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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05867082
Other study ID # 009
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 30, 2021
Est. completion date November 15, 2021

Study information

Verified date May 2023
Source Okan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date November 15, 2021
Est. primary completion date October 30, 2021
Accepts healthy volunteers No
Gender All
Age group 25 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Neural Mobilization
Radial Nerve Mobilization, Medial Mobilization, Ulnar Mobilization

Locations

Country Name City State
Turkey Medical Park Gebze Hosptal Gebze Kocaeli

Sponsors (1)

Lead Sponsor Collaborator
Okan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change from baseline respiratory function at 3 weeks
Primary 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. Change from baseline ROM at 3 weeks
Primary 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 Change from baseline pain intensity at 3 weeks
Secondary 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. Change from baseline FreNAQ-T at 3 weeks
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