Scapulocostal SyndromeNCT01168180
Traditional Thai Massage and Scapulocostal Syndrome
A study testing Traditional Thai massage and Ultrasound therapy and hot pack in people with Scapulocostal Syndrome, run by Khon Kaen University at 2 sites in Thailand.
Trial summary
The purpose of this study is to evaluate the efficacy of traditional Thai massage on pain intensity, pressure pain threshold, muscle tension, anxiety, cervical range of motion, patient satisfaction and side effects in the treatment of scapulocostal syndrome. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Scapulocostal Syndrome
- What is being tested?
- Traditional Thai massage and Ultrasound therapy and hot pack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesThailand
- Study dates
- Jul 2010to Dec 2011
- 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
- Male or female
- Age between 18 - 50 years old
- The participants have experienced spontaneous scapular pain (VAS ≥ 3) for longer than 12 weeks (chronic) and that at least one trigger point will be present in the scapular region (serratus posterior superior, rhomboid groups, levator scapulae and 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
- A history of the following diseases or disorders:
- Rotator cuff disease
- Cervical radiculopathy
- Degenerative shoulder joint disease
- Shoulder stiffness
- Contraindications of traditional Thai massage
Show all 12Show fewer
- Contagious skin disease
- Injury or inflammation of muscle
- Bone fracture and/or joint dislocation
- Open wound
- Uncontrolled hypertension
- Drug and/or alcohol intoxication
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Faculty of Associated Medical Sciences, Khon Kaen University
Muang, Changwat Khon Kaen, 40002
School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University
Muang, Changwat Khon Kaen, 40002
About this study
Official title: Efficacy of Traditional Thai Massage on Patients With Scapulocostal Syndrome
The purpose of this study is to evaluate the efficacy of traditional Thai massage on pain intensity, pressure pain threshold, muscle tension, anxiety, cervical range of motion, patient satisfaction and side effects in the treatment of scapulocostal syndrome.
- Conditions
- Scapulocostal Syndrome
- Being tested
- Traditional Thai massage, Ultrasound therapy and hot pack
- Keywords
- Traditional Thai Massage, Scapulocostal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Thai massageOther
The participants will receive thirty minutes session of traditional Thai massage onto the scapular region for 9 sessions over a period of 3 weeks
Ultrasound therapy and hot packOther
| Study group | Role | What they receive |
|---|---|---|
| Traditional Thai massage | Experimental | The participants will receive thirty minutes session of traditional Thai massage onto the scapular region for 9 sessions over a period of 3 weeks Receives: Other: Traditional Thai massage |
| Ultrasound therapy and hot pack | Active comparator | The participants will receive thirty minutes session of Ultrasound therapy and hot pack for 9 sessions over a period of 3 weeks Receives: Other: Ultrasound therapy and hot pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (Visual analog scale)
The intensity of pain will be reported by the participant on a numerical analog scale ranging from 0 to 10. Zero indicates no pain anywhere and 10 indicates the most pain ever experienced.
Measured: 4 months
Secondary outcomes (5)
Pressure Pain Threshold
Measured: 4 months
Muscle tension (Visual analog scale)
Measured: 4 months
State Anxiety Inventory
Measured: 4 months
patient satisfaction
Measured: 3 weeks
Side effects
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scapulocostal 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168180
- Sponsor's protocol ID
- 527090004-4
- Status last verified
- Jun 2011
- First submitted
- 19 Jul 2010
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Traditional Thai Massage on Patients With Scapulocostal Syndrome
- ClinicalTrials.gov ID
- NCT01168180
- Acronym / sponsor ID
- 527090004-4
- Conditions
- Scapulocostal Syndrome
- Keywords
- Traditional Thai Massage, Scapulocostal Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Jul 2010 (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 evaluate the efficacy of traditional Thai massage on pain intensity, pressure pain threshold, muscle tension, anxiety, cervical range of motion, patient satisfaction and side effects in the treatment of scapulocostal syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Thai massage | Experimental | Other: Traditional Thai massageThe participants will receive thirty minutes session of traditional Thai massage onto the scapular region for 9 sessions over a period of 3 weeks |
| Ultrasound therapy and hot pack | Active comparator | Other: Ultrasound therapy and hot packThe participants will receive thirty minutes session of Ultrasound therapy and hot pack for 9 sessions over a period of 3 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female
- Age between 18 - 50 years old
- The participants have experienced spontaneous scapular pain (VAS ≥ 3) for longer than 12 weeks (chronic) and that at least one trigger point will be present in the scapular region (serratus posterior superior, rhomboid groups, levator scapulae and 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 (12 listed)
- A history of the following diseases or disorders:
- Contraindications of traditional Thai massage
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 |
|---|---|---|
| Traditional Thai massageThe participants will receive thirty minutes session of traditional Thai massage onto the scapular region for 9 sessions over a period of 3 weeks | Other | Traditional Thai massage |
| Ultrasound therapy and hot pack | Other | Ultrasound therapy and hot pack |
Primary outcome
Pain intensity (Visual analog scale)
Time frame: 4 months
The intensity of pain will be reported by the participant on a numerical analog scale ranging from 0 to 10. Zero indicates no pain anywhere and 10 indicates the most pain ever experienced.
5 secondary outcomes
Pressure Pain Threshold
Time frame: 4 months
Muscle tension (Visual analog scale)
Time frame: 4 months
State Anxiety Inventory
Time frame: 4 months
patient satisfaction
Time frame: 3 weeks
Side effects
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Thai massage and Ultrasound therapy and hot pack in people with Scapulocostal Syndrome, run by Khon Kaen University at 2 sites in Thailand.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 14 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (Visual analog scale) (time frame: 4 months). 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 14 Aug 2012.