Back PainNCT02314507
Gua Sha for Chronic Low Back Pain in Elderly
A study testing Gua sha and Hot pack in people with Back Pain, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Back Pain
- What is being tested?
- Gua sha and Hot pack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteHong Kong
- Study dates
- Jul 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Nursing, The Hong Kong Polytechnic University
Kowloon
About this study
Official title: 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.
Read the 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.
- Conditions
- Back Pain
- Being tested
- Gua sha, Hot pack
- Keywords
- Gua sha
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gua shaOther
Also called Skin scraping
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Gua sha | Experimental | Paritcipants in this group will receive a single treatment of Gua sha conducted by a well-trained nurse or Chinese practitioner Receives: 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 Receives: Other: Hot pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Visual Analog Scale (VAS)
Measured: Day 0 before treatment, Day 1 and day 7 after treatment
Secondary outcomes (7)
Back range of motion
By using inclinometer
Measured: 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
Measured: Day 0 before treatment, day 7 after treatment
Self-perceived disability
Roland-Morris Disability Questionnaire (RMDQ)
Measured: Day 0 before treatment, Day 1 and day 7 after treatment
Depression level
Geriatric Depression Scale (GDS)
Measured: Day 0 before treatment, Day 1 and day 7 after treatment
Sleeping quality
Pittsburgh Sleep Quality index (PSQI)
Measured: Day 0 before treatment, Day 1 and day 7 after treatment
Quality of life
Short-Form (12) Questionnaire (SF-12)
Measured: Day 0 before treatment, day 7 after treatment
Record for oral intake of NSAIDs and analgesic drugs
Record
Measured: Day 0 before treatment, day 7 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, John Yuen, The Hong Kong Polytechnic University
- Investigators
- John Yuen, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314507
- Sponsor's protocol ID
- GS-001
- Status last verified
- Mar 2015
- First submitted
- 9 Dec 2014
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gua Sha and Hot Pack for Relieving Chronic Low Back Pain in Elderly: A Crossover Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02314507
- Acronym / sponsor ID
- GS-001
- Conditions
- Back Pain
- Keywords
- Gua sha
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gua sha | Experimental | Other: Gua shaParitcipants in this group will receive a single treatment of Gua sha conducted by a well-trained nurse or Chinese practitioner |
| Hot Pack Therapy | Active comparator | Other: Hot packParticipants in this group will receive a single treatment of Hot Pack conducted by a well-trained nurse or Physiotherapist |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gua shaAlso: Skin scrapingA 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 | Gua sha |
| Hot packA 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. | Other | Hot Pack Therapy |
Primary outcome
Pain intensity
Time frame: Day 0 before treatment, Day 1 and day 7 after treatment
Visual Analog Scale (VAS)
7 secondary outcomes
Back range of motion
Time frame: Day 0 before treatment, Day 1 and day 7 after treatment
Biomarkers for inflammation and anti-inflammation
Time frame: Day 0 before treatment, day 7 after treatment
Self-perceived disability
Time frame: Day 0 before treatment, Day 1 and day 7 after treatment
Depression level
Time frame: Day 0 before treatment, Day 1 and day 7 after treatment
Sleeping quality
Time frame: Day 0 before treatment, Day 1 and day 7 after treatment
Quality of life
Time frame: Day 0 before treatment, day 7 after treatment
Record for oral intake of NSAIDs and analgesic drugs
Time frame: Day 0 before treatment, day 7 after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Yuen, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gua sha and Hot pack in people with Back Pain, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Day 0 before treatment, Day 1 and day 7 after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015; AzTrials last refreshed its copy on 4 Nov 2026.