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

Non-specific Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06431503
• Other study ID #: CMUH112-REC1-132
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 11, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: May 2024
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 14
• Est. completion date: July 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Non-specific Chronic Low Back Pain

Intervention

Other:
• Tok-Sen Massage
Press the wedge and tapping: the strength for pressing the wadge is 1000g±50g, the height for mallet free fall(instead of beating by arm)10cm±2cm. For Pressure massage, the strength for pressing the wadge is 1500g±50g.
• Pressure Massage
Press the wedge: the strength for pressing the wadge is 1500g±50g,

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung City	North Dist

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (19)

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improve the disability of low back pain	Improvement in ODI score	From enrollment to the end of follow up at 4 months
Secondary	Pain relieving	Improvement of VAS score	From enrollment to the end of 4 times treatments at 4 weeks