Evaluation the effectiveness and comparing of True and Sham Thread Embedding in acupoints on Spasticity in Multiple Sclerosis
Design
A concealed, block randomized, double-blinded, 3rd phase of sham controlled clinical trial with a parallel group design of 38 patients
Settings and conduct
Patients referred to the neurology clinic of Mashhad Qaem Hospital, suffering from RRMS in the recovery phase, according to the inclusion criteria and the approval of the MS fellowship, are referred to the acupuncture clinic of Imam Reza hospital. After signing the informed consent form, first evaluations are performed. In addition to the routine neurological treatment, the participants are placed in two groups and 30 acupoints are intervented. In True Embedding intervention group, after disinfection, 2cm PDO threads are embedded in the acupoints by a 20 gauge needle. In the Sham control group, the needle is inserted in the same points for blinding, but the thread is not embedded in the tissue. To prevent infection, cephalexin and to control pain, cold compress or Ibuprofen are prescribed. After 4 and 12 weeks, the outcomes are evaluated.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Definite diagnosis of MS; EDSS<7; Age>18; Resistant spasticity; Signing informed consent. Non-Inclusion Criteria: Receiving acupuncture in the last 6 months; Relapse or changing maintenance treatment in the last 2 months; Severe chronic systemic disease, cancers and coagulopathy; Sensitivity to Cephalosporins or thread; Pregnancy, Breastfeeding or uncertain contraception
Intervention groups
Intervention group: True Embedding of Polydioxanone Threads in 30 Acupoints. Sham control group: Needling in 30 Acupoints Without inserting Threads
Main outcome variables
Disability, Spasm, Walking quality, Daily life activities, Pain, Fatigue, Sleep, Urinary symptoms, Depression, Anxiety and Quality of life score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121228011912N8
Registration date:2024-03-22, 1403/01/03
Registration timing:prospective
Last update:2024-03-22, 1403/01/03
Update count:2
Registration date
2024-03-22, 1403/01/03
Registrant information
Name
Hamidreza Bahrami Taghanaki
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1841 5666
Email address
bahramihr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-08-21, 1403/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of True and Sham Thread Embedding Acupuncture on Spasticity in Multiple Sclerosis Patients
Public title
Effect of Thread Embedding Acupuncture on Spasticity of M.S
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of MS based on McDonald's 2017 criteria by a neurologist
EDSS<7
Moderate to severe spasticity reported by the patient as NRS score≥4 with poor response to usual antispasmodics
Willingness to participate in the study and sign informed consent
Not taking anticoagulants
No history of any coagulopathy
No history of acupuncture in the last 6 months
No history of relapse phase in the last 2 months
No change in maintenance treatments during the last 2 months
No history of sensivity to cephalosporins
No history of sensivity to each components of the thread
No history of incurable chronic systemic diseases and cancers
Not being pregnant or breastfeeding and using a safe contraceptive method
Exclusion criteria:
Imbalance to continue cooperation with the study
Incidence of sensivity reaction to the embedded thread
Incidence of resistant bleeding requires medicinal intervention
Incidence of the relapse phase requires receiving a medicinal pulse
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Using the online site www.sealedenvelope.com, random allocation is done in two groups A (intervention) and group B (control). Block Randomization will be done with block sizes of 4 and 6 for random allocation. The prepared blocks will be placed inside the envelope. One of the envelopes will be randomly selected according to the order of patients' arrival, and patients will be assigned to groups.
Allocation concealment is done using sealed opaque envelopes. By one of the team members, random numbers will be prepared and placed inside the envelope. The envelopes will be closed and their contents will not be visible from the outside.
First, the purpose of the study is explained to the person with entry requirement critrias. Then, the person signs the informed consent form and takes an envelope, opens it and entered into one of the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the intervention group is True embedding group and the Sham group is designed as a control group, and the participants are thus blinded.
The statistical analyst evaluates the information based on group A and B and is blinded to which group is belongs to A or B.
Placebo
Used
Assignment
Parallel
Other design features
The control group in acupuncture studies is called sham. Embedding studies are limited and the use of sham is not common in them. In this study, the sham is designed in such a way that all the embedding steps are performed, but the thread is not placed in the body tissue.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghoreyshi complex, University Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2024-03-09, 1402/12/19
Ethics committee reference number
IR.MUMS.REC.1402.345
Health conditions studied
1
Description of health condition studied
Multiple sclerosis (M.S)
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Disability Status Score
Timepoint
Before intervention and 4 and 12 weeks after intervention
Method of measurement
Expanded Disability Status Scale (EDSS)
2
Description
Spasticity Score
Timepoint
Before intervention and 4 and 12 weeks after intervention
Method of measurement
Numerical Rating Scale (NRS)
3
Description
Quality of Walking Score
Timepoint
Before intervention and 4 and 12 weeks after intervention
Method of measurement
Multiple Sclerosis Walking Scale-12 (MSWS-12)
4
Description
Activities of Daily Living (ADL) Score
Timepoint
Before intervention and 4 and 12 weeks after intervention
Method of measurement
Barthel Index
5
Description
Pain Score
Timepoint
Before intervention and 4 and 12 weeks after intervention
Method of measurement
McGill pain questionnaire
Secondary outcomes
1
Description
Fatigue Score
Timepoint
Before intervention and 4 and 12 weeks after intervention