Low Back PainNCT05974761
Clinical Observation on the Treatment of Massage Based on Fascia Chain
A study testing massage and Traditional Chinese massage in people with Low Back Pain, run by muxing zhu at 1 site in China.
Trial summary
The goal of thisclinical trial is to observe and quantify the impact of our massage methods on the human body based on B-mode ultrasound, Vas score, and ODI score, and to compare our massage methods with traditional Chinese massage treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- massage and Traditional Chinese massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2023to 1 Jul 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who met the diagnostic criteria of chronic low back pain, aged 18-65 years, volunteered to join the trial and signed the informed consent.
Who cannot join
- In the course of treatment, the skin of waist and buttocks was obviously damaged, infected and ulcerated, and the women were in the period of menstruation, pregnancy or lactation Patients with cardiac cerebrovascular disease, hepatic and renal insufficiency, bleeding disorders and mental disorders, and participants in other clinical trials within one month.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Shandong University of traditional Chinese medicine
Jinan, Shandong, 250013
muxing zhu, 15966649706, 807132313@qq.com
About this study
Official title: Clinical Observation on the Treatment of Chronic Low Back Pain With Side-lying Massage Based on Fascia Chain
The goal of thisclinical trial is to observe and quantify the impact of our massage methods on the human body based on B-mode ultrasound, Vas score, and ODI score, and to compare our massage methods with traditional Chinese massage treatment. The main questions it aims to answer are:
- To set up our standard operating procedure of massage therapy to adjust the stress line of psoas myofascial chain, and provide a more simple and effective therapy for Chronic low back pain.
- try to establish a kind of ultrasonic standard to evaluate the curative effect of treating chronic low back pain.
The subjects were randomly divided into two groups, the experimental group and the control group, the experimental group was given our characteristic massage treatment, the control group was given traditional Chinese massage treatment.Both groups were treated once every other day, 3 times a week, 2 weeks as a course of treatment, 2 courses of treatment.
Read the detailed description
- the patients in the observation group were treated with the manipulation of side-lying and tendons poking. The specific manipulation methods were as follows: (1) the relaxation method: the patients were in prone position, in order to relieve the superficial muscle and fascia, the doctor applied the method of massage, palm massage and arm movement up and down the vertical spine muscle for 3-5 minutes, move your body as close to the bedside as possible. Straighten your lower legs, bend your hips and knees, rest your ankles on your lower legs, and lift your arms to the side of your head. The surgeon stands on the ventral side of the patient, with the crotch resting on the anterior edge of the superior iliac crest, with the elbow rising from the medial top of the superior iliac crest, and slowly following the palpation along the vertical edge of the skeleton toward the spine (avoiding the L 3 transverse process) , and focus on the pain point or the rope to repeatedly apply elbow pressure, elbow plucking method 1-2 minutes to ease the spasm and analgesia, ease adhesion, promote the absorption of inflammatory edema, manipulation is appropriate to ease the gentle; Then the elbow moved down to the buttocks, with the elbow tip touch to find the sinew knot and along the vertical direction of the vertical plucking 3-5 times, the force should be deep penetration. (3) the method of adjusting the extensor muscles and bones: keeping the upper posture, doing the lumbar oblique pulling, one time each side, further stretching the deep muscles of the waist, adjusting the disorder of the lumbar facet joints caused by the twinning contraction of the muscles and fascia. 4 ending type: with double palm up and down alternately percussion waist muscle ten times to end.
- control group: according to the Tuina treatment scheme of low back pain in the textbook of the 13th five-year plan for higher education of Chinese medicine published by China Traditional Chinese Medicine Press in July 2016 and edited by Fan Binghua. The specific methods of operation are as follows: 1 relaxation method: the patient lies prone, the operator stands on the affected side, and applies the massage to the affected side waist, arm and thigh back and forth for 5 minutes, the strength should be deep and gentle, in order to relax the tendons and activate the blood circulation, promote the absorption of peripheral inflammation and edema. 2 point method: the Doctor uses one finger to push the middle acupoints in Ashi, Shenshu, Baihuanshu, Huantiao, zhibian, Chengfu, and massages each point for about half a minute to relax the muscles and activate the blood, 3 method of relieving spasm and pain: the Doctor applied the thumb plucking method at the tendon of the cord-like muscle 2-3cm below the medial side of the highest point of the skeletal crest. The manipulation was from light to heavy, and could be alternately operated with the thumb pressing and kneading method for about 2 minutes, in order to release adhesion, Pain Relief 4 end: the operator to small thenar vertical rub both sides of the erector muscles, transverse rub lumbosacral department, diaphanous heat for the degree. To double palm up and down alternately tap the lumbosacral end of a dozen times. The Observation Group and the control group were treated once every other day, 3 times a week, 2 weeks as a course of treatment, 2 courses of treatment.
