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Gua Sha for Chronic Low Back Pain in Elderly

Primary Purpose

Back Pain

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Gua sha
Hot pack
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain focused on measuring Gua sha

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School of Nursing, The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gua sha

Hot Pack Therapy

Arm Description

Paritcipants in this group will receive a single treatment of Gua sha conducted by a well-trained nurse or Chinese practitioner

Participants in this group will receive a single treatment of Hot Pack conducted by a well-trained nurse or Physiotherapist

Outcomes

Primary Outcome Measures

Pain intensity
Visual Analog Scale (VAS)

Secondary Outcome Measures

Back range of motion
By using inclinometer
Biomarkers for inflammation and anti-inflammation
Saliva specimen is collected from each subject for measuring the levels of Tumor
Self-perceived disability
Roland-Morris Disability Questionnaire (RMDQ)
Depression level
Geriatric Depression Scale (GDS)
Sleeping quality
Pittsburgh Sleep Quality index (PSQI)
Quality of life
Short-Form (12) Questionnaire (SF-12)
Record for oral intake of NSAIDs and analgesic drugs
Record

Full Information

First Posted
December 9, 2014
Last Updated
March 17, 2015
Sponsor
The Hong Kong Polytechnic University
Collaborators
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02314507
Brief Title
Gua Sha for Chronic Low Back Pain in Elderly
Official Title
Effects of Gua Sha and Hot Pack for Relieving Chronic Low Back Pain in Elderly: A Crossover Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
Gua sha

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gua sha
Arm Type
Experimental
Arm Description
Paritcipants in this group will receive a single treatment of Gua sha conducted by a well-trained nurse or Chinese practitioner
Arm Title
Hot Pack Therapy
Arm Type
Active Comparator
Arm Description
Participants in this group will receive a single treatment of Hot Pack conducted by a well-trained nurse or Physiotherapist
Intervention Type
Other
Intervention Name(s)
Gua sha
Other Intervention Name(s)
Skin scraping
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Hot pack
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity
Description
Visual Analog Scale (VAS)
Time Frame
Day 0 before treatment, Day 1 and day 7 after treatment
Secondary Outcome Measure Information:
Title
Back range of motion
Description
By using inclinometer
Time Frame
Day 0 before treatment, Day 1 and day 7 after treatment
Title
Biomarkers for inflammation and anti-inflammation
Description
Saliva specimen is collected from each subject for measuring the levels of Tumor
Time Frame
Day 0 before treatment, day 7 after treatment
Title
Self-perceived disability
Description
Roland-Morris Disability Questionnaire (RMDQ)
Time Frame
Day 0 before treatment, Day 1 and day 7 after treatment
Title
Depression level
Description
Geriatric Depression Scale (GDS)
Time Frame
Day 0 before treatment, Day 1 and day 7 after treatment
Title
Sleeping quality
Description
Pittsburgh Sleep Quality index (PSQI)
Time Frame
Day 0 before treatment, Day 1 and day 7 after treatment
Title
Quality of life
Description
Short-Form (12) Questionnaire (SF-12)
Time Frame
Day 0 before treatment, day 7 after treatment
Title
Record for oral intake of NSAIDs and analgesic drugs
Description
Record
Time Frame
Day 0 before treatment, day 7 after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Yuen, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Nursing, The Hong Kong Polytechnic University
City
Kowloon
Country
Hong Kong

12. IPD Sharing Statement

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Gua Sha for Chronic Low Back Pain in Elderly

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