Clinical trial NCT06431503: Effect of Tok-Sen Massage for Non-specific Low Back Pain
Official title: Effect of Tok-Sen Massage for Non-specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-specific Chronic Low Back Pain
Keywords: Tok-Sne massage
pressure massage
low back pain
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain relieving from Visual analogue scale
timeFrame: From enrollment to the end of 4 times treatments at 4 weeks
measure: The Oswestry Disability Index
timeFrame: From enrollment to the end of follow up at 3 months
Secondary outcomes:
measure: Forward bend fingertip-to-floor distance
timeFrame: From enrollment to the end of 4 times treatments at 4 weeks
measure: Left and right side bending fingertip-to-floor distance subtraction
timeFrame: From enrollment to the end of 4 times treatments at 4 weeks
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
state: North Dist
Study officials:
affiliation: China Medical University, China
name: Yu-Chen Lee, M.D. & Ph.D.
role: STUDY_DIRECTOR
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