Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03785457 |
| Other study ID # |
L19-024 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 15, 2019 |
| Est. completion date |
March 6, 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Texas Tech University Health Sciences Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: Standing trunk extension postures have been used for many years as a mechanical
approach to low back pain (LBP), sometimes directed by therapeutic intervention, sometimes
subconsciously performed by patientsto relieve LBP. However, no study to date has
investigated the effect of standing trunk extension postures on spinal height and clinical
outcome measures.
Objective: The purpose of this study will be to evaluate in subjects with LBP following a
period of trunk loading, how spinal height and/or pain, symptoms' centralization, and
function outcome measures respond to:(1) standing repetitive trunk extension posture; and (2)
standing sustained trunk extension posture. Lumbar range of motion (ROM) achieved during
these two trunk extension postures will be compared to spinal height and outcome measures.
Methods:A pre-test, post-test comparison group design (randomized clinical trial) will be
used to determine how spinal height changes in response to sustained and repetitive standing
trunk extension after a period of spinal loading. The study will evaluate the effects of
sustained and repetitive trunk extension in standing on spinal height, pain, symptoms'
centralization and function.
Statistical Analysis: A mixed ANOVA will be used to statistically identify significant
interactions and main effects for spinal height, pain and functionoutcome measures. Post-hoc
pairwise comparisons will be used to locate significant differences between the different
conditions. Significance will be set at α = 0.05. The Kruskal-Wallis 1-factor ANOVA for
difference scores will used to determine changes of intensity and location of symptoms
following sustained versus repetitive standing trunk extension. Spearman Rank correlation
will be used to evaluate the relationship between spinal height changes and changes of pain
and location of symptoms for each group.
Description:
Standing trunk extension postures have been used for many years as a mechanical approach to
low back pain (LBP), sometimes directed by therapeutic intervention, sometimes subconsciously
performed by patients to relieve LBP. However, no study to date has investigated the effects
of standing extension postures on spinal height, pain, centralization and function.
Therefore, the purposes of this study will be to evaluate in a sample of LBP patients the
effect of standing trunk extension, both sustained and repetitive, following a period of
spinal loading, on (1) spinal height; (2) pain; (3) symptoms centralization and (4)
functional measures.
Research Design(s) A pre-test, post-test comparison group design (randomized clinical trial)
will be used to determine how spinal height changes in response to sustained and repetitive
standing trunk extension after a period of spinal loading. The study will use a 2 (between
subjects - type of trunk extension: sustained vs. repetitive) x 3 (within subjects - time:
before vs. after vs. 2 weeks after) mixed design to evaluate the effects of sustained and
repetitive trunk extension in standing on spinal height, pain, centralization and function
outcome measures.
Subjects / Specimens Systematic consecutive sampling of up to 100 subjects with LBP (40
subjects completing both days of data collection) attending "Sports medicine and Physical
therapy clinic" in Fredericksburg (Texas) as patients or for the purpose of health and
wellness will be recruited. Flyers will also be posted at physician offices and the general
Fredericksburg community and surrounding areas to inform subjects about the study.
Testing Sequence Subjects will be asked to attend two physical therapy sessions over
approximately a 60-minute period each to complete the study.
SESSION 1
Participants will complete a pre-screening questionnaire regarding inclusion. Each subject
will watch an audio-visual power point presentation explaining the study, test procedures and
describing the interventions (standing repetitive trunk extension and standing sustained
trunk extension). Written informed consent will be obtained. To determine directional
preference, the investigator (JH) will use the guidelines set forth in the directional
preference definition and based off of standards set forth in randomized clinical trials.
Directional preference has been defined as either (1) a specific direction of trunk movement
or posture noted during the physical examination or (2) a specific easing factor reported by
the patient during the subjective history that alleviates or decreases the patient's pain,
with or without the pain having changed location and/or increased the patient's lumbar range
of motion. A questionnaire including pertinent medical history will be completed. Subjects
will complete (1) a Numerical Pain Rating Scale (NPRS) to rate their current, minimum,
maximum and average LBP over the last two days as well as paresthesia signs/symptoms
intensity; (2) Body Diagram for indicating location of symptoms; (3) Modified Oswestry low
back pain questionnaire; (4) Fear Avoidance Belief Questionnaire. A researcher will record
subject's height and weight.
If the subject meets criteria for inclusion in the study, the subject will complete a
familiarization procedure to determine the consistency to reposition themselves in the
stadiometer. Subjects able to reposition themselves in the stadiometer with a SD of 1.3mm or
less for five consecutive measurements will be included in the study. The digital display
will be covered to blind the researcher performing the measurements. The data will be
automatically recorded by the stadiometer and manually downloaded to a laptop computer.
At the beginning of data collection, a randomization plan generator
(http://www.randomization.com ) will assign each subject to one of two interventions: (1)
standing repetitive trunk extension at a rate of 10 per 45 seconds, repeated five times with
15-second rest breaks; or (2) standing sustained trunk extension for 5 x 45 seconds with
15-second rest breaks. Each subject will complete one intervention. The intervention number
assigned will be recorded by the subject next to their name to allow blinding of the
investigator as to which intervention the subject is assigned to. The subject will undergo
the test sequence after a 10-minute period of trunk unloading in a supine posture to ensure
spinal height is normalized, head in neutral posture, knees supported over a small bolster
pillow, hands placed on the abdomen. The subject will reposition on the stadiometer and
spinal height will be measured after a relaxed exhalation. The subject then will undergo a
five-minute period of loaded upright sitting with a 4.5kg bag secured on each shoulder and
spinal height will be measured (Measurement 2). As continued spinal height reduction has been
demonstrated following loaded sitting, the subject will undergo an additional five minutes
sitting without load and spinal height will be measured (Measurement 3). Inclinometers will
be used to take an initial measure of each subject trunk extension prior to intervention. The
subject will then undergo one intervention for 5 minutes as previously described, according
to the randomization assignment. In order to determine how sustained and repetitive
interventions related in terms of change in spinal height, the time to perform the sustained
lumbar posture matches the time necessary to perform the repetitive lumbar extension
postures.
The subject will reposition on the stadiometer and spinal height will be measured
(Measurement 4). Trunk extension will be measured to determine the strength of correlations
between the degree of trunk extension during standing trunk extension posture and spinal
height, pain and centralization testing outcomes changes. The subject will score their low
back and lower extremity symptoms using NPRS, and map their pain on a body pain diagram prior
to intervention, immediately after and 2-week following the intervention to determine pain
rating and centralization of symptoms. The principal investigator will apply a numeric
overlay template to the patient's body diagrams to document the most distal pain location
scores between 1 and 6. Higher score will indicate a more distal symptoms' location.
Home instructions Subjects will be instructed to continue to use their medications, including
medications aimed at decreasing their pain, as prescribed by their primary healthcare
provider and not to change them during the follow-up two-week period. A sheet including home
exercise instructions will be provided to each patient. Instructions will include repetitive
or sustained trunk extension based on random group assignment, performed approximately 5
times per day. Each subject will complete a sheet recording home exercise compliance upon
arrival in session 2.
SESSION 2
Subjects will complete: (1) a NPRS to rate their current, minimum, maximum and average LBP
over the last two days as well as paresthesia signs/symptoms intensity; (2) Body Diagram for
indicating location of symptoms; (3) Modified Oswestry low back pain questionnaire; (4) Fear
Avoidance Belief Questionnaire. Each subject will then complete a familiarization procedure
to determine the consistency to reposition themselves in the stadiometer as described in
session 1. The subject will undergo a 10-minute period of trunk unloading in a supine posture
to ensure spinal height is normalized as described in session 1. The subject will reposition
on the stadiometer and spinal height will be measured after a relaxed exhalation (Measurement
1). The subject then will undergo a five-minute period of loaded upright sitting with a 4.5kg
bag secured on each shoulder and spinal height will be measured. The subject will then
undergo an additional five minutes sitting without load and spinal height will be measured
(Measurement 3). Inclinometers will be used to take an initial measure of each subject trunk
extension prior to intervention. The subject will then undergo the same intervention as in
session 1 for 5 minutes as previously described (standing repetitive trunk extension or
standing sustained trunk extension). The subject will reposition on the stadiometer and
spinal height will be measured (Measurement 4). Trunk extension will be measured to determine
the strength of correlations between the degree of trunk extension during standing trunk
extension posture and spinal height, pain and centralization testing outcomes changes. The
subjects will then score their low back and lower extremity symptoms using NPRS, and map
their pain on a body pain diagram.
Investigator Blinding Two investigators will be involved with data collection and will carry
out inclinometer measurements of lumbar and sacral posture, supervised positioning in the
stadiometer and stadiometric measurements. The measuring investigator will be blinded to the
intervention (each subject will receive a hidden random number and will perform independently
the intervention in a treatment room) and the stadiometric measurements during the
experiment. He will also be responsible for assigning subjects to their initial groups,
supervising the subjects' positioning in the different standing postures and confirming that
a stadiometer reading is recorded on an Excel spreadsheet.
Subjects Charges There will be no charge for the two physical therapy sessions, including
examination and intervention. Following the two intervention sessions, subjects referred by
primary care providers (physicians, chiropractors, nurse practitioners, physician assistants)
to physical therapy for LBP will have the choice to receive standard care and be charged for
physical therapy intervention.
