## Protocol Section
### Identification Module
**NCT ID:** NCT06431503

**Brief Title:** Effect of Tok-Sen Massage for Non-specific Low Back Pain

**Official Title:** Effect of Tok-Sen Massage for Non-specific Low Back Pain

#### Organization Study ID Info
**ID:** CMUH112-REC1-132
#### Organization
**Class:** OTHER
**Full Name:** China Medical University Hospital
### Status Module
#### Completion Date
**Date:** 2024-07-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-11-11

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** China Medical University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**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.

### Conditions Module

**Conditions:**

- Non-specific Chronic Low Back Pain

**Keywords:**

- Tok-Sne massage

- pressure massage

- low back pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 14

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Tok-Sen massage uses a mallet to hit a wooden wedge to produce impact and sound.

**Intervention Names:**

- Other: Tok-Sen Massage

**Label:** Tok-Sen massage

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Pressure massage uses the wooden wedge to press.

**Intervention Names:**

- Other: Pressure Massage

**Label:** Pressure massage

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Tok-Sen massage

**Description:** 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.

**Name:** Tok-Sen Massage

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Pressure massage

**Description:** Press the wedge: the strength for pressing the wadge is 1500g±50g,

**Name:** Pressure Massage

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Improvement in ODI score

**Measure:** Improve the disability of low back pain

**Time Frame:** From enrollment to the end of follow up at 4 months

#### Secondary Outcomes

**Description:** Improvement of VAS score

**Measure:** Pain relieving

**Time Frame:** From enrollment to the end of 4 times treatments at 4 weeks

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 69 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Taichung City

**Country:** Taiwan

**Facility:** China Medical University Hospital

**State:** North Dist

**Zip:** 404

#### Overall Officials

**Official 1:**

**Affiliation:** China Medical University, China

**Name:** Yu-Chen Lee, M.D. & Ph.D.

**Role:** STUDY_DIRECTOR

### References Module

#### References

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**PMID:** 15638255

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**PMID:** 37116719

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**PMID:** 34115979

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**PMID:** 30496104

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**PMID:** 31210680

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4714

- Name: Back Pain

- Relevance: HIGH

- As Found: Back Pain

- ID: M19433

- Name: Low Back Pain

- Relevance: HIGH

- As Found: Low Back Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001416

- Term: Back Pain

- ID: D000017116

- Term: Low Back Pain

### Misc Info Module

- Version Holder: 2024-05-31
