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Effects of Neural Mobilization on Respiratory Parameters in Chronic Neck Pain

Primary Purpose

Neck Pain, Respiratory

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neural Mobilization
Sponsored by
Okan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Medical Park Gebze Hosptal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Neural Mobilization Group

Control Group

Arm Description

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.

Each participant underwent 15 treatment sessions (5 days per week for 3 weeks).

Outcomes

Primary Outcome Measures

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
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.
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

Secondary Outcome Measures

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.

Full Information

First Posted
May 9, 2023
Last Updated
May 17, 2023
Sponsor
Okan University
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1. Study Identification

Unique Protocol Identification Number
NCT05867082
Brief Title
Effects of Neural Mobilization on Respiratory Parameters in Chronic Neck Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
November 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Okan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Respiratory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neural Mobilization Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Each participant underwent 15 treatment sessions (5 days per week for 3 weeks).
Intervention Type
Other
Intervention Name(s)
Neural Mobilization
Intervention Description
Radial Nerve Mobilization, Medial Mobilization, Ulnar Mobilization
Primary Outcome Measure Information:
Title
Pulmonary function test
Description
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
Time Frame
Change from baseline respiratory function at 3 weeks
Title
Range of Motion (ROM) of the Joint
Description
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.
Time Frame
Change from baseline ROM at 3 weeks
Title
Pain Intensity
Description
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
Time Frame
Change from baseline pain intensity at 3 weeks
Secondary Outcome Measure Information:
Title
Fremantle Neck Awareness Questionnaire (FreNAQ in Turkish (FreNAQ-T)
Description
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.
Time Frame
Change from baseline FreNAQ-T at 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Tunç, Msc
Organizational Affiliation
Medical Park Gebze Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Medical Park Gebze Hosptal
City
Gebze
State/Province
Kocaeli
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Neural Mobilization on Respiratory Parameters in Chronic Neck Pain

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