NCT06453798

Brief Summary

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. 1.Whether cervical spine operation combined with nerve mobilization is effective for cervical radiculopathy.
  2. 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.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

July 5, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

June 1, 2024

Last Update Submit

July 5, 2024

Conditions

Radiculopathy, Cervical

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Tanaka Yasuhisa Cervical Spondylopathy Symptom Scale

    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.

    baseline and 4 weeks

  • the medical outcomes study 36-item short-form health survey

    baseline and 4 weeks

Study Arms (3)

cervical spine exercises

EXPERIMENTAL

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

Neuromobilization

EXPERIMENTAL

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

cervical spine exercises combined with nerve mobilization

EXPERIMENTAL

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 exercisesOther: Neuromobilization

Interventions

cervical spine exercisesOTHER

Cervical spine exercise training is a method to improve the neck function through the patient's self-exercise.

cervical spine exercisescervical spine exercises combined with nerve mobilization
NeuromobilizationOTHER

Neuromobilization is a technical technique for rehabilitation therapists to loosen the trapped nerves of patients with professional methods.

Neuromobilizationcervical spine exercises combined with nerve mobilization

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lingshan County second People's Hospital

Qinzhou, Guangxi, China

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Primary rehabilitation therapist

Study Record Dates

First Submitted

June 1, 2024

First Posted

June 12, 2024

Study Start

July 5, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

July 8, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)