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Low Back PainNCT03785457

Standing Trunk Extension and Spinal Height in Low Back Pain

A study testing Repetitive Trunk Extension and Sustained Trunk Extension in people with Low Back Pain, run by Texas Tech University Health Sciences Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Low Back Pain
What is being tested?
Repetitive Trunk Extension and Sustained Trunk Extension
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
15 Nov 2019to 6 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability and willingness to come twice to the clinic for approximately 60 minutes each
  • Subjects with LBP and directional preference in back extension
  • Age 18-80
  • Ability to stand for 5 minutes
  • Ability to sit for 10 minutes
  • Low back pain on Numerical Pain Rating scale (NPRS) of at least 2/10 and less or equal to 9/10

Who cannot join

  • Pregnancy by subject report
  • history of back surgery or spinal fractures within the last six months
  • history of spinal fusion or physician's diagnosis of spinal instability
  • current history of acute systemic infection, active inflammatory disease, or malignancy
  • subjects engaged in legal/compensation claims for their back symptoms

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Sports Medicine & Physical Therapy

    Fredericksburg, Texas, 78624

Other trials in United States

About this study

Official title: Immediate Effect Of Standing Trunk Extension Postures On Spinal Height And Clinical Outcome Measures In Low Back Pain: A Randomized Clinical Trial

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.

Read more

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.

Read the detailed 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.

Conditions
Low Back Pain
Being tested
Repetitive Trunk Extension, Sustained Trunk Extension
Keywords
Low Back Pain, Extension, Posture, Physical Therapy
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Repetitive Trunk ExtensionOther

    Subjects will be asked to perform standing repetitive trunk extension at a rate of 10 per 45 seconds (Figure 2), repeated five times with 15-second rest breaks.

  • Sustained Trunk ExtensionOther

    Subjects will be asked to perform standing sustained trunk extension for 5 x 45 seconds with 15-second rest breaks.

Study groups in NCT03785457
Study groupRoleWhat they receive
Repetitive Trunk ExtensionExperimentalParticipants with low back pain will be asked to perform standing repetitive trunk extension at a rate of 10 per 45 seconds, repeated five times with 15-second rest breaks
Receives: Other: Repetitive Trunk Extension
Sustained Trunk ExtensionExperimentalParticipants with low back pain will be asked to perform standing sustained trunk extension for 5 x 45 seconds with 15-second rest breaks
Receives: Other: Sustained Trunk Extension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Spinal Height (Stadiometry)

    Spinal height of subjects measured in stadiometer (mm) from 100 to 2000 mm.

    Measured: Before intervention at first visit

  2. Spinal Height (Stadiometry)

    Spinal height of subjects measured in stadiometer (mm) from 100 to 2000 mm. Height will be compared to height at initial measure. Greater height than at initial measure will indicate height gain.

    Measured: Immediately after intervention at first visit

  3. Spinal Height (Stadiometry)

    Spinal height of subjects measured in stadiometer (mm) from 100 to 2000 mm. Height will be compared to height at initial measure. Greater height than at initial measure will indicate height gain.

    Measured: 2-week following initial visit

Secondary outcomes (11)
  1. Lumbar Extension range of motion (Inclinometer)

    Lumbar extension range of motion measured using bubble inclinometers (degrees) from 0 to 180 degrees. Greater numbers indicate greater trunk extension range of motion.

    Measured: Before intervention at first visit

  2. Lumbar Extension range of motion (Inclinometer)

    Lumbar extension range of motion measured using bubble inclinometers (degrees) from 0 to 180 degrees. Greater numbers indicate greater trunk extension range of motion.

    Measured: Immediately after intervention at first visit

  3. Lumbar Extension range of motion (Inclinometer)

    Lumbar extension range of motion measured using bubble inclinometers (degrees) from 0 to 180 degrees. Greater numbers indicate greater trunk extension range of motion.

    Measured: 2-week following initial visit

  4. Pain (Numerical pain rating scale - NPRS)

    Pain (Numerical Pain Rating Scale - NPRS) from 0 (no pain) to 10 (most severe pain requiring emergency room consultation)

    Measured: Before intervention at first visit

  5. Pain (Numerical pain rating scale - NPRS)

    Pain (Numerical Pain Rating Scale - NPRS) from 0 (no pain) to 10 (most severe pain requiring emergency room consultation)

    Measured: After intervention at first visit

  6. Pain (Numerical pain rating scale - NPRS)

    Pain (Numerical Pain Rating Scale - NPRS) from 0 (no pain) to 10 (most severe pain requiring emergency room consultation)

    Measured: 2-week following initial visit

  7. Centralization (Dallas Pain Diagram)

    Centralization of symptoms will be assessed using Dallas Pain diagram. A numeric overlay template will be applied to the patient's body diagram to document the most distal pain location scores between 1 and 6. Higher score will indicate a more distal symptoms' location.

    Measured: Before intervention at first visit

  8. Centralization (Dallas Pain Diagram)

    Centralization of symptoms will be assessed using Dallas Pain diagram. A numeric overlay template will be applied to the patient's body diagram to document the most distal pain location scores between 1 and 6. Higher score will indicate a more distal symptoms' location.

    Measured: After intervention at first visit

  9. Centralization (Dallas Pain Diagram)

    Centralization of symptoms will be assessed using Dallas Pain diagram. A numeric overlay template will be applied to the patient's body diagram to document the most distal pain location scores between 1 and 6. Higher score will indicate a more distal symptoms' location.

    Measured: 2-week following initial visit

  10. Modified Oswestry low back pain questionnaire

    The questionnaire measures how well patient function in life with scale from 0 (normal-no disability) to 100 (crippled with severe disability).

    Measured: Before intervention at first visit

  11. Modified Oswestry low back pain questionnaire

    The questionnaire measures how well patient function in life with scale from 0 (normal-no disability) to 100 (crippled with severe disability).

    Measured: 2-week following initial visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2018
  2. Study start15 Nov 2019
  3. Primary completion6 Mar 2022
  4. Study completion6 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03785457
Sponsor's protocol ID
L19-024
Status last verified
Mar 2022
First submitted
12 Dec 2018
Last updated
21 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ibrahim MA, Brismee JM, Farouk O, Said HG, Abdelhameed B, Beltagi A. Immediate Weight-Bearing after tibial plateau fractures Enhances spatiotemporal gait parameters and minimize fall Risk: A randomized clinical trial. J Biomech. 2025 May;184:112668. doi: 10.1016/j.jbiomech.2025.112668. Epub 2025 Apr 2.

    PubMed 40188679

Questions about this trial

What is this clinical trial studying?

A study testing Repetitive Trunk Extension and Sustained Trunk Extension in people with Low Back Pain, run by Texas Tech University Health Sciences Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spinal Height (Stadiometry) (time frame: Before intervention at first visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03785457, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.

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