NCT02314507

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

5 months

First QC Date

December 9, 2014

Last Update Submit

March 17, 2015

Conditions

Back Pain

Keywords

Gua sha

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Visual Analog Scale (VAS)

    Day 0 before treatment, Day 1 and day 7 after treatment

Secondary Outcomes (7)

  • Back range of motion

    Day 0 before treatment, Day 1 and day 7 after treatment

  • Biomarkers for inflammation and anti-inflammation

    Day 0 before treatment, day 7 after treatment

  • Self-perceived disability

    Day 0 before treatment, Day 1 and day 7 after treatment

  • Depression level

    Day 0 before treatment, Day 1 and day 7 after treatment

  • Sleeping quality

    Day 0 before treatment, Day 1 and day 7 after treatment

  • +2 more secondary outcomes

Study Arms (2)

Gua sha

EXPERIMENTAL

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

Other: Gua sha

Hot Pack Therapy

ACTIVE COMPARATOR

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

Other: Hot pack

Interventions

Gua shaOTHER

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.

Also known as: Skin scraping
Gua sha
Hot packOTHER

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.

Hot Pack Therapy

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic University

Kowloon, Hong Kong

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John Yuen, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 9, 2014

First Posted

December 11, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

HK(1)