Low Back PainNCT05736393

Translation of Robotic Apparel for Alleviating Low Back Pain

A study testing Back Exosuit in people with Low Back Pain, run by Boston University Charles River Campus 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

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Low Back Pain
What is being tested?: Back Exosuit
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteUnited States
Study dates: 15 Mar 2024to 10 May 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-70
Diagnosis of LBP by licensed medical provider or self-report of lower back pain (initially gathered through partial HIPAA waiver, and confirmed during in-person screening visit)
Self-reported LBP with bending or lifting
Able to walk without an assistive device.
Willing and able to provide informed consent.
Provide HIPAA Authorization to allow communication with the primary healthcare provider (e.g., treating physical therapist) for communication (as needed) during the study period.
Must undergo physical therapy examination with research physical therapist and be assigned a Treatment-Based Classification (TBC) of movement impairment or control impairment.

Who cannot join

Unable to attend all scheduled visits and 1-month phone follow-up
Currently pregnant or likely to become pregnant within 6 weeks
Having received surgery to address current LBP
Having pain or symptoms below the knee that seems related to their current LBP
Having current LBP lasting less than 2 weeks
Diagnosed or self-reported neurological disorders effecting motor control (stroke, Parkinson's disease, etc.)

Show all 10Show fewer

Use of a pacemaker or other implanted medical devices
Currently under treatment for cancer
Skin issues / sensitivity that an exosuit could exacerbate (e.g., Epidermolysis Bullosa)
Any other medical conditions that would preclude safe use of the exosuit device as determined by a physical therapist

Trial locations and contacts

1 site in 1 country.

United States1 site

Boston University Physical Therapy Center
Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Translation of Robotic Apparel for Alleviating Low Back Pain: Back Pain Consortium (BACPAC)

This is a NIAMS-sponsored clinical trial being conducted through the NIH Helping to End Addition Long-term (HEAL) Initiative's Back Pain Consortium (BACPAC) Research Program. This is a single-arm controlled trial with individuals aged 18-70 with low back pain (LBP). This study investigates the effect(s) of augmenting physical therapy (PT) interventions with the use of an experimental wearable soft robotic device ('exosuit').

Read the detailed description

Low back pain (LBP) has a lifetime prevalence of 80%, with approximately 20% of individuals experiencing recurrent episodes or chronic LBP (cLBP). Unfortunately, the evidence for the effectiveness of most rehabilitative treatment is low. With an economic burden approaching $100-billion in the United States alone, the National Institutes of Health has invested millions of dollars in innovative technologies aiming to improve rehabilitative care for low back injuries. As part of this initiative, the investigator's collaborative network of expert clinicians, engineers, and researchers have developed and tested robotic apparel technology (exosuit) that supplements ergonomic and biomechanical training and can be utilized by clinicians in the treatment of individuals with LBP.

Failed rehabilitation, and thus progression from acute to cLBP, is thought to be caused by maladaptive motor control strategies, muscle hyperactivity, reduced movement variability, and development of fear-avoidance-beliefs. The exosuit technology was designed to reduce exertion, encourage safe, varied movement strategies, and promote recovery through well-timed assistive forces to the trunk and hips during flexion postures and lifting tasks. The proposed project builds on this work through use of the exosuit to augment traditional physical therapy care. In doing so, the investigators will determine whether this technology can enhance rehabilitation after back injuries, interrupt the progression of acute to chronic LBP, encourage non-maladaptive movement strategies, and expedite the timeline of return to prior level of function.

To examine the effects of exosuit augmented physical therapy rehabilitation and reduce disability, the investigators will recruit individuals with LBP who are referred to or receiving physical therapy into a single arm clinical trial. The investigators will evaluate feasibility, safety and usability of the exosuit, as well as changes in pain and disability throughout 6 weeks of rehabilitation and compare outcomes to a historical control group who received usual care. The investigators will also evaluate changes in fear-avoidance beliefs, range of motion, and motor control and compare outcomes between exosuit-augmented and no suit conditions over the 6 weeks. Primary outcomes of feasibility, usability, and safety of using a back exosuit to augment routine physical therapy will be evaluated. Secondary outcomes include the efficacy of using a back exosuit to augment routine physical therapy, measured by comparing changes in self-perceived pain and disability compared to the historical control group. Tertiary outcomes include the identification of interventional phenotypes by determining the relationship between changes in symptoms and changes in biomechanics function through exosuit-augmented physical therapy.

