neck Disability Index is a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. Pain severity, personal care, concentration, driving, headache, lifting, working, sleeping, recretion, reading are questioned. This questionnaire consists of 10 questions, each question is given 0-5 points, and the higher the score, the higher the degree of disability. While 50 points is the highest possible score, 0 points is the lowest.

    Change in functionality at 8 weeks

  • Tampa Kinesiophobia Scale

    Tampa Kinesiophobia Scale is 17 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. The questionnaire using 4 points to assess that are based on; the model of fear-avoidance, fear of work-related activities, fear of movement, and fear of re-injury. The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia.

    Change in fear of movement at 8 weeks

  • Numeric Pain Rating Scale

    The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults with chronic pain. NPRS is a segmented numeric version of the visual analog scale in which selects a whole number (0-10 integers) that best reflects the intensity of patients pain. An NPRS score of 3 and less than 3 represents low pain, 4-6 represents moderate pain, and greater than 7 represents severe pain.

    Change in pain intensity at 8 weeks

  • Joint Range of Motion Measurement

    Joint movements of the cervical region are performed using clinical instruments such as goniometer and cervical joint range of motion device. With the innovations brought by technology opportunities, different applications have been started to be used in the measurement of joint range of motion. The application named 'G-Pro' has good reliability and high validity in measuring active cervical joint range of motion in nonspecific neck pain participants. Participants will be evaluated with the G-Pro application. Values that should be in a healthy individual; 45-65 degrees for flexion, 45-50 degrees for extension, 55 degrees for rotation, and 40 degrees for lateral flexion.

    Change in range of motion at 8 weeks

  • Joint Position Error Test

    The Cervical Joint Position Error (JPE) Test is a measurement tool used to clinically assess an individual's cervicocephalic proprioception ability. A target is placed on a wall 90cm away from the patient, at the patient's head height in sitting. The target is 90x80 cm in diameter. A laser pointer device is 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 centre. 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. The patient should verbally indicate when they feel they have returned to the starting position. The distance of this point from the origin is measured. The more deteriorated the joint position sense is, the higher the value will be.

    Change in joint position sense at 8 weeks

Study Arms (2)

Sensorimotor Exercise Group

EXPERIMENTAL

Sensorimotor exercise group; oculomotor exercise to provide information from the visual system, laser target exercise to provide information from the proprioception system, and postural stability exercise to provide information from the vestibular system. Within the scope of oculomotor exercise, gaze stability exercise and head-body coordination exercise will be given to the participants. Laser target exercise will be given with the laser target fixed on the participant's head and 90 cm away from the target. Postural stability exercise will be given in the form of tandem exercise and standing on one leg.

Other: Sensorimotor Exercises and Yoga

Yoga Exercise Group

EXPERIMENTAL

Yoga group will be given yoga exercises including 14 poses. These exercises are: bridge pose, corpse pose, bharadvaja's twist, downward facing dog, downward facing hero, extended side angle, extended triangle, mountain pose, prosperous pose, reclining big toe, standing half forward bend, thunderbolt pose, upward hand pose, warrior pose II.

Other: Sensorimotor Exercises and Yoga

Interventions

Within the content of sensorimotor exercise; oculomotor exercise, laser target exercise and postural stability exercise were applied. 14 yoga poses were applied within the content of Yoga Exercises.

Sensorimotor Exercise GroupYoga Exercise Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being diagnosed with chronic neck pain at Grade 1 and 2 level,
  • Being over 18 years old,
  • Pain lasting more than 3 months,
  • Absence of neurogenic deficit

You may not qualify if:

  • Having been diagnosed with chronic neck pain at Grade 3 and 4 level,
  • Having problems with speaking and understanding,
  • Having undergone surgery on the neck region,
  • Having a history of trauma,
  • Having a history of cancer,
  • Diagnosis of vestibular disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic PainNeck Pain

Interventions

Yoga

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 19, 2022

First Posted

August 11, 2022

Study Start

December 1, 2020

Primary Completion

August 15, 2022

Study Completion

August 15, 2022

Last Updated

August 15, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations