ClinicalTrials.gg
CompletedNCT01221233Updated Oct 28, 2019Results posted

Investigation of Trunk Muscle Size and Function in Older Adults With Chronic Low Back Pain

An interventional study of Neuromuscular Electrical Stimulation and Moist Heat in Low Back Pain, sponsored by University of Delaware. Completed at 1 site in United States. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-10-28.

Sponsored by University of Delaware · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
60 Years to 85 Years
Sex
All
01

Study summary

Rehabilitative Ultrasound Imaging (US) is a procedure used to evaluate skeletal muscle size and function to inform clinical practice. US has been shown to be a reliable and valid tool for measuring changes in trunk muscle (i.e. abdominal and back muscle) size and activity during sub-maximal contractions in younger populations. Younger adults with low back pain as compared with healthy adults without pain demonstrate smaller back muscle size, lower back muscle activity, and greater back muscle asymmetry (differences in right side compared with left side).

No trials are published evaluating muscle adaptations using US in response to clinical treatments for low back pain in the older adult population. Increased muscle size and improved muscle symmetry have been reported in younger adults with low back pain who participate in low back stabilization exercises. These exercises use voluntary contractions of the back muscles with prolonged hold times and low loads. Neuromuscular Electrical Stimulation (NMES) is a treatment modality that increases muscle activity when voluntary activity is impaired and increases muscle size. Most studies assessing muscle size and activity in response to NMES have been conducted in the knee muscles (i.e. the quadriceps), while the impact of NMES on the back muscles remains relatively unexplored. Given the potential to evaluate back muscle size and activity with US, this assessment tool may be used to document muscle adaptations to a clinical intervention in older adults with low back pain.

The purpose of this study is to conduct a 6-week clinical trial to determine if NMES plus lumbar stabilization exercises (i.e. NMES AND Stabilization Exercises) is superior to lumbar stabilization exercises (i.e. Moist Heat AND Stabilization Exercises) for improving back muscle size, activity, and side-to-side (i.e. right side versus left side) symmetry in older adults with chronic low back pain (i.e. low back pain of greater than 3 months). Muscle size, activity, and symmetry will be assessed using US before and after the treatments to determine if the treatments positively impact muscle. Secondary clinical measures of success will include improvements in physical, psychological, and social function pre- to post-treatment.

02

Conditions studied

  • Low Back Pain

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03

In context

Low Back Pain

2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.

This study's enrollment of 38 is below the median of 60 across 2,315 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

University of Delaware is the lead sponsor of 128 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: This study will use a sample consisting of 36, English-speaking and English-reading, older male and female adults (ages 60-85 years) with chronic low back pain, i.e. pain of greater than 3 months duration. During the examination, potential participants must have 2/4 of the following for inclusion, based on previous work by Hicks et al, which outlined clinical predictors of success with a trunk muscle stabilization exercise program:

  1. Fear-Avoidance Beliefs Questionnaire (FABQ) Physical Activity Sub-Scale score ≥9: The FABQ is a measure of an individual's beliefs regarding the impact of physical activity and work on his/her low back pain. The FABQ is comprised of two sub-scales: physical activity and work. Higher FABQ scores have been shown to predict pain and disability in individuals with chronic low back pain.
  2. Aberrant Movement: Aberrant movement may be classified as any one of the following: (1) an "instability catch", defined as deviation from the plane of movement during flexion or extension; (2) "thigh climbing", which is defined as using the hands and pushing on the thighs to assist in obtaining an upright trunk position; (3) a "painful arc of motion", when flexing or returning to upright from a flexed spinal position; or (4) "reversal of the lumbopelvic rhythm", where the trunk is first extended and then the hips and pelvis extend to bring the body upright from a flexed position.
  3. Posterior-to-Anterior Segmental Hypermobility: The participant will lie on his/her stomach and the examiner will apply a posterior-to-anterior (back-to-front) force over the spinous processes from S1 to T12 (just below the belt-line to the rib cage). The available mobility will be graded hypermobile (too much motion), normal, or hypomobile (too little motion).
  4. Positive Prone Instability Test: The participant will lie on his/her stomach with the legs off the edge of the table and the feet resting on the floor. The examiner will apply a posterior-to-anterior pressure at each spinous process (T12-S1). Any provocation of pain will require the participant to lift their legs off the floor while the pressure is reapplied to the painful level. If the pain subsides with elevation of the legs, this is considered a positive test.

Exclusion Criteria: Exclusion criteria for participants includes (1) history of low back surgery; (2) recent trauma (i.e. motor vehicle accident, fall, etc. ); (3) receipt of services for low back pain within the last 6 months; (4) non-ambulatory or severely impaired mobility (i.e. use of an assistive device greater than a cane); (5) severe hearing or visual impairment; (6) non-mechanical low back pain; (7) neurological disorder; (8) presence of an acute illness; (9) diagnosis of scoliosis; (10) symptoms related to the back below the knee; (11) presence of a pacemaker; (12) participation in R21 clinical trial ongoing at the University of Delaware Physical Therapy Clinic; or (13) the inability to participate in the study for the full six weeks for any known reason (i.e. moving away, extended vacation). Potential participants will also be excluded if during the evaluation any of the following are found:

  1. score \< 24 on the Folstein Mini-Mental State Examination (MMSE): As scores greater than or equal to 24 may identify individuals who are cognitively intact, this screening tool will exclude those older adults with questionable reliability (i.e. consistency) on the self-report questionnaires secondary to cognitive impairment.
  2. Modified Oswestry Low Back Pain Questionnaire (mOSW) score \< 14 percent: This questionnaire will exclude those individuals with chronic low back pain who demonstrate minimal low back pain-related disability. Individuals with minimal disability may not be representative of those seeking outpatient physical therapy services for their back pain.
  3. Facial Pain Scale-Revised (FPS-R) "worst" low back pain rating in last 24 hours of \< 3/10: Pain rating ≥ 3/10 is being used in the hopes of recruiting a group of individuals who may be representative of those likely to seek clinical services for their low back pain. Also, all FPS-Rs ("current", "best", and "worst") will be used to document the impact of treatment on self-reported pain.
  4. Inability to tolerate lying on belly with legs straight: This is a requirement for our standardized position for ultrasound.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    NMES AND Stabilization Exercises

    Neuromuscular Electrical Stimulation and Lumbar Stabilization Exercises

    Other: Neuromuscular Electrical Stimulation

  • Active comparator
    Moist Heat AND Stabilization Exercises

    Moist Heat and Lumbar Stabilization Exercises

    Other: Moist Heat

Interventions

  • OtherNeuromuscular Electrical Stimulation

    Neuromuscular Electrical Stimulation (NMES) to the low back muscles (i.e. spinal extensors) will be applied at the parameters previously used in the knee muscles at the maximal tolerable intensity, which results in a full, sustained isometric contraction of the back muscles. Pad placement will be just below the waist line, with 2, 2X2 inch pads, on either side of the spine. Participants will be positioned on their belly with 2 pillows under their stomach to level the spine and secured to a table using a belt that crosses the buttock. The lumbar stabilization program will include exercises targeting the back muscles in three positions: standing, prone (belly), and quadruped (hands and knees).

    Also known as: Lumbar Stabilization Exercises

  • OtherMoist Heat

    For participants who do not receive NMES, moist heat will be applied for 15 minutes in a position of comfort for the participant. The lumbar stabilization program will include exercises targeting the back muscles in three positions: standing, prone (belly), and quadruped (hands and knees).

    Also known as: Lumbar Stabilization Exercises

06

What researchers measure

Primary outcomes

  1. Difference in Percent Change From Baseline in L4 Paraspinal Cross-Sectional Area Asymmetry at 6 Weeks Between Intervention Arms

    Percent change (baseline-6 weeks)/baseline X100% was calculated for each participant in each intervention arm and then these differences were compared using a Mann-Whitney U test since data did not meet parametric assumptions.

    Time frame: Baseline and 6 Weeks

07

Results

Posted Oct 28, 2019
Limitations and caveats
Lack of long-term follow-up; short-duration intervention may have been insufficient for muscle change

Participant flow

Participant flow — Overall Study
MilestoneNMES AND Stabilization ExercisesMoist Heat AND Stabilization Exercises
Started1820
Completed1519
Not completed31
Withdrew: Withdrawal by subject31

Outcome measures

PrimaryDifference in Percent Change From Baseline in L4 Paraspinal Cross-Sectional Area Asymmetry at 6 Weeks Between Intervention Arms

Percent change (baseline-6 weeks)/baseline X100% was calculated for each participant in each intervention arm and then these differences were compared using a Mann-Whitney U test since data did not meet parametric assumptions.

Time frame:
Baseline and 6 Weeks
Reported as:
Median · % change
Difference in Percent Change From Baseline in L4 Paraspinal Cross-Sectional Area Asymmetry at 6 Weeks Between Intervention Arms
% changeNMES AND Stabilization ExercisesMoist Heat AND Stabilization Exercises
Difference in Percent Change From Baseline in L4 Paraspinal Cross-Sectional Area Asymmetry at 6 Weeks Between Intervention Arms0 (-57.1 to 104.3)-17.6 (-51.1 to 250.0)
Statistical analysis
  • NMES AND Stabilization Exercises · Wilcoxon (Mann-Whitney) · p = 1.000 · Median difference (final values): 17.6

Adverse events

Collected over Baseline, 6 weeks of intervention, and 6-week follow-up.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
NMES AND Stabilization Exercises0/18 (0%)0/18 (0%)1/18 (5.6%)
Moist Heat AND Stabilization Exercises0/20 (0%)0/20 (0%)0/20 (0%)
Most frequent other events
Most frequent other events
EventNMES AND Stabilization ExercisesMoist Heat AND Stabilization Exercises
PruritusSkin and subcutaneous tissue disorders1/180/20

Baseline characteristics

Age, Continuous
Age, Continuous(years)NMES AND Stabilization ExercisesMoist Heat AND Stabilization ExercisesTotal
Mean71.9 ± 7.671.3 ± 7.771.6 ± 7.6
Sex: Female, Male
Sex: Female, Male(Participants)NMES AND Stabilization ExercisesMoist Heat AND Stabilization ExercisesTotal
Female7916
Male81018
Race (NIH/OMB)
Race (NIH/OMB)(Participants)NMES AND Stabilization ExercisesMoist Heat AND Stabilization ExercisesTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American022
White151732
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)NMES AND Stabilization ExercisesMoist Heat AND Stabilization ExercisesTotal
United States151934
Modified Oswestry Disability Index
Modified Oswestry Disability Index(%)NMES AND Stabilization ExercisesMoist Heat AND Stabilization ExercisesTotal
Mean25.5 ± 8.722.2 ± 7.923.6 ± 8.3
Fear-Avoidance Beliefs Questionnaire-Physical Activity Subscale
Fear-Avoidance Beliefs Questionnaire-Physical Activity Subscale(scores on a scale)NMES AND Stabilization ExercisesMoist Heat AND Stabilization ExercisesTotal
Mean13.7 ± 4.415.2 ± 6.514.5 ± 5.7
Left L4/5 Lumbar Multifidus Activity
Left L4/5 Lumbar Multifidus Activity(percentage of activity)NMES AND Stabilization ExercisesMoist Heat AND Stabilization ExercisesTotal
Mean11.1 ± 5.612.3 ± 4.911.8 ± 5.2
Right L4/5 Lumbar Multifidus Activity
Right L4/5 Lumbar Multifidus Activity(percentage of activity)NMES AND Stabilization ExercisesMoist Heat AND Stabilization ExercisesTotal
Mean9.5 ± 6.011.8 ± 4.410.8 ± 5.3

3 further baseline measures are reported on the registry.

08

Study locations

1 site
  • University of Delaware
    Newark, Delaware 19716, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 8, 2010

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2011 to primary completion in Nov 2011, 9 months.

Results were first posted in Oct 2019, 7 years 11 months after primary completion.

Of 1,187 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 9 months is below that.

Counting every sponsor, half of 1,246 studies reached it within 11 months; a quarter within 5 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2010
First posted
Oct 14, 2010
StartActual
Feb 14, 2011
Primary completionActual
Nov 22, 2011
CompletionActual
Nov 22, 2011
Results first posted
Oct 28, 2019
Last update
Oct 28, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01221233
Responsible party
Jaclyn Sions (Assistant Professor, Physical Therapy, University of Delaware) — Principal investigator
First posted
Oct 14, 2010
Start date
Feb 14, 2011
Primary completion
Nov 22, 2011
Completion
Nov 22, 2011
Results posted
Oct 28, 2019
Last update
Oct 28, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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