Conditions: Low Back Pain
Being tested: Back Exosuit
Keywords: Low Back Pain, Chronic Pain, Rehabilitation, Exosuit, Clinical Trial
Medical subject headings: Low Back Pain, Chronic Pain

What participants receive

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

Back ExosuitDevice
The device is worn like a backpack. It weighs 6 pounds. Participants will be able to perform movements naturally in the device. A ribbon serves as an external muscle to reduce the load and effort during lifting. As participants bend forward, the device assists the participant by supporting some of their body weight by gently pulling back. As participants stand up, the device assists them by gently pulling their trunk upright. Participants will feel the level of assistance change slightly as they move faster or slower. Participants will use this device during 20-40 minutes of physical therapy exercises during 12 visits over 4-6 weeks. Once it is fit and adjusted to each participant's comfort, the physical therapist will control the level of assistance the device provides similarly to how they would adapt any given exercise. Participants may start with more assistance and wean down over the course of the study.

Study groups in NCT05736393
Study group	Role	What they receive
Exosuit Augmented Physical Therapy	Experimental	Participants will attend an in person screening, initial visit (1), 10 (2-11) sessions of physical therapy and a discharge visit (12). Participants will undergo a comprehensive biomechanical analysis on visits 1, 3, 6, 9 and 12, completing an extensive battery of surveys at visits 1, discharge, and 1-month post-discharge. Treatment will incorporate evidence-based physical therapy care based on clinical presentation to include manual therapy, therapeutic exercise, and functional therapeutic activities. A portion of each session will include exosuit use. Receives: Device: Back Exosuit

What is being measured

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

Suit Usability Measured by Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST Survey 2.0)
Suit usability measured by the QUEST survey 2.0. The QUEST is a standardized usability scale to determine a user's device satisfaction. Results range from 1 to 5 on a Likert Scale, with higher scores (5) corresponding to a very satisfied response.
Measured: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Suit Safety Measured by Patient-reported Pain
The Numerical Rating Scale of Pain will measure patient-reported levels of current pain intensity at the beginning and end of every study visit. Results range from 0 to 10, with higher scores indicating increased pain intensity.
Measured: Pre and Post Every Visit including baseline (time 0), all follow-up visits (up to 8 weeks of treatment)
Suit Effect & Safety Measured by Perceived Task Discomfort
The patient-reported level of task discomfort will be measured at the end of selected biomechanical assessment tasks (performed with the suit in a slack and active condition). Participants will rank task discomfort on a numerical rating scale of task discomfort. Results range from 0 to 10, with higher scores indicating higher total body difficulty.
Measured: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Suit Effect Measured by Concern of Movement
Patient-reported level of concern of movement will be measured at the end of each biomechanical visit. Four selected images from the Photo Series of Daily Activity will be ranked, with the participants envisioning themselves completing the task with or without the aid of the exosuit (Quirk et al., 2023). Results range from 0 to 10, with higher scores indicating higher concern with completing the task.
Measured: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Suit Effect Measured by Perceived Task Effort
Patient-reported level of task effort will be measured at the end of selected biomechanical assessment tasks (performed with the suit in a slack and active condition). Participants will rank task difficulty on a numerical rating scale of task difficulty. Results range from 0 to 10, with higher scores indicating higher task difficulty.
Measured: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Functional Suit Effect Measured by Peak Deadlift Pull Force
Measured during maximum voluntary isometric contractions pounds will be measured using a stationary dynamometer. Peak full force will be measured for the slack and active suit condition.
Measured: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Failure Percentage Level 6
For this progressive lifting test starting in a randomized active or slack condition women and men would start from level 1 lifting a 8 or 13 pound weighted tote off of the floor and unto a 75cm high table with the goal to complete 4 repetitions within 20 seconds. If the participants were successful (pass) they would advance to the next level adding 5 pounds to the tote, however if they were unwilling or failed a level the task would end. The task advanced to a maximum of 6 levels corresponding to a 33 and 38 pound mass for women and men respectively. The following outcome identifies the % of participants who failed the task at or before level 6 in their slack and active condition.
Measured: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Functional Suit Effect Measured by Endurance Lifting Task
Measured during dynamic 2.5 minute dynamic asymmetric lifting task. The maximum number of continuous repetitions (rep) performed will compared between the slack and active suit conditions.
Measured: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.

