Clinical trial NCT03610204: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain, Mechanical
Keywords: Alternative therapy
Massage
Manual therapy
Myofascial
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 56
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients are randomly assigned into two treatment arms.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.)

Primary outcomes:
measure: Visual analogue scale (VAS) for pain severity
timeFrame: 7 weeks
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: 7 weeks
measure: Roland-Morris Low Back Pain Disability Questionnaire
timeFrame: 7 weeks
measure: Short form of "World Health Organization Quality of Life Instrument" (WHOQOL-BREF)
timeFrame: 7 weeks
measure: Pain pressure threshold
timeFrame: 3 weeks
measure: Range of motion (ROM) of the trunk
timeFrame: 3 weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: WanFang Hospital
Study officials:
affiliation: Department of Rehabilitation, Wan-Fang Hospital
name: Yen-Nung Lin
role: PRINCIPAL_INVESTIGATOR
References: