Transpubic Symphysis Reset for Treatment of Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      To verify the efficacy of transpubic symphysis reset therapy for low back pain, and provide
      support for the clinical application of this treatment.
    

Detailed description: 
      Low back pain is a common clinical affliction involving the back muscles, nerves, and bones.
      This condition mainly manifests as limited lumbar mobility, decreased back muscle strength
      and endurance, and disordered as well as asymmetrical movement of lower back muscles.
      Although these symptoms can severely impact quality of life and work, most patients report no
      precise origin of the condition. Low back pain may be associated with mechanical
      musculoskeletal damage, inflammation, cancer, and infection. More than 80% of adults
      experience low back pain at some point during their lifespan, although most patients are
      between 40-80 years old. As many countries have an aging population, the incidence of low
      back pain is increasing globally. Most patients suffer recurrent low back pain, which becomes
      more and more serious with each manifestation.

      Patients with nonspecific low back pain often choose conservative treatments, such as
      physiotherapy. Compared with surgery and drug therapy, physiotherapy is advantageous as a
      treatment associated with low trauma, high comfort, few side effects, and low cost. Previous
      studies have confirmed that treatment with ultrashort waves can improve blood and lymph
      circulation in diseased areas and enhance the phagocytosis of macrophages and leukocytes, as
      well as having an anti-inflammatory effect, making it effective in the treatment of low back
      pain. Additionally, thermotherapy can directly expand the microvascular network of external
      annulus fibrosus, increase vascular permeability, promote venous return of partial metabolic
      waste, increase analgesic substance endorphin levels in vivo, suppress the generation of
      pathological excitatory foci in the brain, and accelerate the self-repair of injured cells,
      thus improving low back pain.

      Chinese traditional massage is also a common clinical therapy. The application of pressure to
      the waist, hip, and lower limb on the affected side of the body can improve local blood
      circulation, promote the absorption of inflammatory exudates, reduce muscle tension, loosens
      abdominal adhesion, and mitigate muscle spasms to restore a normal anatomical position.
      Indeed, the efficacy of massage in the treatment of low back pain has been confirmed,
      according to five reports addressing manipulation for treating low back pain in Science
      Citation Index and four separate trials regarding such manipulation listed in
      ClinicalTrials.gov.

      Transpubic symphysis reset is a massage therapy for treatment of low back pain. Although the
      efficacy of this treatment has been observed in the clinic, few studies have reported on the
      efficacy of transpubic symphysis reset in mitigating low back pain.

      Data collection, management, analysis, and open access Data collection Two physicians, who
      will not participate in the experimental treatment or evaluation, will collect all patient
      data. The investigators will use the double data entry strategy. The data will be summarized
      and numbered by the research manager. A database will be established using Excel software.
      For questionable data, the data manager will present the data query table to the investigator
      for review and response. The researcher will answer the questions and return the table as
      soon as possible. The data manager will modify and check the data according to the
      researcher's answer. If necessary, the data manager can resubmit a question sheet.

      Data management After blind review and database confirmation, the researcher in charge,
      sponsor, and statisticians will lock the database. The locked database will not be altered
      and will be preserved, along with the original records, by Shengjing Hospital, China Medical
      University, China.

      Data analysis All data will be statistically analyzed by professional statisticians. The
      results of these statistical analyses will be reported to a researcher and used to prepare
      the research report. An independent data monitoring committee will be responsible for data
      monitoring and management throughout the entire trial to ensure scientific accuracy,
      stringency, authenticity, and integrity.

      Open access Published data will be available at www.figshare.com.

      Statistical analysis All data will be statistically analyzed using the SPSS 17.0 statistical
      software package in line with the intention-to-treat principle. Data will be expressed as
      mean ± SD. Measurement data will be analyzed with an analysis of variance for independent
      samples. Normally distributed data will be analyzed using group t-tests. Non-normally
      distributed data will be compared using the Wilcoxon test. A value of P < 0.05 will be
      considered statistically significant.

      Confidentiality Patient information, including name, identity card number, address, and
      telephone number, will be encrypted in accordance with relevant Chinese laws and regulations.
      The findings will be published for scientific purposes without revealing any patient
      identities, except as required by law. Encoded information will be stored properly in
      Shengjing Hospital of China Medical University. To ensure that the research is in accordance
      with the applicable laws and regulations, relevant national authorities and the Ethics
      Committee of Shengjing Hospital of China Medical University will review patient records.
    

Intervention name(s): Transpubic symphysis reset therapy group; Physiotherapy group
Intervention type(s): Procedure; Procedure
Intervention description(s): The patients in the treatment group will undergo daily transpubic symphysis reset therapy for 7 consecutive days.; The patients in the control group will undergo physiotherapy and a sham treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment