Protocol summary
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Study aim
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The purpose of this study is to investigate the effect of the Neurodynamic technique with electroacupuncture on pain, strength, and hand function in people with carpal tunnel syndrome.
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Design
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A clinical trial, with a control group, with two parallel groups, double-blinded, randomized through blocking, was conducted on 38 people. The website https://www.randomizer.org/ will be used for randomization.
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Settings and conduct
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The study is performed in the rehabilitation faculty of Iran University of Medical Sciences. Then eligible participants sign an informed consent form and are randomly assigned to two groups of Electroacupuncture and placebo Electroacuouncture by Block-balanced randomization technique. Treatment and assessment are done by separate persons and the assessor and analyzer of data will be kept blind. The assessor is present only at the time of the assessment
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1.18_60 year old.
2.Numbness and pain in the area of the median nerve (between 1 to 6 months).
3.Participants who have diminished nerve conduction values (<50 m/s), increased motor latency (>4 m/s), and increased sensory latency (> 3.5 m/s). 4.Positive phalen and tinel sign.
Exclusion criteria:
1.Muscular atrophy.
2. Pregnancy.
3.Prior decompression surgery.
4.Post trauma to the wrist.
5.Diabetes Mellitus in case of taking insulin or suffering from diabetic neuropathy.
6.Cervical radiculopathy.
7.Any contraindication for needling such as local infection, bleeding tendency, or a history of needling shock.
8.Rheumatoid arthritis.
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Intervention groups
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Neurodynamic techniques along with electroacupuncture are used in the treatment group, and in the control group, neurodynamic techniques along with electroacupuncture are used as a placebo.
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Main outcome variables
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Pain, hand function, hand grip strength
General information
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Reason for update
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Correction following pilot study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191208045652N5
Registration date:
2022-12-07, 1401/09/16
Registration timing:
prospective
Last update:
2023-08-11, 1402/05/20
Update count:
1
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Registration date
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2022-12-07, 1401/09/16
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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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2023-01-20, 1401/10/30
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Expected recruitment end date
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2023-09-22, 1402/06/31
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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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The effect of neurodynamic techniques and Electroacupuncture on pain, grip strength and hand function in subject with carpal tunnel syndrome: Randomized control trial
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Public title
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The effect of electroacupuncture in carpal tunnel syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
18_60 year old
Symptoms associated with carpal tunnel syndrome (pain and numbness) in at least 2 of the outer 3½ fingers for a period of one to six months
Participants who have diminished nerve conduction values (<50 m/s), increased motor latency (>4 m/s), and increased sensory latency (> 3.5 m/s)
Positive phalen and tinel sign
Exclusion criteria:
Thenar muscle atrophy
Pregnancy
Prior decompression surgery
History of trauma in wrist and hand
Metabolic problems (diabetes mellitus in case of insulin use or diabetic neuropathy)
Cervical radiculopathy
Any contraindication for needling such as local infection, bleeding tendency or a history of needling shock
Rheumatoid diseases
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Age
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From 18 years old to 60 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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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
38
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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After the completion of participant information and questionnaires, patients with carpal tunnel syndrome are randomly divided into two groups of treatment (group A) and control group (group B) with a ratio of one to one. Random allocation is done by variable blocks method, which will include four-letter blocks consisting of letters A and B. In each numbered envelope, one of the four-letter blocks containing two letters A and B is placed. Then, the treatment allocation list will be obtained at https://www.randomizer.org/.The letter A indicates electroacupuncture group and the letter B indicates non-real electroacupuncture. The random allocation process will be done by someone outside of the research team before the start of the study. After the initial evaluation of the patient by the examiner, numbered envelopes and stamps corresponding to the number of each person entered into the study will be given to him. Finally, after each patient enters the treatment sessions, the person providing the techniques will adjust the treatment interventions based on the letters inside the envelope. The examiners will be completely unaware of the letters inside the envelopes. Also, it should be noted that after placing the patients in the desired group, they are asked not to provide their grouping information to the examiner.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Evaluation and treatment will be done by two people. The person evaluating and analyzing the data are those who do not know about the grouping and will be unaware of which group each subject belongs to. The evaluator is present in the research only during the evaluation. The participants will not know which treatment group they have entered, in the treatment group, electroacupuncture along with neurodynamic techniques will be used, and in the control group, electroacupuncture placebo along with neurodynamic techniques will be used.
