Neck PainNCT05259358
The Effect of Muscular Endurance on Disability Level and Participation in Life
A study testing exercise in people with Neck Pain, run by Kırklareli University at 2 sites in Turkey (Türkiye).
Trial summary
Non-specific neck pain (NSBA), which is one of the most common causes of neck pain in the literature, occurs as a result of a postural or mechanical cause without a specific pathology or injury to the musculoskeletal system. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 6 Jan 2022to 25 Jan 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary consent to participate in the study
- Clinical diagnosis of non spesific neck pain
Who cannot join
- There is physical/mental problem that may prevent exercise
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Suleyman Demirel University Education and Training Hospital
Isparta, East Campus, 32260
Suleyman Demirel University
Isparta, East Campus, 32260
About this study
Official title: The Effect of Muscular Endurance on Disability Level and Participation in Life in Non-specific Neck Pain
Non-specific neck pain (NSBA), which is one of the most common causes of neck pain in the literature, occurs as a result of a postural or mechanical cause without a specific pathology or injury to the musculoskeletal system. NSBA causes an increase in superficial cervical muscle activity, and a decrease in deep cervical muscle activity, which contains a large amount of muscle spindles. Patients with chronic neck pain face functional limitations in many ways. Evaluation of disability as a result of loss of functions related to neck pain is necessary to cope with neck pain. In the ICF activity and participation section due to neck pain, it is stated that the daily life activities of the person are limited due to neck pain, both at work and at home, and with this, the level of disability of the person increases. Loss of endurance, on the other hand, appears as a physical marker in the development of chronic neck pain due to the effect of muscle functions in patients who have problems in the neck region, according to ICF.
Read the detailed description
Patients with non-specific neck pain who volunteered to participate in the study and who met the inclusion criteria of the study will be included in the study after signing the voluntary consent form. First of all, the demographic and clinical characteristics of the patients will be questioned with the evaluation form. The personal information of the patients (gender, height, weight, smoking, etc.) and clinical status (pain type, pain intensity, muscle endurance measurements) will be recorded by the physiotherapist in the evaluation form. In addition to the evaluation form, the Northwick Park Neck Pain Questionnaire will evaluate the patients' neck disability, while the Keele Participation Evaluation will evaluate their level of participation in life.
- Conditions
- Neck Pain
- Being tested
- exercise
- Keywords
- non specific neck pain, endurance, disability, participation, pain
- Medical subject headings
- Neck Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
exercises that increase muscular endurance
| Study group | Role | What they receive |
|---|---|---|
| exercise | Active comparator | In addition to routine treatment:
Postural evenness
Chin tuck exercise
Range of motion exercises for all angles of the cervical joint
Neck isometric exercises
Cervical stabilization exercises (with ball)
Stretching exercises of pectoralis, latissimus dorsi, trapezius upper part, levator scapula, rhomboid and scalene muscles Receives: Other: exercise |
| routine | No intervention | only routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
KEELE ASSESMENT OF PARTICIPATION
participation in life: 15 items total; min:0; max:11; 1-11:participation restriction in at least
one activity. Mobility; Self-Care; Domestic Life; Interpersonal Interactions and Relationships; Major Life Areas; Community Social \& Civic life
Mean response for each question was reported, with a lower score indicating better perceived participation; question scores range from 1 to 5
Measured: change in participation in life in one month
Northwick Park Neck Pain Questionnaire
the neck pain and the consequent patient disabilities: The neck pain score is the sum of the points scored for the first nine questions.
Question 9 (about the driving) is not applicable if the patient doesn't drive a car in good health.
- If the nine questions are answered: NPQ percentage = ((neck pain score) / 36) x 100%.
- If the first eight questions are answered: NPQ percentage = ((neck pain score) / 32) x 100%. The higher the percentage, the greater the disability and the pain.
Measured: change in disability level in one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start6 Jan 2022
- Primary completion20 Jan 2025
- Study completion25 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients included in the treatment group had 10 sessions postural smoothness, Chin tuck exercises, Range of motion exercises at all angles of the cervical joint, Neck isometric exercises, Cervical stabilization exercises (with ball), Pectoralis, latissimus dorsi, trapezoidal upper part, rhomboid and scalene muscle stretching exercises will be done face-to-face with a physiotherapist. At the end of 10 sessions of face-to-face training, the patients will perform the same exercises at home for 1 month. The patients will not given any exercises in the control group. Measurements and evaluations of the patients in both groups will be made twice that is before and after the treatment.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Özüberk, Kırklareli University
- Investigators
- Mine A Deniz, PT, PhD, Study director, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259358
- Sponsor's protocol ID
- 72867572-050.01.04-95509
- Status last verified
- Apr 2025
- First submitted
- 15 Jan 2022
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ozuberk B, Argali Deniz M, Soyupek F. Effects of home exercise program on endurance, disability and daily participation in non-specific neck pain. Sci Rep. 2026 Aug 4;16(1):28085. doi: 10.1038/s41598-026-60188-4.
PubMed 42711358
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Muscular Endurance on Disability Level and Participation in Life in Non-specific Neck Pain
- ClinicalTrials.gov ID
- NCT05259358
- Acronym / sponsor ID
- 72867572-050.01.04-95509
- Conditions
- Neck Pain
- Keywords
- non specific neck pain, endurance, disability, participation, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 25 Jan 2025 (actual)
- First posted
- 28 Feb 2022 (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.
Non-specific neck pain (NSBA), which is one of the most common causes of neck pain in the literature, occurs as a result of a postural or mechanical cause without a specific pathology or injury to the musculoskeletal system. NSBA causes an increase in superficial cervical muscle activity, and a decrease in deep cervical muscle activity, which contains a large amount of muscle spindles. Patients with chronic neck pain face functional limitations in many ways. Evaluation of disability as a result of loss of functions related to neck pain is necessary to cope with neck pain. In the ICF activity and participation section due to neck pain, it is stated that the daily life activities of the person are limited due to neck pain, both at work and at home, and with this, the level of disability of the person increases. Loss of endurance, on the other hand, appears as a physical marker in the development of chronic neck pain due to the effect of muscle functions in patients who have problems in the neck region, according to ICF.
Detailed description
Patients with non-specific neck pain who volunteered to participate in the study and who met the inclusion criteria of the study will be included in the study after signing the voluntary consent form. First of all, the demographic and clinical characteristics of the patients will be questioned with the evaluation form. The personal information of the patients (gender, height, weight, smoking, etc.) and clinical status (pain type, pain intensity, muscle endurance measurements) will be recorded by the physiotherapist in the evaluation form. In addition to the evaluation form, the Northwick Park Neck Pain Questionnaire will evaluate the patients' neck disability, while the Keele Participation Evaluation will evaluate their level of participation in life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients included in the treatment group had 10 sessions postural smoothness, Chin tuck exercises, Range of motion exercises at all angles of the cervical joint, Neck isometric exercises, Cervical stabilization exercises (with ball), Pectoralis, latissimus dorsi, trapezoidal upper part, rhomboid and scalene muscle stretching exercises will be done face-to-face with a physiotherapist. At the end of 10 sessions of face-to-face training, the patients will perform the same exercises at home for 1 month. The patients will not given any exercises in the control group. Measurements and evaluations of the patients in both groups will be made twice that is before and after the treatment.
| Arm | Type | Receives |
|---|---|---|
| exercise | Active comparator | Other: exerciseIn addition to routine treatment: Postural evenness Chin tuck exercise Range of motion exercises for all angles of the cervical joint Neck isometric exercises Cervical stabilization exercises (with ball) Stretching exercises of pectoralis, latissimus dorsi, trapezius upper part, levator scapula, rhomboid and scalene muscles |
| routine | No intervention | –only routine treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Voluntary consent to participate in the study
- Clinical diagnosis of non spesific neck pain
Key exclusion criteria (1 listed)
- There is physical/mental problem that may prevent exercise
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 |
|---|---|---|
| exerciseexercises that increase muscular endurance | Other | exercise |
Primary outcome
KEELE ASSESMENT OF PARTICIPATION
Time frame: change in participation in life in one month
participation in life: 15 items total; min:0; max:11; 1-11:participation restriction in at least one activity. Mobility; Self-Care; Domestic Life; Interpersonal Interactions and Relationships; Major Life Areas; Community Social \& Civic life Mean response for each question was reported, with a lower score indicating better perceived participation; question scores range from 1 to 5
Northwick Park Neck Pain Questionnaire
Time frame: change in disability level in one month
the neck pain and the consequent patient disabilities: The neck pain score is the sum of the points scored for the first nine questions. Question 9 (about the driving) is not applicable if the patient doesn't drive a car in good health. • If the nine questions are answered: NPQ percentage = ((neck pain score) / 36) x 100%. • If the first eight questions are answered: NPQ percentage = ((neck pain score) / 32) x 100%. The higher the percentage, the greater the disability and the pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Derived from this study: PubMed 42711358Ozuberk B, Argali Deniz M, Soyupek F. Effects of home exercise program on endurance, disability and daily participation in non-specific neck pain. Sci Rep. 2026 Aug 4;16(1):28085. doi: 10.1038/s41598-026-60188-4.
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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.
Mine A Deniz, PT, PhD study director
Suleyman Demirel University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Neck Pain, run by Kırklareli University at 2 sites 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KEELE ASSESMENT OF PARTICIPATION (time frame: change in participation in life in one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05259358, which also lists 1 linked publication.
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 4 May 2025.