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Completed

NCT Number: NCT01861418

Effects of Lumbopelvic Manipulation on Neuromuscular Activity of Back & 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.

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Key information

Conditions

Chronic Low Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Woman's University

Dallas, Texas, 75235, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumbopelvic manipulation

Other

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 names: Chicago Manipulation Technique

Sham Manipulation

Other

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 outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Texas Woman's University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 23, 2013
Registry last updated
Oct 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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