Gua Sha for Chronic Low Back Pain in Elderly

Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314507
• Other study ID #: GS-001
• Status: Completed
• Phase: N/A
• First received: December 9, 2014
• Last updated: March 17, 2015
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	School of Nursing, The Hong Kong Polytechnic University	Kowloon

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Massachusetts General Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Visual Analog Scale (VAS)	Day 0 before treatment, Day 1 and day 7 after treatment	No
Secondary	Back range of motion	By using inclinometer	Day 0 before treatment, Day 1 and day 7 after treatment	No
Secondary	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	No
Secondary	Self-perceived disability	Roland-Morris Disability Questionnaire (RMDQ)	Day 0 before treatment, Day 1 and day 7 after treatment	No
Secondary	Depression level	Geriatric Depression Scale (GDS)	Day 0 before treatment, Day 1 and day 7 after treatment	No
Secondary	Sleeping quality	Pittsburgh Sleep Quality index (PSQI)	Day 0 before treatment, Day 1 and day 7 after treatment	No
Secondary	Quality of life	Short-Form (12) Questionnaire (SF-12)	Day 0 before treatment, day 7 after treatment	No
Secondary	Record for oral intake of NSAIDs and analgesic drugs	Record	Day 0 before treatment, day 7 after treatment	No