MassageNCT04815421
Deep Tissue Massage on Stiff-neck Syndrome
A study testing the paste group and the meridian group in people with Massage and Meridian, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- What is being tested?
- the paste group and the meridian group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
About this study
Official title: Therapeutic Efficacy of Dredging Three Yang Meridians of Hand With Deep Tissue Massage on Stiff-neck Syndrome
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 .
Read the 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 .
- Being tested
- the paste group, the meridian group
- Keywords
- meridian; massage; stiff-neck syndrome; pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the paste groupOther
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 meridian groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: the paste group |
| the meridian group | Experimental | Patients in the meridian group were treated with dredging the same side Hand yang meridian techniques Receives: Other: the meridian group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 )
Measured: day1 to day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Mar 2019
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MassageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lingyun Zhang, Master, Study chair, The Affiliated Hospital of Qingdao UniversityXue Jing, Doctor, Principal investigator, The Affiliated Hospital of Qingdao UniversityXiaoju Peng, Doctor, Principal investigator, The Affiliated Hospital of Qingdao UniversityYing Liu, no, Study director, The Affiliated Hospital of Qingdao UniversityXueguo Sun, Doctor, Study director, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815421
- Sponsor's protocol ID
- zhanglingyun
- Status last verified
- Apr 2021
- First submitted
- 9 Mar 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Efficacy of Dredging Three Yang Meridians of Hand With Deep Tissue Massage on Stiff-neck Syndrome
- ClinicalTrials.gov ID
- NCT04815421
- Acronym / sponsor ID
- zhanglingyun
- Keywords
- meridian; massage; stiff-neck syndrome; pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| the paste group | Experimental | Other: the paste groupPatients 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. |
| the meridian group | Experimental | Other: the meridian groupPatients in the meridian group were treated with dredging the same side Hand yang meridian techniques |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the paste groupPatients 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. | Other | the paste group |
| the meridian groupPatients 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. | Other | the meridian group |
Primary outcome
clinical effects
Time frame: day1 to day 6
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
Time frame: day1 to day 6
We used the visual analogue scale(VAS) to evaluate the score of pain score(0=none,10=maximum )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lingyun Zhang, Master study chair
The Affiliated Hospital of Qingdao University
Xue Jing, Doctor principal investigator
The Affiliated Hospital of Qingdao University
Xiaoju Peng, Doctor principal investigator
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the paste group and the meridian group in people with Massage and Meridian, run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical effects (time frame: day1 to day 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.