Protocol summary
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Study aim
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Comparison of the effects of two manual treatments separately in treating the active trigger points
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Design
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Clinical trial with control group, experimental-interventional, convenience sampling, random allocation.
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Settings and conduct
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The target community is selected from the students of the Rehabilitation School who have active trigger points in upper trapezius muscle. Sampling method is non-random and allocation of samples to groups will be random. Sampling will be done at the Biomechanics Laboratory of the Faculty of Rehabilitation.In this study data analyzer will be blind.
The physiotherapist assesses the local pain intensity through (visual analog scale), active cervical contra lateral flexion using Goniometer and pressure pain threshold using algometer. Iranian version of neck disability index questionnaire will be used to determine the level of patient's ability.
Variables will be assessed at the first session before and after the intervention and the fourth session and fourth week after the end of the treatment.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Subjects between 18 and 40 years,
Presence of active trigger points,
Pain at least 30 mm in visual analog scale,
Exclusion criteria:
History of whiplash injury,
History of head , neck , cervical spine or shoulder surgery,
History of cervical radiculopathy,
Diagnosed fibromyalgia and myopathy,
History of cancer,
Pregnancy,
History of treatment in a past month,
Contraindication of dry needling technique,
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Intervention groups
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Intervention group 1: Instrument assisted soft tissue mobilization technique , twice a week , For 2 weeks.
Intervention group 2: Dry needling , twice a week , For 2 weeks.
Control group: There is no intervention.
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Main outcome variables
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Pain intensity at the visual scale of pain,
Pressure pain threshold,
Active cervical contra lateral flexion,
Neck disability index,
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180311039049N1
Registration date:
2018-11-03, 1397/08/12
Registration timing:
prospective
Last update:
2018-12-24, 1397/10/03
Update count:
1
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Registration date
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2018-11-03, 1397/08/12
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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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2018-11-22, 1397/09/01
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Expected recruitment end date
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2019-09-23, 1398/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effectiveness of instrument assisted soft tissue mobilization technique (IASTM) with dry needling (DN) in improving pain pressure threshold (PPT) , active cervical contra lateral flexion (ACCLF) , pain intensity (PI) and neck disability index (NDI) in patients with active trigger points of the upper trapezius muscle
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Public title
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Comparison of instrument assisted soft tissue mobilization technique (IASTM) with dry needling (DN) on the active trigger points of the upper trapezius muscle
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Subjects between 18 and 40 years
Presence of active trigger points in upper trapezius muscle
Pain at least 30 mm in visual analog scale
Exclusion criteria:
History of whiplash injury
History of head , neck , cervical spine or shoulder surgery
History of cervical radiculopathy
Diagnosed fibromyalgia and myopathy
History of cancer
Pregnancy
Myofascial therapy within the past month
Contraindication of dry needling technique
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Age
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From 18 years old to 40 years old
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Gender
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Female
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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:
75
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, a sample of 75 people, 25 cards for each intervention group and 25 cards for control group were considered and placed inside a sealed envelope that is non-transparent to draw then each patient takes one of the cards randomly and their group is identified and the generated sequence is recorded.
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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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2017-08-13, 1396/05/22
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1396.278
Health conditions studied
1
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Description of health condition studied
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Myofascial Trigger Points of the Upper Trapezius Muscle
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Pain intensity in the visual scale of pain
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Timepoint
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Measure the severity of pain in the first session before and after the intervention and the fourth session and fourth week after the end of treatment
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Method of measurement
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Visual analogue scale
Secondary outcomes
1
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Description
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Pain pressure threshold
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Timepoint
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Measurement at first session before and after intervention and the fourth session and fourth week after the end of treatment
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Method of measurement
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Digital algometer (Lutron FG-5020)
2
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Description
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Active cervical contra lateral flexion
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Timepoint
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Measurement at first session before and after intervention and the fourth session and fourth week after the end of treatment
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Method of measurement
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Goniometry
3
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Description
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Neck disability index
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Timepoint
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Measurement at first session before intervention and the fourth session and fourth week after the end of treatment
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Method of measurement
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Neck disability index- iranian version questionnaire
Intervention groups
1
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Description
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Intervention group: In this technique is first step to increase blood flow and muscle tissue temperature for 5 minutes, superficial heat will be used and then using the myo-release tool, muscle tissue will be massaged for 5 minutes. The soft tissue mobilization technique is carried out using the myo-release tool No. 1, made in Iran. The tool is made of stainless steel. Immediately after massage, the therapist applies 3 passive stretches for 30 seconds on the muscle and this phase is completed by the 2nd 12th active muscle stretches by the patient herself and in the final stage, the patient performs the shoulder elevation as 2 sets of 15. This technique is performed in 4 sessions and twice a week.
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Category
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Treatment - Other
2
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Description
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Intervention group: Dry needle technique is done using sterile needles and disposable Dong Bang with a length of 40 mm and a thickness of 0.25 mm.After the tight bundles are found in the upper trapezius muscle, the therapist inserts the needle at a 30-degree angle and inserts the needle out frequently and then again into another part of the trigger point, this procedure is repeated as long as no other local twitch response is felt. This technique is performed in 4 sessions and twice a week.
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Category
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Treatment - Other
3
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Description
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Control group:There is no intervention.
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Category
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N/A
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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Shahid Beheshti 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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Undecided - It is not yet known if there will be a plan to make this available
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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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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available