NCT06236737

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

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

1.2 years

First QC Date

January 24, 2024

Last Update Submit

January 24, 2024

Conditions

Keywords

RehabilitationPainYogaProprioception

Outcome Measures

Primary Outcomes (1)

  • Cervical Joint Position Error Test

    Cervical joint position error (JPE) test was used a laser pointer. A laser pointer was mounted onto a lightweight headband is then placed on the patient's head. The patient was sut 90 cm from the wall, and the started point (center of target or reference point) of the laser projection was marked. The participant (blindfolded or closed) performed active neck movement and then returned to the starting position as accurately as possible. The final laser position was measured relative to the starting position (distance or angle). The errors was measured after cervical extension, flexion, lateral flexions, and rotations.

    8 weeks

Secondary Outcomes (5)

  • Range of Motion (ROM)

    8 weeks

  • Numerical Pain Rating Scale (NPRS)

    8 weeks

  • Neck Disability Index (NDI)

    8 weeks

  • Tampa Scale for Kinesiophobia (TSK)

    8 weeks

  • Quality of Life (Short Form-36)

    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 Exercise

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

Other: Yoga Exercise

Interventions

The sensorimotor group was given oculomotor, gaze stability and postural stability exercises. Each session lasted 40 minutes in total.

Sensorimotor Exercise Group

A flow was created for the yoga group. Each session lasting 40 minutes was included ocular motor, balance, meditation and stretching. Practices illustrated in table one were repeated for the eight weeks. Beginning of each session was focused on breathing exercises and the yoga flow is designed. Weeks 1-2. were prepared by focusing mostly on sagittal plane asanas. While 3-5. tweeks were focused on frontal plane asanas, 6-8. weeks were focused on transvers plan. Each session commenced with a 5-minute practice of a three dimensional breathing technique. This was followed by a 25-minute yoga asana flow, concluding with a 10-minute meditation in shavasana, also known as Corpse Pose. NDY was taught by an academician physiotherapist who has completed graduation in yoga therapy.

Yoga Exercise Group

Eligibility Criteria

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

You may qualify if:

  • aged 24-60 years of either sex, at least a 12 weeks history of CNP, CNP according to the Quebec Task Force grading system in Grade 1 and 2

You may not qualify if:

  • according to Quebec Task Force grading system Grade 3 and 4 neck pain, neurological defects, speech and perception disorders, psychiatric diagnosis, recent history of neck trauma, recent history of cancer, diagnosed vestibular disorder, participants who diagnosed eye disorders, recent history of surgery, contraindications to yoga.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dilanur Kutlu Özkaraoğlu, MsC

    Istanbul MedipolUniversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two intervention group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT,MSc

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 1, 2024

Study Start

December 1, 2020

Primary Completion

March 1, 2022

Study Completion

June 30, 2022

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations