Protocol summary
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Study aim
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The effect of dry needling of tenar muscles on the management of patients with carpal tunnel syndrome.
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Design
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The clinical trial with a control group, with parallel groups, randomized, single-center. The sample size is 12 patients (consist of 2 groups of 50 control and intervention).
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Settings and conduct
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Physiotherapy clinics, Semnan University of Medical Sciences
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: patients who Phalen and Tinel tests are positive; patients electromyography (EMG) has a median reduction in NCV. Exclusion criteria: presence of patients with symptoms of CTS; drugs that cause neuropathy; the pregnancy and breastfeeding, history of previous surgeries or injections Astrvyydal to the wrist, elbow and wrist deformity tumor.
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Intervention groups
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]ntervention group: In the intervention group DN, DN two sessions with an interval of two days of one another, occurs. In both groups immediately after the second meeting with the re-evaluation electrodiagnostic tests of functional performance and completion of a questionnaire by volunteers Boston is repeated. To assess the reliability of the effect of treatment, all evaluations are done after two weeks.
Control group: There is no intervention in the control group. In both groups immediately after the second meeting with the re-evaluation electrodiagnostic tests of functional performance and completion of a questionnaire by volunteers Boston is repeated.
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Main outcome variables
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The functional operations of the maximum power of pinching and groping f
General information
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Reason for update
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Change the sampling date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016032625732N4
Registration date:
2016-04-18, 1395/01/30
Registration timing:
prospective
Last update:
2020-10-02, 1399/07/11
Update count:
1
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Registration date
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2016-04-18, 1395/01/30
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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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Vice Chancellor for Research and Technology, Semnan University of Medical Sciences
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Expected recruitment start date
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2016-05-21, 1395/03/01
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Expected recruitment end date
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2016-10-21, 1395/07/30
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Actual recruitment start date
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2016-05-21, 1395/03/01
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Actual recruitment end date
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2016-10-21, 1395/07/30
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Trial completion date
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2017-01-19, 1395/10/30
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Scientific title
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The effect of dry needling of tenar muscles on the management of patients with carpal tunnel syndrome
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Public title
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The effect of dry needling thenar (thumb muscle down) the treatment of patients with trapped nerve in the wrist
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients who test positive Phalen and Tinel them
patients in their study, electromyography (EMG) decreased median nerve conduction velocity has been confirmed
Patients who evaluate trigger Myofascial trigger points in the muscles Tnarshan according to diagnostic criteria simons been confirmed
Exclusion criteria:
The existence of a disease that mimics the symptoms of CTS such as polyneuropathy, radiculopathy, cervical, thoracic outlet syndrome and double-crush syndrome
There are conditions such as hyperthyroidism, gout, systemic lupus erythematosus, rheumatoid arthritis, diabetes, chronic kidney failure and acromegaly
drugs that cause neuropathy is
Pregnancy and lactation
previous surgery or injection wrist Astrvyydal
Tumors or deformities elbow and wrist are effective on carpal tunnel dimensions
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Age
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No age limit
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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:
100
Actual sample size reached:
100
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Randomization (investigator's opinion)
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N/A
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Randomization description
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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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2016-02-24, 1394/12/05
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Ethics committee reference number
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IR.SEMUMS.REC.1394.185
Health conditions studied
1
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Description of health condition studied
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dry needling of tenar muscles on the management of patients with carpal tunnel syndrome
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ICD-10 code
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G56.0
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ICD-10 code description
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Carpal tunnel syndrome
Primary outcomes
1
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Description
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The functional operations of the maximum power of pinching and groping f
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Timepoint
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Two treatments with an interval of two days of the DN
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Method of measurement
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Electrodiagnostic evaluation with the tests functional performance and completion of a questionnaire Boston by volunteers
Intervention groups
1
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Description
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Volunteers are randomized into two treatment groups. There is no intervention in the control group. In both groups immediately after the second meeting with the re-evaluation electrodiagnostic tests of functional performance and completion of a questionnaire by volunteers Boston is repeated. To assess the reliability of the effect of treatment, all evaluations are done after two weeks.
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Category
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Prevention
2
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Description
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Volunteers are randomized into two treatment groups. In the intervention group DN, DN two sessions with an interval of two days of one another, occurs. In both groups immediately after the second meeting with the re-evaluation electrodiagnostic tests of functional performance and completion of a questionnaire by volunteers Boston is repeated. To assess the reliability of the effect of treatment, all evaluations are done after two weeks.
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Category
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Prevention
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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Semnan 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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No - There is not a plan to make this available