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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
Conditions the study is for
Massage, Meridian, Pain
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

Other trials in China

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 .

Conditions
Massage, Meridian, Pain
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 groups in NCT04815421
Study groupRoleWhat they receive
the paste groupExperimentalPatients 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 groupExperimentalPatients 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.

  1. 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

  2. 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.

  1. First posted25 Mar 2021
  2. Study start1 Mar 2019
  3. Primary completion1 May 2021 (estimated)
  4. Study completion1 May 2021 (estimated)

Resources

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)
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

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.

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