To evaluate the effects of instrument-assisted soft tissue mobilization on trigger points of the cervical and lumbar region among sedentary individuals
Design
The research will use a prospective randomized control trial as a study design. a study design in which participants are randomly assigned to either an experimental or control group. A hypothesis may be tested to see which variables are most likely to be significant explanatory factors.
Settings and conduct
Data will be collected from department of Physical and Rehabilitative Medicine of Memon Medical Institute Hospital Karachi
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
• 18 – 40 years of age male and female both
• Cervical and lumbar pain more than 6 months
• Pain intensity of at least 3 in the numeric pain scale
Exclusion Criteria:
• Any type of trauma related to pain area
• Acute Fractures
• Tuberculosis of spine
• Who has history of whiplash injury
• History of head, neck, cervical spinal surgery
• History of cervical radiculopathy
• Diagnosed fibromyalgia and myopathy
• History of cancer in relevant area
• Myofascial therapy within the past month
• Who has taking any medicine for psychiatric disorder
Intervention groups
Intervention group: 25 participants will be received instrument-assisted soft tissue mobilization treatment technique using ergon tool. Along with ergon technique conventional treatment including hot pack 15 minutes, strengthening exercises of all weak cervical and lumbar muscles with 10-12 repetitions of each muscle would be performed. Stretching exercises of all tight cervical and lumbar muscles 3-6 repetition with 10 seconds hold
Control Group: 25 participants will be received only conventional treatment same as included in intervention group
Effects of Instrument-Assisted Soft Tissue Mobilization (IASTM) on trigger points of the cervical and lumbar region among sedentary individuals
Public title
Effects of Instrument-Assisted Soft Tissue Mobilization (IASTM) on trigger points versus manual Exercises
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 40 years are included
Who having cervical and lumbar pain more than 6 months
Patients diagnosed with at least active trigger points in cervical & lumbar region
Patients having pain intensity of at least 3 in the numeric pain scale
Exclusion criteria:
If the pain is related to any trauma or fracture
Patients with tuberculosis of spine
Patients with any types of wounds
History of infections or any other cause of back pain not due to muscles spasm or trigger point
If the patients have a history of whiplash injury
If the patients have history of head, neck and cervical spinal surgery
If the patients have a history of cervical radiculopathy
If the patients have diagnosed with fibromyalgia and myopathy
If the patients have history of cancer at relevant area of body
If the patients get the myofascial physical therapy treatment within the past one month
If the patients are taking any anti-psychotic medicine
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be used in this study. This method is used to ensure a balance in sample size across groups over time. Blocks are small and balanced with predetermined group assignments, which keeps the number of participants in each group similar at all times. The block size is determined with 2 treatment groups, a block size of 4. After block size has been determined, all possible balanced combinations of assignment within the block (ie, an equal number for all groups within the block) will be calculated. Blocks are then randomly chosen to determine the participants' assignment into the groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board Memon Medical Institute Hospital
Street address
Safoora Goth Scheme 33
City
Karachi
Postal code
75270
Approval date
2022-07-14, 1401/04/23
Ethics committee reference number
IRB/MMIH/2022/03
Health conditions studied
1
Description of health condition studied
To treat the myofascial trigger points in cervical and lumbar region
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Instrumental versus manual exercises for trigger point release
Timepoint
The outcomes will be measured at the baseline and re-measured after the 18 sessions. The intervention protocol is based on three sessions per week for six weeks.
Method of measurement
Outcome will measure by numeric pain rating scale, neck disability index, pain sensitivity questionnaire and modified somatic perception questionnaire
Secondary outcomes
1
Description
Muscle power
Timepoint
Before and after 18 session of treatment
Method of measurement
Manual muscle power test
2
Description
To check range of motion before and after intervention
Timepoint
Before and after 18 session of treatment
Method of measurement
Range of motion will be check by inclinometer
3
Description
To check pain scale before an after the interventions
Timepoint
Before and after 18 session of treatment
Method of measurement
Pain will be check by numeric pain scale
Intervention groups
1
Description
Twenty five participants will be received instrument-assisted soft tissue mobilization treatment technique using ergon tool. The position of patients will be in prone lying. With the help of ergon tool, we give strokes (sweeping motion) proximal to distal or distal to proximal in both ways over the myofascial restrictions for 10 minutes. Along with ergon technique conventional treatment including hot pack 15 minutes, strengthening exercises of all weak cervical and lumbar muscles with 10-12 repetitions of each muscle would be performed. Stretching exercises of all tight cervical and lumbar muscles 3-6 repetition with 10 seconds hold. Every patient undergoes 45 minutes’ treatment session, 3 sessions/ week for 6 weeks. Assessment will be performed at baseline and at the end of 6th week treatment protocol.
Category
Rehabilitation
2
Description
Twenty five participants will be received only conventional treatment including hot pack therapy for 15 minutes. Strengthening exercises of all weak cervical and lumbar muscles with 10-12 repetitions of each muscle would be performed. Stretching exercises of all tight cervical and lumbar muscles, 3-6 repetitions with 10 seconds hold. Every patient undergoes 45 minutes’ treatment session, 3 sessions/ week for 6 weeks. Assessment will be performed at baseline and at the end of 6th week treatment protocol.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Memon Medical Institute Hospital
Full name of responsible person
Dr. Mohabbat Ali
Street address
Safoora Goth
City
Karachi
Postal code
75270
Phone
+92 21 99261810
Fax
+92 21 34691193
Email
ramal_209@yahoo.com
Web page address
https://mmi.edu.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Memon College of Physical and Rehasbilitaive Medicine
Full name of responsible person
Dr. Mohabbat Ali Principal of MCPRM
Street address
Safoora
City
Karachi
Postal code
75270
Phone
+92 300 2294869
Fax
+92 21 34691193
Email
info.mcprm@mhef.edu.pk
Web page address
https://phy.mmi.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Memon College of Physical and Rehasbilitaive Medicine
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
Memon Medical Institute Hospital
Full name of responsible person
Dr. Mohabbat Ali
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Safoora goth
City
Karachi
Province
Sindh
Postal code
75270
Phone
+92 21 99261810
Fax
+92 21 34861193
Email
ramal_209@yahoo.com
Web page address
https://mmi.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Memon Medical Institute Hospital
Full name of responsible person
Dr. Mohabbat Ali
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Safoora
City
Karachi
Province
Sindh
Postal code
75270
Phone
+92 21 99261810
Fax
+92 21 34861193
Email
ramal_209@yahoo.com
Web page address
https://mmi.edu.pk/
Person responsible for updating data
Contact
Name of organization / entity
Memon Medical Institute Hospital
Full name of responsible person
Dr. Mohabbat Ali
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Safoora
City
Karachi
Province
Sindh
Postal code
75270
Phone
+92 21 99261810
Fax
+92 21 34861193
Email
ramal_209@yahoo.com
Web page address
https://mmi.edu.pk/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
analytical data will be avail in published article or can be request by email to get the data