Effects of Traditional Thai Massage on Pain and Pain Related Parameters in Patients With Upper Back Pain
Primary Purpose
Myofascial Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Thai massage
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pain Syndrome
Eligibility Criteria
Inclusion Criteria:
- Male or female
- Age between 18 - 50 years old
- The participants have experienced spontaneous upper pain for longer than 12 weeks (chronic) and that at least one trigger point will be present in the s trapezius muscles. Trigger points will be diagnosed as the presence of focal tenderness in a taut band and with pain recognition.
- The participants will be able to follow instructions.
- Good communication and cooperation.
Exclusion Criteria:
- A history of the following diseases or disorders:
- Cervical radiculopathy
- Contraindications of traditional Thai massage
- Contagious skin disease
- Injury or inflammation of muscle
- Bone fracture and/or joint dislocation
- Open wound
- Uncontrolled hypertension
- Drug and/or alcohol intoxication
Sites / Locations
- School of Health Science, Mae Fah Luang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Thai massage
Sham Microwave diathermy
Arm Description
The participants will receive a thirty minutes session of Thai massage onto the trapezius muscle
The participants will receive a thirty minutes session of Sham microwave diathermy onto the trapezius muscle
Outcomes
Primary Outcome Measures
Pain score on Visual analog scale
The intensity of pain will be reported by the participant on a visual analog scale ranging from 0 to 10. Zero indicates no pain anywhere and 10 indicates the most pain ever experienced.
Secondary Outcome Measures
Pressure Pain Threshold as a measure by algometry
Muscle tension on Visual analog scale
Anxiety on State Anxiety Inventory
Cervical range of motion as a measure by Cervical Range of Motion Goniometer
Pain intensity on McGill Pain Questionnaire
Pain frequency occurred per week
24 hours pain intensity on Visual analog scale
Patient satisfaction level
Number of Participants with Adverse Events
Full Information
NCT ID
NCT02067312
First Posted
February 17, 2014
Last Updated
May 5, 2015
Sponsor
Mae Fah Luang University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02067312
Brief Title
Effects of Traditional Thai Massage on Pain and Pain Related Parameters in Patients With Upper Back Pain
Official Title
Effects of Traditional Thai Massage on Pain and Pain Related Parameters in Patients With Upper Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mae Fah Luang University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the effect of Thai massage on pain related parameters including Pain intensity, 24 hours pain intensity, Pressure pain threshold, anxiety, muscle tension, cervical range of motion, pain frequency, patient satisfaction and side effect in patients with chronic upper back pain associated with myofascial trigger points
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thai massage
Arm Type
Experimental
Arm Description
The participants will receive a thirty minutes session of Thai massage onto the trapezius muscle
Arm Title
Sham Microwave diathermy
Arm Type
Sham Comparator
Arm Description
The participants will receive a thirty minutes session of Sham microwave diathermy onto the trapezius muscle
Intervention Type
Other
Intervention Name(s)
Thai massage
Primary Outcome Measure Information:
Title
Pain score on Visual analog scale
Description
The intensity of pain will be reported by the participant on a visual analog scale ranging from 0 to 10. Zero indicates no pain anywhere and 10 indicates the most pain ever experienced.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Pressure Pain Threshold as a measure by algometry
Time Frame
5 weeks
Title
Muscle tension on Visual analog scale
Time Frame
5 weeks
Title
Anxiety on State Anxiety Inventory
Time Frame
5 weeks
Title
Cervical range of motion as a measure by Cervical Range of Motion Goniometer
Time Frame
5 weeks
Title
Pain intensity on McGill Pain Questionnaire
Time Frame
5 weeks
Title
Pain frequency occurred per week
Time Frame
5 weeks
Title
24 hours pain intensity on Visual analog scale
Time Frame
5 weeks
Title
Patient satisfaction level
Time Frame
3 weeks
Title
Number of Participants with Adverse Events
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female
Age between 18 - 50 years old
The participants have experienced spontaneous upper pain for longer than 12 weeks (chronic) and that at least one trigger point will be present in the s trapezius muscles. Trigger points will be diagnosed as the presence of focal tenderness in a taut band and with pain recognition.
The participants will be able to follow instructions.
Good communication and cooperation.
Exclusion Criteria:
A history of the following diseases or disorders:
Cervical radiculopathy
Contraindications of traditional Thai massage
Contagious skin disease
Injury or inflammation of muscle
Bone fracture and/or joint dislocation
Open wound
Uncontrolled hypertension
Drug and/or alcohol intoxication
Facility Information:
Facility Name
School of Health Science, Mae Fah Luang University
City
Mueang
State/Province
Chiang Rai
ZIP/Postal Code
57100
Country
Thailand
12. IPD Sharing Statement
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Effects of Traditional Thai Massage on Pain and Pain Related Parameters in Patients With Upper Back Pain
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