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

NCT05108610 | Unknown DMC

• 1 other identifier: Nonspecific Neck Pain
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Nonspecific Neck Pain

Keywords

Randomized controlled study；nonspecific neck pain；Shi-style manipulations；Mechanical parameters

Outcome Measures

Primary Outcomes (9)

• Musculoskeletal ultrasound

  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)

  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

  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

  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)

  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

  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

  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)

  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

  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

Secondary Outcomes (9)

• Neck Disabilitv Index， (NDI)

  changes from baseline at 2 weeks

• the MOS item short from health survey，(SF-36)

  changes from baseline at 2 weeks

• Cervical range of motion

  changes from baseline at 2 weeks

• Neck Disabilitv Index， (NDI)

  changes from baseline at 1 month

• the MOS item short from health survey，(SF-36)

  changes from baseline at 1 month

Other Outcomes (3)

• The doctor of traditional Chinese medicine syndrome

  changes from baseline at 2 weeks

• The doctor of traditional Chinese medicine syndrome

  changes from baseline at 1 month

• The doctor of traditional Chinese medicine syndrome

  changes from baseline at 3 months

Study Arms (2)

Traction

ACTIVE COMPARATOR

6kg to 10kg, 3 times a week, once the other day（except the weekends）,20 minutes, 2 weeks.

Other: Cervical Traction control

Shi-style manipulations

EXPERIMENTAL

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.

Other: Shi-style manipulations

Interventions

Shi-style manipulations OTHER

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.

Also known as: manipulations for cervical radiculopathy

Shi-style manipulations

Cervical Traction control OTHER

6kg to 10kg, 3 times a week, once the other day（except the weekends）,20 minutes, 2 weeks.

Also known as: Cervical traction

Traction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead
• Beijing Hospital: collaborator
• Shenzhen Pingle Orthopaedic Hospital: collaborator
• Dongzhimen Hospital, Beijing: collaborator
• Traditional Chinese Medicine Hospital of the Ningxia Hui Autonomous Region: collaborator
• Traditional Chinese Medicine Hospital of Ganzhou Nankang District: collaborator

Study Officials

• Yongjun Wan, Doctor of Medicine(M.D.)

  Shanghai University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuejun Cui, Doctor of Medicine(M.D.)

CONTACT

86-21-64385700; 13917715524@139.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Base of Traditional Chinese Medicine

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 5, 2021
• Study Start: November 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: November 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share