- Conditions
- Low Back Pain
- Being tested
- massage, Traditional Chinese massage
- 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.
massageOther
The patient was placed in a lateral decubitus position with the physician standing on the ventral side of the patient, with the crotch resting on the anterior edge of the superior iliac crest, and the elbow rising from the medial side of the highest point of the superior iliac crest, follow the palpation (avoiding the L3 transverse process) along the steep edge of the skeleton slowly toward the spine, and focus on the painful points or cords by repeatedly applying the elbow press method and the elbow flick method for 1-2 minutes, and then the elbow tip contact to find the sinew knot and along the vertical direction of 3-5 times, the force should be deep penetration.
Traditional Chinese massageOther
Through the point, massage, bone-setting treatment
| Study group | Role | What they receive |
|---|---|---|
| Side lying muscle massage | Experimental | The patient was placed in a lateral decubitus position with the physician standing on the ventral side of the patient, with the crotch resting on the anterior edge of the superior iliac crest, and the elbow rising from the medial side of the highest point of the superior iliac crest, follow the palpation (avoiding the L3 transverse process) along the steep edge of the skeleton slowly toward the spine, and focus on the painful points or cords by repeatedly applying the elbow press method and the elbow flick method for 1-2 minutes, after that, the tendon was found to be induration with elbow tip probing, and the tendon was plucked 3-5 times vertically along the vertical direction. Receives: Other: massage |
| Traditional Chinese massage | Other | Through the point, massage, bone-setting treatment Receives: Other: Traditional Chinese massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of fascia of erector spine muscle before and after 4 weeks treatment were compared.
The position of the lower edge of the transverse process of T12, the lower edge of the transverse process of L 3 and the upper edge of the sacral pathway were determined, take these three points as the placement point of probe center position. After placing the probe, move the probe up and down to get a clear echo of the center point. The musculus erectus erectus muscle appeared between l 3 transverse process, T 12 transverse process lower edge, sacral camel upper edge and fascia layer lower edge, and the thickness of musculus erectus erectus muscle was measured in turn. 3 measurements are required at the same location, and the mean value is taken as the corrected thickness value.
Measured: 24months
The changes of Vas score were compared before and after 4 weeks treatment
Before and after the treatment, the changes of the thickness membrane of the erector spine muscle were observed by b-mode ultrasonography, and the therapeutic effect of lateral supine massage on Psoas myofascitis was quantitatively expressed,A straight line with a ruler is divided into 10 segments, with 0 and 10 marks at both ends. The larger the scale, the higher the pain level. 0 was painless, 1-3 was mild pain that could be tolerated, 4-6 was pain that affected sleep but could be tolerated, 7-9 was pain that was gradually intense and affected appetite and sleep, and 10 was severe pain.
