ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01861418
Recruitment Status : Completed
First Posted : May 23, 2013
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Texas Woman's University

May 20, 2013
May 23, 2013
October 12, 2017
April 2013
July 2017   (Final data collection date for primary outcome measure)
Amount of Change in Muscles Endurance [ Time Frame: Baseline, Immediately, 15-minutes, 30-minutes, and two to four days after the intervention ]
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).
EMG median Frequency [ Time Frame: Baseline, Immediately, 15-minutes, 30-minutes, and two to four days after the intervention ]
Complete list of historical versions of study NCT01861418 on ClinicalTrials.gov Archive Site
Amount of Change in Pain Level [ Time Frame: Baseline, immediately, 15-minutes, 30-minutes, and two to four days after the intervention ]
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.
Visual Analogue Scale (VAS) [ Time Frame: Baseline, immediately, 15-minutes, 30-minutes, and two to four days after the intervention ]
Not Provided
Not Provided
 
Effects of Lumbopelvic Manipulation on Neuromuscular Activity of Back & Hip Muscles in Adults With Chronic Low Back Pain
Effects of Lumbopelvic Manipulation on Neuromuscular Activity of Back and Hip Muscles in Adults With Chronic Low Back Pain

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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Chronic Low Back Pain
  • Other: Lumbopelvic Manipulation
    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.
    Other Name: Chicago Manipulation Technique
  • Other: 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 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.
  • Placebo Comparator: Sham manipulation
    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.
    Intervention: Other: Sham manipulation
  • Experimental: Lumbopelvic Manipulation, Chicago
    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: Other: Lumbopelvic Manipulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
55
July 2017
July 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01861418
TexasWU
Yes
Not Provided
Not Provided
Texas Woman's University
Texas Woman's University
Not Provided
Principal Investigator: Mohammad A Almadan, PhD Student Texas Woman's University
Texas Woman's University
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP