NCT01168180

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 14, 2012

Status Verified

June 1, 2011

Enrollment Period

1.4 years

First QC Date

July 19, 2010

Last Update Submit

August 13, 2012

Conditions

Keywords

Traditional Thai MassageScapulocostal Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 months

Secondary Outcomes (5)

  • Pressure Pain Threshold

    4 months

  • Muscle tension (Visual analog scale)

    4 months

  • State Anxiety Inventory

    4 months

  • patient satisfaction

    3 weeks

  • Side effects

    3 weeks

Study Arms (2)

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

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

Other: Ultrasound therapy and hot pack

Interventions

The participants will receive thirty minutes session of traditional Thai massage onto the scapular region for 9 sessions over a period of 3 weeks

Traditional Thai massage
Ultrasound therapy and hot pack

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • A history of the following diseases or disorders:
  • Rotator cuff disease
  • Cervical radiculopathy
  • Degenerative shoulder joint disease
  • Shoulder stiffness
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Associated Medical Sciences, Khon Kaen University

Muang, Changwat Khon Kaen, 40002, Thailand

Location

School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University

Muang, Changwat Khon Kaen, 40002, Thailand

Location

MeSH Terms

Interventions

Medicine, Thai TraditionalUltrasonic Therapy

Intervention Hierarchy (Ancestors)

Medicine, TraditionalComplementary TherapiesTherapeuticsDiathermyHyperthermia, Induced

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2010

First Posted

July 23, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

August 14, 2012

Record last verified: 2011-06

Locations