To compare the effect of trigger point Dry needling and Thera Press tool in treating myofascial neck pain, range of motion and pain pressure threshold.
Design
two groups,single blinded randomized controlled trial
Settings and conduct
Revive Spine & Pain Relief PT Clinic
Max Rehab
Participants/Inclusion and exclusion criteria
inclusion:
1. Age 27 to 50 years
2. Both gender (Male &Females)
3. Male and females having neck pain .
4. Patients having trigger points (Active/latent) diagnosed by Simons and travell criteria
exclusion:
1. Any surgical and traumatic condition.
2. Any neurological symptom and sign (partial or complete loss of sensation, seizures, poor cognitive ability).
3. Cervical radiculopathy (inflamed/damaged nerve root due to bone spur or cervical herniated disc).
4. Any systemic disease (rheumatoid arthritis, tumors, infections).
Intervention groups
intervention group A dry needling technique
intervention group B manual pressure technique with thera press tool
Main outcome variables
Pain,Function, Range of Motion,Pain Pressure Threshold
General information
Reason for update
Acronym
DNMPTMTrPsNPRSNDIPPTLTR
IRCT registration information
IRCT registration number:IRCT20200219046547N1
Registration date:2020-06-30, 1399/04/10
Registration timing:registered_while_recruiting
Last update:2020-06-30, 1399/04/10
Update count:0
Registration date
2020-06-30, 1399/04/10
Registrant information
Name
Fatima Majeed
Name of organization / entity
Riphah international university Lahore
Country
Pakistan
Phone
+92 42 32185426
Email address
drfatimach@outlook.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-01, 1399/01/13
Expected recruitment end date
2020-09-30, 1399/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Trigger Point Dry Needling and Thera Press Tool in Myofascial Neck Pain.
Public title
Comparison of Trigger Point Dry Needling and Thera Press Tool in Myofascial Neck Pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 27 to 50 years
both genders(Male/Females)
Male and females having neck pain
Patients having trigger points (Active/Latent)diagnosed by simons and travell criteria
Exclusion criteria:
1. Any surgical and traumatic condition.
Ant neurological symptoms and sign(partial or complete loss of sensation,seizures,poor cognitive ability.
Cervical radiculopathy (inflamed/damaged nerve root due to bone spur or cervical herniated disc)
Any systemic disease (rheumatoid arthritis, tumors, infections).
Age
From 27 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
written informed consent will be taken .After enrollment into study, the subjects will be divided into subgroups called blocks, then subjects within each block will randomly assigned into treatment group A or group B by block randomization method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome Assessor will be blinded by labeling the participants with different codes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Secretary ethical review committee, Riphah College of Rehabilitation and Allied health Sciences
Street address
28-M, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore.
City
Lahore
Postal code
54000
Approval date
2020-02-08, 1398/11/19
Ethics committee reference number
1033
Health conditions studied
1
Description of health condition studied
myofascial Neck pain
ICD-10 code
M54.2
ICD-10 code description
Myofascial pain syndrome of Neck/cervicalgia
Primary outcomes
1
Description
Pain
Timepoint
baseline, after 3rd treatment session and after 6th treatment session
Method of measurement
Numeric Pain Rating Scale
2
Description
range of motion
Timepoint
baseline, after 3rd treatment session and after 6th treatment session
Method of measurement
Goniometer
Secondary outcomes
1
Description
function
Timepoint
baseline, after 3rd treatment session and after 6th treatment session
Method of measurement
Neck disability index
2
Description
pain pressure thershold
Timepoint
baseline, after 3rd treatment session and after 6th treatment session
Method of measurement
Algometer
Intervention groups
1
Description
Intervention group: group A dry needling
Category
Treatment - Other
2
Description
Intervention group: group B manual pressure technique with thera press tool
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Revive Spine & Pain Relief PT Clinic
Full name of responsible person
Fatima Majeed
Street address
4C,GCP Shoukat Khanum Society Lahore
City
Lahore
Postal code
54000
Phone
+92 42 32184747
Email
Drfatimach@outlook.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Street address
28-M,Quaid-e Azam, Industrial Estate Kot Lakhpat, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Grant name
Educational
Grant code / Reference number
1033
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
Proportion provided by this source
15
Public or private sector
Public
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
Riphah international university Lahore
Full name of responsible person
Fatima Majeed
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
house No 264 F2 phase 1 wapda town Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 32185426
Email
Drfatimach@outlook.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Fatima Majeed
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House No 264 F2 phase 1 wapda town Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 32184747
Email
Drfatimach@outlook.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Fatima Majeed
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House No 264 F2 phase 1 wapda town Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 32185426
Email
Drfatimach@outlook.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