NCT05887427

Brief Summary

The aim of this study was to investigate the immediate effect of neural mobilization techniques, one of the manual therapy methods that can be used in the treatment of cervical radiculopathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

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

Study Start

First participant enrolled

November 10, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
Last Updated

June 2, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

May 24, 2023

Last Update Submit

May 24, 2023

Conditions

Cervical Radiculopathy

Keywords

NEURAL MOBİLİSATİON,CERVİCAL RADİCULOPATHY,

Outcome Measures

Primary Outcomes (2)

  • Numerical Pain Rating Scale (NPRS)

    Pain in the neck region of the participants was evaluated using NPRS before and after the intervention. On this scale, patients were asked to mark the pain they felt on a 10 cm scale. Accordingly, the participants marked the range of values "0" was no pain, and "10" was the most severe.

    2 Month

  • Neuropathic Pain Questionnaire (NPQ)

    Before and after the intervention, the characteristics and severity of the patients' pain were evaluated with the Neuropathic Pain Questionnaire. This scale was used for initial screening of patients with pain. It has the ability to provide a quantitative measurement for the symptoms that are important in the diagnosis and evaluation of neuropathic pain. In the questionnaire consisting of 12 questions, 10 questions were asked about the nature of pain and the other two questions about changes in sensitivity.

    2 Month

Secondary Outcomes (2)

  • Hand Grip Strength

    2 Month

  • Pinch Grip Strength

    2 Month

Study Arms (2)

Neural Mobilisation Group (NMG)

EXPERIMENTAL

The neural mobilisation group received one session of conservative physiotherapy and neural mobilization at the end of the session. The content of the conservative program was the same in both groups. Before the neural mobilization application, a nerve stretching test was performed to provide a specific stretching position for each nerve and the patient was asked if he/she had any complaints. After adjusting the intensity of the neural mobilization tension, all participants were asked if they felt numbness, tension or tingling sensation in the nerve. When the symptoms were at a level that did not bother the patient, the nerve was held in that position for 10 seconds and then the nerve was left in the relaxation position. Each neural mobilization was performed in 10 repetitions.

Other: Neural Mobilisation

Control Group (CG)

ACTIVE COMPARATOR

Control group patients received one session of conservative physiotherapy program. The conservative program consisted of 20 minutes of heat application to the cervical region, 20 minutes of Transcutaneous Electrical Stimulation (TENS) application and 5 minutes of ultrasound application.

Other: Conservative physiotherapy

Interventions

Neural MobilisationOTHER

Transcutaneous Electrical Stimulation, hotpack, ultrasound and neural mobilization(radial,ulnar,median)

Neural Mobilisation Group (NMG)
Conservative physiotherapyOTHER

Hotpack,Transcutaneous Electrical Stimulation ,Ultrasound

Control Group (CG)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants meeting the following criteria were included in the study: age between 18 and 65 years, referred to physiotherapy with a diagnosis of cervical disc herniation, self-reported neck pain with a visual analog scale (VAS) score of more than 5, presence of pain radiating from the neck to the arm, and at least 3 of the following tests were positive: Spurling's Test, Upper Extremity Tension Test-1, Distraction Test, and ipsilateral cervical rotation less than 60 degrees. These tests were assessed by a trained examiner according to standardized procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Üsküdar University

Istanbul, Üsküdar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • BERNA KARAMANCIOĞLU

    berna.karamancioğlu@uskudar.edu.tr

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 24, 2023

First Posted

June 2, 2023

Study Start

November 10, 2022

Primary Completion

January 6, 2023

Study Completion

January 6, 2023

Last Updated

June 2, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)