- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05974761
Clinical Observation on the Treatment of Massage Based on Fascia Chain
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.
Study Overview
Status
Conditions
Intervention / 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: muxing zhu
- Phone Number: 15966649706
- Email: 807132313@qq.com
Study Contact Backup
- Name: jiageng zhao
- Phone Number: 18769546572
- Email: 2388022175@qq.com
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250013
- Recruiting
- Affiliated Hospital of Shandong University of Traditional Chinese Medicine
-
Contact:
- muxing zhu
- Phone Number: 15966649706
- Email: 807132313@qq.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Side lying muscle massage
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.
|
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.
|
Other: Traditional Chinese massage
Through the point, massage, bone-setting treatment
|
Through the point, massage, bone-setting treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24months
|
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.
|
24months
|
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
|
24months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: shuwen mao, Shandong University of Traditional Chinese Medicine
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- jigubchao202307
- Z-2022046 (Other Grant/Funding Number: Health Commission of Shandong Province)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
Karolinska InstitutetCompletedChronic Low Back Pain | Recurrent Low Back Pain | Persistent Low Back PainSweden
-
Ache Laboratorios Farmaceuticos S.A.Unknown
-
Palmer College of ChiropracticDepartment of Health and Human ServicesCompletedChronic Low Back Pain | Subacute Low Back PainUnited States
-
Universität Duisburg-EssenSiemens-BetriebskrankenkasseCompletedChronic Low Back Pain | Recurrent Low Back Pain
-
Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
Clinical Trials on massage
-
Chulalongkorn UniversityCompletedIschemic StrokeThailand
-
Mayo ClinicCompletedFatigue | Stress | Anxiety | TensionUnited States
-
TC Erciyes UniversityCompletedAbdominal Pain | Satisfaction, Patient | DistentionTurkey
-
Cukurova UniversityEnrolling by invitationPain | Sleep | Self EfficacyTurkey
-
São Paulo State UniversityFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
University of ValenciaCompletedHamstring ContracturesSpain
-
Emre ErkalRecruiting
-
University Hospital, ToulouseInstitut National de la Santé Et de la Recherche Médicale, FranceCompletedMusculoskeletal ManipulationsFrance
-
Mersin UniversityCompletedHemodialysis PatientsTurkey
-
Universitat Internacional de CatalunyaUnknown