Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Shi-style Cervical Manipulations for Nonspecific Neck Pain: a Multi-center, Randomized, Controlled Clinical Trial

25 ottobre 2021 aggiornato da: Cui xuejun, Shanghai University of Traditional Chinese Medicine
Spinal instability diseases have a high prevalence and great harm. The research on how to prevent and treat degenerative spinal instability diseases has become a hot spot in the international academic community, and it is also an important research content in the field of "population and health" in my country. Clinical studies have shown that the "Shi-style manipulations" have outstanding efficacy and high safety in the treatment of degenerative spinal instability diseases. The study intends to carry out a randomized, traction-controlled study in 5 tertiary hospital test centers, with patients with non-specific neck pain as the research object, using "Shi-style manipulations" and traction as intervention methods, and checking indicators and subjective effects through relevant instruments Indicators, quantitative verification of the mechanical parameters and biological effects of the "Shi-style manipulations", scientific evaluation of the efficacy and safety of the "Shi-style manipulations" in non-specific neck pain diseases.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Spinal diseases are listed as the second most serious diseases in the world's top ten Diseases released by WHO. With the rapid pace of life, the aging of the population and the increase in chronic strain, the incidence of degenerative spinal instability diseases remains high and medical expenses increase.

From 1999 to 2006, 534 patients with various types of degenerative spine instability diseases (except myelomyelitis) were treated by the project team, and the total effective rate of the "three steps and nine steps" in the treatment of clinical symptoms and signs of degenerative spine instability diseases was 91.76%. Through reviewing 60 cases of nerve root type of randomized controlled trials, 8 weeks after treatment, treatment group 30 cases (the whole neck three-step nine method), total effective rate 93.3%, control group total effective rate was 73.3% (cervical traction) (P < 0.01), the treatment group in improving the neck shoulder pain, upper limb numbness, dizziness, tinnitus, brachial plexus pull test is better than that in control group (P < 0.05), the clinical operation without adverse reaction.

Clinical studies have shown that the "Shi-style manipulations" have outstanding efficacy and high safety in the treatment of degenerative spinal instability diseases. The study intends to carry out a randomized, traction-controlled study in 5 tertiary hospital test centers, with patients with non-specific neck pain as the research object, using "Shi-style manipulations" and traction as intervention methods, and checking indicators and subjective effects through relevant instruments Indicators, quantitative verification of the mechanical parameters and biological effects of the "Shi-style manipulations", scientific evaluation of the efficacy and safety of the "Shi-style manipulations" in non-specific neck pain diseases.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

240

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Xuejun Cui, Doctor of Medicine(M.D.)
  • Numero di telefono: 86-21-64385700
  • Email: 13917715524@139.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • The diagnosis is non-specific neck pain;
  • Male or female between the ages of 18 and 65 (including 18 and 65);
  • VAS score ≥30 mm;
  • Sign the informed consent voluntarily.

Exclusion Criteria:

  • Have received surgical treatment or neck trauma for cervical spondylosis in the past;
  • With cervical nerve compression or spinal cord compression symptoms and signs, MRI found spinal compression;
  • The vertebral body was shifted, horizontally shifted >3 mm forward, backward or laterally, and the adjacent intervertebral space had an Angle difference of >11°;
  • Patients with liver, kidney, hematopoietic system and other serious primary diseases, with a history of opioid analgesics, sedative and hypnotic drugs and alcohol abuse;
  • Patients with osteoporosis, spinal tuberculosis, vertebral body malformation, malignant tumors and mental diseases;
  • Pregnant women and lactating women;
  • Unable to participate in the follow-up (for example, the plan of migration or long-distance relocation within half a year, no communication tools such as mobile phones, etc.), and the patients without the ability to participate in the half-year follow-up cannot read and write Chinese;
  • received radio frequency, minimally invasive, ozone, small needle knife, manipulation, traction or closed treatment Within the last two weeks;
  • Participating in other clinical trials related to cervical spondylosis.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Traction
6kg to 10kg, 3 times a week, once the other day（except the weekends）,20 minutes, 2 weeks.
Altro: Controllo della trazione cervicale
Da 6 kg a 10 kg, 3 volte a settimana, una volta l'altro giorno (tranne i fine settimana), 20 minuti, 2 settimane.
Altri nomi:
  • Trazione cervicale
Sperimentale: Shi-style manipulations
Shi-style manipulations is a cervical manipulation for cervical spondylosis.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.
Altro: Shi-style manipulations
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.
Altri nomi:
  • manipolazioni per radicolopatia cervicale

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Musculoskeletal ultrasound
Lasso di tempo: changes from baseline at 2 weeks
Measure the ratio of the muscle thickness of the back of the neck muscles to the strain rate of the back of the neck muscles.Use real-time dual-frame imaging to adjust the area of interest to ensure coverage of trapezius, supraspinatus, infraspinatus, levator scapula, and sternocleidomastoid. During operation, the probe lightly touches the ultrasonic coupling patch and is perpendicular to the body surface, hold the probe to slightly vibrate up and down, and keep the pressure release index at 3-4. Collect the elastic image to ensure that the image is clear and stable for 3-4 seconds. Observe the elastic image and outline the reference area and the area of interest. Calculate the SR values of the reference area and the area of interest with the software that comes with the ultrasound system. Measure 3 times and take the average value.
changes from baseline at 2 weeks
Visual Analogue scale，(VAS)
Lasso di tempo: changes from baseline at 2 weeks
The visual analog scale is used to measure the patient's current pain level.This scoring ruler has a scale in centimeters on one side, and the smallest scale is millimeters; on the other side, the two ends are marked as "painless" and "most painful". When using, the researcher holds both ends of the visual analog scale with both hands. The scale faces the researcher and the non-scale faces the patient. The patient is asked to use the thumb and index finger to move the upper scale of the ruler to the level of pain.Read the scale value corresponding to the red line of the vernier of the visual analog scale and record it in the research medical record. The value is rounded to a single digit, and the unit is millimeter (mm). The red line is between the two scales, and the left value is taken. Such as "53mm".
changes from baseline at 2 weeks
pressure pain threshold
Lasso di tempo: changes from baseline at 2 weeks
Determine the corresponding acupoints on the subject's neck, use a round probe to find the pain sensitive points, and mark them with a marker to be measured. There are 10 points in total.In order to fully relax the tested muscles, supine or lateral positions are used in the measurement. Before measuring, inform the subject of the entire operation process.The measurement was started after he entered the examination room and rested quietly for 5 minutes. During the measurement, a tester holds a digital dynamometer, touches the instrument probe vertically downwards to the skin, and applies pressure to the test point at a uniform speed when applying force. When the subject begins to feel pain, immediately remove the test probe and read the data on the instrument at the same time. After the measurement is completed, press the zero button to perform the next measurement. The same acupuncture point was tested 3 times with an interval of 30s, and the average value was taken.
changes from baseline at 2 weeks
Musculoskeletal ultrasound
Lasso di tempo: changes from baseline at 1 month
Measure the ratio of the muscle thickness of the back of the neck muscles to the strain rate of the back of the neck muscles.Use real-time dual-frame imaging to adjust the area of interest to ensure coverage of trapezius, supraspinatus, infraspinatus, levator scapula, and sternocleidomastoid. During operation, the probe lightly touches the ultrasonic coupling patch and is perpendicular to the body surface, hold the probe to slightly vibrate up and down, and keep the pressure release index at 3-4. Collect the elastic image to ensure that the image is clear and stable for 3-4 seconds. Observe the elastic image and outline the reference area and the area of interest. Calculate the SR values of the reference area and the area of interest with the software that comes with the ultrasound system. Measure 3 times and take the average value.
changes from baseline at 1 month
Visual Analogue scale，(VAS)
Lasso di tempo: changes from baseline at 1 month
The visual analog scale is used to measure the patient's current pain level.This scoring ruler has a scale in centimeters on one side, and the smallest scale is millimeters; on the other side, the two ends are marked as "painless" and "most painful". When using, the researcher holds both ends of the visual analog scale with both hands. The scale faces the researcher and the non-scale faces the patient. The patient is asked to use the thumb and index finger to move the upper scale of the ruler to the level of pain.Read the scale value corresponding to the red line of the vernier of the visual analog scale and record it in the research medical record. The value is rounded to a single digit, and the unit is millimeter (mm). The red line is between the two scales, and the left value is taken. Such as "53mm".
changes from baseline at 1 month
pressure pain threshold
Lasso di tempo: changes from baseline at 1 month
Determine the corresponding acupoints on the subject's neck, use a round probe to find the pain sensitive points, and mark them with a marker to be measured. There are 10 points in total.In order to fully relax the tested muscles, supine or lateral positions are used in the measurement. Before measuring, inform the subject of the entire operation process.The measurement was started after he entered the examination room and rested quietly for 5 minutes. During the measurement, a tester holds a digital dynamometer, touches the instrument probe vertically downwards to the skin, and applies pressure to the test point at a uniform speed when applying force. When the subject begins to feel pain, immediately remove the test probe and read the data on the instrument at the same time. After the measurement is completed, press the zero button to perform the next measurement. The same acupuncture point was tested 3 times with an interval of 30s, and the average value was taken.
changes from baseline at 1 month
Musculoskeletal ultrasound
Lasso di tempo: changes from baseline at 3 months
Measure the ratio of the muscle thickness of the back of the neck muscles to the strain rate of the back of the neck muscles.Use real-time dual-frame imaging to adjust the area of interest to ensure coverage of trapezius, supraspinatus, infraspinatus, levator scapula, and sternocleidomastoid. During operation, the probe lightly touches the ultrasonic coupling patch and is perpendicular to the body surface, hold the probe to slightly vibrate up and down, and keep the pressure release index at 3-4. Collect the elastic image to ensure that the image is clear and stable for 3-4 seconds. Observe the elastic image and outline the reference area and the area of interest. Calculate the SR values of the reference area and the area of interest with the software that comes with the ultrasound system. Measure 3 times and take the average value.
