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Investigation of Pressure Pain Threshold and Pinch 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
To assess pressure pain threshold and pinch grip strengths.
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, Pinch Grip Strength, Quality of life

Eligibility Criteria

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

Inclusion Criteria: Complaining of neck pain for more than three months, With any chronic disease diagnosed, No past or present mental illness, 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

Individuals with neck pain

Healthy group

Arm Description

To assess pressure pain threshold and pinch grip strengths.

To assess pressure pain threshold and pinch grip strengths.

Outcomes

Primary Outcome Measures

Pressure pain threshold
Pressure pain threshold will be measured using Baseline® dolorimeter (Fabrication Enterprises, White Plains, NY, USA). Pressure pain thresholds of the upper trapezius, sternocleidomastoid, levator scapula, and suboccipital region muscles (semispinalis capitis and splenius capitis) will be evaluated. Two measurements will be taken from all muscles in the same order and with five minutes intervals. The average of the measurements will be recorded in kilograms/centimeter2 (kg/cm2). The procedure will be explained to individuals by showing them by manual palpation before testing begins. Pressure pain threshold measurement with algometer has been reported as a valid and reliable method.
Pinch grip strength
Baseline® pinch meter (Mechanical Pinch Gauges, NexGen Ergonomics, Inc. Montreal, Canada) will be used to assess pinch grip strength. While measuring pinch grip strength, patients will be asked to place the pinch meter between the pulp of the thumb and index finger and squeeze with all their strength. All measurements will be performed in 3 repetitions with one-minute intervals on the right and left hands. The average of the obtained values will be recorded in kilogram force.
Neck disorders
Neck disorders will be assessed with the Bournemouth Questionnaire (BQ). BQ 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 BQ has been proven to be valid and reliable.
Arm, shoulder, and hand problems
Arm, shoulder, and hand problems will be evaluated with the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). The questionnaire consists of a disability/symptom scale (11 items) and two optional scales: work (four items) and sports/performing arts (four items). In the disability/symptom scale, each item questions the severity of pain, activity-related pain, tingling, weakness and stiffness, difficulty in performing physical activity due to upper extremity problems, and the effect of upper extremity problems on social activities, work, and sleep. 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 assessed by NHP
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 questionnaire 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 16, 2023
Last Updated
September 13, 2023
Sponsor
Tokat Gaziosmanpasa University
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1. Study Identification

Unique Protocol Identification Number
NCT05797025
Brief Title
Investigation of Pressure Pain Threshold and Pinch Grip Strength in Individuals With and Without Chronic Neck Pain
Official Title
Investigation of Pressure Pain Threshold and Pinch 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 aims to determine whether there is a difference in pressure pain threshold and pinch grip strength in individuals with and without chronic neck pain.
Detailed Description
Neck pain is a common musculoskeletal disease. In chronic pain clinics, neck pain ranks second in frequency after low back pain. Lifetime prevalence is higher in workers. 51-80% of workers experience at least one episode of neck and arm pain. Neck pain symptoms may disappear spontaneously within a few weeks, while 30% of them continue as chronic neck pain. Today, studies are planned with the theory that pathology leads to deficiencies, deficiencies lead to functional limitations, and functional limitations lead to disability. Chronic neck pain increases the cost of treatment and reduces work capacity. In addition, neck pain in industrial workplaces causes loss of work days as much as low back pain. The aim of this study is to determine whether there is a difference in pressure pain threshold and pinch grip strength in individuals with and without chronic neck pain. In addition, it is aimed to examine the relationship of these parameters with quality of life.

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, Pinch Grip Strength, Quality of life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individuals with neck pain
Arm Type
Other
Arm Description
To assess pressure pain threshold and pinch grip strengths.
Arm Title
Healthy group
Arm Type
Other
Arm Description
To assess pressure pain threshold and pinch grip strengths.
Intervention Type
Other
Intervention Name(s)
To assess pressure pain threshold and pinch grip strengths.
Intervention Description
To assess pressure pain threshold and pinch grip strengths.
Primary Outcome Measure Information:
Title
Pressure pain threshold
Description
Pressure pain threshold will be measured using Baseline® dolorimeter (Fabrication Enterprises, White Plains, NY, USA). Pressure pain thresholds of the upper trapezius, sternocleidomastoid, levator scapula, and suboccipital region muscles (semispinalis capitis and splenius capitis) will be evaluated. Two measurements will be taken from all muscles in the same order and with five minutes intervals. The average of the measurements will be recorded in kilograms/centimeter2 (kg/cm2). The procedure will be explained to individuals by showing them by manual palpation before testing begins. Pressure pain threshold measurement with algometer has been reported as a valid and reliable method.
Time Frame
1 day
Title
Pinch grip strength
Description
Baseline® pinch meter (Mechanical Pinch Gauges, NexGen Ergonomics, Inc. Montreal, Canada) will be used to assess pinch grip strength. While measuring pinch grip strength, patients will be asked to place the pinch meter between the pulp of the thumb and index finger and squeeze with all their strength. All measurements will be performed in 3 repetitions with one-minute intervals on the right and left hands. The average of the obtained values will be recorded in kilogram force.
Time Frame
1 day
Title
Neck disorders
Description
Neck disorders will be assessed with the Bournemouth Questionnaire (BQ). BQ 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 BQ 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 evaluated with the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). The questionnaire consists of a disability/symptom scale (11 items) and two optional scales: work (four items) and sports/performing arts (four items). In the disability/symptom scale, each item questions the severity of pain, activity-related pain, tingling, weakness and stiffness, difficulty in performing physical activity due to upper extremity problems, and the effect of upper extremity problems on social activities, work, and sleep. 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 assessed by NHP
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 questionnaire 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: Complaining of neck pain for more than three months, With any chronic disease diagnosed, No past or present mental illness, 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 Pinch Grip Strength in Individuals With and Without Chronic Neck Pain

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