To determine the effectiveness of low level laser therapy for treatment of cervical pain in patients with trigger point of upper trapezius muscle.
Design
Single Blind , parallel , Randomized Controlled Trial
Settings and conduct
This Randomized Controlled Trial ,Double Blind ,Parallel study will be conducted at University of Lahore Teaching Hospital
Participants/Inclusion and exclusion criteria
Inclusion : Patients diagnosed with active upper trapezius trigger point.
•Both Male and female
•Age ranges from 18 to 55
Exclusion : Participants having contraindications for LASER e.g. Pregnancy, Tumors, Implants, Pacemaker,
•Past History of fracture of shoulder joint or cervical spine
•Whiplash injury
•Comorbid medical diagnosis e.g. osteoarthritis
•Psychiatric illness (e.g., schizophrenia or substance abuse)
•Irritable skin around the area of treatment
Intervention groups
Patients of group-A will receive conventional physical therapy along with low level laser therapy ( LLLT with Omega Class IIIB Laser therapy unit with pen probe.)
While patients of group B, will receive conventional physical therapy only.
Main outcome variables
Neck pain , Neck Range of Motion and Neck Disability Indexes
General information
Reason for update
Acronym
Cervical pain Trigger points Upper trapezius Neck Pain Neck Range of Motion Neck Disability Index Low Level Laser Therapy
IRCT registration information
IRCT registration number:IRCT20210409050912N1
Registration date:2021-08-29, 1400/06/07
Registration timing:registered_while_recruiting
Last update:2021-08-29, 1400/06/07
Update count:0
Registration date
2021-08-29, 1400/06/07
Registrant information
Name
Iqra Waseem
Name of organization / entity
Faisal Institute of Health Sciences
Country
Pakistan
Phone
+92 41 8818334
Email address
iqra.waseem91@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-28, 1400/05/06
Expected recruitment end date
2021-12-25, 1400/10/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Low Level Laser Therapy for treatment of cervical pain in patients with trigger points of upper trapezius
Public title
Low Level Laser Therapy for treatment of cervical pain in patients with trigger points of upper trapezius
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed patients with active upper trapezius trigger point
Age range from 18-55 years
Male and Females
Exclusion criteria:
Participants having contraindications for LASER e.g. Pregnancy, Tumors, Implants, Pacemaker,
Irritable skin around the area of treatment
Past History of fracture of shoulder joint or cervical spine
Whiplash injury
Comorbid medical diagnosis e.g. osteoarthritis Psychiatric illness (e.g., schizophrenia or substance abuse).
Psychiatric illness (e.g., schizophrenia or substance abuse).
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly allocated by use of computer-generated randomization sheet into two groups
One for Group A and other for B.
2 Sets of 27 Unique Numbers per Set
Range: From 1 to 54
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor will be blind and will assess the subjects for inclusion criteria and will make assessment at the baseline ,then after 2 weeks and than after 4 weeks . Then outcome assessor will give all the recorded data to the principal investigator
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The University of Lahore
Street address
Lahore
City
Lahore
Postal code
38000
Approval date
2020-03-07, 1398/12/17
Ethics committee reference number
IRB-UOL-FAHS/718-IX/2020
Health conditions studied
1
Description of health condition studied
Upper Trapezius Trigger Points
ICD-10 code
Y93
ICD-10 code description
Trigger Points , Neck pain, neck ROM , Neck Functioning
Primary outcomes
1
Description
Neck pain
Timepoint
It will be assessed three times ,First at Baseline , Second after 02 weeks of treatment and third and last at the end of 04 weeks of treatment .
Method of measurement
Numeric Pain Rating Score- The numerical pain rating scale is considered as one of the best method available for the estimation of the intensity of pain. The NPRS is a categorical scale which provides a continuous scale for magnitude estimation of pain. NPRS consists of 11 points, which range from 0-10.0=no pain, 1-4=mild pain, 4-7=moderate pain 7-10=severe pain.
Secondary outcomes
1
Description
Neck Range of Motion.
Timepoint
First it will be assessed three times at Baseline , then after 02 weeks and at the end of 04 weeks of treatment .
Method of measurement
Universal Goniometer will used for measurement of Range of Motions of neck in all sides .
2
Description
Neck disability Index
Timepoint
First it will be assessed three times at Baseline , then after 02 weeks and at the end of 04 weeks of treatment.
Method of measurement
Neck Disability Index- The Neck Disability Index (NDI) is a 10-item questionnaire that measures a patient's self-reported neck pain related disability. It is a questionnaire which measures the functional ability of the patient. It is of subjective nature i.e. patient fills the questionnaire himself by ranking his ability to do some specific task. It includes assessment of 10 tasks including personal care, pain, reading, headaches, lifting, concentration, driving, work, sleeping and recreation. Patient ranks questions according to the limitations he faces in ADLs and IADLs. NDI is most commonly used questionnaire for neck pain.
Intervention groups
1
Description
Experimental Group (Intervention group: One group will receive low-level laser therapy. Patient position: Patient comfortably will be seated on chair with arm rest and avoided unnecessary stretching of neck and shoulder muscles. Both physiotherapist and patient will wear protective googles. After identification of trigger point, trigger point will be marked with erasable marker than the treatment will be provided by the following parameters: Wavelength 820nm, Power 200mW, Pulse Rate 2.5Hz Energy Transferring 24 Jcm-2 for 15 sec and with pen probe.
Category
Rehabilitation
2
Description
Control group: Control group: Standard Chartered Society of Physiotherapy recommendations for neck pain will be followed. Moving head downwards to tuck in your chin on your chest and maintain this position for 5 seconds. Moving head backward and upward by pushing your chin forward so that throat is stretched and maintain this position for five seconds. All this protocol will be followed.
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data document will be available on demand if any of the researcher want to use like data evaluation Performa and outcome assessment sheets.
When the data will become available and for how long
The data will be available after compilation and statistical analysis of the study.
To whom data/document is available
Researchers
Under which criteria data/document could be used
For sake of help and research promotion .
From where data/document is obtainable
from principal Investigator
What processes are involved for a request to access data/document
The email is provided for this purpose .
Comments
This trial is purely based for study purpose .It has not involved any third party and any funding except educational support from the relative institute .