Standing Trunk Extension and Spinal Height in Low Back Pain

NCT03785457 | Completed

• 1 other identifier: L19-024
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain

Keywords

Low Back Pain; Extension; Posture; Physical Therapy

Outcome Measures

Primary Outcomes (3)

• Spinal Height (Stadiometry)

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

  Before intervention at first visit

• 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.

  Immediately after intervention at first visit

• 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.

  2-week following initial visit

Secondary Outcomes (11)

• Lumbar Extension range of motion (Inclinometer)

  Before intervention at first visit

• Lumbar Extension range of motion (Inclinometer)

  Immediately after intervention at first visit

• Lumbar Extension range of motion (Inclinometer)

  2-week following initial visit

• Pain (Numerical pain rating scale - NPRS)

  Before intervention at first visit

• Pain (Numerical pain rating scale - NPRS)

  After intervention at first visit

Study Arms (2)

Repetitive Trunk Extension

EXPERIMENTAL

Participants 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

Other: Repetitive Trunk Extension

Sustained Trunk Extension

EXPERIMENTAL

Participants with low back pain will be asked to perform standing sustained trunk extension for 5 x 45 seconds with 15-second rest breaks

Other: Sustained Trunk Extension

Interventions

Repetitive Trunk Extension OTHER

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.

Repetitive Trunk Extension

Sustained Trunk Extension OTHER

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

Sustained Trunk Extension

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Sports Medicine & Physical Therapy

Fredericksburg, Texas, 78624, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The primary investigator will be blinded to the measurements of spinal height using stadiometry, and to the group assignment of each participant (sustained versus repetitive extension postures)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 24, 2018
• Study Start: November 15, 2019
• Primary Completion: March 6, 2022
• Study Completion: March 6, 2022
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

US (1)