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Effects of Lumbopelvic Manipulation on Neuromuscular Activity of Back & Hip Muscles in Adults With Chronic Low Back Pain

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumbopelvic Manipulation
Sham manipulation
Sponsored by
Texas Woman's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring chronic low back pain, low back pain, lumbopelvic manipulation, Chicago manipulation, EMG median frequency, electromyography, reliability

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Healthy subjects or the reliability phase:

Inclusion Criteria:

  • Subjects without any history of back problems
  • Subjects without any known pathology.

Exclusion Criteria:

  • Any serious spinal condition such as tumor, fracture, or infection,
  • Signs of nerve root compression (i.e. straight leg- raise ≤ 45° or diminished reflexes, sensation or lower extremity strength),
  • Structural deformity,
  • Spondylolithesis ,
  • Ankylosing spondylitis
  • Spinal stenosis,
  • Osteoporosis,
  • Previous surgery to the back or the hip, and
  • Current pregnancy.

Subjects with Chronic low back pain for both the reliability and the manipulation phases:

Inclusion Criteria:

  • Participants should be between the age of 20 to 60 years.
  • Have had complaints of chronic low back pain for at least three months.

Exclusion Criteria:

  • Any serious spinal condition such as tumor, fracture, or infection,
  • Signs of nerve root compression (i.e. straight leg- raise ≤ 45° or diminished reflexes, sensation or lower extremity strength),
  • Structural deformity,
  • Spondylolithesis ,
  • Ankylosing spondylitis
  • Spinal stenosis,
  • Osteoporosis,
  • Previous surgery to the back or the hip, and
  • Current pregnancy

Sites / Locations

  • Texas Woman's University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Sham manipulation

Lumbopelvic Manipulation, Chicago

Arm Description

Each participant will lie in a supine position. The treating investigator (TI) will stand on the opposite side of the low back pain. Then, the participant will be asked to clasp his/her hand behind the neck. The TI will side bend the participant's spine towards the non-painful side, reach through the participant's hands and perform a spinal rotation away from the painful side. The TIs other hand will be placed over the anterior superior iliac spine (ASIS) of the painful side. Lastly, the TI will take up the slack and maintain the pressure on the ASIS for 5-10 seconds and ask the participant whether he/she can tolerate the pressure. If the participant can tolerate the pressure for at least 5 seconds. Then, the subjects will be re-positioned to the starting position.

Each participant will lie in supine position. The treating investigator (TI) will stand opposite of the low back pain. Participant will clasp his/her hand behind the neck. TI will side bend the participant's spine toward non-painful side, reach through participant's hands and perform a spinal rotation away from the painful side. TI's other hand will be placed over the anterior superior iliac spine (ASIS) of the painful side. The TI will take up the slack and maintain pressure on the ASIS for 5-10 seconds and ask participant whether he/she can tolerate the pressure. If participant can tolerate the pressure for at least 5 seconds, verbal permission will be obtained from the participant and the TI will proceed and apply a high-velocity low-amplitude posterior thrust force over the ASIS.

Outcomes

Primary Outcome Measures

Amount of Change in Muscles Endurance
electromyographic (EMG) median frequency will be used to determine the endurance of the gluteus maximums, gluteus medius and the lumbar multifidus muscles. The EMG median frequency will be measured in Hertz (Hz).

Secondary Outcome Measures

Amount of Change in Pain Level
Pain Visual Analogue Scale (VAS) will be used in this study. Participants will be asked to rate their pain level on a 10-cm horizontal line which is marked on the left end "No pain" and on the right end "Extreme pain". Then, the pain level for a specific participant will be determined by measuring the line from the "No pain" end to the mark placed by the participant.

Full Information

First Posted
May 20, 2013
Last Updated
October 11, 2017
Sponsor
Texas Woman's University
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1. Study Identification

