Trial record 16 of 258 for:    Open Studies | "Back Pain"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Texas Woman's University
Sponsor:
Information provided by (Responsible Party):
Texas Woman's University
ClinicalTrials.gov Identifier:
NCT01861418
First received: May 20, 2013
Last updated: February 20, 2014
Last verified: July 2013
  Purpose

The purposes of this study are:

  1. 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
  2. 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)
  3. 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:

  1. 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.
  2. 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.
  3. 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.

Condition Intervention
Chronic Low Back Pain
Other: Lumbopelvic Manipulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Lumbopelvic Manipulation on Neuromuscular Activity of Back and Hip Muscles in Adults With Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Texas Woman's University:

Primary Outcome Measures:
  • Amount of Change in Muscles Endurance [ Time Frame: Baseline, Immediately, 15-minutes, 30-minutes, and two to four days after the intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, immediately, 15-minutes, 30-minutes, and two to four days after the intervention ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 55
Study Start Date: April 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sham manipulation
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. The treating investigator will reach through the participant's hands and perform a spinal rotation away from the painful side. The treating investigator's other hand will be placed over the anterior superior iliac spine (ASIS) of the painful side. Lastly, the treating investigator 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.
Experimental: Lumbopelvic Manipulation, Chicago Manipulation Technique
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. The treating investigator will reach through the participant's hands and perform a spinal rotation away from the painful side. The treating investigator's other hand will be placed over the anterior superior iliac spine (ASIS) of the painful side. Lastly, the treating investigator 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, a verbal permission will be obtained from the participant and then the treating investigator will proceed and apply a high-velocity low-amplitude posterior thrust force over the ASIS.
Other: Lumbopelvic Manipulation
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. The treating investigator will reach through the participant's hands and perform a spinal rotation away from the painful side. The treating investigator's other hand will be placed over the anterior superior iliac spine (ASIS) of the painful side. Lastly, the treating investigator 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, a verbal permission will be obtained from the participant and then the treating investigator will proceed and apply a high-velocity low-amplitude posterior thrust force over the ASIS.
Other Name: Chicago Manipulation Technique

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01861418

Locations
United States, Texas
Texas Woman's University Recruiting
Dallas, Texas, United States, 75235
Contact: Sharon Wang, PhD    214-689-7715    swang@twu.edu   
Sponsors and Collaborators
Texas Woman's University
Investigators
Principal Investigator: Mohammad A Almadan, PhD Student Texas Woman's University
Study Director: Sharon Wang, PhD Texas Woman's University
  More Information

No publications provided

Responsible Party: Texas Woman's University
ClinicalTrials.gov Identifier: NCT01861418     History of Changes
Other Study ID Numbers: TexasWU
Study First Received: May 20, 2013
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Woman's University:
chronic low back pain
low back pain
lumbopelvic manipulation
Chicago manipulation
EMG median frequency
electromyography
reliability

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014