The aim of the study is to evaluate the safety and efficacy of carpal bone mobilization and median nerve mobilization in the treatment of carpal tunnel syndrome patient.
Design
randomized clinical trial with parallel randomized control and treatment, single blinded groups, trial on 30 patients. randomization will be done using lottery method.
Settings and conduct
In different medical hospital of Faisalabad. consecutively enroll 5-10 eligible patients who meet the eligibility criteria and sign the informed consent by themselves or their guardians. four hospital District Head Quarter Hospital Faisalabad, Medina teaching hospital Faisalabad, Chinot hospital Faisalabad ,Faisal hospital Faisalabad.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Included all patients with mild and moderate CTS.Positive phalen’s test and Tinel sign .EXclusion Criteria:Excluded a patient with Any congenital deformity.People with any kind of systematic diseases i.e. Rheumatoid Arthritis.
Intervention groups
Patients allocated to group A were given carpal bone mobilization 3 times a week with hot pack and exercises. Furthermore, patients in the group B received median nerve mobilization 3 times a week plus exercises and hot pack.
Main outcome variables
Boston Carpal Tunnel Syndrome Questionnaire(BCTQ) to measure symptom severity and function status of carpal tunnel syndrome patient. visual analogues scale(VAS) to measure pain carpal tunnel syndrome patient
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220617055202N1
Registration date:2022-07-27, 1401/05/05
Registration timing:retrospective
Last update:2022-07-27, 1401/05/05
Update count:0
Registration date
2022-07-27, 1401/05/05
Registrant information
Name
Dr Attia Noreen
Name of organization / entity
The university Of faisalabad
Country
Pakistan
Phone
+92 333 6564583
Email address
attia.latif@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-20, 1400/12/29
Expected recruitment end date
2022-03-28, 1401/01/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparative effects of carpal bone mobilization and median nerve mobilization in the treatment of patient with carpal tunnel syndrome
Public title
carpal bone mobilization and median nerve mobilization in the treatment of patient with carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed cases of carpal tunnel syndrome according to positive Hoffman Tinel sign and phalen’s maneuver.
Exclusion criteria:
Diagnosis cases of Cervical radiculopathy
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
randomize patients at a 1:1 ratio to receive either carpal bone mobilization or median nerve mobilization. randomization will be done using lottery method. the study is single blinded and the trial monitor throughout by the data monitoring committee. Sealed enevolp will made upon which allocation of participants of both groups can be possible without biasnes.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this single blinded study, patients who received the carpal bone mobilization or median nerve mobilization blinded to the study groups (carpal bone mobilization or median nerve mobilization) Similar labeling will be used for the carpal bone mobilization or median nerve mobilization and the researchers will be aware of the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of the University of Faisalabad
Street address
Samundari road
City
Faisalabad
Postal code
52250
Approval date
2022-03-13, 1400/12/22
Ethics committee reference number
1021
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
Pain
Timepoint
Total 4 weeks of intervention period in which every week 3 sessions and assessment of pain before and after every session.
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Symptom severity
Timepoint
Total 4 weeks of intervention period in which every week 3 sessions and assessment of symptom severity before and after every session.
Method of measurement
Boston carpal tunnel syndrome questionnaire
Intervention groups
1
Description
Intervention 1:patients allocated to group A, were given carpal bone mobilization 10 repetition 3 second hold per day one session for 5 mint in clinic for 4 weeks.3 session per week. visual analogue scale recording pain pre and post of every session. patient also receive hot pack and payer stretch, extension stretch, flexion stretch.
Category
Rehabilitation
2
Description
Intervention group: patients allocated to group B, this group receive median nerve mobilization 10 repetition 3 second hold per day one session for 5 mint in clinic for 4 weeks.3 session per week. visual analogue scale recording pain pre and post of every session. patient also receive hot pack and payer stretch, extension stretch, flexion stretch.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
District Head Quarter Hospital Faisalabad
Full name of responsible person
Dr shasita bino
Street address
Sumadri road
City
Faisalabad
Postal code
52250
Phone
+92 333 6564583
Email
attia.latif233@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr zermain zernish
Street address
Sumadri road
City
Faisalabad
Postal code
52250
Phone
+92 333 6564583
Email
attia.latif233@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Faisalabad
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
PK
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr zermain zernish
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy p
Street address
Samundari road
City
Faisalabad
Province
Punjab
Postal code
52250
Phone
+92 333 6564583
Email
attia.latif233@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr zermain zernish
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Samundari
City
Faisalabad
Province
Punjab
Postal code
52250
Phone
+92 333 6564583
Email
attia.latif233@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Latif Medicare Hospital
Full name of responsible person
Dr Attia Noreen
Position
Clinical physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Samundari road
City
Faisalabad
Province
Punjab
Postal code
52250
Phone
+92 333 6564583
Email
attia.latif233@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
IPD collect for primary and secondary outcomes measures.
When the data will become available and for how long
Jan 2023
To whom data/document is available
People working in any domain can be authorized to get this data
Under which criteria data/document could be used
For research purpose and meta analysis studies
From where data/document is obtainable
This data is only available on demand via email mention to the person responsible
What processes are involved for a request to access data/document
Document can also be processed via University e-mail
mspp-fa20-018@tuf.edu.pk