Unique Protocol Identification Number
NCT01861418
Brief Title
Effects of Lumbopelvic Manipulation on Neuromuscular Activity of Back & Hip Muscles in Adults With Chronic Low Back Pain
Official Title
Effects of Lumbopelvic Manipulation on Neuromuscular Activity of Back and Hip Muscles in Adults With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Woman's University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purposes of this study are: To examine the within-day and between-day test-retest reliability of a testing protocol measuring the back and hip muscles fatigability using EMG median frequency To examine the immediate and the carry-over effects of the lumbopelvic manipulation on the EMG median frequency of the lumbar multifidus (MULT), gluteus medius (GMED) and gluteus maximus (GMAX) muscles in patients with chronic low back pain (CLBP) To compare the fatigability levels of the MULT, GMED and GMAX muscles by measuring the EMG median frequency between the participants who will receive lumbopelvic manipulation. The research hypotheses are: The testing protocol using EMG median frequency as a fatigue indicator for MULT,GMED and GMAX muscles will have good (ICC ≥ 0.80) within-day and between-day test-retest reliability. The fatigability level of the MULT, GMED and GMAX muscles will significantly decrease immediately after the lumbopelvic manipulation and will be maintained over two to four days following the manipulation. The fatigability of the MULT, GMED and GMAX muscles will significantly decrease after the intervention in the manipulation group while no change will occur in the placebo group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
chronic low back pain, low back pain, lumbopelvic manipulation, Chicago manipulation, EMG median frequency, electromyography, reliability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham manipulation
Arm Type
Placebo Comparator
Arm Description
Each participant will lie in a supine position. The treating investigator (TI) will stand on the opposite side of the low back pain. Then, the participant will be asked to clasp his/her hand behind the neck. The TI will side bend the participant's spine towards the non-painful side, reach through the participant's hands and perform a spinal rotation away from the painful side. The TIs other hand will be placed over the anterior superior iliac spine (ASIS) of the painful side. Lastly, the TI will take up the slack and maintain the pressure on the ASIS for 5-10 seconds and ask the participant whether he/she can tolerate the pressure. If the participant can tolerate the pressure for at least 5 seconds. Then, the subjects will be re-positioned to the starting position.
Arm Title
Lumbopelvic Manipulation, Chicago
Arm Type
Experimental
Arm Description
Each participant will lie in supine position. The treating investigator (TI) will stand opposite of the low back pain. Participant will clasp his/her hand behind the neck. TI will side bend the participant's spine toward non-painful side, reach through participant's hands and perform a spinal rotation away from the painful side. TI's other hand will be placed over the anterior superior iliac spine (ASIS) of the painful side. The TI will take up the slack and maintain pressure on the ASIS for 5-10 seconds and ask participant whether he/she can tolerate the pressure. If participant can tolerate the pressure for at least 5 seconds, verbal permission will be obtained from the participant and the TI will proceed and apply a high-velocity low-amplitude posterior thrust force over the ASIS.
Intervention Type
Other
Intervention Name(s)
Lumbopelvic Manipulation
Other Intervention Name(s)
Chicago Manipulation Technique
Intervention Description
Participant will lie in supine position. The treating investigator (TI) will stand on opposite side of low back pain. Participant will clasp his/her hand behind the neck. TI will side bend participant's spine towards non-painful side. TI will reach through participant's hands and perform spinal rotation away from painful side. TI's other hand will be placed over anterior superior iliac spine (ASIS) of painful side. TI will take up the slack and maintain pressure on the ASIS for 5-10 seconds and ask the participant whether he/she can tolerate the pressure. If participant can tolerate the pressure for at least 5 seconds, verbal permission will be obtained from participant and TI will proceed and apply a high-velocity low-amplitude posterior thrust force over the ASIS.
Intervention Type
Other
Intervention Name(s)
Sham manipulation
Intervention Description
Each participant will be asked to lie in a supine position. The treating investigator will stand on the opposite side of the low back pain. Then, the participant will be asked to clasp his/her hand behind the neck. The treating investigator will side bend the participant's spine towards the non-painful side to mid-range. The treating investigator will reach through the participant's hands and perform a spinal rotation away from the painful side to the mid-range. The treating investigator's other hand will be placed over the anterior superior iliac spine (ASIS) of the painful side.
Primary Outcome Measure Information:
Title
Amount of Change in Muscles Endurance
Description
electromyographic (EMG) median frequency will be used to determine the endurance of the gluteus maximums, gluteus medius and the lumbar multifidus muscles. The EMG median frequency will be measured in Hertz (Hz).
Time Frame
Baseline, Immediately, 15-minutes, 30-minutes, and two to four days after the intervention
Secondary Outcome Measure Information:
Title
Amount of Change in Pain Level
Description
Pain Visual Analogue Scale (VAS) will be used in this study. Participants will be asked to rate their pain level on a 10-cm horizontal line which is marked on the left end "No pain" and on the right end "Extreme pain". Then, the pain level for a specific participant will be determined by measuring the line from the "No pain" end to the mark placed by the participant.
Time Frame
Baseline, immediately, 15-minutes, 30-minutes, and two to four days after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Healthy subjects or the reliability phase: Inclusion Criteria: Subjects without any history of back problems Subjects without any known pathology. Exclusion Criteria: Any serious spinal condition such as tumor, fracture, or infection, Signs of nerve root compression (i.e. straight leg- raise ≤ 45° or diminished reflexes, sensation or lower extremity strength), Structural deformity, Spondylolithesis , Ankylosing spondylitis Spinal stenosis, Osteoporosis, Previous surgery to the back or the hip, and Current pregnancy. Subjects with Chronic low back pain for both the reliability and the manipulation phases: Inclusion Criteria: Participants should be between the age of 20 to 60 years. Have had complaints of chronic low back pain for at least three months. Exclusion Criteria: Any serious spinal condition such as tumor, fracture, or infection, Signs of nerve root compression (i.e. straight leg- raise ≤ 45° or diminished reflexes, sensation or lower extremity strength), Structural deformity, Spondylolithesis , Ankylosing spondylitis Spinal stenosis, Osteoporosis, Previous surgery to the back or the hip, and Current pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad A Almadan, PhD Student
Organizational Affiliation
Texas Woman's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Woman's University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effects of Lumbopelvic Manipulation on Neuromuscular Activity of Back & Hip Muscles in Adults With Chronic Low Back Pain

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