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Non-specific Chronic Low Back PainNCT06431503

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

A study testing Tok-Sen Massage and Pressure Massage in people with Non-specific Chronic Low Back Pain, run by China Medical University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 69 years
Conditions the study is for
Non-specific Chronic Low Back Pain
What is being tested?
Tok-Sen Massage and Pressure Massage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteTaiwan
Study dates
11 Nov 2023to 30 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • China Medical University Hospital

    Taichung, North Dist, 404

Other trials in Taiwan

About this study

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.

Read more

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.

Read the 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.

Being tested
Tok-Sen Massage, Pressure Massage
Keywords
Tok-Sne massage, pressure massage, low back pain
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tok-Sen MassageOther

    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.

  • Pressure MassageOther

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

Study groups in NCT06431503
Study groupRoleWhat they receive
Tok-Sen massageExperimentalTok-Sen massage uses a mallet to hit a wooden wedge to produce impact and sound.
Receives: Other: Tok-Sen Massage
Pressure massageActive comparatorPressure massage uses the wooden wedge to press.
Receives: Other: Pressure Massage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain relieving from Visual analogue scale

    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)

    Measured: From enrollment to the end of 4 times treatments at 4 weeks

  2. The Oswestry Disability Index

    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).

    Measured: From enrollment to the end of follow up at 3 months

Secondary outcomes (2)

  1. Forward bend fingertip-to-floor distance

    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.

    Measured: From enrollment to the end of 4 times treatments at 4 weeks

  2. Left and right side bending fingertip-to-floor distance subtraction

    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.

    Measured: From enrollment to the end of 4 times treatments at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2024
  2. Study start11 Nov 2023
  3. Primary completion13 Mar 2024
  4. Study completion30 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06431503
Sponsor's protocol ID
CMUH112-REC1-132
Status last verified
Aug 2024
First submitted
22 May 2024
Last updated
30 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Snook SH. Self-care guidelines for the management of nonspecific low back pain. J Occup Rehabil. 2004 Dec;14(4):243-53. doi: 10.1023/b:joor.0000047427.21710.07.

    PubMed 15638255

  • Farooque M. Specific and nonspecific low back pain-mind the gap and its impact in clinical practice: opinion of a recovering interventional spine physiatrist. Spine J. 2023 Aug;23(8):1101-1107. doi: 10.1016/j.spinee.2023.04.011. Epub 2023 Apr 27. No abstract available.

    PubMed 37116719

  • Knezevic NN, Candido KD, Vlaeyen JWS, Van Zundert J, Cohen SP. Low back pain. Lancet. 2021 Jul 3;398(10294):78-92. doi: 10.1016/S0140-6736(21)00733-9. Epub 2021 Jun 8.

    PubMed 34115979

  • Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.

    PubMed 11074683

  • Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.

    PubMed 27745712

  • Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.

    PubMed 21982256

  • Chenot JF, Greitemann B, Kladny B, Petzke F, Pfingsten M, Schorr SG. Non-Specific Low Back Pain. Dtsch Arztebl Int. 2017 Dec 25;114(51-52):883-890. doi: 10.3238/arztebl.2017.0883.

    PubMed 29321099

  • Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.

    PubMed 28192789

  • GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.

    PubMed 30496104

  • Merritt JL, McLean TJ, Erickson RP, Offord KP. Measurement of trunk flexibility in normal subjects: reproducibility of three clinical methods. Mayo Clin Proc. 1986 Mar;61(3):192-7. doi: 10.1016/s0025-6196(12)61848-5.

    PubMed 3945120

  • Chen S, Chen M, Wu X, Lin S, Tao C, Cao H, Shao Z, Xiao G. Global, regional and national burden of low back pain 1990-2019: A systematic analysis of the Global Burden of Disease study 2019. J Orthop Translat. 2021 Sep 10;32:49-58. doi: 10.1016/j.jot.2021.07.005. eCollection 2022 Jan.

    PubMed 34934626

  • Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020 Sep 1;161(9):1976-1982. doi: 10.1097/j.pain.0000000000001939.

    PubMed 32694387

  • Shafshak TS, Elnemr R. The Visual Analogue Scale Versus Numerical Rating Scale in Measuring Pain Severity and Predicting Disability in Low Back Pain. J Clin Rheumatol. 2021 Oct 1;27(7):282-285. doi: 10.1097/RHU.0000000000001320.

    PubMed 31985722

  • Klineberg E, Mazanec D, Orr D, Demicco R, Bell G, McLain R. Masquerade: medical causes of back pain. Cleve Clin J Med. 2007 Dec;74(12):905-13. doi: 10.3949/ccjm.74.12.905.

    PubMed 18183841

  • Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49:1. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20.

    PubMed 26487293

Questions about this trial

What is this clinical trial studying?

A study testing Tok-Sen Massage and Pressure Massage in people with Non-specific Chronic Low Back Pain, run by China Medical University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain relieving from Visual analogue scale (time frame: From enrollment to the end of 4 times treatments at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06431503, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.

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