Clinical trial NCT04815421: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Massage
Meridian
Pain
Keywords: meridian; massage; stiff-neck syndrome; pain
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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 .

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

Primary outcomes:
measure: clinical effects
timeFrame: day1 to day 6
measure: VAS evaluation between the 2 groups
timeFrame: day1 to day 6
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Lingyun Zhang, Master
role: STUDY_CHAIR
affiliation: The Affiliated Hospital of Qingdao University
name: Xue Jing, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Qingdao University
name: Xiaoju Peng, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Qingdao University
name: Ying Liu, no
role: STUDY_DIRECTOR
affiliation: The Affiliated Hospital of Qingdao University
name: Xueguo Sun, Doctor
role: STUDY_DIRECTOR
References: