Deep Tissue Massage on Stiff-neck Syndrome
Primary Purpose
Massage, Meridian, Pain
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the paste group
the meridian group
Sponsored by

About this trial
This is an interventional treatment trial for Massage focused on measuring meridian; massage; stiff-neck syndrome; pain
Eligibility Criteria
Inclusion Criteria:
- The onset of symptoms and signs are less than 24 hours
- Male or female aged from 14 to 60 years
- No other therapy before grouped
- Be willing to participate the study and sign the informed consent
Exclusion Criteria:
- Stiff neck patients who had diagnosed cervical vertebra or cervical spondylosis
- Suffered from systemic collagen immune diseases or other acute or chronic infection
- Use pain-killer drugs may affect the outcome evaluation
- Refuse to join the trial; Drop out in follow-up visit
- Aggravation of disease or complications during the study
Sites / Locations
- The Affiliated Hospital of Qingdao University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
the paste group
the meridian group
Arm Description
Patients in the paste group were treated with Nanxing paste on the affected region include shoulder, neck or back and no more than 3 pieces. The therapy duration was 6 days.
Patients in the meridian group were treated with dredging the same side Hand yang meridian techniques
Outcomes
Primary Outcome Measures
clinical effects
cure or improvement or failure(Cure: Absence of neck-stiff, neck sore and free functional activities. Improvement: partially functional activities with light to moderate pain. Failure: No improvement or alleviation of neck stiff and agony)
VAS evaluation between the 2 groups
We used the visual analogue scale(VAS) to evaluate the score of pain score(0=none,10=maximum )
Secondary Outcome Measures
Full Information
NCT ID
NCT04815421
First Posted
March 9, 2021
Last Updated
April 18, 2021
Sponsor
The Affiliated Hospital of Qingdao University
1. Study Identification
Unique Protocol Identification Number
NCT04815421
Brief Title
Deep Tissue Massage on Stiff-neck Syndrome
Official Title
Therapeutic Efficacy of Dredging Three Yang Meridians of Hand With Deep Tissue Massage on Stiff-neck Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of Qingdao University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized controlled study . The objective is to observe the therapeutic effects of dredging three yang meridians of hand with deep tissue massage on stiff-neck syndrome.
Methods: patients with stiff-neck syndrome were randomly divided into meridian group and paste group.The meridian group were treated once a day for 3 days and the paste group therapy was a 3 courses therapy( one course includes 24-hour rest and 24-hour paste). After 3 courses, pain was assessed by visual analogue scale (VAS), the therapeutic effects were compared between the two groups in every stage of the therapy and the self-controlled study.The evaluation criteria on stiff-neck syndrome is based on criteria of diagnostic and therapeutic effect of orthopaedic and traumatologic diseases and syndromes in traditional Chinese medicine . Cure: Absence of neck-stiff, neck sore and free functional activities. Improvement: partially functional activities with light to moderate pain. Failure: No improvement or alleviation of neck stiff and agony. All data will be analyzed by SPSS 16.0, the statistical difference is considered if the P<0.05 and the significant difference is considered if the P<0.01 .
Detailed Description
1 Clinical Materials 1.1 Diagnostic criteria Acute onset of severe pain and stiffness in one-sided neck after sleep; Mostly because of bad sleep posture or cold in neck, shoulder or head; Pain or discomfort can radiate to head, arm and back; Any attempt to move neck can obviously exacerbate the pain; The head slants to the affected side; Without neck injury history or other relative systematic diseases.; Neck X-ray film has no positive signs such as degenerative lesions of cervical spine; Trachelismus and rhomboideus major/ minor, levator scapulae accessible lumps or streak in muscle. All criteria conformed to the prescription in criteria of diagnostic and therapeutic effect of orthopaedic and traumatologic diseases and syndromes in traditional Chinese medicine.
1.2 Inclusion criteria The onset of symptoms and signs are less than 24 hours; Male or female aged from 14 to 60 years; No other therapy before grouped; Be willing to participate the study and sign the informed consent.
1.3 Exclusion criteria Stiff neck patients who had diagnosed cervical vertebra or cervical spondylosis; Suffered from systemic collagen immune diseases or other acute or chronic infection; Use pain-killer drugs may affect the outcome evaluation; Refuse to join the trial; Drop out in follow-up visit; Aggravation of disease or complications during the study.
1.4 Patients All patients were outpatients and be diagnosed with stiff-neck syndrome according to the diagnostic criteria. They were randomly allocated into 2 groups (meridian group and paste group) according to the visiting time (with digital random table)and their wills.
2.1 meridian group Patients in the meridian group were treated with dredging the same side three yang meridians of hand techniques(include the gliding techniques of deep tissue massage on the three yang meridians of back hand (the second, fourth and fifth metacarpal bone); pinching and kneading the second, fourth and fifth phalanges of fingers of the affected side hand; Encourage the patient to try his best to roll his neck to the most tolerable degree during dredging the meridians) and the total time was about 3 to 5 minutes according the tolerance of every patient and the smooth of three yang meridians of hand. The massage will not stop until the meridian route was relatively smooth, soft and thermal. The sequence of massage is Hand Yangming meridian(LI) the first, Hand Taiyang meridian(SI) the second and Hand Sanjiao(SJ) the last. The frequency of massage was once a day.
2.2 paste group Patients in the paste group were treated with Nanxing paste on the affected region include shoulder, neck or back and no more than 3 pieces. The paste lasted for 24 hours and then peeled it rested the pasted region for 24 hours and changed another paste on the pain region. The therapy duration was 6 days.
Pain was assessed by visual analogue scale (VAS), the therapeutic effects were compared between the two groups in every stage of the therapy and the self-controlled study.The evaluation criteria on stiff-neck syndrome is based on criteria of diagnostic and therapeutic effect of orthopaedic and traumatologic diseases and syndromes in traditional Chinese medicine . Cure: Absence of neck-stiff, neck sore and free functional activities. Improvement: partially functional activities with light to moderate pain. Failure: No improvement or alleviation of neck stiff and agony. All data will be analyzed by SPSS 16.0, the statistical difference is considered if the P<0.05 and the significant difference is considered if the P<0.01 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Massage, Meridian, Pain
Keywords
meridian; massage; stiff-neck syndrome; pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients who were diagnosed with stiff-neck syndrome according to the diagnostic criteria(Acute onset of severe pain and stiffness in one-sided neck after sleep; Mostly because of bad sleep posture or cold in neck, shoulder or head; Pain or discomfort can radiate to head, arm and back; Any attempt to move neck can obviously exacerbate the pain; The head slants to the affected side; Without neck injury history or other relative systematic diseases.; Neck X-ray film has no positive signs such as degenerative lesions of cervical spine; Trachelismus and rhomboideus major/ minor, levator scapulae accessible lumps or streak in muscle. All criteria conformed to the prescription in criteria of diagnostic and therapeutic effect of orthopaedic and traumatologic diseases and syndromes in traditional Chinese medicine). They were randomly enrolled in meridian group or paste group according to the visiting time (with digital random table).
Masking
Outcomes Assessor
Masking Description
Two persons of our protocol who was unknown of the patients' treatment method and period estimated the VAS of every patient freely and evaluated the clinical effects and outcomes according to the criteria of diagnostic and therapeutic effect of orthopaedic and traumatologic diseases and syndromes in traditional Chinese medicine
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the paste group
Arm Type
Experimental
Arm Description
Patients in the paste group were treated with Nanxing paste on the affected region include shoulder, neck or back and no more than 3 pieces. The therapy duration was 6 days.
Arm Title
the meridian group
Arm Type
Experimental
Arm Description
Patients in the meridian group were treated with dredging the same side Hand yang meridian techniques
Intervention Type
Other
Intervention Name(s)
the paste group
Intervention Description
Patients in the paste group were treated with Nanxing paste on the affected region include shoulder, neck or back and no more than 3 pieces. The paste lasted for 24 hours and then peeled it rested the pasted region for 24 hours and changed another paste on the pain region. The therapy duration was 6 days.
Intervention Type
Other
Intervention Name(s)
the meridian group
Intervention Description
Patients in the meridian group were treated with dredging the same side three yang meridian techniques(include the gliding techniques of deep tissue massage on three yang meridians of back hand (the second, fourth and fifth metacarpal bone); pinching and kneading the second, fourth and fifth phalanges of fingers of the affected side hand; Encourage the patient to try his best to roll his neck to the most tolerable degree during dredging the meridian) and the total time was about 3 to 5 minutes according the tolerance of every patient . The massage will not stop until the meridian route was relatively smooth, soft and thermal or light red. The sequence of massage is Hand Yangming meridian(LI) the first, Hand Taiyang meridian(SI) the second and Hand Sanjiao(SJ) the last. The frequency of massage was once a day.
Primary Outcome Measure Information:
Title
clinical effects
Description
cure or improvement or failure(Cure: Absence of neck-stiff, neck sore and free functional activities. Improvement: partially functional activities with light to moderate pain. Failure: No improvement or alleviation of neck stiff and agony)
Time Frame
day1 to day 6
Title
VAS evaluation between the 2 groups
Description
We used the visual analogue scale(VAS) to evaluate the score of pain score(0=none,10=maximum )
Time Frame
day1 to day 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The onset of symptoms and signs are less than 24 hours
Male or female aged from 14 to 60 years
No other therapy before grouped
Be willing to participate the study and sign the informed consent
Exclusion Criteria:
Stiff neck patients who had diagnosed cervical vertebra or cervical spondylosis
Suffered from systemic collagen immune diseases or other acute or chronic infection
Use pain-killer drugs may affect the outcome evaluation
Refuse to join the trial; Drop out in follow-up visit
Aggravation of disease or complications during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lingyun Zhang, Master
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xue Jing, Doctor
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaoju Peng, Doctor
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ying Liu, no
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Xueguo Sun, Doctor
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Study Director
Facility Information:
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Deep Tissue Massage on Stiff-neck Syndrome
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