Clinical Observation on the Treatment of Massage Based on Fascia Chain

NCT05974761 | Unknown DMC

• 2 other identifiers: jigubchao202307Z-2022046
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  24months

Study Arms (2)

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.

Other: massage

Traditional Chinese massage

OTHER

Through the point, massage, bone-setting treatment

Other: Traditional Chinese massage

Interventions

massage OTHER

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.

Side lying muscle massage

Traditional Chinese massage OTHER

Through the point, massage, bone-setting treatment

Traditional Chinese massage

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• muxing zhu: lead

Study Sites (1)

Affiliated Hospital of Shandong University of traditional Chinese medicine

Jinan, Shandong, 250013, China

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• shuwen mao

  Shandong University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

muxing zhu

CONTACT

15966649706; 807132313@qq.com

jiageng zhao

CONTACT

18769546572; 2388022175@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 3, 2023
• Study Start: October 21, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 24, 2023

Record last verified: 2023-10

Locations

CN (1)