Low Back Pain, ChronicNCT07203430
Biopsychosocial Factors and Muscle Morphology After a Resistance Exercise
A study testing 45-Degree Roman Chair Exercise in people with Low Back Pain, Chronic, run by University of Central Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Low Back Pain, Chronic
- What is being tested?
- 45-Degree Roman Chair Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2025to 9 Apr 2026
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32816
About this study
Official title: Assessing Adaptations in Biopsychosocial Factors and Muscle Morphology After a Resistance Exercise Intervention in Individuals With Low Back Pain
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).
- Conditions
- Low Back Pain, Chronic
- Being tested
- 45-Degree Roman Chair Exercise
- Keywords
- Exercise, Low Back Pain
- Medical subject headings
- Low Back Pain, Bronchiolitis Obliterans Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
45-Degree Roman Chair ExerciseOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 1 and 4
Muscle Thickness
Ultrasound imaging to assess muscle thickness of the erector spinae and the multifidus muscles will be completed.
Measured: 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.
Measured: 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.
Measured: Weeks 1 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start15 Oct 2025
- Primary completion9 Apr 2026
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abigail Wilson, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203430
- Sponsor's protocol ID
- 12
- Status last verified
- Apr 2026
- First submitted
- 22 Sep 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Adaptations in Biopsychosocial Factors and Muscle Morphology After a Resistance Exercise Intervention in Individuals With Low Back Pain
- ClinicalTrials.gov ID
- NCT07203430
- Acronym / sponsor ID
- 12
- Conditions
- Low Back Pain, Chronic
- Keywords
- Exercise, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: 45-Degree Roman Chair ExerciseDuring 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). |
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 45-Degree Roman Chair ExerciseParticipants 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 | Intervention Group |
Primary outcome
Exercise Induced Hypoalgesia
Time frame: Weeks 1 and 4
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.
Muscle Thickness
Time frame: Weeks 1 and 4
Ultrasound imaging to assess muscle thickness of the erector spinae and the multifidus muscles will be completed.
Muscle Strength
Time frame: Weeks 1 and 4
Back extensor strength will be assessed using maximal voluntary isometric contraction of the back extensor muscles using a handheld dynamometer.
Muscle Endurance
Time frame: Weeks 1 and 4
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 45-Degree Roman Chair Exercise in people with Low Back Pain, Chronic, run by University of Central Florida 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 5 inclusion and 10 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 14 Apr 2026. 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?
Exercise Induced Hypoalgesia (time frame: Weeks 1 and 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2026.