Low Back Pain, MechanicalNCT03610204
Pressure Intensity of a Chinese Massage Technique for Treating Low Back Pain
A study testing Buffalo horn technique in people with Low Back Pain, Mechanical, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
The Investigators conduct this study to compare two different massage methods with "buffalo horn technique": the deep massage and the superficial massage. To explore the effects of the two interventions on low back pain, the investigators evaluated the outcome measurements regarding pain severity and physical… Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Buffalo horn technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Aug 2018to 26 Sep 2020
- 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 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Non-specific low back pain over 1 months
- 20-65 years old
- No experience of massage therapy within 2 months prior to the study inclusion.
Who cannot join
- Pregnancy
- Back pain associated with systemic disease (autoimmune, infectious, vascular, endocrine, metabolic, or neoplastic disease)
- Previous spine surgery.
- Presentation with neurological signs such as radiating pain.
- .Skin diseases (psoriasis, urticaria, wounds, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pressure Intensity of a Chinese Massage With the "Buffalo Horn Technique" on Pain Relief for Mechanical Low Back Pain.
The Investigators conduct this study to compare two different massage methods with "buffalo horn technique": the deep massage and the superficial massage. To explore the effects of the two interventions on low back pain, the investigators evaluated the outcome measurements regarding pain severity and physical functions before and after 6 times of treatment through a 3-week period.
Read the detailed description
Background: Nonspecific lower back pain is an important global health issue, with high prevalence over the world and causing huge economic loss.
This research is a double-blind randomized controlled trial. In this study the investigators introduce a technique derived from traditional Chinese massage using a special tool made from buffalo's horns to perform the massage, so called "buffalo horn technique". The tool is like a short rod in about 15-cm length with a cone-like end. During the massage, the therapist presses the cone-like end against the painful region of back. Because the cone-like end has a small contact area with the participant's body surface, it may release deep layer fascia with higher pressure produced by the therapist toward the treatment area. During the intervention of shallow massage, the therapist applies a lower force then that used in the deep massage. Thus it produces a lower pressure on the painful region due to a larger contact surface when pressing the rod end against the body of the participant.
Participants are randomly assigned to either deep-massage group (DM) or superficial-massage (SM) group. The participants received two sessions a week for a total six sessions. The outcome measures include the structured questionnaire to investigate the pain-related outcomes and back pain-related disabilities. The investigators also perform the clinical assessments such as range of motion of trunk. All the outcomes are assessed before-intervention (pretest) and after the end of intervention (posttest).
- Conditions
- Low Back Pain, Mechanical
- Being tested
- Buffalo horn technique
- Keywords
- Alternative therapy, Massage, Manual therapy, Myofascial
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buffalo horn techniqueOther
Also called Massage with a Chinese therapeutic tool
The participants receive a 30-min massage session, twice a week for a total 6 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Deep massage (DM) group | Experimental | The therapist performs the deep massage with "buffalo horn technique". A small rod with a cone-like end was used in the technique. By pressuring the rod end with a higher force against the body surface of the participant, it produces higher pressure that may release the deep-layer fascia of muscles. Thus this technique features a deep massage. Receives: Other: Buffalo horn technique |
| Superficial massage (SM) group | Active comparator | The therapist performs the superficial massage with "buffalo horn technique". By pressuring the rod end with a lower force against the body surface of the participant, it produces lower pressure. Thus this intervention features a superficial massage. Receives: Other: Buffalo horn technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS) for pain severity
0-100mm VAS where 0 represents no pain and 100 represents the strongest pain
Measured: 7 weeks
Secondary outcomes (5)
Oswestry Disability Index
Patients rate the severity (from no problem scored "0" to the worst scored "5") on 10 daily activities. Thus the total scores range from 0 to 50.
Measured: 7 weeks
Roland-Morris Low Back Pain Disability Questionnaire
Participants answer "true" or "false" on 24 items that describe the impact of low back pain on daily activity. Thus the total scores range from 0 to 24.
Measured: 7 weeks
Short form of "World Health Organization Quality of Life Instrument" (WHOQOL-BREF)
The Chinese version has 28 items covering 4 domains in terms of "physical, emotional, social, and environmental". Scores are transformed from 0 to 100 for each domain with higher scores indicating better quality of life.
