Comparative effects of nerve mobilization and active release technique on pain range of motion and disability in carpel tunnel syndrome patients among pregnant women.
To study the comparative effects of active release technique and nerve mobilization technique on the pain, range of motion and disability in carpel tunnel syndrome patient among pregnant women
Design
Study design will be randomized clinical trial.
Settings and conduct
The study will be held at Arif memorial hospital, Lahore.
Participants/Inclusion and exclusion criteria
Pregnant females with age between 20-40 years and having numbness in hands will included in the study. while non pregnant diabetic patients or patients suffering from hypothyroidism, rheumatoid arthritis, osteoarthritis and sarcoidesis will exclude from our research.
Intervention groups
Participants will be divided in two treatment groups. Both groups will be assessed before (pre) and after (post) the treatment. Group A patients will be treated with the active release technique and conventional physical therapy treatment. Group b patient will be treated with nerve mobilization technique and conventional physical therapy treatment.
Main outcome variables
Boston questionnaire will used to assess the symptom severity and functional status in carpal tunnel syndrome patients. NPRS will be used to assess pain severity. Goniometer will be used for wrist range of motion.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221205056713N1
Registration date:2023-01-24, 1401/11/04
Registration timing:prospective
Last update:2023-01-24, 1401/11/04
Update count:0
Registration date
2023-01-24, 1401/11/04
Registrant information
Name
hafiza Nida Rasheed
Name of organization / entity
Rashid Latif Medical college, Lahore
Country
Pakistan
Phone
+92 336 4535979
Email address
naddia.rasheed20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-31, 1401/11/11
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of nerve mobilization and active release technique on pain range of motion and disability in carpel tunnel syndrome patients among pregnant women.
Public title
Effects of nerve mobilization and active release technique in treatment of carpel tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-40 years.
Pregnant women with numbness in hands
Subjects with diagnosed carpal tunnel syndrome and related symptoms that scored 3 or worse on the symptom severity and functional status questionnaire
Exclusion criteria:
If subjects have a history of causes of carpal tunnel syndrome e.g. diabetes mellitus, rheumatoid arthritis, chronic renal failure treated by hemodialysis, sarcoidesis.
If subjects have already been treated with wrist splint or have previous carpal tunnel release surgery
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
The sample size of study is 34. Participants will allocate in two treatment groups by simple random sampling using lottery method. We will make 100 chits, each with the name of a participant written on it. The chits are placed in a container of some kind, give a good shake, and 30 chits will picked. Those whose names on the chits will selected for the respective treatment.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome asesser will not know which participant will allocated in group A or group B. So study will single blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The institutional board of Rashid Latif Medical College, Lahore
Street address
35KM Ferozepur Road, Lahore.
City
Lahore
Postal code
54900
Approval date
2022-05-10, 1401/02/20
Ethics committee reference number
IRB/2022/051
Health conditions studied
1
Description of health condition studied
carpal tunnel syndrome
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome
Primary outcomes
1
Description
symptom severity and functional status
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Boston Carpal Tunnel Score questionnaire
2
Description
Pain
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Numeric pain rating scale will use to measure pain intensity
3
Description
Range of motion
Timepoint
Before treatment and 4 weeks after treatment
Method of measurement
Goniometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: nerve mobilization technique group, group A will consist of 17 patients which will randomly allocate. Patients will treat with median nerve mobilization and heating pad. The patient will be in sitting position, therapist standing by side of patient to straighten the arm extend the wrist and apply passive pressure on the fingers. Repeat this procedure three times a day (3 sets 10 rep) and two times per week for four weeks. Assessment of patient's symptom will take before and after treatment.
Category
Treatment - Other
2
Description
Intervention group: active release technique group, group B will also be included 17 patients. Patients will treated with active release technique and heating pad.The patient may sit or lie supine and therapist stand in front or the patient or at the side respectively. The therapist thumb is placed on the medial and lateral attachment of the transverse carpel ligament. As the therapist fingers wrap around the dorsal surface of the wrist. The therapist exert the tension on the carpel region ( especially the flexor retinaculum) by pressing the thumb into the volar surface of the base of the thumb and pushing the thumb apart. This position is held for 20-60 sec and then release. 3 set with 5 to 6 repetition will be performed, two times per week. The treatment will be given for 4 week. Assessment of patient's symptom will take before and after treatment.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arif memorial teaching hospital, Lahore
Full name of responsible person
Amna Batool
Street address
35-KM, Ferozepur Road. Lahore.
City
Lahore
Postal code
54900
Phone
+92 321 1185253
Email
bamna8894@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rashid Latif Medical college
Full name of responsible person
Hafiza Nida Rasheed
Street address
35-KM, Ferozepur Road. Lahore.
City
Lahore
Postal code
54900
Phone
+92 336 4535979
Email
naddia.rasheed20@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rashid Latif Medical college
Proportion provided by this source
100
Public or private sector
Private
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
Rashid Latif Medical College
Full name of responsible person
Amna Batool
Position
Physical Therapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
35-KM, Ferozepur Road. Lahore.
City
Lahore
Province
Punjab
Postal code
54900
Phone
+92 321 1185253
Email
bamna8894@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Hafiza Nida Rasheed
Position
Physical Therapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
35-KM, Ferozepur Road. Lahore
City
Lahore
Province
Punjab
Postal code
54900
Phone
+92 336 4535979
Email
naddia.rasheed20@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Hafiza Nida Rasheed
Position
Physical Therapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
35-KM, Ferozepur Road. Lahore
City
Lahore
Province
Punjab
Postal code
54900
Phone
+92 336 4535979
Email
naddia.rasheed20@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
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available