Secondary outcomes (2)

Pain Measured by Numerical Rating Scale of Pain (Worst in Last 24 Hours)
Patient-reported level of their worse pain intensity in the last 24 hours will be measured by the Numerical Rating Scale of Pain, at the beginning of every study visit. Results range from 0 to 10, with higher scores indicating increased pain intensity.
Measured: Pre Every Visit including baseline (time 0), all follow-up visits
Patient-reported Disability Score Measured by the Modified Oswestry Disability Questionnaire (MDQ)
Patient-reported pain intensity and interference is measured by the Modified Oswestry Disability Questionnaire (MDQ) scale. The MDQ is a series of 10 questions. Results range from 0 to 50, with higher scores indicating increased low-back related disability.
Measured: Pre Every Visit including baseline (time 0)

Timeline

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

15 Mar 202410 May 2025

First posted21 Feb 2023
Study start15 Mar 2024
Primary completion10 May 2025
Study completion10 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies 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: Not applicable
Intervention model: Single group
Model description: Single arm clinical trials with propensity-matched control group.
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05736393
Sponsor's protocol ID: 6716
Other IDs: 4UH3AR076731-02
Status last verified: Jul 2026
First submitted: 10 Jan 2023
Last updated: 30 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: De-identified IPD will be made available to other researchers in BACPAC.

Publications

Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.
PubMed 24665116
Rubin DI. Epidemiology and risk factors for spine pain. Neurol Clin. 2007 May;25(2):353-71. doi: 10.1016/j.ncl.2007.01.004.
PubMed 17445733
Dieleman JL, Cao J, Chapin A, Chen C, Li Z, Liu A, Horst C, Kaldjian A, Matyasz T, Scott KW, Bui AL, Campbell M, Duber HC, Dunn AC, Flaxman AD, Fitzmaurice C, Naghavi M, Sadat N, Shieh P, Squires E, Yeung K, Murray CJL. US Health Care Spending by Payer and Health Condition, 1996-2016. JAMA. 2020 Mar 3;323(9):863-884. doi: 10.1001/jama.2020.0734.
PubMed 32125402
Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
PubMed 21982256
Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
PubMed 27745712
Chou R, Shekelle P. Will this patient develop persistent disabling low back pain? JAMA. 2010 Apr 7;303(13):1295-302. doi: 10.1001/jama.2010.344.
PubMed 20371789
Vlaeyen JWS, Linton SJ. Fear-avoidance model of chronic musculoskeletal pain: 12 years on. Pain. 2012 Jun;153(6):1144-1147. doi: 10.1016/j.pain.2011.12.009. Epub 2012 Feb 8. No abstract available.
PubMed 22321917
Leeuw M, Goossens ME, Linton SJ, Crombez G, Boersma K, Vlaeyen JW. The fear-avoidance model of musculoskeletal pain: current state of scientific evidence. J Behav Med. 2007 Feb;30(1):77-94. doi: 10.1007/s10865-006-9085-0. Epub 2006 Dec 20.
PubMed 17180640
Christe G, Crombez G, Edd S, Opsommer E, Jolles BM, Favre J. Relationship between psychological factors and spinal motor behaviour in low back pain: a systematic review and meta-analysis. Pain. 2021 Mar 1;162(3):672-686. doi: 10.1097/j.pain.0000000000002065.
PubMed 33591109
Wertli MM, Rasmussen-Barr E, Weiser S, Bachmann LM, Brunner F. The role of fear avoidance beliefs as a prognostic factor for outcome in patients with nonspecific low back pain: a systematic review. Spine J. 2014 May 1;14(5):816-36.e4. doi: 10.1016/j.spinee.2013.09.036. Epub 2013 Oct 18.
PubMed 24412032
Johansson H, Sojka P. Pathophysiological mechanisms involved in genesis and spread of muscular tension in occupational muscle pain and in chronic musculoskeletal pain syndromes: a hypothesis. Med Hypotheses. 1991 Jul;35(3):196-203. doi: 10.1016/0306-9877(91)90233-o.
PubMed 1943863
van Dieen JH, Reeves NP, Kawchuk G, van Dillen LR, Hodges PW. Motor Control Changes in Low Back Pain: Divergence in Presentations and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):370-379. doi: 10.2519/jospt.2019.7917. Epub 2018 Jun 12.
PubMed 29895230
George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA, Gilliam JR, Hendren S, Norman KS. Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. J Orthop Sports Phys Ther. 2021 Nov;51(11):CPG1-CPG60. doi: 10.2519/jospt.2021.0304.
PubMed 34719942
Alrwaily M, Timko M, Schneider M, Stevans J, Bise C, Hariharan K, Delitto A. Treatment-Based Classification System for Low Back Pain: Revision and Update. Phys Ther. 2016 Jul;96(7):1057-66. doi: 10.2522/ptj.20150345. Epub 2015 Dec 4.
PubMed 26637653
van Middelkoop M, Rubinstein SM, Kuijpers T, Verhagen AP, Ostelo R, Koes BW, van Tulder MW. A systematic review on the effectiveness of physical and rehabilitation interventions for chronic non-specific low back pain. Eur Spine J. 2011 Jan;20(1):19-39. doi: 10.1007/s00586-010-1518-3. Epub 2010 Jul 18.
PubMed 20640863

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Translation of Robotic Apparel for Alleviating Low Back Pain: Back Pain Consortium (BACPAC)
ClinicalTrials.gov ID: NCT05736393
Acronym / sponsor ID: 6716
Conditions: Low Back Pain
Keywords: Low Back Pain, Chronic Pain, Rehabilitation, Exosuit, Clinical Trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Boston University Charles River CampusUniversity, hospital or other
Collaborators: Harvard University, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study start: 15 Mar 2024 (actual)
Primary completion: 10 May 2025 (actual)
Study completion: 10 May 2025 (actual)
First posted: 21 Feb 2023 (actual)
Results: Posted 30 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single arm clinical trials with propensity-matched control group.

Arm	Type	Receives
Exosuit Augmented Physical Therapy	Experimental	Device: Back ExosuitParticipants will attend an in person screening, initial visit (1), 10 (2-11) sessions of physical therapy and a discharge visit (12). Participants will undergo a comprehensive biomechanical analysis on visits 1, 3, 6, 9 and 12, completing an extensive battery of surveys at visits 1, discharge, and 1-month post-discharge. Treatment will incorporate evidence-based physical therapy care based on clinical presentation to include manual therapy, therapeutic exercise, and functional therapeutic activities. A portion of each session will include exosuit use.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age 18-70
Diagnosis of LBP by licensed medical provider or self-report of lower back pain (initially gathered through partial HIPAA waiver, and confirmed during in-person screening visit)
Self-reported LBP with bending or lifting
Able to walk without an assistive device.
Willing and able to provide informed consent.

Key exclusion criteria (10 listed)

Unable to attend all scheduled visits and 1-month phone follow-up
Currently pregnant or likely to become pregnant within 6 weeks
Having received surgery to address current LBP
Having pain or symptoms below the knee that seems related to their current LBP
Having current LBP lasting less than 2 weeks

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
Back ExosuitThe device is worn like a backpack. It weighs 6 pounds. Participants will be able to perform movements naturally in the device. A ribbon serves as an external muscle to reduce the load and effort during lifting. As participants bend forward, the device assists the participant by supporting some of their body weight by gently pulling back. As participants stand up, the device assists them by gently pulling their trunk upright. Participants will feel the level of assistance change slightly as they move faster or slower. Participants will use this device during 20-40 minutes of physical therapy exercises during 12 visits over 4-6 weeks. Once it is fit and adjusted to each participant's comfort, the physical therapist will control the level of assistance the device provides similarly to how they would adapt any given exercise. Participants may start with more assistance and wean down over the course of the study.	Device	Exosuit Augmented Physical Therapy

Primary outcome

Suit Usability Measured by Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST Survey 2.0)
Time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Suit usability measured by the QUEST survey 2.0. The QUEST is a standardized usability scale to determine a user's device satisfaction. Results range from 1 to 5 on a Likert Scale, with higher scores (5) corresponding to a very satisfied response.
Suit Safety Measured by Patient-reported Pain
Time frame: Pre and Post Every Visit including baseline (time 0), all follow-up visits (up to 8 weeks of treatment)
The Numerical Rating Scale of Pain will measure patient-reported levels of current pain intensity at the beginning and end of every study visit. Results range from 0 to 10, with higher scores indicating increased pain intensity.
Suit Effect & Safety Measured by Perceived Task Discomfort
Time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
The patient-reported level of task discomfort will be measured at the end of selected biomechanical assessment tasks (performed with the suit in a slack and active condition). Participants will rank task discomfort on a numerical rating scale of task discomfort. Results range from 0 to 10, with higher scores indicating higher total body difficulty.
Suit Effect Measured by Concern of Movement
Time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Patient-reported level of concern of movement will be measured at the end of each biomechanical visit. Four selected images from the Photo Series of Daily Activity will be ranked, with the participants envisioning themselves completing the task with or without the aid of the exosuit (Quirk et al., 2023). Results range from 0 to 10, with higher scores indicating higher concern with completing the task.
Suit Effect Measured by Perceived Task Effort
Time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Patient-reported level of task effort will be measured at the end of selected biomechanical assessment tasks (performed with the suit in a slack and active condition). Participants will rank task difficulty on a numerical rating scale of task difficulty. Results range from 0 to 10, with higher scores indicating higher task difficulty.
Functional Suit Effect Measured by Peak Deadlift Pull Force
Time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Measured during maximum voluntary isometric contractions pounds will be measured using a stationary dynamometer. Peak full force will be measured for the slack and active suit condition.
Failure Percentage Level 6
Time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
For this progressive lifting test starting in a randomized active or slack condition women and men would start from level 1 lifting a 8 or 13 pound weighted tote off of the floor and unto a 75cm high table with the goal to complete 4 repetitions within 20 seconds. If the participants were successful (pass) they would advance to the next level adding 5 pounds to the tote, however if they were unwilling or failed a level the task would end. The task advanced to a maximum of 6 levels corresponding to a 33 and 38 pound mass for women and men respectively. The following outcome identifies the % of participants who failed the task at or before level 6 in their slack and active condition.
Functional Suit Effect Measured by Endurance Lifting Task
Time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.
Measured during dynamic 2.5 minute dynamic asymmetric lifting task. The maximum number of continuous repetitions (rep) performed will compared between the slack and active suit conditions.

2 secondary outcomes

Pain Measured by Numerical Rating Scale of Pain (Worst in Last 24 Hours)
Time frame: Pre Every Visit including baseline (time 0), all follow-up visits
Patient-reported Disability Score Measured by the Modified Oswestry Disability Questionnaire (MDQ)
Time frame: Pre Every Visit including baseline (time 0)

Results and safety

Results posted to the registry on 30 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exosuit Augmented Physical Therapy	44	39

Primary outcome: Suit Usability Measured by Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST Survey 2.0)

Time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.. Mean (Standard Deviation). Unit: units on a scale

Measure	Exosuit Augmented Physical Therapy n = 44
Visit 1	4.2 (0.7)
Visit 3	4.3 (0.6)
Visit 6	4.4 (0.7)
Visit 9	4.4 (0.6)
Visit 12	4.4 (0.6)

Population analysed: The number of participants changed with the visit number.

Primary outcome: Suit Safety Measured by Patient-reported Pain

Time frame: Pre and Post Every Visit including baseline (time 0), all follow-up visits (up to 8 weeks of treatment). Mean (Standard Deviation). Unit: units on a scale

Measure	Start of Visit for Exosuit Augmented Physical Therapy n = 44	End of Visit for Exosuit Augmented Physical Therapy n = 44
Visit 1	2.4 (1.5)	3.7 (2.2)
Visit 3	2.2 (1.6)	3.0 (1.5)
Visit 6	2.1 (1.8)	3.4 (1.9)
Visit 9	1.5 (1.1)	2.4 (1.7)
Visit 12	1.5 (1.4)	2.6 (2.2)

Population analysed: Not all participants attended each visit so the number of participants are different by visit.

Primary outcome: Suit Effect & Safety Measured by Perceived Task Discomfort

Time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.. Mean (Standard Deviation). Unit: units on a scale

Measure	Exosuit Augmented Physical Therapy- Active n = 44	Exosuit Augmented Physical Therapy- Slack n = 44
Visit 1	4.6 (2.3)	5.2 (2.4)
Visit 3	3.9 (1.7)	4.2 (1.8)
Visit 6	4.0 (1.8)	4.2 (1.8)
Visit 9	3.5 (1.8)	3.9 (1.7)
Visit 12	3.7 (2.2)	3.8 (2.2)

Population analysed: Not all participants attended each visit so the number of participants are different by visit.

