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

NCT ID: NCT03610204

Last Updated: 2021-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-03

Study Completion Date

2020-09-26

Brief Summary

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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

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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

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Low Back Pain, Mechanical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients are randomly assigned into two treatment arms.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Buffalo horn technique

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Buffalo horn technique

Intervention Type OTHER

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

Interventions

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Buffalo horn technique

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

Intervention Type OTHER

Other Intervention Names

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Massage with a Chinese therapeutic tool

Eligibility Criteria

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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.)
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University WanFang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yen-Nung Lin

Director of Physical Medicine and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yen-Nung Lin

Role: PRINCIPAL_INVESTIGATOR

Department of Rehabilitation, Wan-Fang Hospital

Locations

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WanFang Hospital

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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N201709004

Identifier Type: -

Identifier Source: org_study_id

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