Neck PainNCT05867082
Effects of Neural Mobilization on Respiratory Parameters in Chronic Neck Pain
A study testing Neural Mobilization in people with Neck Pain and Respiratory, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
Objective: Neural mobilization (NM) is commonly used to treat nerve disorders, and it is useful for disorders associated with neck and arm pain. This study aimed to determine the effects of NM on respiratory function in patients with chronic neck pain. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Neck Pain, Respiratory
- What is being tested?
- Neural Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2023to 27 Oct 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 25-65 years,
- those with neck pain for >3 months
- those with complaints of pain, tension
- numbness on neurodynamic nerve tests
Who cannot join
- individuals with spinal stenosis,
- neurological diagnosis, malignancy,
- upper extremity vascular problems,
- osteoporosis,
- pregnancy,
- history of newly repaired peripheral nerves,
Show all 9Show fewer
- inflammatory processes,
- cervical spine and upper extremity surgeries,
- conditions affecting lung capacity (such as asthma, bronchitis, and diabetes mellitus)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Neural Mobilization on Respiratory Parameters, Pain, Range of Motion, and Neck Awareness in Patients With Chronic Neck Pain: A Randomized Controlled Trial
Objective: Neural mobilization (NM) is commonly used to treat nerve disorders, and it is useful for disorders associated with neck and arm pain. This study aimed to determine the effects of NM on respiratory function in patients with chronic neck pain.
Methods: Overall, 26 patients with neck pain were randomly assigned to two groups: NM or control. In these participants, respiratory function and active cervical range of motion were assessed before and after intervention. Furthermore, the participants were provided a visual analog scale (VAS) and Fremantle Neck Awareness Questionnaire (FreNAQ). Each participant underwent 15 treatment sessions (5 days per week for 3 weeks). Further, in the NM group, in addition to conventional treatment, 10 sessions of neural mobilization were performed.
- Conditions
- Neck Pain, Respiratory
- Being tested
- Neural Mobilization
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural MobilizationOther
Radial Nerve Mobilization, Medial Mobilization, Ulnar Mobilization
| Study group | Role | What they receive |
|---|---|---|
| Neural Mobilization Group | Experimental | Each participant underwent 15 treatment sessions (5 days per week for 3 weeks). Further, in the NM group, in addition to conventional treatment, 10 sessions of neural mobilization were performed. Receives: Other: Neural Mobilization |
| Control Group | Experimental | Each participant underwent 15 treatment sessions (5 days per week for 3 weeks). Receives: Other: Neural Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function test
PFTs were performed using a spirometer (Schiller SP-260). Spirometric measurements were obtained using a nasal clamp while the patient was in a sitting position. At least three measurements were obtained for each participant, and the best value was considered for the study. In PFT measurements, forced expiratory volume in the 1st second (FEV1), forced vital capacity (FVC), and FEV1/FVC values were compared between the two groups
Measured: Change from baseline respiratory function at 3 weeks
Range of Motion (ROM) of the Joint
Participants' ROM of the neck was measured using a universal goniometer at baseline. The measurements for neck flexion, extension, lateral flexion, and rotation were made during active neck movements while the patient was in a seating position. For the measurement of ROM during neck flexion and extension, the goniometer was placed on the acromion, and the ROM was measured by following the midline of the ear. To measure ROM during lateral flexion, the goniometer was placed on the spinous process of the cervical vertebra 7, and the ROM was measured by tracking its movement. For the measurement of ROM during rotation, the goniometer was placed in the center of the head, and the ROM was measured by following the nose. All measurements were reported in degrees.
Measured: Change from baseline ROM at 3 weeks
Pain Intensity
Pain intensity was assessed using Visual Analog Scale. A description of the parameter being evaluated was written at either end of a 10-cm horizontal line, with scores ranging from 0 (no pain) to 10 (excruciating pain). The participants were asked to choose the score that best described their pain
Measured: Change from baseline pain intensity at 3 weeks
Secondary outcomes (1)
Fremantle Neck Awareness Questionnaire (FreNAQ in Turkish (FreNAQ-T)
FreNAQ-T is a Likert-type questionnaire that assesses individual-specific altered perception (0 = I never felt/never feel this way, 1 = I rarely feel this way, 2 = I sometimes or some of the time feel this way, 3 = I often feel this way, 4 = I always or most of the time feel this way). The questionnaire consists of nine questions, for example, about how they perceive their neck in relation to their body and how they perceive their body position. The total score ranges from 0 to 36. High score indicates a poor prognosis. Onan et al. (2020) developed the Turkish version of the questionnaire and assessed its validity and reliability.
Measured: Change from baseline FreNAQ-T at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start26 Jun 2023
- Primary completion27 Oct 2023
- Study completion27 Oct 2023
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Atıcı, Okan University
- Investigators
- Elif Tunç, Msc, Study director, Medical Park Gebze Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867082
- Sponsor's protocol ID
- 009
- Status last verified
- Jul 2024
- First submitted
- 9 May 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neural Mobilization on Respiratory Parameters, Pain, Range of Motion, and Neck Awareness in Patients With Chronic Neck Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05867082
- Acronym / sponsor ID
- 009
- Conditions
- Neck Pain, Respiratory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 19 May 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.
Objective: Neural mobilization (NM) is commonly used to treat nerve disorders, and it is useful for disorders associated with neck and arm pain. This study aimed to determine the effects of NM on respiratory function in patients with chronic neck pain.
Methods: Overall, 26 patients with neck pain were randomly assigned to two groups: NM or control. In these participants, respiratory function and active cervical range of motion were assessed before and after intervention. Furthermore, the participants were provided a visual analog scale (VAS) and Fremantle Neck Awareness Questionnaire (FreNAQ). Each participant underwent 15 treatment sessions (5 days per week for 3 weeks). Further, in the NM group, in addition to conventional treatment, 10 sessions of neural mobilization were performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neural Mobilization Group | Experimental | Other: Neural MobilizationEach participant underwent 15 treatment sessions (5 days per week for 3 weeks). Further, in the NM group, in addition to conventional treatment, 10 sessions of neural mobilization were performed. |
| Control Group | Experimental | Other: Neural MobilizationEach participant underwent 15 treatment sessions (5 days per week for 3 weeks). |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals aged 25-65 years,
- those with neck pain for >3 months
- those with complaints of pain, tension
- numbness on neurodynamic nerve tests
Key exclusion criteria (9 listed)
- individuals with spinal stenosis,
- neurological diagnosis, malignancy,
- upper extremity vascular problems,
- osteoporosis,
- pregnancy,
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 |
|---|---|---|
| Neural MobilizationRadial Nerve Mobilization, Medial Mobilization, Ulnar Mobilization | Other | Control Group, Neural Mobilization Group |
Primary outcome
Pulmonary function test
Time frame: Change from baseline respiratory function at 3 weeks
PFTs were performed using a spirometer (Schiller SP-260). Spirometric measurements were obtained using a nasal clamp while the patient was in a sitting position. At least three measurements were obtained for each participant, and the best value was considered for the study. In PFT measurements, forced expiratory volume in the 1st second (FEV1), forced vital capacity (FVC), and FEV1/FVC values were compared between the two groups
Range of Motion (ROM) of the Joint
Time frame: Change from baseline ROM at 3 weeks
Participants' ROM of the neck was measured using a universal goniometer at baseline. The measurements for neck flexion, extension, lateral flexion, and rotation were made during active neck movements while the patient was in a seating position. For the measurement of ROM during neck flexion and extension, the goniometer was placed on the acromion, and the ROM was measured by following the midline of the ear. To measure ROM during lateral flexion, the goniometer was placed on the spinous process of the cervical vertebra 7, and the ROM was measured by tracking its movement. For the measurement of ROM during rotation, the goniometer was placed in the center of the head, and the ROM was measured by following the nose. All measurements were reported in degrees.
Pain Intensity
Time frame: Change from baseline pain intensity at 3 weeks
Pain intensity was assessed using Visual Analog Scale. A description of the parameter being evaluated was written at either end of a 10-cm horizontal line, with scores ranging from 0 (no pain) to 10 (excruciating pain). The participants were asked to choose the score that best described their pain
1 secondary outcome
Fremantle Neck Awareness Questionnaire (FreNAQ in Turkish (FreNAQ-T)
Time frame: Change from baseline FreNAQ-T at 3 weeks
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 1 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Elif Tunç, Msc study director
Medical Park Gebze Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neural Mobilization in people with Neck Pain and Respiratory, 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 4 inclusion and 9 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 1 Aug 2024. 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?
Pulmonary function test (time frame: Change from baseline respiratory function at 3 weeks). The study lists 3 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 1 Aug 2024.