Protocol summary
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Study aim
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Evaluation of the effectiveness of massage cupping on pain, fatigue and quality of life in patient with trapezius myofascial syndrome
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Design
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This is a two arm parallel group randomized control clinical trial including intervention(A) and control(B) groups. The patients with trapezious myofacial syndrome assigned into one the two groups by using sealed envelops. The patients, the persons which perform the intervention and the person who analyze the data are unaware about patient assignment.
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Settings and conduct
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40 patients with trapezius myofascial syndrome referred from physical medicine and rehabilitation office based on inclusion and exclusion criteria. After describing the study, method and the objectives, the patients signed an informed consent and divided in two group randomly by using sealed envelops: 1-massage cupping therapy 2- control group. At first demographic and disease history questionnaire and SF-36 QOL questionnaire will be completed and pain will be measured using visual analog scale (VAS) for all patients then, the first group will be treated by massage cupping for 4 weeks(2 sessions a week), every session lasts 15 minutes. For the second group (control group), a routine exercise therapy was performed. The exercises consisted of three strengthening exercises and five stretching exercises for the upper, middle and lower trapezius muscles. Each movement was performed 10 repetitions and 3 times a day. All data will be collected after the last session of therapy as well as three months later. Data will be analyzed with SPSS using ANOVA and repeated measure test.
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Participants/Inclusion and exclusion criteria
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patient with trapezius myofascial syndrome
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Intervention groups
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Group A: massage cupping therapy and drug therapy
Group B: exercise therapy and drug therapy
Drug therapy: drug therapy for both groups: Tab acetaminophen 500mg daily
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Main outcome variables
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Pain
General information
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Reason for update
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Correction of the control group
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180804040685N2
Registration date:
2020-08-03, 1399/05/13
Registration timing:
prospective
Last update:
2021-05-03, 1400/02/13
Update count:
2
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Registration date
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2020-08-03, 1399/05/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-01-21, 1398/11/01
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Expected recruitment end date
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2021-01-20, 1399/11/01
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Actual recruitment start date
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2020-08-07, 1399/05/17
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Actual recruitment end date
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2021-01-11, 1399/10/22
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Trial completion date
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2021-04-12, 1400/01/23
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Scientific title
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Evaluation of the effectiveness of massage cupping on pain and quality of life in patient with trapezius myofascial syndrome
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Public title
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Evaluation of the effectiveness of massage cupping in patient with trapezius myofascial syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
patient with trapezius myofascial syndrome according to physiatrist diagnosis
18-65 y/o
VAS>2
Exclusion criteria:
Patients with uncontrolled systemic disease
Patients with similar symptoms such as radiculopathy, etc
Patients with coagulopathy or treated with anticoagulants
CNS disorders
Mental disorders and bacterial infection
Pregnant
Local disease
Participate in other studies and interventions
Disinclination to continue participating in the present study
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
40
Actual sample size reached:
44
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The patients primary evaluation, will be assigned into one of the 2 groups A or B randomly by using sealed envelops, so that each patient picks up a sealed envelop in which the group A or B is defined and enters to one of the two groups.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-06-03, 1398/03/13
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1398.177
Health conditions studied
1
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Description of health condition studied
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trapezius myofascial syndrome
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ICD-10 code
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ICD-10 code description
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سندرم میوفاسیال
Primary outcomes
1
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Description
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pain
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Timepoint
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before and after intervention and three months after end of intervention
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Method of measurement
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Visual Analog Scale
2
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Description
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quality of life
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Timepoint
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before and after intervention and one and three months after end of intervention
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Method of measurement
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SF-36 QOL questionnaire
Intervention groups
1
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Description
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Intervention group(massage cupping): cupping will be perform by moving a cup over the trapezious muscle by imposing negative pressure trough suctioning.
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Category
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Rehabilitation
2
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Description
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Control group: control group receive routine exercise therapy and drug.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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preservation of patients private limit
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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all data will be shared after making them non-identified-able the patients
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When the data will become available and for how long
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6 months after ending the study
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To whom data/document is available
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researchers in universities and scientific associations
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Under which criteria data/document could be used
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for confirming to be publication
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From where data/document is obtainable
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corresponding auther
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What processes are involved for a request to access data/document
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email contact and accomplished legal process
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Comments
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