NCT06689722

Brief Summary

The aim of this study is to investigate the effectiveness of chiropractic treatment combined with ergonomic training in factory workers with nonspecific neck pain.

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 Nov 2024

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

November 12, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2025

Completed
Last Updated

January 6, 2025

Status Verified

January 1, 2025

Enrollment Period

1 month

First QC Date

November 12, 2024

Last Update Submit

January 3, 2025

Conditions

Keywords

chiropracticoccupational diseases

Outcome Measures

Primary Outcomes (3)

  • The Pittsburgh Sleep Quality Index (PSQI)

    Pittsburgh Sleep Quality Index; It evaluates sleep duration, sleep disturbance, sleep efficiency, subjective sleep quality, sleep medication use, daytime dysfunction, and sleep delay and consists of a total of 24 questions. 19 of them are self-report scales and 5 of them consist of questions to be answered by a friend or spouse. There are 7 components with 18 questions scored in the scale, and each component is evaluated between 0 and 3 points. The total score ranges from 0 to 21, and 5 or more is an indicator of "poor sleep quality".

    5 weeks

  • Neck Pain Disability Index Questionnaire

    The scale includes 10 titles. It includes pain sensitivity, heavy lifting, personal hygiene, reading, sleep, headache, concentration, work, driving, social activities. There are 6 answer options according to the severity of the limitation or pain. Scoring is between 0 and 5. The highest score is 50 and the least is 0. The neck disability level classification according to the total score is as follows 0-4: no restrictions 5-14: mild limitation 15-24: moderate limitation 25-34: severe limitation 34 and up: completely restricted

    5 weeks

  • Bournemouth Neck Pain Survey

    The survey consists of 7 questions. In addition to questions about pain and disability, it also includes questions about psychosocial issues. Each question is scored between 0 and 10. The highest score is 70, with a higher score indicating a higher level of disability. The content of the survey consists of variables that must be questioned for individuals with neck pain, such as pain severity, the effect of pain on daily life activities and social life, anxiety-depression level, kinesiophobia and coping with pain.

    5 weeks

Study Arms (3)

chiropractic

EXPERIMENTAL

chiropractic practices

Other: chiropracticOther: ergonomics

placebo

SHAM COMPARATOR

sham manipulation applications

Other: shamOther: ergonomics

control

ACTIVE COMPARATOR

those who did not receive any intervention

Other: ergonomics

Interventions

Chiropractic practice was applied using the diversified technique, which is one of the types of chiropractic techniques.

chiropractic
shamOTHER

The patient was asked if he/she had any pain or other complaints during the trial mobilization. High-velocity, low-amplitude impulses were applied to the inferior and lateral directions for patients who did not describe any complaints.

placebo

Ergonomics training will be given to each of the control group participants individually. The content of this training will include "what is ergonomics, the purpose of ergonomics, musculoskeletal diseases in employees, work-related musculoskeletal risk fa

chiropracticcontrolplacebo

Eligibility Criteria

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

You may qualify if:

  • Being between 18-65 years of age,
  • Having neck pain for the last 3 months,
  • Neck pain being 4 or higher on the Visual Analog Scale

You may not qualify if:

  • Having undergone surgery in the last 6 months,
  • Not being cooperative,
  • Presence of psychological problems,
  • Neck pain being of radicular or neurological origin,
  • Presence of a systemic or metabolic disease such as cancer, Instability in the neck,
  • Vertebro-basilar insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kemalpaşa Heat treatment factory

Izmir, Turkey (Türkiye)

Location

Related Publications (3)

  • Pehlevan E, Sevgin O. Effect of exercise given to factory workers with ergonomics training on pain and functionality: A randomized controlled trial. Work. 2024;78(1):195-205. doi: 10.3233/WOR-230663.

    PMID: 38701125BACKGROUND
  • Zengi H, Safran EE, Sevgin O. The effect of home exercises with kinesiotaping on pain, functionality, and work performance in bus drivers with non-specific neck pain. J Back Musculoskelet Rehabil. 2024;37(6):1617-1630. doi: 10.3233/BMR-240001.

    PMID: 38943382BACKGROUND
  • Chaibi A, Allen-Unhammer A, Kopke Vollestad N, Russell MB. Chiropractic spinal manipulative therapy for acute neck pain: A 4-arm clinical placebo randomized controlled trial. A prospective study protocol. PLoS One. 2023 Dec 7;18(12):e0295115. doi: 10.1371/journal.pone.0295115. eCollection 2023.

    PMID: 38060549BACKGROUND

MeSH Terms

Conditions

Neck PainOccupational Diseases

Interventions

Manipulation, Chiropracticsalicylhydroxamic acidErgonomics

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsEngineeringTechnology, Industry, and Agriculture

Study Officials

  • Deniz Balıkçı

    Bahçeşehir University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 14, 2024

Study Start

November 15, 2024

Primary Completion

December 25, 2024

Study Completion

January 2, 2025

Last Updated

January 6, 2025

Record last verified: 2025-01

Locations