NCT05259358

Brief Summary

Non-specific neck pain (NSBA), which is one of the most common causes of neck pain in the literature, occurs as a result of a postural or mechanical cause without a specific pathology or injury to the musculoskeletal system. NSBA causes an increase in superficial cervical muscle activity, and a decrease in deep cervical muscle activity, which contains a large amount of muscle spindles. Patients with chronic neck pain face functional limitations in many ways. Evaluation of disability as a result of loss of functions related to neck pain is necessary to cope with neck pain. In the ICF activity and participation section due to neck pain, it is stated that the daily life activities of the person are limited due to neck pain, both at work and at home, and with this, the level of disability of the person increases. Loss of endurance, on the other hand, appears as a physical marker in the development of chronic neck pain due to the effect of muscle functions in patients who have problems in the neck region, according to ICF.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

January 6, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2025

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

3 years

First QC Date

January 15, 2022

Last Update Submit

April 30, 2025

Conditions

Keywords

non specific neck painendurancedisabilityparticipationpain

Outcome Measures

Primary Outcomes (2)

  • KEELE ASSESMENT OF PARTICIPATION

    participation in life: 15 items total; min:0; max:11; 1-11:participation restriction in at least one activity. Mobility; Self-Care; Domestic Life; Interpersonal Interactions and Relationships; Major Life Areas; Community Social \& Civic life Mean response for each question was reported, with a lower score indicating better perceived participation; question scores range from 1 to 5

    change in participation in life in one month

  • Northwick Park Neck Pain Questionnaire

    the neck pain and the consequent patient disabilities: The neck pain score is the sum of the points scored for the first nine questions. Question 9 (about the driving) is not applicable if the patient doesn't drive a car in good health. • If the nine questions are answered: NPQ percentage = ((neck pain score) / 36) x 100%. • If the first eight questions are answered: NPQ percentage = ((neck pain score) / 32) x 100%. The higher the percentage, the greater the disability and the pain.

    change in disability level in one month

Study Arms (2)

exercise

ACTIVE COMPARATOR

In addition to routine treatment: Postural evenness Chin tuck exercise Range of motion exercises for all angles of the cervical joint Neck isometric exercises Cervical stabilization exercises (with ball) Stretching exercises of pectoralis, latissimus dorsi, trapezius upper part, levator scapula, rhomboid and scalene muscles

Other: exercise

routine

NO INTERVENTION

only routine treatment

Interventions

exercises that increase muscular endurance

exercise

Eligibility Criteria

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

You may qualify if:

  • Voluntary consent to participate in the study
  • Clinical diagnosis of non spesific neck pain

You may not qualify if:

  • There is physical/mental problem that may prevent exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Suleyman Demirel University Education and Training Hospital

Isparta, East Campus, 32260, Turkey (Türkiye)

Location

Suleyman Demirel University

Isparta, East Campus, 32260, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck PainPain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mine A Deniz, PT, PhD

    Suleyman Demirel University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients included in the treatment group had 10 sessions postural smoothness, Chin tuck exercises, Range of motion exercises at all angles of the cervical joint, Neck isometric exercises, Cervical stabilization exercises (with ball), Pectoralis, latissimus dorsi, trapezoidal upper part, rhomboid and scalene muscle stretching exercises will be done face-to-face with a physiotherapist. At the end of 10 sessions of face-to-face training, the patients will perform the same exercises at home for 1 month. The patients will not given any exercises in the control group. Measurements and evaluations of the patients in both groups will be made twice that is before and after the treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 15, 2022

First Posted

February 28, 2022

Study Start

January 6, 2022

Primary Completion

January 20, 2025

Study Completion

January 25, 2025

Last Updated

May 4, 2025

Record last verified: 2025-04

Locations