Neck PainNCT05791292
Investigation of Pressure Pain Threshold and Hand Grip Strength in Individuals With and Without Chronic Neck Pain
A study testing Evaluation in people with Neck Pain, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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. 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?
- Evaluation
- 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
- 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.
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 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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Evaluation
- Keywords
- Pressure pain threshold, Neck, Neck pain, Hand 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.
EvaluationOther
To evaluate hand grip strength, neck discomfort, arm, shoulder and hand problems, and overall quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Patients group | Other | To evaluate hand grip strength, neck discomfort, arm, shoulder and hand problems, and overall quality of life. Receives: Other: Evaluation |
| Healthy group | Other | To evaluate hand grip strength, neck discomfort, arm, shoulder and hand problems, and overall quality of life. Receives: Other: Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
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 posted30 Mar 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Case control study
- 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
- NCT05791292
- Sponsor's protocol ID
- 83116987-658
- Status last verified
- Sep 2023
- First submitted
- 15 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 Hand Grip Strength in Individuals With and Without Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT05791292
- Acronym / sponsor ID
- 83116987-658
- Conditions
- Neck Pain
- Keywords
- Pressure pain threshold, Neck, Neck pain, Hand 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
- 30 Mar 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Case control study
| Arm | Type | Receives |
|---|---|---|
| Patients group | Other | Other: EvaluationTo evaluate hand grip strength, neck discomfort, arm, shoulder and hand problems, and overall quality of life. |
| Healthy group | Other | Other: EvaluationTo evaluate hand grip strength, neck discomfort, arm, shoulder and hand problems, and overall quality of life. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| EvaluationTo evaluate hand grip strength, neck discomfort, arm, shoulder and hand problems, and overall quality of life. | Other | Healthy group, Patients group |
Primary outcome
Hand grip strength
Time frame: 1 day
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
Time frame: 1 day
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
Time frame: 1 day
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
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 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.
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 Evaluation 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?
Hand grip strength (time frame: 1 day). The study lists 4 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.