Efficacy of Massage in Stroke Spasticity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01448980
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : June 6, 2014
Information provided by (Responsible Party):
Vilai Kuptniratsaikul, Mahidol University

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke; Sequelae Procedure: Thai Traditional Massage (TTM) Procedure: Physical therapy program Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Thai Traditional Massage in Decreasing Spasticity for Elderly With Stroke
Study Start Date : May 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Physical therapy
The control group will receive physical therapy 2 time per week for 6 weeks
Procedure: Physical therapy program
Physical therapy program 2 times per week for 6 weeks.
Other Name: Physical therapy
Experimental: Thai Traditional Massage
The experimental group will receive Thai traditional massage program 2 times per week for 6 weeks.
Procedure: Thai Traditional Massage (TTM)
Thai Traditional Massage will receive massage 2 time per week for 6 weeks
Other Name: Thai Traditional Massage

Primary Outcome Measures :
  1. Modified Ashworth scale (MAS) [ Time Frame: 6 weeks ]
    The massage will be considered success if MAS decreased at least 1 level after treatment.

Secondary Outcome Measures :
  1. Modified Barthel index (BI) [ Time Frame: 6 weeks ]
    Massage will be considered success if BI score increases after treatment.

  2. Hospital anxiety depression score (HADS) [ Time Frame: 6 weeks ]
    Massage will be considered success if HADS decreases after treatment.

  3. Thai Pictorial Quality of Life questionnaire [ Time Frame: 6 weeks ]
    Massage will be considered if Thai pictorial QoL score increases after treatment.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01448980

Faculty of Medicine Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Principal Investigator: Vilai Kuptniratsaikul, MD Rehabilitation Medicine Department, Siriraj Hospital, Mahidol University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Vilai Kuptniratsaikul, Rehabilitation Medicine Department, Siriraj Hospital, Mahidol University Identifier: NCT01448980     History of Changes
Other Study ID Numbers: Si205/2011
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: June 6, 2014
Last Verified: June 2014

Keywords provided by Vilai Kuptniratsaikul, Mahidol University:
stroke spasticity

Additional relevant MeSH terms:
Muscle Spasticity
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms