NCT05791292

Brief Summary

This study will be determined whether the pressure pain threshold and hand grip strength are affected in individuals with neck pain compared to individuals without 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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

March 15, 2023

Last Update Submit

September 13, 2023

Conditions

Neck Pain

Keywords

Pressure pain thresholdNeckNeck painHand grip strengthQuality of life

Outcome Measures

Primary Outcomes (4)

  • Hand grip strength

    A hand dynamometer (Baseline® Digital Smedley Dynamometer) will be used to evaluate hand grip strength. Measurements will be made with the feet on the chair in an upright sitting position without elbow support, with the shoulder joint in adduction, the elbow joint in 90 degrees flexion, and the forearm and wrist in the neutral position. Measurements will be made for both the right side and the left side. During the measurements, 3 separate measurements will be made by giving rest intervals and the average of these measurements will be taken and recorded in kilograms (kg).

    1 day

  • Neck disorder

    Neck disorders will be assessed with the Neck Bournemouth Questionnaire (NBQ). NBQ consists of 7 questions that examine pain intensity, activities of daily living, social activities, anxiety, emotional aspects of depression, kinesiophobia, and ability to control pain. The items in the questionnaire are specific to patients with neck pain, and each question evaluates a different parameter. A high score indicates a high degree of discomfort. The Turkish version of the NBQ has been proven to be valid and reliable.

    1 day

  • Arm, shoulder, and hand problems

    Arm, shoulder, and hand problems will be assessed with the Disabilities of the Arm, Shoulder, and Hand (DASH). DASH is an abbreviated version of DASH to measure physical function and symptoms in patients with upper extremity musculoskeletal disorders. Answers are given on a scale of one to five, and each question is scored from 1 to 5. Scores on the three subscales of the DASH disability/symptom scale, the work scale, and the sports/performing arts scale all range from 0 (no disability) to 100 (most severe disability). The Turkish version of DASH has been reported to be valid and reliable.

    1 day

  • General quality of life

    The Nottingham Health Profile (NHP) is a general quality of life questionnaire that measures a person's perceived health problems and the extent to which these problems affect normal daily activities. The NHP consists of 38 items. Questions are answered as 'yes' or 'no'. The questionnaire assesses six parameters related to health status. These parameters are; pain (8 items), physical activity (8 items), energy (3 items), sleep (5 items), social isolation (5 items), and emotional reactions (9 items). Each sub-parameter is scored between 0-100. 0 indicates best health, and 100 indicates worst health. The total NHP score is derived from the sum of the subscores.

    1 day

Study Arms (2)

Patients group

OTHER

To evaluate hand grip strength, neck discomfort, arm, shoulder and hand problems, and overall quality of life.

Other: Evaluation

Healthy group

OTHER

To evaluate hand grip strength, neck discomfort, arm, shoulder and hand problems, and overall quality of life.

Other: Evaluation

Interventions

EvaluationOTHER

To evaluate hand grip strength, neck discomfort, arm, shoulder and hand problems, and overall quality of life.

Healthy groupPatients group

Eligibility Criteria

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

You may qualify if:

  • Having neck pain complaint for more than three months,
  • Without any diagnosed chronic disease,
  • Have no past or present psychological disorders,
  • Individuals who can speak, read and write Turkish.

You may not qualify if:

  • Having any neurological, psychiatric or cognitive disorder,
  • Individuals who cannot speak, read or write Turkish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, 60250, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Halime ARIKAN, PhD

CONTACT

+90 546 576 51 32halimearikan92@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Case control study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 30, 2023

Study Start

April 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations

TU(1)