- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05797025
Investigation of Pressure Pain Threshold and Pinch Grip Strength in Individuals With and Without Chronic Neck Pain
September 13, 2023 updated by: Halime Arikan, Tokat Gaziosmanpasa University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Halime ARIKAN, PhD
- Phone Number: +90 546 576 51 32
- Email: halimearikan92@gmail.com
Study Locations
-
-
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Tokat, Turkey, 60250
- Recruiting
- Tokat Gaziosmanpasa University
-
Contact:
- Halime ARIKAN, PhD
- Phone Number: +90 546 576 51 32
- Email: halimearikan92@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Individuals with neck pain
To assess pressure pain threshold and pinch grip strengths.
|
To assess pressure pain threshold and pinch grip strengths.
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Other: Healthy group
To assess pressure pain threshold and pinch grip strengths.
|
To assess pressure pain threshold and pinch grip strengths.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure pain threshold
Time Frame: 1 day
|
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.
|
1 day
|
Pinch grip strength
Time Frame: 1 day
|
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.
|
1 day
|
Neck disorders
Time Frame: 1 day
|
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.
|
1 day
|
Arm, shoulder, and hand problems
Time Frame: 1 day
|
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.
|
1 day
|
General quality of life assessed by NHP
Time Frame: 1 day
|
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.
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1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2023
Primary Completion (Estimated)
November 1, 2023
Study Completion (Estimated)
December 1, 2023
Study Registration Dates
First Submitted
March 16, 2023
First Submitted That Met QC Criteria
March 31, 2023
First Posted (Actual)
April 4, 2023
Study Record Updates
Last Update Posted (Actual)
September 14, 2023
Last Update Submitted That Met QC Criteria
September 13, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 83116987-761
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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