Effect of Cervical Exercise Combined With Nerve Mobilization on Cervical Spondylotic Radiculopathy

The objective of this clinical trial was to investigate the effects of cervical spine exercises combined with nerve mobilization in patients with radiculopathy.

The main questions it aims to answer are:

1. Whether cervical spine operation combined with nerve mobilization is effective for cervical radiculopathy.
2. Is there any difference between cervical spine operation combined with nerve mobilization and single method? The participants were patients with cervical radiculopathy and were divided into three groups in this study.

1. Experimental group: received cervical spine operation combined with nerve mobilization 2. Control group 1: cervical spine exercises were performed 3. Control group 2: received neuromobilization

Study Overview

• Status: Recruiting
• Conditions: Radiculopathy, Cervical
• Intervention / Treatment: Other: cervical spine exercises; Other: Neuromobilization

Detailed Description

After being informed of the risks, participants are required to sign an informed consent form. Eligible participants will be randomly assigned to cervical spine operation combined with nerve mobilizatio or cervical spine exercises or neuromobilization on a 1:1:1 ratio.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangxi
    • Qinzhou, Guangxi, China
      • Recruiting
      • Lingshan County second People's Hospital
      • Contact: Quanzheng Chen; Phone Number: 13647819715; Email: 904404227@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Meet the diagnostic criteria of CSR and have no other complications;
2. Age 18-65 years old, gender unlimited;
3. No other treatment for cervical spondylosis in the last 1 month;
4. No previous surgical treatment for cervical spondylosis;
5. Good compliance;
6. Good mental state, no history of mental illness;
7. Informed consent, and sign the informed consent.

Exclusion Criteria:

1. does not meet the diagnostic criteria;
2. Women during pregnancy;
3. severe stenosis of the foramen;
4. osteoporosis combined with spinal cord tumor, osteomyelitis;
5. infectious diseases, skin defects, allergies;
6. have serious heart, lung and other important organ dysfunction;
7. unable to cooperate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cervical spine exercises; Cervical spine exercise training, patients received the intervention, once a day, 6 times a week, 2 weeks as a course of intervention, a total of 2 courses of intervention	Other: cervical spine exercises; Cervical spine exercise training is a method to improve the neck function through the patient's self-exercise.
Experimental: Neuromobilization; Neuromobilization, patients received this intervention, once a day, 6 times a week, 2 weeks as a course of intervention, a total of 2 courses of intervention	Other: Neuromobilization; Neuromobilization is a technical technique for rehabilitation therapists to loosen the trapped nerves of patients with professional methods.
Experimental: cervical spine exercises combined with nerve mobilization; cervical spine exercises combined with nerve mobilization，patients received this intervention, once a day, 6 times a week, 2 weeks as a course of intervention, a total of 2 courses of intervention	Other: cervical spine exercises; Cervical spine exercise training is a method to improve the neck function through the patient's self-exercise.; Other: Neuromobilization; Neuromobilization is a technical technique for rehabilitation therapists to loosen the trapped nerves of patients with professional methods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale	A scale used to evaluate pain. The scale consists of 0 to 10 points, with a higher score indicating greater pain and a lower one.	baseline and 4 weeks
Range of motion	The range of motion of the associated joints in the neck was measured using a joint protractor	baseline and 4 weeks
Muscle strength	The microFET2 instrument was used to test the muscle strength of the neck related muscles.	baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tanaka Yasuhisa Cervical Spondylopathy Symptom Scale	To assess the status of the patient's cervical spine. The scale includes a score of -2 to 20, with the larger the score, the less severe the symptoms associated with the cervical spine.	baseline and 4 weeks
neck disability index. The total score ranges from 0 (accessibility) to 50 (total paralysis), with higher scores indicating more severe dysfunction.	A scale used to assess the degree of cervical spine dysfunction	baseline and 4 weeks
the medical outcomes study 36-item short-form health survey	A scale used to assess quality of life.The exact score of the SF-36 varies from item to item, but in general, the higher the score, the better the quality of life.	baseline and 4 weeks

Collaborators and Investigators

• Sponsor: Quanzheng Chen

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 1, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 5, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: 20230601001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No