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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02029391
Other study ID # 201304048RINB
Secondary ID
Status Completed
Phase N/A
First received January 6, 2014
Last updated January 7, 2014
Start date October 2013
Est. completion date December 2013

Study information

Verified date January 2014
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Ministry of Health and Welfare
Study type Interventional

Clinical Trial Summary

Musculoskeletal dysfunction is considered as a major public health problem affecting about one third of the adult population. Myofascial pain syndrome (MPS) characterized by myofacial trigger points as well as fascia tenderness are thought to be the main cause of musculoskeletal dysfunction. The aim of the treatment for musculoskeletal dysfunction is to reduce pain and restore normal function. Clinically, some evidence supports the application of kinesio tape in these patients. The underlying mechanism, however, is not clear. The investigators goal was to validate proposed mechanism of kinesio tape in these patients. The primary outcome are muscle stiffness, pain intensity and sensitivity.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date December 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

- age between 20 and 60 years

- shoulder or neck pain corresponding with the area covered by the upper trapezius muscle

- Trigger point (taut band) in the upper trapezius muscle

Exclusion Criteria:

- diagnosis of fibromyalgia syndrome

- having undergone myofascial therapy within the past month before the study

- history of cervical spine or shoulder surgery

- previous history of a whiplash injury;

- diagnosis of cervical radiculopathy or myelopathy;

- taking medicine that might change the pain intensity or pain threshold, such as analgesics, sedatives, substance abuse (including alcohol, narcotics);

- a cognitive impairment that would prevent them from being able to understand and/or participate fully in the intervention or the measures.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Other:
Manual pressure release
Therapist applied non-painful pressure with slowly increase over the myofascial trigger point until he felts a tissue resistance barrier.
Kinesio tape
Kinesio tape was adhered from insertion to origin of the upper trapezius muscle

Locations

Country Name City State
Taiwan Institute of Physical Therapy, National Taiwan University Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle stiffness baseline, immediate after intervention and at week 1 Yes
Secondary Visual analog scale (VAS) baseline, immediate after intervention and at week 1 Yes
Secondary Pressure pain threshold baseline, immediate after intervention and at week 1 Yes
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