Efficacy of Massage in Stroke Spasticity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vilai Kuptniratsaikul, Mahidol University
ClinicalTrials.gov Identifier:
NCT01448980
First received: October 5, 2011
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Stroke; Sequelae
Procedure: Thai Traditional Massage (TTM)
Procedure: Physical therapy program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Thai Traditional Massage in Decreasing Spasticity for Elderly With Stroke

Resource links provided by NLM:


Further study details as provided by Mahidol University:

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


Secondary Outcome Measures:
  • Modified Barthel index (BI) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Massage will be considered success if BI score increases after treatment.

  • Hospital anxiety depression score (HADS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Massage will be considered success if HADS decreases after treatment.

  • Thai Pictorial Quality of Life questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Massage will be considered if Thai pictorial QoL score increases after treatment.


Enrollment: 396
Study Start Date: May 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448980

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

No publications provided

Responsible Party: Vilai Kuptniratsaikul, Rehabilitation Medicine Department, Siriraj Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT01448980     History of Changes
Other Study ID Numbers: Si205/2011
Study First Received: October 5, 2011
Last Updated: June 5, 2014
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
massage
stroke spasticity

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

ClinicalTrials.gov processed this record on July 26, 2014