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Gua Sha for Chronic Low Back Pain in Elderly

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ClinicalTrials.gov Identifier: NCT02314507
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : March 18, 2015
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
John Yuen, The Hong Kong Polytechnic University

Study Description
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Brief Summary:
The purpose of the study is to investigate whether Gua sha is an effective modality for relieving chronic low back pain specifically in the aged population by comparing the baseline measures of pain intensity, self-perceived disability, back range of motion, back local muscle stiffness, depression, sleeping quality, quality of life, biomarkers measurement, and analgesic intake on days 1 and 7 after a single session of Gua sha treatment. In addition, the investigators are going to compare between Gua sha and hot pack treatments for the above parameters.

Condition or disease Intervention/treatment Phase
Back Pain Other: Gua sha Other: Hot pack Not Applicable

Detailed Description:
Subjects will be randomized to receive firstly either one of the treatment arms, and then crossed over to receive another arm after 30 days washing out period. It is expected that Gua sha is 1) effective in reducing the intensity of chronic low back pain in the elderly; 2) effective in helping one or more outcome measures in this study and 3) more effective on relieving the low back pain than hot pack in terms of the outcome measures in this study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Gua Sha and Hot Pack for Relieving Chronic Low Back Pain in Elderly: A Crossover Randomized Controlled Trial
Study Start Date : July 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Gua sha
Paritcipants in this group will receive a single treatment of Gua sha conducted by a well-trained nurse or Chinese practitioner
 Other: Gua sha
A smooth, rounded-edged Gua sha tool will be press-stroked into the flesh enough to contact the fascial layer start at the midline of the subject's back. A stroke line is typically 4 to 6 inches long. Press-stroking will be repeated in one direction until the petechiae raises on that stroke line, typically 8 to 12 strokes. Gua sha will then be continued at the next stroke line directly adjacent to the one before, until the area covered the lower one third of the back.
Other Name: Skin scraping
Active Comparator: Hot Pack Therapy
Participants in this group will receive a single treatment of Hot Pack conducted by a well-trained nurse or Physiotherapist
 Other: Hot pack
A hydrocollator pack will be used and it will be stored at 42-43oC in the hydrocollator. 6 layers of towel will be used to cover the hydrocollator pack when applying to the back of the subjects.


Outcome Measures
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Primary Outcome Measures :
  1. Pain intensity [ Time Frame: Day 0 before treatment, Day 1 and day 7 after treatment ]
    Visual Analog Scale (VAS)


Secondary Outcome Measures :
  1. Back range of motion [ Time Frame: Day 0 before treatment, Day 1 and day 7 after treatment ]
    By using inclinometer

  2. Biomarkers for inflammation and anti-inflammation [ Time Frame: Day 0 before treatment, day 7 after treatment ]
    Saliva specimen is collected from each subject for measuring the levels of Tumor

  3. Self-perceived disability [ Time Frame: Day 0 before treatment, Day 1 and day 7 after treatment ]
    Roland-Morris Disability Questionnaire (RMDQ)

  4. Depression level [ Time Frame: Day 0 before treatment, Day 1 and day 7 after treatment ]
    Geriatric Depression Scale (GDS)

  5. Sleeping quality [ Time Frame: Day 0 before treatment, Day 1 and day 7 after treatment ]
    Pittsburgh Sleep Quality index (PSQI)

  6. Quality of life [ Time Frame: Day 0 before treatment, day 7 after treatment ]
    Short-Form (12) Questionnaire (SF-12)

  7. Record for oral intake of NSAIDs and analgesic drugs [ Time Frame: Day 0 before treatment, day 7 after treatment ]
    Record


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 60 or above
  • Self-reported painful restriction of lumbar spine mobility for at least 3 months or self-reported low back pain on at least 5 days a week for at least 3 months
  • Have pain intensity score 40 or above on a 100mm Visual Analog Scale (VAS) at baseline

Exclusion Criteria:

  • Prior history of radiculopathy or spinal stenosis or spinal fusion or failed surgery syndrome
  • Having radiating pain below the knee
  • Received the following surgery at the region of treatment in the past 12 months laminectomy, laminotomy or discectomy
  • Serious illness (e.g. malignancy)
  • Having wounds or skin lesions at the region of treatment
  • Having blood pressure at140/90 mmHg or above at baseline
  • Having Body Mass Index (BMI) at 18.5 or lower at baseline (as calculated by the weight in kilograms divided by the square of the height in metres (kg/m2)
  • Having active psychiatric disorders, significant mood disorder or dementia
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02314507


Locations
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Hong Kong
School of Nursing, The Hong Kong Polytechnic University
Kowloon, Hong Kong
Sponsors and Collaborators
The Hong Kong Polytechnic University
Massachusetts General Hospital
Investigators
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Principal Investigator: John Yuen, PhD The Hong Kong Polytechnic University
More Information
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Responsible Party: John Yuen, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02314507    
Other Study ID Numbers: GS-001
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015
Keywords provided by John Yuen, The Hong Kong Polytechnic University:
Gua sha
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations