Gua Sha for Chronic Low Back Pain in Elderly

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Gua Sha and Hot Pack for Relieving Chronic Low Back Pain in Elderly: A Crossover Randomized Controlled Trial

Conditions
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Back Pain

Intervention / Treatment
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* Other: Gua sha
* Other: Hot pack


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gua sha<br>Paritcipants in this group will receive a single treatment of Gua sha conducted by a well-trained nurse or Chinese practitioner | Other: Gua sha<br>* 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.<br>* Other names: Skin scraping;|
| Active Comparator: Hot Pack Therapy<br>Participants in this group will receive a single treatment of Hot Pack conducted by a well-trained nurse or Physiotherapist | Other: Hot pack<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Visual Analog Scale (VAS) | Day 0 before treatment, Day 1 and day 7 after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back range of motion | By using inclinometer | Day 0 before treatment, Day 1 and day 7 after treatment | 
| Biomarkers for inflammation and anti-inflammation | Saliva specimen is collected from each subject for measuring the levels of Tumor | Day 0 before treatment, day 7 after treatment | 
| Self-perceived disability | Roland-Morris Disability Questionnaire (RMDQ) | Day 0 before treatment, Day 1 and day 7 after treatment | 
| Depression level | Geriatric Depression Scale (GDS) | Day 0 before treatment, Day 1 and day 7 after treatment | 
| Sleeping quality | Pittsburgh Sleep Quality index (PSQI) | Day 0 before treatment, Day 1 and day 7 after treatment | 
| Quality of life | Short-Form (12) Questionnaire (SF-12) | Day 0 before treatment, day 7 after treatment | 
| Record for oral intake of NSAIDs and analgesic drugs | Record | Day 0 before treatment, day 7 after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gua sha