Myofascial Pain SyndromeNCT02437292
Effect of Ischemic Compression With Stretching on Patients With Upper Back Pain
A study testing Ischemic compression with stretching in people with Myofascial Pain Syndrome, run by Mae Fah Luang University Hospital.
Trial summary
The purpose of this study is to determine the effect of ischemic compression with stretching on pain related parameters including pain intensity, pressure pain threshold, anxiety, cervical range of motion and patient satisfaction in patients with scapular pain associated with myofascial trigger point. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- Ischemic compression with stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The participants have experienced spontaneous upper back 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.
Who cannot join
- Fibromyalgia syndrome
- Cervical radiculopathy or myelopathy)
- Cervical spine surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Ischemic Compression With Stretching on Pain Related Parameters in Patients With Upper Back Pain Associated With Myofascial Trigger Point
The purpose of this study is to determine the effect of ischemic compression with stretching on pain related parameters including pain intensity, pressure pain threshold, anxiety, cervical range of motion and patient satisfaction in patients with scapular pain associated with myofascial trigger point.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- Ischemic compression with stretching
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic compression with stretchingOther
| Study group | Role | What they receive |
|---|---|---|
| Ischemic compression with stretching | Experimental | The participants will receive the ischemic compression with stretching onto the trapezius muscle Receives: Other: Ischemic compression with stretching |
| Control | No intervention | Rest on the bed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 weeks
Secondary outcomes (4)
Pressure Pain Threshold as a measure by pressure algometry
Measured: 5 weeks
Anxiety on State Anxiety Inventory
Measured: 5 weeks
Cervical range of motion
Measured: 5 weeks
Patient satisfaction level
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mae Fah Luang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Vitsarut Buttagat, Mae Fah Luang University Hospital
- Investigators
- VITSARUT BUTTAGAT, Ph.D., Principal investigator, Mae Fah Luang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437292
- Sponsor's protocol ID
- 55218152-6
- Status last verified
- May 2015
- First submitted
- 5 May 2015
- Last updated
- 7 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ischemic Compression With Stretching on Pain Related Parameters in Patients With Upper Back Pain Associated With Myofascial Trigger Point
- ClinicalTrials.gov ID
- NCT02437292
- Acronym / sponsor ID
- 55218152-6
- Conditions
- Myofascial Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mae Fah Luang University HospitalUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 7 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of ischemic compression with stretching on pain related parameters including pain intensity, pressure pain threshold, anxiety, cervical range of motion and patient satisfaction in patients with scapular pain associated with myofascial trigger point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic compression with stretching | Experimental | Other: Ischemic compression with stretchingThe participants will receive the ischemic compression with stretching onto the trapezius muscle |
| Control | No intervention | –Rest on the bed |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The participants have experienced spontaneous upper back 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.
Key exclusion criteria (3 listed)
- Fibromyalgia syndrome
- Cervical radiculopathy or myelopathy)
- Cervical spine surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ischemic compression with stretching | Other | Ischemic compression with stretching |
Primary outcome
Pain score on Visual analog scale
Time frame: 5 weeks
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
4 secondary outcomes
Pressure Pain Threshold as a measure by pressure algometry
Time frame: 5 weeks
Anxiety on State Anxiety Inventory
Time frame: 5 weeks
Cervical range of motion
Time frame: 5 weeks
Patient satisfaction level
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VITSARUT BUTTAGAT, Ph.D. principal investigator
Mae Fah Luang University
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic compression with stretching in people with Myofascial Pain Syndrome, run by Mae Fah Luang University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact VITSARUT BUTTAGAT, Ph.D. (66882674423, vitsarutbut@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score on Visual analog scale (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2015.