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

Primary Purpose

Low Back Pain, Mechanical

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Buffalo horn technique
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain, Mechanical focused on measuring Alternative therapy, Massage, Manual therapy, Myofascial

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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:

  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.)

Sites / Locations

  • WanFang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Deep massage (DM) group

Superficial massage (SM) group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Visual analogue scale (VAS) for pain severity
0-100mm VAS where 0 represents no pain and 100 represents the strongest pain

Secondary Outcome Measures

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.
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.
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.
Pain pressure threshold
Using the pressure algometer to measure the pressure enough to elicit the tenderness,
Range of motion (ROM) of the trunk
ROM of flexion and extension of the back

Full Information

First Posted
July 18, 2018
Last Updated
June 2, 2021
Sponsor
Taipei Medical University WanFang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03610204
Brief Title
Pressure Intensity of a Chinese Massage Technique for Treating Low Back Pain
Official Title
The Effect of Pressure Intensity of a Chinese Massage With the "Buffalo Horn Technique" on Pain Relief for Mechanical Low Back Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 3, 2018 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
September 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University WanFang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical
Keywords
Alternative therapy, Massage, Manual therapy, Myofascial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients are randomly assigned into two treatment arms.
Masking
ParticipantOutcomes Assessor
Masking Description
Since the patient are prone during the low back massage, the patient will not know what treatment they receive, as the two treatments are similar and only different in the pressure force. The primary outcome is assessed by a self-reported questionnaire. The assessor who performs the clinical assessments will be blinded to the treatment assignment.
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deep massage (DM) group
Arm Type
Experimental
Arm Description
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.
Arm Title
Superficial massage (SM) group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Buffalo horn technique
Other Intervention Name(s)
Massage with a Chinese therapeutic tool
Intervention Description
The participants receive a 30-min massage session, twice a week for a total 6 sessions.
Primary Outcome Measure Information:
Title
Visual analogue scale (VAS) for pain severity
Description
0-100mm VAS where 0 represents no pain and 100 represents the strongest pain
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Oswestry Disability Index
Description
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
Title
Roland-Morris Low Back Pain Disability Questionnaire
Description
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
Title
Short form of "World Health Organization Quality of Life Instrument" (WHOQOL-BREF)
Description
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
Title
Pain pressure threshold
Description
Using the pressure algometer to measure the pressure enough to elicit the tenderness,
Time Frame
3 weeks
Title
Range of motion (ROM) of the trunk
Description
ROM of flexion and extension of the back
Time Frame
3 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yen-Nung Lin
Organizational Affiliation
Department of Rehabilitation, Wan-Fang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
WanFang Hospital
City
New Taipei City
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
only for this study

Learn more about this trial

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

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