Transpubic Symphysis Reset for Treatment of Low Back Pain

March 3, 2020 updated by: Hongliang Liu, Shengjing Hospital

Transpubic Symphysis Reset for Treatment of Low Back Pain: a Stratified, Randomized, Controlled Clinical Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No abnormalities of the lumbar spine and no intervertebral disc slipping or mild protrusion revealed via CT scans or MRI
  • Pain in the lumbosacral region
  • Pain in the unilateral lower back, including the buttocks, inguinal region, and perineal region
  • Patient is unable to sit for a long duration
  • Varying degrees of crooked hip and claudication
  • A history of chronic fatigue disease involving a lumbar sprain, a fall injury affecting the buttocks, or prolonged sitting
  • Tenderness of sacroiliac joint on the affected side
  • Course of disease between 1 day and 6 months
  • Age between 18 and 75 years old, any gender
  • Provision of informed consent regarding the trial procedure

Exclusion Criteria:

  • Sciatic nerve radiating pain caused by lumbar disc herniation
  • Lumbar spinal stenosis combined with intermittent claudication
  • Edema and necrosis produced by lumbar spinal cord compression revealed by MRI
  • Clear spinal deformity
  • Low back pain induced by cancer and associated inflammation
  • Hip malformation and bone disease
  • Coagulopathy
  • Ongoing participation in physiotherapy and massage therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Transpubic symphysis reset therapy group
Transpubic symphysis reset therapy will be conducted once a day for 7 consecutive days.
Procedure: Transpubic symphysis reset therapy group
The patients in the treatment group will undergo daily transpubic symphysis reset therapy for 7 consecutive days.
Experimental: Physiotherapy group
Physiotherapy and a sham reset treatment will be performed once a day for 7 consecutive days.
Procedure: Physiotherapy group
The patients in the control group will undergo physiotherapy and a sham treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale pain scores
Time Frame: 14 days after treatment
To use the Visual Analog Scale for pain to evaluate the severity of low back pain. The scale consists of a 10-cm line with 0 on one end, representing no pain, and 10 on the other, representing the worst pain ever experienced. The patient indicates their level of pain by placing a mark somewhere on the scale, between 0 and 10
14 days after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes of Oswestry Disability Index
Time Frame: 1, 7, and 14 days, and 1 month after treatment
To assess the degree of impairment of limb function induced by low back pain.
1, 7, and 14 days, and 1 month after treatment
Changes of hip muscle strength
Time Frame: 1 day before treatment, 1, 7, 14 days, and 1 month after treatment
To be measured using a Biodex isokinetic muscle testing machine (Biodex, Germany).
1 day before treatment, 1, 7, 14 days, and 1 month after treatment
Changes of joint motion
Time Frame: 1 day before treatment, 1, 7, 14 days, and 1 month after treatment
To be measured using a Biodex isokinetic muscle testing machine (Biodex, Germany).
1 day before treatment, 1, 7, 14 days, and 1 month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shengjing Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hongliang Liu, Ph.D, Shengjing Hospital Of China Medical University,China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ShengjingH_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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