NCT07203430

Brief Summary

The purpose of this study is to evaluate the longitudinal effects of a four-week dynamic resistance training program using the 45-degree Roman chair on pain sensitivity changes after exercise and lumbar muscle performance in individuals with chronic low back pain (LBP). This study will consist of three specific aims. Aim 1 examines changes in local exercise-induced hypoalgesia. Aim 2 will assess changes in lumbar multifidus and erector spinae thickness using ultrasound imaging before and after the intervention. Aim 3 will evaluate changes in lumbar extensor strength (handheld dynamometry (HHD)) and endurance (Biering-Sørensen test).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

October 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2026

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

September 22, 2025

Last Update Submit

April 9, 2026

Conditions

Keywords

ExerciseLow Back Pain

Outcome Measures

Primary Outcomes (4)

  • Exercise Induced Hypoalgesia

    Participants will perform one set of back extension exercise on a 45-degree Roman chair until volitional exhaustion. Pressure Pain Threshold applied over the low back will be examined before and after exercise.

    Weeks 1 and 4

  • Muscle Thickness

    Ultrasound imaging to assess muscle thickness of the erector spinae and the multifidus muscles will be completed.

    Weeks 1 and 4

  • Muscle Strength

    Back extensor strength will be assessed using maximal voluntary isometric contraction of the back extensor muscles using a handheld dynamometer.

    Weeks 1 and 4

  • Muscle Endurance

    The Biering-Sorensen test will be performed in which participants lie prone on a treatment table with the lower body secured to the table. Participants will be instructed to cross their arms over their chest and maintain their torso in a horizontal position with the upper body unsupported, parallel to the floor.

    Weeks 1 and 4

Study Arms (2)

Intervention Group

EXPERIMENTAL

During visits 2-13, participants will attend 2-3 sessions per week, with a minimum of 48 hours between visits, and must complete all study visits 6 weeks after enrollment. Participants in the intervention group will perform 3 sets of low back extension exercise on the Roman chair until volitional exhaustion. The three sets will be performed to volitional exhaustion or 20 repetitions, whichever comes first. If more than 20 repetitions can be completed after a set the investigator will add resistance according to the NSCA's guidelines (2.5-10% increase).

Other: 45-Degree Roman Chair Exercise

Control Group

NO INTERVENTION

Participants in the control group will not complete the low back extension exercise and will be told to continue activity as usual. All participants will complete a training log and detail the type of resistance exercise performed, the number of sets and repetitions completed, and the weight used.

Interventions

Participants in the intervention group will perform 3 sets of low back extension exercise on the Roman chair until volitional exhaustion. The three sets will be performed to volitional exhaustion or 20 repetitions, whichever comes first. If more than 20 repetitions can be completed after a set the investigator will add resistance according to the NSCA's guidelines (2.5-10% increase).

Intervention Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • chronic low back pain lasting ≥ 12 weeks
  • current pain intensity ≥ 3/10 but no higher than an 8/10 on the Numeric Pain Rating Scale (NPRS) within the past 48 hours
  • resistance trained (defined as 2x/week for the past 8-12 weeks)
  • able to read and speak English for informed consent and completion of questionnaires
  • willing and physically able to complete all testing and intervention sessions.

You may not qualify if:

  • History of spinal surgery, fusion, or fracture within the past 6 months
  • diagnosed degenerative disc disease, scoliosis, or spinal pathology that precludes safe exercise participation
  • use of an assistive device for walking (cane, walker) within the past year
  • pregnancy, due to contraindications for exercise testing and ultrasound -body weight ≥ 300 lbs., which exceeds the safe capacity of the Roman chair --
  • current tobacco/nicotine use
  • current enrollment in physical therapy or structured rehabilitation for LBP,
  • cardiovascular, pulmonary, metabolic, or systemic disease that increases risk during exercise
  • nociplastic pain conditions (e.g., fibromyalgia) or neurological conditions that confound EIH responses
  • inability to complete ≥ 8 Roman chair repetitions with proper form during screening
  • non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

Location

MeSH Terms

Conditions

Low Back PainBronchiolitis Obliterans SyndromeMotor Activity

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 22, 2025

First Posted

October 2, 2025

Study Start

October 15, 2025

Primary Completion

April 9, 2026

Study Completion

April 9, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations