Cervical RadiculopathyNCT01500967
Shi-style Cervical Manipulations for Cervical Radiculopathy
A study testing Shi-style cervical manipulations in people with Cervical Radiculopathy, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Neck pain and related problems occur frequently in modern societies and have a considerable impact on individuals and the society. Cervical radiculopathy (CR) generally presents with pain, numbness, or weakness in a dermatomal distribution. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Shi-style cervical manipulations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 648 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to May 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent and signed an informed consent;
- aged 18 to 65 year-old male or female ;
- appear cervical nerve root symptoms typical of 3 months to 5 years;
- VAS pain greater than 30 mm.
- positive for one of the following :Brachial plexus traction test, Foraminal compression test, Neck rotation test is less than 60 degrees, Foraminal separation test, Decreased muscle strength.
Who cannot join
- nerve root in the past received surgical treatment of cervical or neck trauma;
- with obvious symptoms of vertigo, TCD examination there was abnormal;
- signs and symptoms of spinal cord compression, MRI found that spinal cord oppressors[e];
- pregnant women, lactating women;
- can not attend follow-up (such as six months or less distance of immigrant relocation plan, no mobile phones and other communication tools, etc.), and no ability to participate in six months follow-up of patients;
- currently participating in cervical spondylosis associated with other clinical trials;
Show all 11Show fewer
- hepatic, renal, hematopoietic system, endocrine system, cardiovascular, nervous system, primary and other serious diseases, tuberculosis, vertebral deformities, cancer and mental illness;
- There are opioid analgesics, sedative hypnotics and alcohol abuse history;
- those who can not read and write Chinese.
- the past two weeks received RF, minimally invasive , ozone , a small knife , or other manual therapy and Closed injection treatment.
- vertebral displacement, forward, backward or lateral horizontal displacement > 3 mm, the angulation between adjacent intervertebral > 11 °.
Trial locations and contacts
1 site in 1 country.
Xuejun Cui, Dr contact
China1 site, 1 recruiting
- Recruiting
Longhua Hospital
Shanghai, Shanghai Municipality, 200032
Xuejun cui, Dr, 13917715524@139.com
About this study
Official title: Shi-style Cervical Manipulations for Cervical Radiculopathy-A Randomized Single Blinded Controlled Trial
Neck pain and related problems occur frequently in modern societies and have a considerable impact on individuals and the society. Cervical radiculopathy (CR) generally presents with pain, numbness, or weakness in a dermatomal distribution. CR results from impingement on a nerve root by either spondylotic narrowing of the neural foramen or a lateral intervertebral disc herniation. Various studies have shown that nonoperative management for CR is effective, such as medications, physical therapy, Spinal manipulation, traction, acupuncture, collar immobilization and epidural steroid injections. Spinal manipulation is one of the manual techniques for treating mechanical neck pain. No high-quality evidence has proved the effectiveness of manipulative therapy in the treatment of cervical radiculopathy. However, limited evidence suggests that manipulation may provide short-term benefit in the treatment of neck pain, cervicogenic headaches and radicular symptoms. Few complications, such as worsening radiculopathy, myelopathy, and spinal cord injury, may occur. Spinal massage manipulation is used for centuries in China. Many patients with cervical disc disease are increasingly turning to manipulations to alleviate their symptoms and reduce the side effects of medications. The goal of this study is to determine the efficacy of a spinal manipulation, three steps and nine manipulations, on treating with the cervical radiculopathy.
Read the detailed description
Radiculopathy generally presents with pain, numbness, or weakness in a dermatomal distribution. Causative factors include an acute nucleus pulposus herniation, spondylitic changes around the foramen causing nerve compression, or a combination of these.
Cervical radiculopathy results from impingement on a nerve root by either spondylotic narrowing of the neural foramen or a lateral intervertebral disc herniation. Frequent complaints include painful neck movements, radicular pain, paraspinal muscle spasm, muscle weakness, and diminished deep tendon reflexes (Radhakrishnan K, 1994). Radiculopathy tends to produce substantial limitation of movement of the head and neck.
The goals of any treatment plan should be well defined. Specifically, it should be the goal of the treating physician to relieve pain, improve function, and prevent recurrence. Although some symptomatic patients meet surgical criteria, most patients are clearly candidates for nonoperative treatment. Treatment modalities for radiculopathy include rest, medications, physical therapy, manipulation, injections, and patient education.
Various studies have shown that nonoperative management of cervical radiculopathy leaves a substantial minority of patients with persistently troublesome symptoms (Lees F, 1963,41, 42). Lees and Turner found that in two thirds of patients, symptoms tend to persist in the absence of surgical treatment (Lees F, 1963). DePalma and Subin found that of 255 patients treated nonoperatively, only 29% experienced complete symptom relief (Radhakrishnan K, 1994,41). Better outcomes with nonoperative management, however, have been observed in studies that were based in physiotherapy centers than those from surgical series (Radhakrishnan K, 1994).
