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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Protocol summary
A clinical trial, with a control group, with two parallel groups, double-blinded, randomized through blocking, was conducted on 36 people. The website https://www.randomizer.org/ will be used for randomization.
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.
A clinical trial, with a control group, with two parallel groups, double-blinded, randomized through blocking, was conducted on 3638 people. The website https://www.randomizer.org/ will be used for randomization.
کارآزمایی بالینی، دارای گروه کنترل، با دو گروه موازی، دو سویه کور، تصادفی شده از طریق بلوک بندی، بر روی 36 نفر انجام شد. برای تصادفی سازی از سایت https://www.randomizer.org/ استفاده خواهد شد.
کارآزمایی بالینی، دارای گروه کنترل، با دو گروه موازی، دو سویه کور، تصادفی شده از طریق بلوک بندی، بر روی 38 نفر انجام شد. برای تصادفی سازی از سایت https://www.randomizer.org/ استفاده خواهد شد.
کارآزمایی بالینی، دارای گروه کنترل، با دو گروه موازی، دو سویه کور، تصادفی شده از طریق بلوک بندی، بر روی 3638 نفر انجام شد. برای تصادفی سازی از سایت https://www.randomizer.org/ استفاده خواهد شد.
General information
36
38
3638
empty
Correction following pilot study
Correction following pilot study
empty
تصحیح به دنبال انجام مطالعه مقدماتی
تصحیح به دنبال انجام مطالعه مقدماتی
Secondary outcomes
#1
The first session before treatment, at the end of the 5th session, 48 hours after the 10th session
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
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
جلسه اول قبل شروع درمان، بعد از اتمام جلسه پنجم، 48 ساعت بعد از جلسه دهم
جلسه اول قبل شروع درمان، بعد از اتمام جلسه پنجم، 48 ساعت بعد از جلسه دهم، دو ماه بعد از اتمام درمان
جلسه اول قبل شروع درمان، بعد از اتمام جلسه پنجم، 48 ساعت بعد از جلسه دهم، دو ماه بعد از اتمام درمان
Visual Analogue Scale
numeric pain rating scale
Visual Analogue Scalenumeric pain rating scale
مقیاس دیداری درد
مقیاس درجه بندی عددی درد
مقیاس دیداریدرجه بندی عددی درد
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Seyed Abbas Motevalian
Full name of responsible person - Persian: دکتر سید عباس متولیان
Street address - English: Iran University of Medical Sciences, Milad tower, Hemmat highway
Street address - Persian: بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 8670 2503
Fax:
Email: motevalian.a@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Hossein Keyvani
Full name of responsible person - Persian: دکتر حسین کیوانی
Street address - English: Iran University of Medical Sciences, Milad tower, Hemmat highway
Street address - Persian: بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 8670 5503
Fax:
Email: Research-m@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Seyed Abbas MotevalianHossein Keyvani Full name of responsible person - Persian: دکتر سید عباس متولیانحسین کیوانی Street address - English: Iran University of Medical Sciences, Milad tower, Hemmat highway Street address - Persian: بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵ Phone: +98 21 8670 25035503 Fax: Email: motevalian.aResearch-m@iums.ac.ir Web page address:
Protocol summary
Study aim
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.
Design
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.
Settings and conduct
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
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Pain, hand function, hand grip strength
General information
Reason for update
Correction following pilot study
Acronym
IRCT registration information
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
Registration date
2022-12-07, 1401/09/16
Registrant information
Name
marzieh Yassin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8052
Email address
m.yassin.pt@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of neurodynamic techniques and Electroacupuncture on pain, grip strength and hand function in subject with carpal tunnel syndrome: Randomized control trial
Public title
The effect of electroacupuncture in carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran university of medical sciences
Street address
Iran university of medical sciences, next to Milad tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-09-18, 1401/06/27
Ethics committee reference number
IR.IUMS.REC.1401.533
Health conditions studied
1
Description of health condition studied
Carpal Tunnel Syndrome
ICD-10 code
G56.00
ICD-10 code description
Carpal tunnel syndrome, unspecified upper limb
Primary outcomes
1
Description
Functional status scale of Boston questionnaire
Timepoint
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
Method of measurement
Persian Boston Questionnaire
2
Description
Symptom severity scale of Boston Questionnaire
Timepoint
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
Method of measurement
Persian Boston Questionnaire
Secondary outcomes
1
Description
Pain
Timepoint
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
Method of measurement
numeric pain rating scale
2
Description
Grip strength
Timepoint
The first session before treatment, at the end of the 5th session, 48 hours after the 10th session
Method of measurement
Hand dynamometer
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy clinic of Rehabilitation Faculty of Iran University of Medical Sciences
Full name of responsible person
Marzieh Yassin
Street address
Faculty of Rehabilitation; Iran University of Medical Sciences; Madadkaran street, Shahid Shahnazari street, Madar square, Mirdamad boulevard
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Phone
+98 21 2222 7124
Email
rehab@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hossein Keyvani
Street address
Iran University of Medical Sciences, Milad tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 5503
Email
Research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?