Measured: 24months
The changes of ODI score were compared before and after 4 weeks treatment
Before and after the treatment, the changes of the thickness membrane of the erector spine muscle were observed by b-mode ultrasonography, and the therapeutic effect of lateral supine massage on Psoas myofascitis was quantitatively expressed,It was divided into 10 related questions, such as pain intensity, self-care ability, lifting ability, walking ability, sitting ability, walking ability, ability, standing time and sleep quality. There are 6 options for each question, with scores ranging from 0 to 5. The maximum cumulative score for 10 questions is 50. The formula is: Total Score = (score/5 × number of questions answered) × 100% . The higher the score, the more severe the dysfunction
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start21 Oct 2023 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- muxing zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, muxing zhu, Shandong University of Traditional Chinese Medicine
- Investigators
- shuwen mao, Principal investigator, Shandong University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974761
- Sponsor's protocol ID
- jigubchao202307
- Other IDs
- Z-2022046
- Status last verified
- Oct 2023
- First submitted
- 7 Jul 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation on the Treatment of Chronic Low Back Pain With Side-lying Massage Based on Fascia Chain
- ClinicalTrials.gov ID
- NCT05974761
- Acronym / sponsor ID
- jigubchao202307
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- muxing zhuUniversity, hospital or other
- Study start
- 21 Oct 2023 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of thisclinical trial is to observe and quantify the impact of our massage methods on the human body based on B-mode ultrasound, Vas score, and ODI score, and to compare our massage methods with traditional Chinese massage treatment. The main questions it aims to answer are:
- To set up our standard operating procedure of massage therapy to adjust the stress line of psoas myofascial chain, and provide a more simple and effective therapy for Chronic low back pain.
- try to establish a kind of ultrasonic standard to evaluate the curative effect of treating chronic low back pain.
The subjects were randomly divided into two groups, the experimental group and the control group, the experimental group was given our characteristic massage treatment, the control group was given traditional Chinese massage treatment.Both groups were treated once every other day, 3 times a week, 2 weeks as a course of treatment, 2 courses of treatment.
Detailed description
- the patients in the observation group were treated with the manipulation of side-lying and tendons poking. The specific manipulation methods were as follows: (1) the relaxation method: the patients were in prone position, in order to relieve the superficial muscle and fascia, the doctor applied the method of massage, palm massage and arm movement up and down the vertical spine muscle for 3-5 minutes, move your body as close to the bedside as possible. Straighten your lower legs, bend your hips and knees, rest your ankles on your lower legs, and lift your arms to the side of your head. The surgeon stands on the ventral side of the patient, with the crotch resting on the anterior edge of the superior iliac crest, with the elbow rising from the medial top of the superior iliac crest, and slowly following the palpation along the vertical edge of the skeleton toward the spine (avoiding the L 3 transverse process) , and focus on the pain point or the rope to repeatedly apply elbow pressure, elbow plucking method 1-2 minutes to ease the spasm and analgesia, ease adhesion, promote the absorption of inflammatory edema, manipulation is appropriate to ease the gentle; Then the elbow moved down to the buttocks, with the elbow tip touch to find the sinew knot and along the vertical direction of the vertical plucking 3-5 times, the force should be deep penetration. (3) the method of adjusting the extensor muscles and bones: keeping the upper posture, doing the lumbar oblique pulling, one time each side, further stretching the deep muscles of the waist, adjusting the disorder of the lumbar facet joints caused by the twinning contraction of the muscles and fascia. 4 ending type: with double palm up and down alternately percussion waist muscle ten times to end.
- control group: according to the Tuina treatment scheme of low back pain in the textbook of the 13th five-year plan for higher education of Chinese medicine published by China Traditional Chinese Medicine Press in July 2016 and edited by Fan Binghua. The specific methods of operation are as follows: 1 relaxation method: the patient lies prone, the operator stands on the affected side, and applies the massage to the affected side waist, arm and thigh back and forth for 5 minutes, the strength should be deep and gentle, in order to relax the tendons and activate the blood circulation, promote the absorption of peripheral inflammation and edema. 2 point method: the Doctor uses one finger to push the middle acupoints in Ashi, Shenshu, Baihuanshu, Huantiao, zhibian, Chengfu, and massages each point for about half a minute to relax the muscles and activate the blood, 3 method of relieving spasm and pain: the Doctor applied the thumb plucking method at the tendon of the cord-like muscle 2-3cm below the medial side of the highest point of the skeletal crest. The manipulation was from light to heavy, and could be alternately operated with the thumb pressing and kneading method for about 2 minutes, in order to release adhesion, Pain Relief 4 end: the operator to small thenar vertical rub both sides of the erector muscles, transverse rub lumbosacral department, diaphanous heat for the degree. To double palm up and down alternately tap the lumbosacral end of a dozen times. The Observation Group and the control group were treated once every other day, 3 times a week, 2 weeks as a course of treatment, 2 courses of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Side lying muscle massage | Experimental | Other: massageThe patient was placed in a lateral decubitus position with the physician standing on the ventral side of the patient, with the crotch resting on the anterior edge of the superior iliac crest, and the elbow rising from the medial side of the highest point of the superior iliac crest, follow the palpation (avoiding the L3 transverse process) along the steep edge of the skeleton slowly toward the spine, and focus on the painful points or cords by repeatedly applying the elbow press method and the elbow flick method for 1-2 minutes, after that, the tendon was found to be induration with elbow tip probing, and the tendon was plucked 3-5 times vertically along the vertical direction. |
| Traditional Chinese massage | Other | Other: Traditional Chinese massageThrough the point, massage, bone-setting treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Those who met the diagnostic criteria of chronic low back pain, aged 18-65 years, volunteered to join the trial and signed the informed consent.
Key exclusion criteria (1 listed)
- In the course of treatment, the skin of waist and buttocks was obviously damaged, infected and ulcerated, and the women were in the period of menstruation, pregnancy or lactation Patients with cardiac cerebrovascular disease, hepatic and renal insufficiency, bleeding disorders and mental disorders, and participants in other clinical trials within one month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| massageThe patient was placed in a lateral decubitus position with the physician standing on the ventral side of the patient, with the crotch resting on the anterior edge of the superior iliac crest, and the elbow rising from the medial side of the highest point of the superior iliac crest, follow the palpation (avoiding the L3 transverse process) along the steep edge of the skeleton slowly toward the spine, and focus on the painful points or cords by repeatedly applying the elbow press method and the elbow flick method for 1-2 minutes, and then the elbow tip contact to find the sinew knot and along the vertical direction of 3-5 times, the force should be deep penetration. | Other | Side lying muscle massage |
| Traditional Chinese massageThrough the point, massage, bone-setting treatment | Other | Traditional Chinese massage |
Primary outcome
The changes of fascia of erector spine muscle before and after 4 weeks treatment were compared.
Time frame: 24months
The position of the lower edge of the transverse process of T12, the lower edge of the transverse process of L 3 and the upper edge of the sacral pathway were determined, take these three points as the placement point of probe center position. After placing the probe, move the probe up and down to get a clear echo of the center point. The musculus erectus erectus muscle appeared between l 3 transverse process, T 12 transverse process lower edge, sacral camel upper edge and fascia layer lower edge, and the thickness of musculus erectus erectus muscle was measured in turn. 3 measurements are required at the same location, and the mean value is taken as the corrected thickness value.
The changes of Vas score were compared before and after 4 weeks treatment
Time frame: 24months
Before and after the treatment, the changes of the thickness membrane of the erector spine muscle were observed by b-mode ultrasonography, and the therapeutic effect of lateral supine massage on Psoas myofascitis was quantitatively expressed,A straight line with a ruler is divided into 10 segments, with 0 and 10 marks at both ends. The larger the scale, the higher the pain level. 0 was painless, 1-3 was mild pain that could be tolerated, 4-6 was pain that affected sleep but could be tolerated, 7-9 was pain that was gradually intense and affected appetite and sleep, and 10 was severe pain.
The changes of ODI score were compared before and after 4 weeks treatment
Time frame: 24months
Before and after the treatment, the changes of the thickness membrane of the erector spine muscle were observed by b-mode ultrasonography, and the therapeutic effect of lateral supine massage on Psoas myofascitis was quantitatively expressed,It was divided into 10 related questions, such as pain intensity, self-care ability, lifting ability, walking ability, sitting ability, walking ability, ability, standing time and sleep quality. There are 6 options for each question, with scores ranging from 0 to 5. The maximum cumulative score for 10 questions is 50. The formula is: Total Score = (score/5 × number of questions answered) × 100% . The higher the score, the more severe the dysfunction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shuwen mao principal investigator
Shandong University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing massage and Traditional Chinese massage in people with Low Back Pain, run by muxing zhu at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Oct 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact muxing zhu (15966649706, 807132313@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of fascia of erector spine muscle before and after 4 weeks treatment were compared. (time frame: 24months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2023.