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Completed

NCT Number: NCT03610204

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

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.

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Key information

Conditions

Low Back Pain, Mechanical Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

WanFang Hospital

New Taipei City, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Buffalo horn technique

Other

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

Other names: Massage with a Chinese therapeutic tool

Primary outcomes

  1. Visual analogue scale (VAS) for pain severity

    Time frame: 7 weeks

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

Secondary outcomes

  1. Oswestry Disability Index

    Time frame: 7 weeks

    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.

  2. Roland-Morris Low Back Pain Disability Questionnaire

    Time frame: 7 weeks

    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.

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

    Time frame: 7 weeks

    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.

  4. Pain pressure threshold

    Time frame: 3 weeks

    Using the pressure algometer to measure the pressure enough to elicit the tenderness,

  5. Range of motion (ROM) of the trunk

    Time frame: 3 weeks

    ROM of flexion and extension of the back

Sponsors and collaborators

Lead sponsor

Taipei Medical University WanFang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 1, 2018
Registry last updated
Jun 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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