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Completed

NCT Number: NCT02314507

Gua Sha for Chronic Low Back Pain in Elderly

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.

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Key information

Conditions

Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing, The Hong Kong Polytechnic University

Kowloon, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gua sha

Other

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

Hot pack

Other

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 outcomes

  1. Pain intensity

    Time frame: Day 0 before treatment, Day 1 and day 7 after treatment

    Visual Analog Scale (VAS)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Massachusetts General Hospital

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 11, 2014
Registry last updated
Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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