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Acute Effect of Neural Mobilization in Cervical Radiculopathy: A Randomized Controlled Study

Primary Purpose

Cervical Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neural Mobilisation
Conservative physiotherapy
Sponsored by
Uskudar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy focused on measuring NEURAL MOBİLİSATİON,CERVİCAL RADİCULOPATHY,

Eligibility Criteria

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

Inclusion Criteria: 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 Exclusion Criteria: Exclusion criteria were surgical intervention in the head and neck region, history of fracture in the head and neck region, known chronic disease, infection and structural disorders in the bone and soft tissue in the cervical spine, malignancy and severe osteoporosis.

Sites / Locations

  • Üsküdar University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neural Mobilisation Group (NMG)

Control Group (CG)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Hand Grip Strength
A digital hand dynamometer (JAMAR Plus Digital Hand Dynamometer) , was used to measure hand grip strength.. The test was performed in an upright sitting position, 3 measurements were performed with one-minute intervals between each measurement and the averages were recorded. For painless grip strength, patients were asked to squeeze the dynamometer until they felt discomfort before and after treatment.The shoulder was in adduction and neutral position, elbow in 90° flexion, forearm in neutral position and wrist in 0 -30° extension and 0-15° ulnar deviation position while the patients were sitting in a chair with their arms supported.Both hands were measured separately.
Pinch Grip Strength
Pinch grip (two-point grip) strength was evaluated with a pinch meter (JAMAR Plus Pinch Gauge). The application was performed comparatively in both extremities; patients were sitting in a chair with support, shoulder in adduction and neutral position, elbow in 90˚ flexion, forearm in neutral position, wrist in 0-30˚ extension and 0-15˚ ulnar deviation position.Measurements were taken before and after the intervention. Three measurements were made with one minute intervals between each measurement and the averages were recorded.

Full Information

First Posted
May 24, 2023
Last Updated
May 24, 2023
Sponsor
Uskudar University
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1. Study Identification

Unique Protocol Identification Number
NCT05887427
Brief Title
Acute Effect of Neural Mobilization in Cervical Radiculopathy: A Randomized Controlled Study
Official Title
Acute Effect of Neural Mobilization in Cervical Radiculopathy: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
January 6, 2023 (Actual)
Study Completion Date
January 6, 2023 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

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.
Detailed Description
This study was designed as a randomized controlled experimental study and was conducted in the Physiotherapy and Rehabilitation Department of Istanbul Medicana International Hospital. Population: The study included patients diagnosed with cervical disc herniation who were referred to physiotherapy sessions by a physician Patients were assigned to the Control Group(CG) or Neural Mobilization Group(NMG) by simple randomization. The control group received conventional physiotherapy while the neural mobilization group received neural mobilization of the ulnar median and radial nerves. The pain of the patients was evaluated with Numeric Pain Rating Sacale (NPRS) and Neuropathic Pain Questionnaire (NPQ) at the beginning and end of the intervention, while hand grip strength and pinch grip strength were evaluated with digital hand dynamometer (JAMAR Plus Digital Hand Dynamometer) and digital pinchmeter (JAMAR Plus Pinch Gauge). Pre- and post-intervention data were statistically analyzed and compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy
Keywords
NEURAL MOBİLİSATİON,CERVİCAL RADİCULOPATHY,

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neural Mobilisation Group (NMG)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group (CG)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Neural Mobilisation
Intervention Description
Transcutaneous Electrical Stimulation, hotpack, ultrasound and neural mobilization(radial,ulnar,median)
Intervention Type
Other
Intervention Name(s)
Conservative physiotherapy
Intervention Description
Hotpack,Transcutaneous Electrical Stimulation ,Ultrasound
Primary Outcome Measure Information:
Title
Numerical Pain Rating Scale (NPRS)
Description
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.
Time Frame
2 Month
Title
Neuropathic Pain Questionnaire (NPQ)
Description
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.
Time Frame
2 Month
Secondary Outcome Measure Information:
Title
Hand Grip Strength
Description
A digital hand dynamometer (JAMAR Plus Digital Hand Dynamometer) , was used to measure hand grip strength.. The test was performed in an upright sitting position, 3 measurements were performed with one-minute intervals between each measurement and the averages were recorded. For painless grip strength, patients were asked to squeeze the dynamometer until they felt discomfort before and after treatment.The shoulder was in adduction and neutral position, elbow in 90° flexion, forearm in neutral position and wrist in 0 -30° extension and 0-15° ulnar deviation position while the patients were sitting in a chair with their arms supported.Both hands were measured separately.
Time Frame
2 Month
Title
Pinch Grip Strength
Description
Pinch grip (two-point grip) strength was evaluated with a pinch meter (JAMAR Plus Pinch Gauge). The application was performed comparatively in both extremities; patients were sitting in a chair with support, shoulder in adduction and neutral position, elbow in 90˚ flexion, forearm in neutral position, wrist in 0-30˚ extension and 0-15˚ ulnar deviation position.Measurements were taken before and after the intervention. Three measurements were made with one minute intervals between each measurement and the averages were recorded.
Time Frame
2 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Exclusion criteria were surgical intervention in the head and neck region, history of fracture in the head and neck region, known chronic disease, infection and structural disorders in the bone and soft tissue in the cervical spine, malignancy and severe osteoporosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BERNA KARAMANCIOĞLU
Organizational Affiliation
berna.karamancioğlu@uskudar.edu.tr
Official's Role
Study Director
Facility Information:
Facility Name
Üsküdar University
City
Istanbul
State/Province
Üsküdar
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Acute Effect of Neural Mobilization in Cervical Radiculopathy: A Randomized Controlled Study

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