Patients With Non-Specific Chronic Neck PainNCT04809337
Therapeutic Exercises and Stabilization Exercises Given After Manual Therapy
A study testing Exercise in people with Patients With Non-Specific Chronic Neck Pain, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted to determine and compare the effects of the therapeutic exercises and stabilization exercises given to the patient after the manual therapy session on pain, neck range of motion, daily living activities and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients With Non-Specific Chronic Neck Pain
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 1 Dec 2020
- 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
- Between the ages of 18-65,
- having neck pain for 3 months or longer,
- was diagnosed with chronic neck pain by a specialist.
Who cannot join
- People with neurological diseases,
- who had previous surgery in the cervical region,
- who had medulla spinalis tumors,
- vascular pathologies,
- fractures,
- osteoporosis,
- rheumatoid arthritis problems were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Therapeutic Exercises and Stabilization Exercises After Manual Therapy in Patients With Non-Specific Chronic Neck Pain
The study was conducted to determine and compare the effects of the therapeutic exercises and stabilization exercises given to the patient after the manual therapy session on pain, neck range of motion, daily living activities and quality of life.
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
After manuel therapy, the patients were allocated into two groups as Stabilization Exercise Group and Therapeutic Exercise Group randomly.
| Study group | Role | What they receive |
|---|---|---|
| Stabilization Exercise Group | Experimental | Not described Receives: Other: Exercise |
| Therapeutic Exercise Group | Experimental | Not described Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The Visual Analog Scale (VAS) was developed to transform values which cannot be measured numerically to a numerical form. The patient is instructed to mark the severity of pain on a line marked at one end as 0=no pain to 10=intolerable pain, thereby providing the level of pain in a numerical form
Measured: 1 minute
Range of motion
Devices to measure range of motion in the joints of the body include the Goniometer and Inclinometer which use a stationary arm, protractor, fulcrum, and movement arm to measure angle from axis of the joint. We measured neck flexio, extantion and rotation
Measured: 10 minute
Secondary outcomes (3)
Lateral Scapular Shift Test
This test involves measuring the distance from the inferior angle of the scapula to the nearest vertebral spinous process using a tape measure or goniometer in three positions: shoulder in neutral, shoulder at 40-45 degrees of coronal plane abduction with hands resting on hips, and the shoulder at 90 degrees abduction with the arms in full internal rotation
Measured: 5 minute
Neck Disability Index
The Neck Disability Index (NDI) is a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain
Measured: 3 minutes
Bournemouth Neck Pain Questionnaire
Neck Bournemouth Questionnaire (NBQ) was created by Bolton and Humphreys due to the necessity of an evaluation measure to various health domains, such as pain, function, incapacity and psychological and social aspects of patients with neck pathologies. This tool is easily applied, reproducible and responsive to clinical alterations, which makes it adequate to be used for scientific research and clinical practice to monitor the pathology progression and to assist treatment planning.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Feb 2020
- Primary completion30 Sep 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Non-Specific Chronic 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Atıcı, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809337
- Sponsor's protocol ID
- 005
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Therapeutic Exercises and Stabilization Exercises After Manual Therapy in Patients With Non-Specific Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04809337
- Acronym / sponsor ID
- 005
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 22 Mar 2021 (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.
The study was conducted to determine and compare the effects of the therapeutic exercises and stabilization exercises given to the patient after the manual therapy session on pain, neck range of motion, daily living activities and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stabilization Exercise Group | Experimental | Other: Exercise |
| Therapeutic Exercise Group | Experimental | Other: Exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 18-65,
- having neck pain for 3 months or longer,
- was diagnosed with chronic neck pain by a specialist.
Key exclusion criteria (7 listed)
- People with neurological diseases,
- who had previous surgery in the cervical region,
- who had medulla spinalis tumors,
- vascular pathologies,
- fractures,
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 |
|---|---|---|
| ExerciseAfter manuel therapy, the patients were allocated into two groups as Stabilization Exercise Group and Therapeutic Exercise Group randomly. | Other | Stabilization Exercise Group, Therapeutic Exercise Group |
Primary outcome
Visual Analogue Scale
Time frame: 1 minute
The Visual Analog Scale (VAS) was developed to transform values which cannot be measured numerically to a numerical form. The patient is instructed to mark the severity of pain on a line marked at one end as 0=no pain to 10=intolerable pain, thereby providing the level of pain in a numerical form
Range of motion
Time frame: 10 minute
Devices to measure range of motion in the joints of the body include the Goniometer and Inclinometer which use a stationary arm, protractor, fulcrum, and movement arm to measure angle from axis of the joint. We measured neck flexio, extantion and rotation
3 secondary outcomes
Lateral Scapular Shift Test
Time frame: 5 minute
Neck Disability Index
Time frame: 3 minutes
Bournemouth Neck Pain Questionnaire
Time frame: 5 minutes
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 23 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Patients With Non-Specific Chronic Neck Pain, run by Okan 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 3 inclusion and 7 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 23 Mar 2021. 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?
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?
Visual Analogue Scale (time frame: 1 minute). 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?
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 23 Mar 2021.