Spinal balance is the way Professor Shi Qi " Arthralgia theory" and " The theory of muscle imbalance " theory under the guidance of mix martial arts, Wang Shi expertise and Traumatology, combined with clinical experience and experimental research. Rub, take, roll, put, loose, pull, friction, shaking, pinching, so called "nine manipulations." It can adjust qi and blood, phlegm stasis, Dredge meridians, spasm pain, support organs, alleviate, correct cervical dynamic and static imbalance. Three steps and nine manipulations is the common method of treatment of Professor Shi Qi for cervical disease .
- Conditions
- Cervical Radiculopathy
- Being tested
- Shi-style cervical manipulations, Cervical Traction control
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shi-style cervical manipulationsOther
Also called manipulations for cervical radiculopathy
Shi-style cervical manipulation is a spinal manipulation for cervical radiculopathy.It is a kind of traditional chinese massage and can dredge the meridian.Patients are treated every day for 30 minutes.Seven times at one course and totally there are two courses.3 times a week, once the other day（except the weekends）,30 minutes, 2 weeks.
Cervical Traction controlOther
Also called Cervical traction
6kg to 10kg, 3 times a week, once the other day（except the weekends）,20 minutes, 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Traction | Active comparator | 6kg to 10kg, 3 times a week, once the other day（except the weekends）,20 minutes, 2 weeks. Receives: Other: Cervical Traction control |
| Manipulations | Experimental | Shi-style manipulations is a cervical manipulation for cervical radiculopathy.This manipulation is a kind of traditional Chinese massage and it can dredge the meridians. Patients are treated every day for 30 minutes. Seven times as one course and totally there are two courses. 3 times a week, once the other day（except the weekends）,30 minutes, 2 weeks. Receives: Other: Shi-style cervical manipulations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
Measured: changes from baseline at 2 weeks
Secondary outcomes (11)
SF 36
Measured: changes from baseline at 2 weeks
Visual Analogue Scale
Measured: changes from baseline at 2 weeks
Neck Disability Index
Measured: changes from baseline at 4 weeks
SF 36
Measured: 4 weeks
Visual Analogue Scale
Measured: 4 weeks
Neck Disability Index
Measured: changes from baseline at 3 months
SF 36
Measured: changes from baseline at 3 months
Visual Analogue Scale
Measured: changes from baseline at 3 months
Neck Disability Index
Measured: changes from baseline at 6 months
SF 36
Measured: changes from baseline at 6 months
Visual Analogue Scale
Measured: changes from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionMay 2012 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 648 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin University of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Cui xuejun, Shanghai University of Traditional Chinese Medicine
- Investigators
- Yongjun Wang, MD, Principal investigator, Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500967
- Sponsor's protocol ID
- Manual Therapy for Cervicalgia
- Status last verified
- Jan 2012
- First submitted
- 30 Aug 2011
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shi-style Cervical Manipulations for Cervical Radiculopathy-A Randomized Single Blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT01500967
- Acronym / sponsor ID
- Manual Therapy for Cervicalgia
- Conditions
- Cervical Radiculopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 648 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Tianjin University of Traditional Chinese Medicine
- Study start
- Dec 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 29 Dec 2011 (estimated)
- 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.
Neck pain and related problems occur frequently in modern societies and have a considerable impact on individuals and the society. Cervical radiculopathy (CR) generally presents with pain, numbness, or weakness in a dermatomal distribution. CR results from impingement on a nerve root by either spondylotic narrowing of the neural foramen or a lateral intervertebral disc herniation. Various studies have shown that nonoperative management for CR is effective, such as medications, physical therapy, Spinal manipulation, traction, acupuncture, collar immobilization and epidural steroid injections. Spinal manipulation is one of the manual techniques for treating mechanical neck pain. No high-quality evidence has proved the effectiveness of manipulative therapy in the treatment of cervical radiculopathy. However, limited evidence suggests that manipulation may provide short-term benefit in the treatment of neck pain, cervicogenic headaches and radicular symptoms. Few complications, such as worsening radiculopathy, myelopathy, and spinal cord injury, may occur. Spinal massage manipulation is used for centuries in China. Many patients with cervical disc disease are increasingly turning to manipulations to alleviate their symptoms and reduce the side effects of medications. The goal of this study is to determine the efficacy of a spinal manipulation, three steps and nine manipulations, on treating with the cervical radiculopathy.
Detailed description
Radiculopathy generally presents with pain, numbness, or weakness in a dermatomal distribution. Causative factors include an acute nucleus pulposus herniation, spondylitic changes around the foramen causing nerve compression, or a combination of these.
