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

Low Back Pain, Mechanical Clinical Trial

Official title:

The Effect of Pressure Intensity of a Chinese Massage With the "Buffalo Horn Technique" on Pain Relief for Mechanical Low Back Pain.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03610204
• Other study ID #: N201709004
• Status: Completed
• Phase: N/A
• Start date: August 3, 2018
• Est. completion date: September 26, 2020

Study information

• Verified date: June 2021
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 functions before and after 6 times of treatment through a 3-week period.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 26, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Mechanical

Intervention

Other:
• Buffalo horn technique
The participants receive a 30-min massage session, twice a week for a total 6 sessions.

Locations

Country	Name	City	State
Taiwan	WanFang Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale (VAS) for pain severity	0-100mm VAS where 0 represents no pain and 100 represents the strongest pain	7 weeks
Secondary	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.	7 weeks
Secondary	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.	7 weeks
Secondary	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.	7 weeks
Secondary	Pain pressure threshold	Using the pressure algometer to measure the pressure enough to elicit the tenderness,	3 weeks
Secondary	Range of motion (ROM) of the trunk	ROM of flexion and extension of the back	3 weeks