NCT02067312

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

February 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

4 months

First QC Date

February 17, 2014

Last Update Submit

May 5, 2015

Conditions

Myofascial Pain Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 weeks

Secondary Outcomes (9)

  • Pressure Pain Threshold as a measure by algometry

    5 weeks

  • Muscle tension on Visual analog scale

    5 weeks

  • Anxiety on State Anxiety Inventory

    5 weeks

  • Cervical range of motion as a measure by Cervical Range of Motion Goniometer

    5 weeks

  • Pain intensity on McGill Pain Questionnaire

    5 weeks

  • +4 more secondary outcomes

Study Arms (2)

Thai massage

EXPERIMENTAL

The participants will receive a thirty minutes session of Thai massage onto the trapezius muscle

Other: Thai massage

Sham Microwave diathermy

SHAM COMPARATOR

The participants will receive a thirty minutes session of Sham microwave diathermy onto the trapezius muscle

Other: Thai massage

Interventions

Thai massageOTHER
Sham Microwave diathermyThai massage

Eligibility Criteria

Age18 Years - 40 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 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Health Science, Mae Fah Luang University

Mueang, Changwat Chiang Rai, 57100, Thailand

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Medicine, Thai Traditional

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Medicine, TraditionalComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mae Fah Luang University

Study Record Dates

First Submitted

February 17, 2014

First Posted

February 20, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

May 6, 2015

Record last verified: 2015-05

Locations

TH(1)