Radiculopathy, CervicalNCT06453798
Effect of Cervical Exercise Combined With Nerve Mobilization on Cervical Spondylotic Radiculopathy
A study testing cervical spine exercises and Neuromobilization in people with Radiculopathy, Cervical, run by Quanzheng Chen at 1 site in China.
Trial 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. Whether cervical spine operation combined with nerve mobilization is effective for cervical radiculopathy. 2. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Radiculopathy, Cervical
- What is being tested?
- cervical spine exercises and Neuromobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lingshan County second People's Hospital
Qinzhou, Guangxi
Quanzheng Chen, 13647819715, 904404227@qq.com
About this study
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:
- Whether cervical spine operation combined with nerve mobilization is effective for cervical radiculopathy.
- 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.
- 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
Read the 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.
- Conditions
- Radiculopathy, Cervical
- Being tested
- cervical spine exercises, Neuromobilization
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical spine exercisesOther
Cervical spine exercise training is a method to improve the neck function through the patient's self-exercise.
NeuromobilizationOther
Neuromobilization is a technical technique for rehabilitation therapists to loosen the trapped nerves of patients with professional methods.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: cervical spine exercises; Other: Neuromobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 4 weeks
Range of motion
The range of motion of the associated joints in the neck was measured using a joint protractor
Measured: baseline and 4 weeks
Muscle strength
The microFET2 instrument was used to test the muscle strength of the neck related muscles.
Measured: baseline and 4 weeks
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start5 Jul 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiculopathy, CervicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quanzheng Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Quanzheng Chen, Lingshan County second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453798
- Sponsor's protocol ID
- 20230601001
- Status last verified
- Jul 2024
- First submitted
- 1 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cervical Exercise Combined With Nerve Mobilization on Cervical Spondylotic Radiculopathy
- ClinicalTrials.gov ID
- NCT06453798
- Acronym / sponsor ID
- 20230601001
- Conditions
- Radiculopathy, Cervical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Quanzheng ChenUniversity, hospital or other
- Study start
- 5 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Whether cervical spine operation combined with nerve mobilization is effective for cervical radiculopathy.
- 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.
- 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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cervical spine exercises | Experimental | Other: cervical spine exercisesCervical 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 |
| Neuromobilization | Experimental | Other: NeuromobilizationNeuromobilization, 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 |
| cervical spine exercises combined with nerve mobilization | Experimental | Other: cervical spine exercises, Other: Neuromobilizationcervical 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervical spine exercisesCervical spine exercise training is a method to improve the neck function through the patient's self-exercise. | Other | cervical spine exercises, cervical spine exercises combined with nerve mobilization |
| NeuromobilizationNeuromobilization is a technical technique for rehabilitation therapists to loosen the trapped nerves of patients with professional methods. | Other | Neuromobilization, cervical spine exercises combined with nerve mobilization |
Primary outcome
Visual analogue scale
Time frame: baseline and 4 weeks
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.
Range of motion
Time frame: baseline and 4 weeks
The range of motion of the associated joints in the neck was measured using a joint protractor
Muscle strength
Time frame: baseline and 4 weeks
The microFET2 instrument was used to test the muscle strength of the neck related muscles.
3 secondary outcomes
Tanaka Yasuhisa Cervical Spondylopathy Symptom Scale
Time frame: 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.
Time frame: baseline and 4 weeks
the medical outcomes study 36-item short-form health survey
Time frame: baseline and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Radiculopathy, Cervical
Recruiting
Ultrasound-Guided Electrical Dry Needling for Chronic Cervical Radiculopathy
Cervical Radiculopathy
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
Recruiting
Myo-Electrical and Nerve Root Function Response to Focused Extracorpeal Shock Wave in Cervical Radiculopathy
Cervical Radiculopathy
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
RecruitingObservational study
Cervical Spinal Cord Signal Abnormalities in Patients With Cervical Radicular Pain
Cervical Radiculopathy, Cervical Myelomalacia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical spine exercises and Neuromobilization in people with Radiculopathy, Cervical, run by Quanzheng Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: baseline and 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.