Efficacy of Massage in Stroke Spasticity

Stroke; Sequelae Clinical Trial

Official title:

The Efficacy of Thai Traditional Massage in Decreasing Spasticity for Elderly With Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448980
• Other study ID #: Si205/2011
• Status: Completed
• Phase: Phase 3
• First received: October 5, 2011
• Last updated: June 5, 2014
• Start date: May 2012
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

Stroke is one of the common diseases in the elderly. It is the third ranking cause of death and affects health care system in our country. One of the most important consequences of stroke is spasticity. Some stroke patients suffered from severe spasticity or hypersensitive reflex to stimuli. It can cause contracture, limit self care function, transfer or ambulation. Most of stroke patients have to depend on their relatives or families.

Description:

Thai traditional massage is one of the popular alternative medicine in Thailand. Lots of stroke patients who suffered from spasticity sought treatment. To the investigators knowledge, there is no study concerning efficacy of massage in decreasing spasticity for stroke patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Stroke with onset of >=6 months

• Age >=50 years

• Spasticity grade of knee flexor or elbow flexor was 2-3 classified by Modified Ashworth scale (MAS)

• Ability to follow command and communicable

Exclusion Criteria:

• Having contraindications for massage including fever > 38 degree, uncontrolled blood pressure, bleeding tendency, on anticoagulant drug, having ulcer or healing fracture of limbs, contamination skin disease, severe osteoporosis

• Serious contact diseases, for example AIDS, TB

• History of malignancy

• Fixed joint contracture at elbow or knee of paralyzed limb

• History of botulinum toxin injection or Phenol/Alcohol nerve block within 3 months

• Previous history of TTM

• Severe dementia or uncontrolled psychiatric problems

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Spasticity
• Stroke
• Stroke; Sequelae

Intervention

Procedure:
• Thai Traditional Massage (TTM)
Thai Traditional Massage will receive massage 2 time per week for 6 weeks
• Physical therapy program
Physical therapy program 2 times per week for 6 weeks.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Ashworth scale (MAS)	The massage will be considered success if MAS decreased at least 1 level after treatment.	6 weeks	Yes
Secondary	Modified Barthel index (BI)	Massage will be considered success if BI score increases after treatment.	6 weeks	No
Secondary	Hospital anxiety depression score (HADS)	Massage will be considered success if HADS decreases after treatment.	6 weeks	No
Secondary	Thai Pictorial Quality of Life questionnaire	Massage will be considered if Thai pictorial QoL score increases after treatment.	6 weeks	No