Cervical radiculopathy results from impingement on a nerve root by either spondylotic narrowing of the neural foramen or a lateral intervertebral disc herniation. Frequent complaints include painful neck movements, radicular pain, paraspinal muscle spasm, muscle weakness, and diminished deep tendon reflexes (Radhakrishnan K, 1994). Radiculopathy tends to produce substantial limitation of movement of the head and neck.
The goals of any treatment plan should be well defined. Specifically, it should be the goal of the treating physician to relieve pain, improve function, and prevent recurrence. Although some symptomatic patients meet surgical criteria, most patients are clearly candidates for nonoperative treatment. Treatment modalities for radiculopathy include rest, medications, physical therapy, manipulation, injections, and patient education.
Various studies have shown that nonoperative management of cervical radiculopathy leaves a substantial minority of patients with persistently troublesome symptoms (Lees F, 1963,41, 42). Lees and Turner found that in two thirds of patients, symptoms tend to persist in the absence of surgical treatment (Lees F, 1963). DePalma and Subin found that of 255 patients treated nonoperatively, only 29% experienced complete symptom relief (Radhakrishnan K, 1994,41). Better outcomes with nonoperative management, however, have been observed in studies that were based in physiotherapy centers than those from surgical series (Radhakrishnan K, 1994).
Spinal balance is the way Professor Shi Qi " Arthralgia theory" and " The theory of muscle imbalance " theory under the guidance of mix martial arts, Wang Shi expertise and Traumatology, combined with clinical experience and experimental research. Rub, take, roll, put, loose, pull, friction, shaking, pinching, so called "nine manipulations." It can adjust qi and blood, phlegm stasis, Dredge meridians, spasm pain, support organs, alleviate, correct cervical dynamic and static imbalance. Three steps and nine manipulations is the common method of treatment of Professor Shi Qi for cervical disease .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traction | Active comparator | Other: Cervical Traction control6kg to 10kg, 3 times a week, once the other day（except the weekends）,20 minutes, 2 weeks. |
| Manipulations | Experimental | Other: Shi-style cervical manipulationsShi-style manipulations is a cervical manipulation for cervical radiculopathy.This manipulation is a kind of traditional Chinese massage and it can dredge the meridians. Patients are treated every day for 30 minutes. Seven times as one course and totally there are two courses. 3 times a week, once the other day（except the weekends）,30 minutes, 2 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent and signed an informed consent;
- aged 18 to 65 year-old male or female ;
- appear cervical nerve root symptoms typical of 3 months to 5 years;
- VAS pain greater than 30 mm.
- positive for one of the following :Brachial plexus traction test, Foraminal compression test, Neck rotation test is less than 60 degrees, Foraminal separation test, Decreased muscle strength.
Key exclusion criteria (11 listed)
- nerve root in the past received surgical treatment of cervical or neck trauma;
- with obvious symptoms of vertigo, TCD examination there was abnormal;
- signs and symptoms of spinal cord compression, MRI found that spinal cord oppressors[e];
- pregnant women, lactating women;
- can not attend follow-up (such as six months or less distance of immigrant relocation plan, no mobile phones and other communication tools, etc.), and no ability to participate in six months follow-up of patients;
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 |
|---|---|---|
| Shi-style cervical manipulationsAlso: manipulations for cervical radiculopathyShi-style cervical manipulation is a spinal manipulation for cervical radiculopathy.It is a kind of traditional chinese massage and can dredge the meridian.Patients are treated every day for 30 minutes.Seven times at one course and totally there are two courses.3 times a week, once the other day（except the weekends）,30 minutes, 2 weeks. | Other | Manipulations |
| Cervical Traction controlAlso: Cervical traction6kg to 10kg, 3 times a week, once the other day（except the weekends）,20 minutes, 2 weeks. | Other | Traction |
Primary outcome
Neck Disability Index
Time frame: changes from baseline at 2 weeks
11 secondary outcomes
SF 36
Time frame: changes from baseline at 2 weeks
Visual Analogue Scale
Time frame: changes from baseline at 2 weeks
Neck Disability Index
Time frame: changes from baseline at 4 weeks
SF 36
Time frame: 4 weeks
Visual Analogue Scale
Time frame: 4 weeks
Neck Disability Index
Time frame: changes from baseline at 3 months
SF 36
Time frame: changes from baseline at 3 months
Visual Analogue Scale
Time frame: changes from baseline at 3 months
Neck Disability Index
Time frame: changes from baseline at 6 months
SF 36
Time frame: changes from baseline at 6 months
Visual Analogue Scale
Time frame: changes from baseline at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2012.
Related trials for Cervical Radiculopathy
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.
Xuejun Cui, Dr contact
Yongjun Wang, MD principal investigator
Longhua Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shi-style cervical manipulations in people with Cervical Radiculopathy, run by Shanghai University of Traditional Chinese Medicine 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 5 inclusion and 11 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 25 Jan 2012. 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?
Contact Xuejun Cui, Dr (13917715524@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: changes from baseline at 2 weeks). 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 25 Jan 2012.