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Placebo
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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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2022-09-18, 1401/06/27
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Ethics committee reference number
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IR.IUMS.REC.1401.533
Health conditions studied
1
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Description of health condition studied
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Carpal Tunnel Syndrome
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ICD-10 code
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G56.00
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ICD-10 code description
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Carpal tunnel syndrome, unspecified upper limb
Primary outcomes
1
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Description
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Functional status scale of Boston questionnaire
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Timepoint
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The first session before treatment, at the end of the 5th session, 48 hours after the 10th session, two months after the end of the treatment
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Method of measurement
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Persian Boston Questionnaire
2
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Description
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Symptom severity scale of Boston Questionnaire
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Timepoint
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The first session before treatment, at the end of the 5th session, 48 hours after the 10th session, two months after the end of the treatment
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Method of measurement
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Persian Boston Questionnaire
Secondary outcomes
1
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Description
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Pain
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Timepoint
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The first session before treatment, at the end of the 5th session, 48 hours after the 10th session, two months after the end of the treatment
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Method of measurement
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numeric pain rating scale
2
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Description
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Grip strength
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Timepoint
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The first session before treatment, at the end of the 5th session, 48 hours after the 10th session
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Method of measurement
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Hand dynamometer
Intervention groups
1
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Description
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Intervention group: Neurodynamic technique: arm adduction to 90, arm external rotation, wrist and fingers extension, forearm supination, and elbow extension. In this sequence, gliding and tension techniques will perform in the proximal and distal directions: (1) 1-direction proximal glide mobilization (movement_elbow extension_large amplitude of motion), (2) 1-direction distal glide mobilization (movement_wrist extension_large amplitude of motion), (3) 1-direction proximal tension mobilization (movement_elbow extension_small amplitude of motion at the end of the movement), and (4) 1-direction distal tension mobilization (movement_wrist extension_small amplitude of motion)In both groups, the standard protocol consisted of 3 series of 20 repetitions of glide and tension neurodynamic techniques separated by inter-series intervals of 15 seconds, twice a week for 10 sessions. Electroacupuncture: The following eight acupoints were applied: TW-5, PC-7, HT-3, PC-3, SI-4, LI-5, LI-10 and LU-5 on the affected side. After disinfecting the skin, therapist would insert sterile, 0.25x40 mm, into each acupoint with the aid of a guide tube. Punctures will make to a depth of 1–3 cm, depending on the thickness of the patient’s wrist, hand and forearm. After insertion would perform bidirectional rotations of the needle sheath to achieve Deqi, indicating a patient-reported sensation of soreness, tingling, heaviness or distension at each acupoints. After insertion of all acupoints, electro-stimulation will apply immediately in the following combinations: TW-5 + PC-7, SI-4 + LI-5, LI-10 + LU-5, and HT-3 + PC-3, using the SDZ-II electroacupuncture instrument (2-4 Hz, continuous wave). The intensity should tolerable to the patient. The electro-simulation lasted for 20 minutes and then needles will remove, twice a week for 10 sessions.
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Category
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Rehabilitation
2
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Description
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Control group: Neurodynamic technique: arm adduction to 90, arm external rotation, wrist and fingers extension, forearm supination, and elbow extension. In this sequence, gliding and tension techniques will perform in the proximal and distal directions: (1) direction proximal glide mobilization (movement_elbow extension_large amplitude of motion), (2) direction distal glide mobilization (movement_wrist extension_large amplitude of motion), (3) direction proximal tension mobilization (movement_elbow extension_small amplitude of motion at the end of the movement), and (4) direction distal tension mobilization (movement_wrist extension_small amplitude of motion)In both groups, standard protocol consisted of 3 series of 20 repetitions of glide and tension neurodynamic techniques separated by inter-series intervals of 15 seconds, twice a week for 10 sessions. Sham electroacupuncture: After disinfecting the skin, sham EA on therapeutic acupoints plus no skin penetration plus no electrical stimulation. After 20 minutes needles will remove, twice a week for 10 sessions.
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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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Iran 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