Measured: 7 weeks
Pain pressure threshold
Using the pressure algometer to measure the pressure enough to elicit the tenderness,
Measured: 3 weeks
Range of motion (ROM) of the trunk
ROM of flexion and extension of the back
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start3 Aug 2018
- Primary completion1 Aug 2020
- Study completion26 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- The patients are randomly assigned into two treatment arms.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yen-Nung Lin, Taipei Medical University WanFang Hospital
- Investigators
- Yen-Nung Lin, Principal investigator, Department of Rehabilitation, Wan-Fang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610204
- Sponsor's protocol ID
- N201709004
- Status last verified
- Jun 2021
- First submitted
- 18 Jul 2018
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only for this study
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pressure Intensity of a Chinese Massage With the "Buffalo Horn Technique" on Pain Relief for Mechanical Low Back Pain.
- ClinicalTrials.gov ID
- NCT03610204
- Acronym / sponsor ID
- N201709004
- Conditions
- Low Back Pain, Mechanical
- Keywords
- Alternative therapy, Massage, Manual therapy, Myofascial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 26 Sep 2020 (actual)
- First posted
- 1 Aug 2018 (actual)
- 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 Investigators conduct this study to compare two different massage methods with "buffalo horn technique": the deep massage and the superficial massage. To explore the effects of the two interventions on low back pain, the investigators evaluated the outcome measurements regarding pain severity and physical functions before and after 6 times of treatment through a 3-week period.
Detailed description
Background: Nonspecific lower back pain is an important global health issue, with high prevalence over the world and causing huge economic loss.
This research is a double-blind randomized controlled trial. In this study the investigators introduce a technique derived from traditional Chinese massage using a special tool made from buffalo's horns to perform the massage, so called "buffalo horn technique". The tool is like a short rod in about 15-cm length with a cone-like end. During the massage, the therapist presses the cone-like end against the painful region of back. Because the cone-like end has a small contact area with the participant's body surface, it may release deep layer fascia with higher pressure produced by the therapist toward the treatment area. During the intervention of shallow massage, the therapist applies a lower force then that used in the deep massage. Thus it produces a lower pressure on the painful region due to a larger contact surface when pressing the rod end against the body of the participant.
Participants are randomly assigned to either deep-massage group (DM) or superficial-massage (SM) group. The participants received two sessions a week for a total six sessions. The outcome measures include the structured questionnaire to investigate the pain-related outcomes and back pain-related disabilities. The investigators also perform the clinical assessments such as range of motion of trunk. All the outcomes are assessed before-intervention (pretest) and after the end of intervention (posttest).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The patients are randomly assigned into two treatment arms.
| Arm | Type | Receives |
|---|---|---|
| Deep massage (DM) group | Experimental | Other: Buffalo horn techniqueThe therapist performs the deep massage with "buffalo horn technique". A small rod with a cone-like end was used in the technique. By pressuring the rod end with a higher force against the body surface of the participant, it produces higher pressure that may release the deep-layer fascia of muscles. Thus this technique features a deep massage. |
| Superficial massage (SM) group | Active comparator | Other: Buffalo horn techniqueThe therapist performs the superficial massage with "buffalo horn technique". By pressuring the rod end with a lower force against the body surface of the participant, it produces lower pressure. Thus this intervention features a superficial massage. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- Non-specific low back pain over 1 months
- 20-65 years old
- No experience of massage therapy within 2 months prior to the study inclusion.
Key exclusion criteria (5 listed)
- Pregnancy
- Back pain associated with systemic disease (autoimmune, infectious, vascular, endocrine, metabolic, or neoplastic disease)
- Previous spine surgery.
- Presentation with neurological signs such as radiating pain.
- .Skin diseases (psoriasis, urticaria, wounds, etc.)
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 |
|---|---|---|
| Buffalo horn techniqueAlso: Massage with a Chinese therapeutic toolThe participants receive a 30-min massage session, twice a week for a total 6 sessions. | Other | Deep massage (DM) group, Superficial massage (SM) group |
Primary outcome
Visual analogue scale (VAS) for pain severity
Time frame: 7 weeks
0-100mm VAS where 0 represents no pain and 100 represents the strongest pain
5 secondary outcomes
Oswestry Disability Index
Time frame: 7 weeks
Roland-Morris Low Back Pain Disability Questionnaire
Time frame: 7 weeks
Short form of "World Health Organization Quality of Life Instrument" (WHOQOL-BREF)
Time frame: 7 weeks
Pain pressure threshold
Time frame: 3 weeks
Range of motion (ROM) of the trunk
Time frame: 3 weeks
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 7 Jun 2021.
- Individual participant dataSharing planned: No. only for this study
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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.
Yen-Nung Lin principal investigator
Department of Rehabilitation, Wan-Fang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buffalo horn technique in people with Low Back Pain, Mechanical, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 4 inclusion and 5 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 7 Jun 2021. 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 Taiwan. 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?
Visual analogue scale (VAS) for pain severity (time frame: 7 weeks). 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 7 Jun 2021.