NCT05488756

Brief Summary

Neck pain is a widespread problem in the general population and is second only to low back pain in musculoskeletal issues.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

August 8, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2022

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

1 month

First QC Date

August 1, 2022

Last Update Submit

September 20, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity Assessment

    The 11-point Verbal Numeric Pain Scale (VNPS; 0 means no pain; 10 means worst pain) will be use to assess pain intensity. The VNPS is a reliable and valid measure for subjective pain measurement. Participants will be asked to report the pain severity at that moment on a scale from 0 to 10.

    4 weeks

Secondary Outcomes (5)

  • Demografic Characteristic of Participants

    1 week before the first treatment session

  • Posture Evaluation

    4 weeks

  • Evaluation of Cervical Range of Motion

    4 weeks

  • Disability Evaluation

    4 weeks

  • Assessment of Quality of Life

    4 weeks

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Conventional training plus isometric neck exercises

Other: Group 1

Group 2

EXPERIMENTAL

Conventional training plus deep cervical flexor exercises

Other: Group 2

Group 3

EXPERIMENTAL

Conventional training plus stabilization exercises of the neck and core region

Other: Group 3

Interventions

Group 1OTHER

Physical therapy agents and isometric exercise training will be applied to the patients. These will be administered a combination of transcutaneous electrical nerve stimulation, ultrasound, a hot pack, and isometric training 3 times a week for 4 weeks by the physical therapist.

Group 1
Group 2OTHER

Physical therapy agents and deep cervical flexor muscle training will be applied to the patients. These will be administered a combination of transcutaneous electrical nerve stimulation, ultrasound, a hot pack, and muscle training 3 times a week for 4 weeks by the physical therapist. Training of the craniocervical flexor muscles is going to be focused on the deep flexor muscles such as longus capitis and longus colli muscles, making neck flexion, not the head.

Group 2
Group 3OTHER

Physical therapy agents and core stabilization training will be applied to the patients. These will be administered a combination of transcutaneous electrical nerve stimulation, ultrasound, a hot pack, and stabilization training 3 times a week for 4 weeks by the physical therapist. These exercises will be performed for 10 repetitions with 10 seconds of contraction and 5 seconds of relaxation.

Group 3

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic neck pain more than 3 months
  • Medically stable

You may not qualify if:

  • Patients with benign or tumors in the cervical region
  • Patients with active, localized osseous and discal infection in the spine (spondylodiscitis)
  • Patients with history of spinal fractures
  • Patients with congenital anomaly
  • Patients with neck surgery and spinal instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eylül Pınar Kısa

Istanbul, 34720, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 5, 2022

Study Start

August 8, 2022

Primary Completion

September 9, 2022

Study Completion

September 16, 2022

Last Updated

September 21, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations