To find out whether graston or laser, comparative or combined helps in speedy recovery of MTrPs of upper Trapezius
To change in quality of life of participants after treatment
Design
Pragmatic, parallel group, single blind, randomized clinical trial
Settings and conduct
The trial is conducted in Allied hospital, Faisalabad and Al- Nawab physiotherapy clinic, Faisalabad. Subjects are chosen according to inclusion criteria. They are asked for their consent to involve them in clinical trial. Subjects are blinded as they don't know about their treatment protocol and group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Females aged 18 to 50 years old with bilateral myofascial pain syndrome of the upper trapezius muscle. According to Simon’s diagnostic criteria five major and one minor sign of myofascial fascial pain syndrome was diagnosed in participants.
Complaint of pain from at least 8 weeks
Pain score between 30mm to 80mm on VAS
Neck extension range up to 30 degrees
Neck right and left side flexion range up to 20 degrees
NDI score between 10 and 24
Exclusion criteria:
Neck or shoulder pain that has lasted less than 8 weeks
Within the previous three months, local injectable physiotherapy.
Infection
Febrile state
Cervical radiculopathy symptoms
Hypertension that has not been treated
Coagulatory disease or anticoagulant therapy
Injury to the cervical spine or surgery
Implants and metal devices
Intervention groups
3 intervention groups has been made; Group A is the graston therapy group, Group B is the Laser therapy group and groups C is the graston and laser therapy group (it will be given both therapies in combination).
Main outcome variables
Pain
Neck disability index score
Cervical extension range of motion
Cervical right lateral flexion range of motion
Cervical left lateral flexion range of motion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210809052129N1
Registration date:2021-10-08, 1400/07/16
Registration timing:registered_while_recruiting
Last update:2021-10-08, 1400/07/16
Update count:0
Registration date
2021-10-08, 1400/07/16
Registrant information
Name
Saba Iqbal
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 2646649
Email address
sabaiqbal71263@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-05, 1400/04/14
Expected recruitment end date
2021-10-30, 1400/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effectiveness of laser therapy and graston technique on trigger points of upper trapezius
Public title
Comparison between the effectiveness of laser therapy and graston technique on trigger points of upper trapezius
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Females aged 18 to 50 years old with bilateral myofascial pain syndrome of the upper trapezius muscle.
As stated by Simon’s diagnostic criteria, following sings should be present: Five majors: 1. Pain in a region 2. Pain referring to another area 3. A tight muscle band 4. A tender/painful location in the tight muscle band 5. Limited ROM.
One minor: 1. Pain that can be regenerated by applying pressure on the location of the tender area 2. A local twitch response in the affected area 3. With prolonged neck and/or shoulder region pain, pain relief that can be achieved with injection or stretching.
Complaint of pain from at least 8 weeks.
Pain score between 30mm to 80mm on VAS.
Neck extension range up to 30 degrees.
Neck right and left side flexion range up to 20 degrees.
NDI score between 10 and 24
Exclusion criteria:
Neck or shoulder pain that has lasted less than 8 weeks
Within the previous three months, local injectable physiotherapy
Infection
Febrile state
Cervical radiculopathy symptoms
Hypertension that has not been treated
Coagulatory disease or anticoagulant therapy
Injury to the cervical spine or surgery
Implants and metal devices
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Care provider
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Lottery method was used for subject randomization in groups. Groups names were written on papers and were folded. After that subjects were asked to pick one paper. The groups were allotted to the subjects and then treatment was started.
Blinding (investigator's opinion)
Single blinded
Blinding description
There were three treatment groups in this study. No control group. Groups were allocated to the subjects by the investigator after lottery method but the subjects weren't told which group they belong to. The measurements taken from the participants on questionnaires were also not shown to the participants.
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
Sargodha Rd, University Town, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Approval date
2021-06-14, 1400/03/24
Ethics committee reference number
TUF/DR/MSPP/299
Health conditions studied
1
Description of health condition studied
Myofascial pain syndrome
ICD-10 code
MG30.01
ICD-10 code description
Chronic widespread pain
Primary outcomes
1
Description
Pain
Timepoint
before intervention and after 2nd, 5th intervention session and then after 5 days of 5th session
Method of measurement
Pain measurement by visual analogue scale.
2
Description
Neck disability Index
Timepoint
before intervention and after 2nd, 5th intervention session and then after 5 days of 5th session
Method of measurement
Neck functioning measurement by neck disability index.
Secondary outcomes
1
Description
(1) Cervical extension ROM.
Timepoint
before intervention and after 2nd, 5th intervention session and then after 5 days of 5th session
Method of measurement
Ranges of motion are measured by goniometry.
2
Description
Cervical right lateral flexion ROM.
Timepoint
before intervention and after 2nd, 5th intervention session and then after 5 days of 5th session
Method of measurement
Ranges of motion are measured by goniometry.
3
Description
Cervical left lateral flexion ROM
Timepoint
before intervention and after 2nd, 5th intervention session and then after 5 days of 5th session
Method of measurement
Ranges of motion are measured by goniometry.
Intervention groups
1
Description
Intervention group 1: Graston therapy. Graston tool is used for 1 minute sweeping of upper trapezius, 2 minute swiveling and fanning of Trps then 1 minute swiveling of upper trapezius. After that stretching of muscle with 30 seconds hold in 3 repetitions.
Category
Treatment - Devices
2
Description
Intervention group 2: Laser therapy. GaAIAs semiconductor laser is used with 808nm wavelength. Myofascial trigger points are marked by drawing an X on them over the skin. With gentle pressure, the laser device is positioned perpendicular to the area of skin to be irradiated and moved in a circular pattern. Each trigger point is irradiated for 60 seconds. After that stretching of muscle with 30 seconds hold in 3 repetitions.
Category
Treatment - Devices
3
Description
Intervention group 3: Graston and laser therapy. GaAIAs semiconductor laser is used with 808nm wavelength. Myofascial trigger points are marked by drawing an X on them over the skin. With gentle pressure, the laser device is positioned perpendicular to the area of skin to be irradiated and moved in a circular pattern. Each trigger point is irradiated for 60 seconds. After that graston tool is used for 1 minute sweeping of upper trapezius, 2 minute swiveling and fanning of Trps then 1 minute swiveling of upper trapezius. After that stretching of muscle with 30 seconds hold in 3 repetitions.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Allied Hospital
Full name of responsible person
Saba Iqbal
Street address
Allied hospital, Dr. Tusi Rd, Faisalabad, Punjab
City
Faisalabad
Postal code
38800
Phone
+92 41 9210082
Email
info@pmc.edu.pk
2
Recruitment center
Name of recruitment center
Al-Nawab physiotherapy clinic
Full name of responsible person
Saba Iqbal
Street address
Al-Nawab physiotherapy clinic, Jail Road Street 1 near Sabqa Board Office Islam Nagar Muhalla, Faisalabad, Punjab
City
Faisalabad
Postal code
37401
Phone
+92 41 2646649
Email
alnawabphysiotherapyclinic@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr. Sidra Majeed, PT
Street address
Sargodha Road, University Town, Faisalabad, Punjab 38000
City
Faisalabad
Postal code
38000
Phone
+92 41 8868326
Email
info@tuf.edu.pk
Web page address
https://www.tuf.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Self financed
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
The University of Faisalabad
Full name of responsible person
Saba Iqbal
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
p# 41, Jail Road Street 1 near Sabqa Board Office Islam Nagar Muhalla, Faisalabad, Punjab
City
Faisalabad
Province
Punjab
Postal code
37401
Phone
+92 41 2646649
Email
sabaiqbal71263@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Saba Iqbal
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Jail road, muhalla Islam nagar, St#1, near sabqa board office, Faisalabad, Pakistan
City
Faisalabad
Province
Punjab
Postal code
37401
Phone
+92 41 2646649
Fax
Email
sabaiqbal71263@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Saba Iqbal
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
p# 41, Jail Road Street 1 near Sabqa Board Office Islam Nagar Muhalla, Faisalabad, Punjab
City
Faisalabad
Province
Punjab
Postal code
37401
Phone
+92 41 2646649
Email
sabaiqbal71263@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available