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CompletedNCT03610204Updated Jun 7, 2021

Pressure Intensity of a Chinese Massage Technique for Treating Low Back Pain

An interventional study of Buffalo horn technique in Low Back Pain, Mechanical, sponsored by Taipei Medical University WanFang Hospital. Completed at 1 site in Taiwan. Open to female participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-07.

Sponsored by Taipei Medical University WanFang Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
Female
01

Study 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 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).

02

Conditions studied

  • Low Back Pain, Mechanical

Keywords

  • Alternative therapy
  • Massage
  • Manual therapy
  • Myofascial
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 56 is close to the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Taipei Medical University WanFang Hospital is the lead sponsor of 196 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Female
  2. Non-specific low back pain over 1 months
  3. 20-65 years old
  4. No experience of massage therapy within 2 months prior to the study inclusion.

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy
  2. Back pain associated with systemic disease (autoimmune, infectious, vascular, endocrine, metabolic, or neoplastic disease)
  3. Previous spine surgery.
  4. Presentation with neurological signs such as radiating pain.
  5. .Skin diseases (psoriasis, urticaria, wounds, etc.)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Deep massage (DM) group

    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.

    Other: Buffalo horn technique

  • Active comparator
    Superficial massage (SM) group

    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.

    Other: Buffalo horn technique

Interventions

  • OtherBuffalo horn technique

    The participants receive a 30-min massage session, twice a week for a total 6 sessions.

    Also known as: Massage with a Chinese therapeutic tool

06

What researchers measure

Primary outcomes

  1. Visual analogue scale (VAS) for pain severity

    0-100mm VAS where 0 represents no pain and 100 represents the strongest pain

    Time frame: 7 weeks

Secondary outcomes

  1. 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.

    Time frame: 7 weeks

  2. 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.

    Time frame: 7 weeks

  3. 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.

    Time frame: 7 weeks

  4. Pain pressure threshold

    Using the pressure algometer to measure the pressure enough to elicit the tenderness,

    Time frame: 3 weeks

  5. Range of motion (ROM) of the trunk

    ROM of flexion and extension of the back

    Time frame: 3 weeks

07

Study locations

1 site
  • WanFang Hospital
    New Taipei City, Taiwan
08

References and documents

Individual participant data

Plan to share: No — only for this study

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03610204
Lead sponsor
Taipei Medical University WanFang Hospital
Responsible party
Yen-Nung Lin (Director of Physical Medicine and Rehabilitation, Taipei Medical University WanFang Hospital) — Principal investigator
First posted
Aug 1, 2018
Start date
Aug 3, 2018
Primary completion
Aug 1, 2020
Completion
Sep 26, 2020
Last update
Jun 7, 2021

Study contacts

Yen-Nung Lin
principal investigator · Department of Rehabilitation, Wan-Fang Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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