changes from baseline at 3 months
Visual Analogue scale，(VAS)
Lasso di tempo: changes from baseline at 3 months
The visual analog scale is used to measure the patient's current pain level.This scoring ruler has a scale in centimeters on one side, and the smallest scale is millimeters; on the other side, the two ends are marked as "painless" and "most painful". When using, the researcher holds both ends of the visual analog scale with both hands. The scale faces the researcher and the non-scale faces the patient. The patient is asked to use the thumb and index finger to move the upper scale of the ruler to the level of pain.Read the scale value corresponding to the red line of the vernier of the visual analog scale and record it in the research medical record. The value is rounded to a single digit, and the unit is millimeter (mm). The red line is between the two scales, and the left value is taken. Such as "53mm".
changes from baseline at 3 months
pressure pain threshold
Lasso di tempo: changes from baseline at 3 months
Determine the corresponding acupoints on the subject's neck, use a round probe to find the pain sensitive points, and mark them with a marker to be measured. There are 10 points in total.In order to fully relax the tested muscles, supine or lateral positions are used in the measurement. Before measuring, inform the subject of the entire operation process.The measurement was started after he entered the examination room and rested quietly for 5 minutes. During the measurement, a tester holds a digital dynamometer, touches the instrument probe vertically downwards to the skin, and applies pressure to the test point at a uniform speed when applying force. When the subject begins to feel pain, immediately remove the test probe and read the data on the instrument at the same time. After the measurement is completed, press the zero button to perform the next measurement. The same acupuncture point was tested 3 times with an interval of 30s, and the average value was taken.
changes from baseline at 3 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Neck Disabilitv Index， (NDI)
Lasso di tempo: changes from baseline at 2 weeks
The Neck Disability Index (NDI) is one of the most frequently used questionnaires in clinical practice. The questionnaire mainly assesses the patient's pain level, self-care ability, weightlifting, reading, headache level, concentration, work, driving, sleep, and entertainment. It quantifies the points of all aspects, and the score ranges from 0 points (no disability) to 5 points (completely disabled), the total score ranges from 0 points (no disability) to 50 points (completely disabled), for a total of 50 points. The lower the total score, the less severe the patient's condition, and vice versa.
changes from baseline at 2 weeks
the MOS item short from health survey，(SF-36)
Lasso di tempo: changes from baseline at 2 weeks
The SF-36 scale is a universal scale developed by the American Medical Research Group to measure the quality of life, and is universally recognized and widely used in the world. This scale has a total of 8 dimensions to evaluate health-related quality of life (HRQOL), which is divided into two categories: physical health and mental health, namely physical function (PF), physical function (RP), physical pain (BP), and general health (CH), Activity (VT), Social Function (SF), Emotional Function (RE), Mental Health (MH).
changes from baseline at 2 weeks
Cervical range of motion
Lasso di tempo: changes from baseline at 2 weeks
Measure the range of cervical spine flexion, extension, lateral flexion, and rotation by using a universal protractor
changes from baseline at 2 weeks
Neck Disabilitv Index， (NDI)
Lasso di tempo: changes from baseline at 1 month
The Neck Disability Index (NDI) is one of the most frequently used questionnaires in clinical practice. The questionnaire mainly assesses the patient's pain level, self-care ability, weightlifting, reading, headache level, concentration, work, driving, sleep, and entertainment. It quantifies the points of all aspects, and the score ranges from 0 points (no disability) to 5 points (completely disabled), the total score ranges from 0 points (no disability) to 50 points (completely disabled), for a total of 50 points. The lower the total score, the less severe the patient's condition, and vice versa.
changes from baseline at 1 month
the MOS item short from health survey，(SF-36)
Lasso di tempo: changes from baseline at 1 month
The SF-36 scale is a universal scale developed by the American Medical Research Group to measure the quality of life, and is universally recognized and widely used in the world. This scale has a total of 8 dimensions to evaluate health-related quality of life (HRQOL), which is divided into two categories: physical health and mental health, namely physical function (PF), physical function (RP), physical pain (BP), and general health (CH), Activity (VT), Social Function (SF), Emotional Function (RE), Mental Health (MH).
changes from baseline at 1 month
Cervical range of motion
Lasso di tempo: changes from baseline at 1 month
Measure the range of cervical spine flexion, extension, lateral flexion, and rotation by using a universal protractor
changes from baseline at 1 month
Neck Disabilitv Index， (NDI)
Lasso di tempo: changes from baseline at 3 months
The Neck Disability Index (NDI) is one of the most frequently used questionnaires in clinical practice. The questionnaire mainly assesses the patient's pain level, self-care ability, weightlifting, reading, headache level, concentration, work, driving, sleep, and entertainment. It quantifies the points of all aspects, and the score ranges from 0 points (no disability) to 5 points (completely disabled), the total score ranges from 0 points (no disability) to 50 points (completely disabled), for a total of 50 points. The lower the total score, the less severe the patient's condition, and vice versa.
changes from baseline at 3 months
the MOS item short from health survey，(SF-36)
Lasso di tempo: changes from baseline at 3 months
The SF-36 scale is a universal scale developed by the American Medical Research Group to measure the quality of life, and is universally recognized and widely used in the world. This scale has a total of 8 dimensions to evaluate health-related quality of life (HRQOL), which is divided into two categories: physical health and mental health, namely physical function (PF), physical function (RP), physical pain (BP), and general health (CH), Activity (VT), Social Function (SF), Emotional Function (RE), Mental Health (MH).
changes from baseline at 3 months
Cervical range of motion
Lasso di tempo: changes from baseline at 3 months
Measure the range of cervical spine flexion, extension, lateral flexion, and rotation by using a universal protractor
changes from baseline at 3 months

