- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05867082
Effects of Neural Mobilization on Respiratory Parameters in Chronic Neck Pain
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kocaeli
-
Gebze, Kocaeli, Turkey
- Medical Park Gebze Hosptal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals aged 25-65 years,
- those with neck pain for >3 months
- those with complaints of pain, tension
- numbness on neurodynamic nerve tests
Exclusion Criteria:
- individuals with spinal stenosis,
- neurological diagnosis, malignancy,
- upper extremity vascular problems,
- osteoporosis,
- pregnancy,
- history of newly repaired peripheral nerves,
- inflammatory processes,
- cervical spine and upper extremity surgeries,
- conditions affecting lung capacity (such as asthma, bronchitis, and diabetes mellitus)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Neural Mobilization Group
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.
|
Radial Nerve Mobilization, Medial Mobilization, Ulnar Mobilization
|
|
Experimental: Control Group
Each participant underwent 15 treatment sessions (5 days per week for 3 weeks).
|
Radial Nerve Mobilization, Medial Mobilization, Ulnar Mobilization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Change from baseline respiratory function at 3 weeks
|
|
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.
|
Change from baseline ROM at 3 weeks
|
|
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
|
Change from baseline pain intensity at 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fremantle Neck Awareness Questionnaire (FreNAQ in Turkish (FreNAQ-T)
Time Frame: Change from baseline FreNAQ-T at 3 weeks
|
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.
|
Change from baseline FreNAQ-T at 3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Elif Tunç, Msc, Medical Park Gebze Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 009 (Other Identifier: Nahrain Medical Research Collective (NMRC))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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