NCT04815421

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

2.2 years

First QC Date

March 9, 2021

Last Update Submit

April 18, 2021

Conditions

Keywords

meridian; massage; stiff-neck syndrome; pain

Outcome Measures

Primary Outcomes (2)

  • 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)

    day1 to day 6

  • VAS evaluation between the 2 groups

    We used the visual analogue scale(VAS) to evaluate the score of pain score(0=none,10=maximum )

    day1 to day 6

Study Arms (2)

the paste group

EXPERIMENTAL

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.

Other: the paste group

the meridian group

EXPERIMENTAL

Patients in the meridian group were treated with dredging the same side Hand yang meridian techniques

Other: the meridian group

Interventions

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.

the paste group

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.

the meridian group

Eligibility Criteria

Age14 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lingyun Zhang, Master

    The Affiliated Hospital of Qingdao University

    STUDY CHAIR
  • Xue Jing, Doctor

    The Affiliated Hospital of Qingdao University

    PRINCIPAL INVESTIGATOR
  • Xiaoju Peng, Doctor

    The Affiliated Hospital of Qingdao University

    PRINCIPAL INVESTIGATOR
  • Ying Liu, no

    The Affiliated Hospital of Qingdao University

    STUDY DIRECTOR
  • Xueguo Sun, Doctor

    The Affiliated Hospital of Qingdao University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 25, 2021

Study Start

March 1, 2019

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

April 20, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations