Clinical trial NCT01861418: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: chronic low back pain
low back pain
lumbopelvic manipulation
Chicago manipulation
EMG median frequency
electromyography
reliability
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Amount of Change in Muscles Endurance
timeFrame: Baseline, Immediately, 15-minutes, 30-minutes, and two to four days after the intervention
Secondary outcomes:
measure: Amount of Change in Pain Level
timeFrame: Baseline, immediately, 15-minutes, 30-minutes, and two to four days after the intervention
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas Woman's University
state: Texas
Study officials:
affiliation: Texas Woman's University
name: Mohammad A Almadan, PhD Student
role: PRINCIPAL_INVESTIGATOR
References: