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

Sponsor
Uskudar University (Other)
Overall Status
Completed
CT.gov ID
NCT05887427
Collaborator
(none)
44
1
2
1.9
23.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Neural Mobilisation
  • Other: Conservative physiotherapy
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Acute Effect of Neural Mobilization in Cervical Radiculopathy: A Randomized Controlled Study
Actual Study Start Date :
Nov 10, 2022
Actual Primary Completion Date :
Jan 6, 2023
Actual Study Completion Date :
Jan 6, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Neural Mobilisation Group (NMG)

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

Active Comparator: Control Group (CG)

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
Hotpack,Transcutaneous Electrical Stimulation ,Ultrasound

Outcome Measures

Primary Outcome Measures

  1. Numerical Pain Rating Scale (NPRS) [2 Month]

    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. Neuropathic Pain Questionnaire (NPQ) [2 Month]

    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

  1. Hand Grip Strength [2 Month]

    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.

  2. Pinch Grip Strength [2 Month]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Üsküdar University Istanbul Üsküdar Turkey

Sponsors and Collaborators

  • Uskudar University

Investigators

  • Study Director: BERNA KARAMANCIOĞLU, berna.karamancioğlu@uskudar.edu.tr

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Büşra Sökmen Yıldırım, physiotherapist, Uskudar University
ClinicalTrials.gov Identifier:
NCT05887427
Other Study ID Numbers:
  • Üsküdar Üniversitesi
First Posted:
Jun 2, 2023
Last Update Posted:
Jun 2, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Büşra Sökmen Yıldırım, physiotherapist, Uskudar University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2023