The aim of this study is to determine the effect of acupuncture on lower limb muscle spasm in comparison to physiotherapy in patients after stroke.
Design
A randomized controlled parallel group trial on 60 patients with equal randomization (1:1 ratio) by Excel Rand function.
Settings and conduct
Study location: Ahmadie Clinic; School of Persian Medicine; Tehran University of Medical Sciences. Study Participants: The patients are recruited from Ahmadie Clinic. In this study blinding is not applied.
Participants/Inclusion and exclusion criteria
Patients aged 40 to 85 years with hemorrhagic or ischemic stroke (confirmed CT scan or MRI or normal CT and MRI but clinically consistent with the World Health Organization definition of stroke) with at least 1 and A maximum of 6 months from the time of the stroke, who have post-stroke hemiplegia and at least 1 month has passed since the stroke. Have at least 2 weeks of moderate or severe spasticity of the knee and ankle joints and problems in the functional use of the lower limb (limited ground support on the affected limb and problems while walking).
Intervention groups
Intervention group: Acupuncture plus routine treatment Control group: Routine treatment alone
Main outcome variables
Examination of muscle spasticity based on the Ashworth score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171007036614N6
Registration date:2024-08-05, 1403/05/15
Registration timing:prospective
Last update:2024-08-05, 1403/05/15
Update count:0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
Mohammad Sadegh Adel-Mehraban
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3624 3214
Email address
sadeghadel@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-09-23, 1404/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of acupuncture compared to physical therapy on lower limb muscle spasm in patients after stroke: a randomized clinical trial
Public title
Investigating the effect of acupuncture on lower limb muscle spasm in patients after stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with hemorrhagic or ischemic stroke (confirmed CT scan or MRI or normal CT and MRI but clinically consistent with the World Health Organization definition of stroke) with a minimum of 1 and a maximum of 6 months Since the stroke
Presence of hemiplegia after stroke
Diagnosis of spastic hypertonia in a lower limb with an average Ashworth score of at least 2 in an affected lower limb on the first screening day
The time interval until the stroke is at least 1 month
The presence of at least 2 weeks of moderate or severe spasticity of the knee and ankle joints
Problems in the functional use of the lower limb (limited ground support on the affected limb and problems while walking)
Exclusion criteria:
Impaired consciousness
Muscle disease
Severe general illness
History of fracture or any deformity that can affect normal walking
Use of any antispasmodic medication during the examination
Age
From 40 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Volunteers are divided into two groups A or B by random blocks (AABB, BBAA, ABAB, BABA, ABBA, BAAB). Group A will receive acupuncture and group B will be control. Each block is assigned a number from 1 to 6. In order to reach the required sample size, the number of 15 blocks is randomly selected by the online random number generation software, and the patients are randomly assigned to the relevant group based on the turn of the visit.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences
Street address
Enqelab St.
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2024-06-26, 1403/04/06
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.148
Health conditions studied
1
Description of health condition studied
Spastic hemiplegic cerebral palsy
ICD-10 code
G80.2
ICD-10 code description
Spastic hemiplegic cerebral palsy
Primary outcomes
1
Description
Lower limb spasticity
Timepoint
Before intervention and 4weeks after intervention
Method of measurement
Ashworth scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients come for acupuncture for 4 weeks and 3 times a week. The acupuncture protocol is manual acupuncture and the points used will be Futu (ST ۳۲), Liangqiu (ST ۳۴), Zusanli (ST ۳۶), Fenglong (ST ۴۰), Xuanzhong (GB ۳۹), Qiuxu (GB ۴۰), Taixi (KI ۳), Sanyinjiao (SP ۶), Yinlingquan (SP۹), Xuehai (SP ۱۰). All patients, including the control group, receive the routine treatment. Sterile stainless acupuncture needles (0.25 mm × 40 mm, manufactured by Zhong Yang Taihe China Co., Ltd.) are inserted vertically at a depth of 10-15 mm into the acupuncture points and left for 20 minutes.
Category
Treatment - Other
2
Description
Control group: The control group receives only the routine treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahmadie clinid
Full name of responsible person
Amir Hooman Kazemi
Street address
Taleqani St.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8897 4535
Email
amirhoomank@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Enqelab St., Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8897 8745
Email
info@tpcf.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Adel Mehraban
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Taleqani St., Ahmadie Clinic
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8897 4535
Email
sadeghadel@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirhooman Kazemi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Traditional Medicine
Street address
Taleqani St., Ahmadie clinic
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8897 4535
Email
amirhoomank@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Adel Mehraban
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Taleqani St., Ahmadie Clinic
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8897 4535
Email
sadeghadel@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available