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

NCT03610204 | Completed DMC

• 1 other identifier: N201709004
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain, Mechanical

Keywords

Alternative therapy; Massage; Manual therapy; Myofascial

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale (VAS) for pain severity

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

  7 weeks

Secondary Outcomes (5)

• Oswestry Disability Index

  7 weeks

• Roland-Morris Low Back Pain Disability Questionnaire

  7 weeks

• Short form of "World Health Organization Quality of Life Instrument" (WHOQOL-BREF)

  7 weeks

• Pain pressure threshold

  3 weeks

• Range of motion (ROM) of the trunk

  3 weeks

Study Arms (2)

Deep massage (DM) group

EXPERIMENTAL

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

Superficial massage (SM) group

ACTIVE COMPARATOR

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

Buffalo horn technique OTHER

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

Deep massage (DM) group; Superficial massage (SM) group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Non-specific low back pain over 1 months
• years old

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

WanFang Hospital

New Taipei City, Taiwan

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Yen-Nung Lin

  Department of Rehabilitation, Wan-Fang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Physical Medicine and Rehabilitation

Model Details: The patients are randomly assigned into two treatment arms.

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 1, 2018
• Study Start: August 3, 2018
• Primary Completion: August 1, 2020
• Study Completion: September 26, 2020
• Last Updated: June 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)