Determine and comparison the pain and depression scores in patients with phantom limb pain before intervention, immediately after each session, one month and six months after treatment with rTMS and compared with control group
Design
Clinical trial with control group, with parallel groups, double blind, randomized
Settings and conduct
The study is conducted in the Physical Medicine and Rehabilitation Department of Firozgar Hospital.
The researcher gives the patient a packet containing the type of treatment and the only physician is aware of the patient's placement in the intervention or control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Patients with phantom limb pain after amputation due to cancer
• Resistant to treatment with gabapentin or pregabalin dosage after one month
• Pass at least three months from the time of amputation
Exclusion criteria:
• history of seizure
• spastic lesion in the brain
• Non-symmetric nerve exam with suspicion of central lesion
• Inability to complete the pain questionnaire
• vascular stent in the heart arteries or head and neck
• metal piece in the body
Intervention groups
The intervention group receives rTMS in the Primary Motor Cortex Left region with 80% of person MEP and 1000 pulses at a frequency of 5 Hz.
In the control group uses the simulated rTMS sample without pulse.
Main outcome variables
pain score, depression score
General information
Reason for update
Acronym
RTMS
IRCT registration information
IRCT registration number:IRCT20180619040148N1
Registration date:2018-08-02, 1397/05/11
Registration timing:prospective
Last update:2018-08-02, 1397/05/11
Update count:0
Registration date
2018-08-02, 1397/05/11
Registrant information
Name
Masumeh Bagherzadeh Cham
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1612
Email address
bagherzadehcham.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of repetitive transcranial magnetic stimulation on pain control in cancer amputee patients with Phantom Limb Pain
Public title
Evaluation of RTMS on Phantom Limb Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Amputee Patients with phantom pain due to cancer
Resistant to treatment with gabapentin or pregabalin dosage after one month
Pass at least three months from the time of amputation
Exclusion criteria:
history of seizure
spastic lesion in the brain
Non-symmetric nerve exam with suspicion of central lesion
Inability to complete the pain questionnaire
vascular stent in the heart arteries or head and neck
metal piece in the body
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher provided packages containing treatment with rTMS or treatment with sham and each patient is randomly given one of them. The patient gave the envelope to the therapist and the physician uses rTMS or sham for the patient's contents in the package. Both rTMS and shame have the same shape and sound. Therefore the patient and the researcher do not know the type of patient's allocation to the test group or the control group.
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
Measurement of pain score before the intervention, immediately after each treatment session, one month and six months after the end of treatment.
Method of measurement
McGill Pain score questioner
Secondary outcomes
1
Description
depression score
Timepoint
Measurement of depression score before the intervention, immediately after each treatment session, one month and six months after the end of treatment.
Method of measurement
Beck Depression Inventory-II
Intervention groups
1
Description
Intervention group: Receiving 10 sessions' rTMS in the Primary Motor Cortex Left area using 80% MEP per person and 1000 pulses at a frequency of 5 Hz.