Comparisons of the effects of Baclofen, Transcutaneous Electrical Nerve Stimulation and sustain stretch for the treatment of spasticity in the traumatic spinal cord injury
1. To compare the effect of baclofen, TENS & sustain stretch for spasticity management in spinal cord injury.
2. To determine the Range of Motion of ankle joint
Design
Randomized Clinical Trail
Settings and conduct
Paraplagic Centre Peshawar.
single blinded
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Spasticity (Grade ≥1 and ≤4 as per MAS)
2. Have sustained a traumatic spinal cord injury a Minimum of 3 months before consent.
3. Age = 20 - 45 years
Exclusion criteria:
1. Have chronic systemic diseases and have any other serious co-morbidity, e.g. hepatitis C, infections and Deep vein thrombosis etc.
2. Have extensive fixed contractures in the lower limbs
3. Have any contraindications to Baclofen, TENS and sustain stretch such as experience clinically significant orthostatic Hypo-tension in response to electrical stimulation or allergies or Have a history of bone fracture or family history of fragility fractures
Intervention groups
1. Group (I) (oral anti-spasticity drug treatment group):
2. Group (II) (TENS treatment group):
3. Group (III) (Sustain stretch treatment group):
Main outcome variables
Spasticity
General information
Reason for update
Acronym
Spasticity Management in Spinal Cord Injury (SMSCI)
IRCT registration information
IRCT registration number:IRCT20210615051585N1
Registration date:2021-07-01, 1400/04/10
Registration timing:retrospective
Last update:2021-07-01, 1400/04/10
Update count:0
Registration date
2021-07-01, 1400/04/10
Registrant information
Name
Saima Gul
Name of organization / entity
Shifa Tameer - e - Millat University
Country
Pakistan
Phone
+92 51 8441751
Email address
saimagul.ahs@stmu.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-12, 1399/12/22
Expected recruitment end date
2021-06-15, 1400/03/25
Actual recruitment start date
2021-03-12, 1399/12/22
Actual recruitment end date
2021-06-09, 1400/03/19
Trial completion date
2021-06-09, 1400/03/19
Scientific title
Comparisons of the effects of Baclofen, Transcutaneous Electrical Nerve Stimulation and sustain stretch for the treatment of spasticity in the traumatic spinal cord injury
Public title
Comparisons of the effects of Baclofen, Transcutaneous Electrical Nerve Stimulation and sustain stretch for the treatment of spasticity in the traumatic spinal cord injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Spasticity (Grade ≥1 and ≤4 as per MAS)
2. Have sustained a traumatic spinal cord injury a Minimum of 3 months before consent
3. Age = 20 - 45 years
Exclusion criteria:
1. Have chronic systemic diseases and have any other serious co-morbidity, e.g. hepatitis C, infections and Deep vein thrombosis etc.
2. Have extensive fixed contractures in the lower limb
3. Have any contraindications to Baclofen, TENS and sustain stretch such as experience clinically significant orthostatic Hypo-tension in response to electrical stimulation or allergies or Have a history of bone fracture or family history of fragility fractures
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
127
Actual sample size reached:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment for traetment
Blinding (investigator's opinion)
Single blinded
Blinding description
Only the researcher doing the study knows which treatment or intervention the participant is receiving. It makes results less likely to be biased.
Placebo
Not used
Assignment
Other
Other design features
N/A
Secondary Ids
1
Registry name
N/A
Secondary trial Id
N/A
Registration date
2021-06-09, 1400/03/19
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board and Ethics Committee (IRB and EC) Shifa International Hospital and Shifa
Street address
Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University