Primary outcome: Suit Effect Measured by Concern of Movement

Time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.. Mean (Standard Error). Unit: units on a scale

Measure	Exosuit Augmented Physical Therapy for Shovel Active n = 44	Exosuit Augmented Physical Therapy for Shovel Stack n = 44
Visit 1	3.5 (2.1)	5.2 (2.5)
Visit 3	3.1 (2.4)	4.7 (2.6)
Visit 6	2.9 (2.3)	4.3 (2.3)
Visit 9	2.7 (2.4)	4.4 (2.7)
Visit 12	2.6 (2.1)	4.1 (2.1)

Population analysed: Not all participants attended each visit so the number of participants are different by visit.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6-8 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exosuit Augmented Physical Therapy	0 of 44 (0%)	4 of 44 (9.1%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24665116Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.
Background: PubMed 17445733Rubin DI. Epidemiology and risk factors for spine pain. Neurol Clin. 2007 May;25(2):353-71. doi: 10.1016/j.ncl.2007.01.004.
Background: PubMed 32125402Dieleman JL, Cao J, Chapin A, Chen C, Li Z, Liu A, Horst C, Kaldjian A, Matyasz T, Scott KW, Bui AL, Campbell M, Duber HC, Dunn AC, Flaxman AD, Fitzmaurice C, Naghavi M, Sadat N, Shieh P, Squires E, Yeung K, Murray CJL. US Health Care Spending by Payer and Health Condition, 1996-2016. JAMA. 2020 Mar 3;323(9):863-884. doi: 10.1001/jama.2020.0734.
Background: PubMed 21982256Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
Background: PubMed 27745712Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
Background: PubMed 20371789Chou R, Shekelle P. Will this patient develop persistent disabling low back pain? JAMA. 2010 Apr 7;303(13):1295-302. doi: 10.1001/jama.2010.344.
Background: PubMed 22321917Vlaeyen JWS, Linton SJ. Fear-avoidance model of chronic musculoskeletal pain: 12 years on. Pain. 2012 Jun;153(6):1144-1147. doi: 10.1016/j.pain.2011.12.009. Epub 2012 Feb 8. No abstract available.
Background: PubMed 17180640Leeuw M, Goossens ME, Linton SJ, Crombez G, Boersma K, Vlaeyen JW. The fear-avoidance model of musculoskeletal pain: current state of scientific evidence. J Behav Med. 2007 Feb;30(1):77-94. doi: 10.1007/s10865-006-9085-0. Epub 2006 Dec 20.
Background: PubMed 33591109Christe G, Crombez G, Edd S, Opsommer E, Jolles BM, Favre J. Relationship between psychological factors and spinal motor behaviour in low back pain: a systematic review and meta-analysis. Pain. 2021 Mar 1;162(3):672-686. doi: 10.1097/j.pain.0000000000002065.
Background: PubMed 24412032Wertli MM, Rasmussen-Barr E, Weiser S, Bachmann LM, Brunner F. The role of fear avoidance beliefs as a prognostic factor for outcome in patients with nonspecific low back pain: a systematic review. Spine J. 2014 May 1;14(5):816-36.e4. doi: 10.1016/j.spinee.2013.09.036. Epub 2013 Oct 18.
Background: PubMed 1943863Johansson H, Sojka P. Pathophysiological mechanisms involved in genesis and spread of muscular tension in occupational muscle pain and in chronic musculoskeletal pain syndromes: a hypothesis. Med Hypotheses. 1991 Jul;35(3):196-203. doi: 10.1016/0306-9877(91)90233-o.
Background: PubMed 29895230van Dieen JH, Reeves NP, Kawchuk G, van Dillen LR, Hodges PW. Motor Control Changes in Low Back Pain: Divergence in Presentations and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):370-379. doi: 10.2519/jospt.2019.7917. Epub 2018 Jun 12.
Data RepositoryLink provided by the sponsor.
Individual participant dataSharing planned: Yes. De-identified IPD will be made available to other researchers in BACPAC.

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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.

Conor Walsh, PhD principal investigator

Harvard University

Lou N. Awad, PhD,DPT principal investigator

Boston University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Back Exosuit in people with Low Back Pain, run by Boston University Charles River Campus 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 7 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 30 Sep 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?

Yes. Results are posted in the registry (first posted 30 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Suit Usability Measured by Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST Survey 2.0) (time frame: Measured periodically (at visits 1, 3, 6, 9, 12) between baseline (time 0) and 6-8 weeks of treatment.). The study lists 8 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 NCT05736393, which also lists 20 linked publications.

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 30 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.