NCT05867082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 26, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2023

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

May 9, 2023

Last Update Submit

July 30, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Fremantle Neck Awareness Questionnaire (FreNAQ in Turkish (FreNAQ-T)

    Change from baseline FreNAQ-T at 3 weeks

Study Arms (2)

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.

Other: Neural Mobilization

Control Group

EXPERIMENTAL

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

Other: Neural Mobilization

Interventions

Radial Nerve Mobilization, Medial Mobilization, Ulnar Mobilization

Control GroupNeural Mobilization Group

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals aged 25-65 years,
  • those with neck pain for \>3 months
  • those with complaints of pain, tension
  • numbness on neurodynamic nerve tests

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Park Gebze Hosptal

Gebze, Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elif Tunç, Msc

    Medical Park Gebze Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2023

First Posted

May 19, 2023

Study Start

June 26, 2023

Primary Completion

October 27, 2023

Study Completion

October 27, 2023

Last Updated

August 1, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations