Neck PainNCT05797025
Investigation of Pressure Pain Threshold and Pinch Grip Strength in Individuals With and Without Chronic Neck Pain
A study testing To assess pressure pain threshold and pinch grip strengths. in people with Neck Pain, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- To assess pressure pain threshold and pinch grip strengths.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Having any neurological, psychiatric or cognitive disorder,
- Individuals who cannot speak, read or write Turkish.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tokat Gaziosmanpasa University
Tokat Province, 60250
Halime ARIKAN, PhD, +90 546 576 51 32, halimearikan92@gmail.com
About this study
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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- To assess pressure pain threshold and pinch grip strengths.
- Keywords
- Pressure Pain Threshold, Neck, Neck Pain, Pinch Grip Strength, Quality of life
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To assess pressure pain threshold and pinch grip strengths.Other
To assess pressure pain threshold and pinch grip strengths.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with neck pain | Other | To assess pressure pain threshold and pinch grip strengths. Receives: Other: To assess pressure pain threshold and pinch grip strengths. |
| Healthy group | Other | To assess pressure pain threshold and pinch grip strengths. Receives: Other: To assess pressure pain threshold and pinch grip strengths. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start1 Apr 2023
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halime Arikan, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797025
- Sponsor's protocol ID
- 83116987-761
- Status last verified
- Sep 2023
- First submitted
- 16 Mar 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pressure Pain Threshold and Pinch Grip Strength in Individuals With and Without Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT05797025
- Acronym / sponsor ID
- 83116987-761
- Conditions
- Neck Pain
- Keywords
- Pressure Pain Threshold, Neck, Neck Pain, Pinch Grip Strength, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with neck pain | Other | Other: To assess pressure pain threshold and pinch grip strengths.To assess pressure pain threshold and pinch grip strengths. |
| Healthy group | Other | Other: To assess pressure pain threshold and pinch grip strengths.To assess pressure pain threshold and pinch grip strengths. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Having any neurological, psychiatric or cognitive disorder,
- Individuals who cannot speak, read or write Turkish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| To assess pressure pain threshold and pinch grip strengths.To assess pressure pain threshold and pinch grip strengths. | Other | Healthy group, Individuals with neck pain |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing To assess pressure pain threshold and pinch grip strengths. in people with Neck Pain, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Halime ARIKAN, PhD (+90 546 576 51 32, halimearikan92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain threshold (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.