Protocol summary

Study aim
To compare the pain intensity, neck range of motion, muscle length, neck disability, and frequency of pain symptoms between Radial Extracorporeal Shockwave Therapy and High-Intensity Laser Therapy in patients with Myofascial Pain Syndrome of the Upper Trapezius muscle.
Design
Randomised control trial with blind participants and outcome assessors
Settings and conduct
This study will be conducted in a laboratory setting, and a schedule will be established to allocate separate times for each group.
Participants/Inclusion and exclusion criteria
Inclusion criteria -Aged between 18-24 years -Diagnosed with Myofascial pain syndrome of the Upper trapezius muscle -Duration of pain is equal to or more than 3 months -Severity of pain is equal to or more than 3 out of 10 Exclusion criteria -Use of medication -History of cancer -Wound in the area requiring treatment -Patient with a pacemaker -Pregnant -Diagnosed by a physician with a mental disorder -Vigorous exercise or physical activity -Experienced trauma in the neck area affecting the function
Intervention groups
This study will be divided into 3 groups. Participants in the Shockwave group will receive 2,000 shocks, consisting of 1,000 shocks at 1.5 bars with a frequency of 15 Hz at trigger points, and 1,000 shocks at 2 bars with a frequency of 8 Hz around the trigger point, with treatments conducted once a week. Participants in the High-intensity Power Laser group will be treated with lasers of wavelengths 810 nm and 980 nm, at a power of 7 watts, also once a week. Participants in the Control group, as well as those in all other groups, will perform stretching exercises daily and record data in a log book. The total duration of treatment for all groups is 4 weeks.
Main outcome variables
- Pain symptoms at the Upper trapezius muscle - Muscle length of the Upper trapezius muscle - Neck range of motion - Neck function - Frequency of pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240207060929N1
Registration date: 2024-02-26, 1402/12/07
Registration timing: prospective

Last update: 2024-02-26, 1402/12/07
Update count: 0
Registration date
2024-02-26, 1402/12/07
Registrant information
Name
Kanruethai Threesittidath
Name of organization / entity
Walailak University
Country
Thailand
Phone
+66 75 672 645
Email address
kanruethai.si@wu.ac.th
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-01, 1402/12/11
Expected recruitment end date
2024-06-30, 1403/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Radial Extracorporeal Shockwave Therapy Versus High Intensity Laser Therapy in Patients With Myofascial Pain Syndrome of Upper Trapezius Muscle
Public title
Comparison of the Effectiveness of Radial Extracorporeal Shockwave Therapy Versus High Intensity Laser Therapy in Patients With Myofascial Pain Syndrome of Upper Trapezius Muscle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A student aged between 18-24 years Diagnosed with Myofascial pain syndrome of the Upper trapezius muscle Duration of pain is equal to or more than 3 months Severity of pain during the day is equal to or more than 3 out of 10 (pain scale ≥ 3/10)
Exclusion criteria:
Use of medication such as anti-coagulants, pain relievers, and anti-inflammatories History of cancer Current infection or wound in the area requiring treatment Patient with a pacemaker History of easy bleeding Pregnant Diagnosed by a physician with a mental disorder such as depression Vigorous exercise or physical activity Experienced trauma in the neck area affecting the function of the upper trapezius muscle, such as wounds, fractures, or whiplash injuries Currently undergoing treatment for pain in the upper trapezius muscle area
Age
From 18 years old to 24 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 69
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified Randomization with matched pairs of variables, including age, gender, and BMI. Subsequently, computer software is employed as the tool for randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
This study employs a double-blind method for both participants and outcome assessors. Once participants are randomized into groups, they are scheduled for treatment sessions at different times for each group. Furthermore, the outcome assessor, who is a physiotherapist unaware of the participant's group allocation, conducts baseline and post-treatment measurements. Another physiotherapist, who is responsible for overseeing the study, performs participant randomization into groups and administers the interventions.
Placebo
Used
Assignment
Parallel
Other design features
The sample size was determined using G*Power. The means and standard deviations were derived from a previous study, with the values being Mean±SD = 6.56 ± 2.06 and 6.46 ± 1.84, respectively. The calculated effect size was 0.46, resulting in a total of 58 participants, with an additional allowance for a 15% dropout rate. Consequently, the total number of participants in this study amounted to 69 (comprising 23 participants per group).

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee in Human Research Walailak University
Street address
222 Thaiburi
City
Thasala
Postal code
80160
Approval date
2024-01-12, 1402/10/22
Ethics committee reference number
WUEC-24-016-01

Health conditions studied

1

Description of health condition studied
Myofascial pain syndrome at Upper trapezius muscle
ICD-10 code
M79
ICD-10 code description
Other and unspecified soft tissue disorders, not elsewhere classified

Primary outcomes

1

Description
Pain symptoms at upper trapezius muscle
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Pain symptoms will be assessed using a Pressure Algometer, with participants indicating their level of pain on the Visual Analog Scale (VAS).

2

Description
Muscle length of the Upper trapezius muscle
Timepoint
Before intervention and 1, 2, 3, 4 weeks after intervention
Method of measurement
Muscle length will be measured using tape measurement, with assessment points located between the Spinous process of C7 and the Distal end of the acromion process. This measurement will be taken during neck flexion combined with lateral flexion to the opposite side and rotation to the same side.

3

Description
Range of motion of the neck
Timepoint
Before intervention and 1, 2, 3, 4 weeks after intervention
Method of measurement
Measurements will be conducted using a cervical range of motion device. The starting position will be seated in a chair. From this position, the degree of neck flexion, neck extension, lateral flexion of the neck, and neck rotation will be measured.

4

Description
Neck function
Timepoint
Before intervention and 1, 2, 3, 4 weeks after intervention
Method of measurement
The Neck Disability Index (NDI) comprises 10 questions covering the following areas: Pain Intensity, Personal Care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleep, and Recreation. Each question offers six choices, with scores ranging from 0 to 5. A score of 0 indicates no pain or interference with activity, while a score of 5 signifies very severe pain or extreme disruption, to the point of being unable to perform the activity. The total possible score for the NDI assessment ranges from 0 to 50 points.

5

Description
Frequency of pain
Timepoint
Before intervention and 1, 2, 3, 4 weeks after intervention
Method of measurement
A questionnaire will be utilized to investigate the frequency of pain.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Participants in the Shockwave group will receive 2,000 shocks, consisting of 1,000 shocks at 1.5 bars with a frequency of 15 Hz at trigger points, and 1,000 shocks at 2 bars with a frequency of 8 Hz around the trigger point, with treatments conducted once a week. The total duration of treatment for all groups is 4 weeks.
Category
Treatment - Devices

2

Description
Intervention group 2: Participants in the High-intensity Power Laser group will be treated with lasers of wavelengths 810 nm and 980 nm, at a power of 7 watts, also once a week. The total duration of treatment for all groups is 4 weeks.
Category
Treatment - Devices

3

Description
Control group: Participants in the Control group, as well as those in all other groups, will perform stretching exercises daily and record data in a log book. The total duration of treatment for all groups is 4 weeks.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Walailak university
Full name of responsible person
Kanruethai Threesittidath
Street address
222 Thaiburi
City
Thasala
Postal code
80160
Phone
+66 88 280 5955
Email
kanruethai.si@wu.ac.th

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Walailak university
Full name of responsible person
School of Allied Health Science
Street address
222 Thaiburi
City
Thasala
Postal code
80160
Phone
+66 75 672 602
Email
cdt@mail.wu.ac.th
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
No funding
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
Walailak University
Full name of responsible person
Sirinthip Pakdee
Position
Assistance Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
222 Thaiburi
City
Thasala
Province
Nakhon Si Thammarat
Postal code
80160
Phone
+66 75 672 611
Email
Sirinthip.pa@wu.ac.th

Person responsible for scientific inquiries

Contact
Name of organization / entity
Walailak University
Full name of responsible person
Kanruethai Threesittidath
Position
Assistance Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
222 Thaiburi
City
Thasala
Province
Nakhon Si Thammarat
Postal code
80160
Phone
66756702645
Email
kanruethai.si@wu.ac.th

Person responsible for updating data

Contact
Name of organization / entity
Walailak university
Full name of responsible person
Kanruethai Threesittidath
Position
Assistance Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
222 Thaiburi
City
Thasala
Province
Nakhon Si Thammarat
Postal code
80160
Phone
66756702645
Email
kanruethai.si@wu.ac.th

Sharing plan

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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data will be collected for the primary outcome measure only and all collected de-identified.
When the data will become available and for how long
Personal information of research project participants will be kept confidential and will not be publicly disclosed individually. A consolidated report will be generated, and all documents will be starting in March 2024 and securely destroyed by January 2028.
To whom data/document is available
The personal data of research participants will be collected on encrypted computers inaccessible to individuals not involved in the study. The researcher will anonymize information for academic purposes.
Under which criteria data/document could be used
The personal data of research participants will be collected on encrypted computers inaccessible to individuals not involved in the study. The researchers will analyze the results using the SPSS program, which is an offline application.
From where data/document is obtainable
Researchers will communicate with participants via telephone. Postal or email addresses, website URLs, and fax numbers are not required for this study. Data files will be treated as confidential and will not be disclosed publicly on an individual basis. A consolidated report will be produced, and all documents will be securely destroyed by January 2028.
What processes are involved for a request to access data/document
The data supporting the findings of this study are available from the corresponding author upon reasonable request. However, access will be provided only for the primary outcome measure and data that cannot be personally identified.
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