Gua Sha for Chronic Low Back Pain in Elderly

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

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.

Study Overview

• Status: Completed
• Conditions: Back Pain
• Intervention / Treatment: Other: Gua sha; Other: Hot pack

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Kowloon, Hong Kong
    • School of Nursing, The Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: December 9, 2014
• First Submitted That Met QC Criteria: December 10, 2014
• First Posted (ESTIMATE): December 11, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): March 18, 2015
• Last Update Submitted That Met QC Criteria: March 17, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Gua sha
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: GS-001