NCT02906540

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable low-back-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

September 2, 2016

Last Update Submit

March 3, 2020

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale pain scores

    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 Outcomes (3)

  • Changes of Oswestry Disability Index

    1, 7, and 14 days, and 1 month after treatment

  • Changes of hip muscle strength

    1 day before treatment, 1, 7, 14 days, and 1 month after treatment

  • Changes of joint motion

    1 day before treatment, 1, 7, 14 days, and 1 month after treatment

Study Arms (2)

Transpubic symphysis reset therapy group

EXPERIMENTAL

Transpubic symphysis reset therapy will be conducted once a day for 7 consecutive days.

Procedure: Transpubic symphysis reset therapy group

Physiotherapy group

EXPERIMENTAL

Physiotherapy and a sham reset treatment will be performed once a day for 7 consecutive days.

Procedure: Physiotherapy group

Interventions

Transpubic symphysis reset therapy groupPROCEDURE

The patients in the treatment group will undergo daily transpubic symphysis reset therapy for 7 consecutive days.

Transpubic symphysis reset therapy group
Physiotherapy groupPROCEDURE

The patients in the control group will undergo physiotherapy and a sham treatment.

Physiotherapy group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Hongliang Liu, Ph.D

    Shengjing Hospital Of China Medical University,China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

September 2, 2016

First Posted

September 20, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2017

Study Completion

September 30, 2018

Last Updated

March 4, 2020

Record last verified: 2020-03