Effect of Tok-Sen Massage for Non-specific Low Back Pain

August 28, 2024 updated by: China Medical University Hospital

The purpose of this clinical trial was to find out whether Tok Sen massage (a massage method with wooden instruments from northern Thailand) is more effective than pressure massage in relieving pain and improving quality of life in participants with chronic low back pain. The main questions it aims to answer are:

Can Tok Sen Massage Relieve Chronic Lower Back Pain? Can Tok Sen massage improve the quality of life of patients with chronic low back pain? Researchers compared Tok Sen massage with pressure massage, which works on low back pain, to see if it could treat chronic low back pain.

Participants will:

Receive Tok Sen massage or pressure massage every week for 1 month. Questionnaires and flexion measurements before and after each massage. After the massage session, fill out the online questionnaire once a month for three months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Low back pain is the world's leading cause of global productivity loss and the leading cause of years lost with disability (YLDs), with a high prevalence of 28%-42% among those aged 40 to 69 years. The prevalence of different occupations in Taiwan ranges from 35% to 90%; according to the summary of the National Health Insurance Database results report: "The annual prevalence of low back pain is 14% to 45%, and 70% to 85% of people in their lifetime Suffering from low back pain. "Most people who experience low back pain cannot identify the specific source of the injury, and up to 90% of low back pain is non-specific. Approximately 85% of patients with low back pain cannot obtain accurate pathological anatomy diagnosis. Tok-Sen Massage is a kind of folk therapy in northern Thailand, specializing in musculoskeletal system diseases. This trial selected Pressure Massage as an active control for evaluating the effectiveness of two massage methods in improving low back pain.

This is an open-label and randomized controlled trial. Patients aged 20-69 years old with non-specific chronic low back pain were randomized divided into two different groups. 7 people in the Tok-Sen Massage group received a 40-minute intervention once a week for a total of 4 times, and 7 people the Pressure Massage group received a 40-minute intervention once a week for a total of 4 times.

Massage area are on the bladder meridian on the back and the spleen, liver and kidney meridian of the lower limbs.

The evaluation methods are: 1. Oswestry Disability Index (ODI) (baseline and after three interventions), 2. Visual Analogue Scale (VAS)before and after each massage, 3. Trunk flexibility test. before and after each massage.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • North Dist
      • Taichung City, North Dist, Taiwan, 404
        • China Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • chronic low back pain for more than 3 months
  • diagnosis of non-specific low back pain

Exclusion Criteria: -

  • Spinal surgery history
  • Joint disease
  • Pregnancy
  • Cancer
  • Systemic disease
  • Mental disease
  • Bone Mass Measurement less than

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tok-Sen massage
Tok-Sen massage uses a mallet to hit a wooden wedge to produce impact and sound.
Other: Tok-Sen Massage
Press the wedge and tapping: the strength for pressing the wedge is 1000g±50g, the height for mallet free fall(instead of beating by arm)10cm±2cm. For Pressure massage, the strength for pressing the wedge is 1500g±50g.
Active Comparator: Pressure massage
Pressure massage uses the wooden wedge to press.
Other: Pressure Massage
Press the wedge: the strength for pressing the wedge is 1500g±50g,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relieving from Visual analogue scale
Time Frame: From enrollment to the end of 4 times treatments at 4 weeks

Pain was assessed using the "Pain Visual Analogue Scale" (P-VAS), which is a self-assessment scale consisting of a 10 cm horizontal line anchored on both sides. The endpoint on the left represents "no pain." , the endpoint on the right represents "severe pain". Subjects can mark their pain level on this line based on how they feel. The distance from the position of the subject's mark to the left is the measurement result. The data range is from 0 mm to 100 mm.

The degree of pain reduction(1%-100%, more percentage is more effective)
From enrollment to the end of 4 times treatments at 4 weeks
The Oswestry Disability Index
Time Frame: From enrollment to the end of follow up at 3 months

Disability assessment uses the Oswestry Disability Index (ODI). The development of ODI was initiated by John O'Brien in 1976.

These 10 items are respectively the degree of pain and the impact of pain on self-care, lifting heavy objects, walking ability, sitting ability, standing ability, sleep, social life, sex life and travel. Each option has 6 alternatives. The answer is scored from 0 to 5, with 0 being no pain at all and not affecting life, and 5 being extreme pain causing severe disability, so the "ODI score" ranges from 0 to 50. The calculation method of "ODI disability value": "Euclidean disability index" = (actual score/total number of questions answered × 5) × 100%. For example, all answers to 10 questions are: (actual score/50) × 100%; answer Question 9 is (actual score/45) × 100% (57, 62).
From enrollment to the end of follow up at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forward bend fingertip-to-floor distance
Time Frame: From enrollment to the end of 4 times treatments at 4 weeks
Fingertip to Floor: The subject puts his feet and knees together, and while standing, slowly bends forward as much as possible, trying to touch the floor. The tester does not need to immobilize the pelvis, so the test allows for movement of the hip joint. Use a tape measure to measure the vertical distance from the subject's middle finger to the floor at the end of the movement.
From enrollment to the end of 4 times treatments at 4 weeks
Left and right side bending fingertip-to-floor distance subtraction
Time Frame: From enrollment to the end of 4 times treatments at 4 weeks
Lateral Fingertip to Floor: The subject is in an upright position, with his back flat against the wall, his feet shoulder-width apart, and his hands hanging freely by his side. Ask the subject to bend his body to the side as much as possible , and keep back and shoulders flat against the wall, knees on both sides straight, and feet flat on the ground. When reach the end of the side bend, mark the distance of finger tip to floor.
From enrollment to the end of 4 times treatments at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Study Director: Yu-Chen Lee, M.D. & Ph.D., China Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2023

Primary Completion (Actual)

March 13, 2024

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Actual)

August 30, 2024

Last Update Submitted That Met QC Criteria

August 28, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH112-REC1-132

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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