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Investigation of Pressure Pain Threshold and Hand Grip Strength in Individuals With and Without Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Evaluation
Sponsored by
Tokat Gaziosmanpasa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neck Pain focused on measuring Pressure pain threshold, Neck, Neck pain, Hand grip strength, Quality of life

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: Having any neurological, psychiatric or cognitive disorder, Individuals who cannot speak, read or write Turkish.

Sites / Locations

  • Tokat Gaziosmanpasa UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients group

Healthy group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2023
Last Updated
September 13, 2023
Sponsor
Tokat Gaziosmanpasa University
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1. Study Identification

Unique Protocol Identification Number
NCT05791292
Brief Title
Investigation of Pressure Pain Threshold and Hand Grip Strength in Individuals With and Without Chronic Neck Pain
Official Title
Investigation of Pressure Pain Threshold and Hand Grip Strength in Individuals With and Without Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
When the literature is examined, there are studies examining different parameters in different occupations, men and women with neck pain, individuals with cervical disc hernia, and individuals with chronic neck pain. Studies have addressed different parameters that may be associated with neck pain from different perspectives. However, no study was found in which the pressure pain threshold and hand grip strengths were determined and the relationship was examined in individuals with and without chronic neck pain. Therefore, with this study, it 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Pressure pain threshold, Neck, Neck pain, Hand grip strength, Quality of life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Case control study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients group
Arm Type
Other
Arm Description
To evaluate hand grip strength, neck discomfort, arm, shoulder and hand problems, and overall quality of life.
Arm Title
Healthy group
Arm Type
Other
Arm Description
To evaluate hand grip strength, neck discomfort, arm, shoulder and hand problems, and overall quality of life.
Intervention Type
Other
Intervention Name(s)
Evaluation
Intervention Description
To evaluate hand grip strength, neck discomfort, arm, shoulder and hand problems, and overall quality of life.
Primary Outcome Measure Information:
Title
Hand grip strength
Description
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).
Time Frame
1 day
Title
Neck disorder
Description
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.
Time Frame
1 day
Title
Arm, shoulder, and hand problems
Description
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.
Time Frame
1 day
Title
General quality of life
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Having any neurological, psychiatric or cognitive disorder, Individuals who cannot speak, read or write Turkish.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Halime ARIKAN, PhD
Phone
+90 546 576 51 32
Email
halimearikan92@gmail.com
Facility Information:
Facility Name
Tokat Gaziosmanpasa University
City
Tokat
ZIP/Postal Code
60250
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Halime ARIKAN, PhD
Phone
+90 546 576 51 32
Email
halimearikan92@gmail.com

12. IPD Sharing Statement

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Investigation of Pressure Pain Threshold and Hand Grip Strength in Individuals With and Without Chronic Neck Pain

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