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
The doctor of traditional Chinese medicine syndrome
Lasso di tempo: changes from baseline at 2 weeks
The TCM Syndrome Feature Scale is based on the patient's general symptoms, signs (including tongue and pulse), physical examination, and laboratory examination results to establish an information table, and then use the difference matrix method to perform attribute reduction and case reduction to obtain The lower approximation set and the upper approximation set are used to extract the definite rules and possible rules of TCM diagnosis. In this way, the subjectivity and one-sidedness of doctors are avoided to a large extent, making TCM syndrome diagnosis and treatment more standardized and scientific
changes from baseline at 2 weeks
The doctor of traditional Chinese medicine syndrome
Lasso di tempo: changes from baseline at 1 month
The TCM Syndrome Feature Scale is based on the patient's general symptoms, signs (including tongue and pulse), physical examination, and laboratory examination results to establish an information table, and then use the difference matrix method to perform attribute reduction and case reduction to obtain The lower approximation set and the upper approximation set are used to extract the definite rules and possible rules of TCM diagnosis. In this way, the subjectivity and one-sidedness of doctors are avoided to a large extent, making TCM syndrome diagnosis and treatment more standardized and scientific
changes from baseline at 1 month
The doctor of traditional Chinese medicine syndrome
Lasso di tempo: changes from baseline at 3 months
The TCM Syndrome Feature Scale is based on the patient's general symptoms, signs (including tongue and pulse), physical examination, and laboratory examination results to establish an information table, and then use the difference matrix method to perform attribute reduction and case reduction to obtain The lower approximation set and the upper approximation set are used to extract the definite rules and possible rules of TCM diagnosis. In this way, the subjectivity and one-sidedness of doctors are avoided to a large extent, making TCM syndrome diagnosis and treatment more standardized and scientific
changes from baseline at 3 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Shanghai University of Traditional Chinese Medicine

Collaboratori

Beijing Hospital
Dongzhimen Hospital, Beijing
Traditional Chinese Medicine Hospital of the Ningxia Hui Autonomous Region
Shenzhen Pingle Orthopaedic Hospital
Traditional Chinese Medicine Hospital of Ganzhou Nankang District

Investigatori

  • Investigatore principale: Yongjun Wan, Doctor of Medicine(M.D.), Shanghai University of Traditional Chinese Medicine

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 novembre 2021

Completamento primario (Anticipato)

30 dicembre 2022

Completamento dello studio (Anticipato)

30 dicembre 2022

Date di iscrizione allo studio

Primo inviato

25 ottobre 2021

Primo inviato che soddisfa i criteri di controllo qualità

25 ottobre 2021

Primo Inserito (Effettivo)

5 novembre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 novembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 ottobre 2021

Ultimo verificato

1 ottobre 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Nonspecific Neck Pain

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Dolore al collo non specifico

Prove cliniche su Controllo della trazione cervicale

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Sri Lanka

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi