Subacute Low Back PainLBPNCT03502187

Subacute Low Back Pain in Active Duty

A study testing Progressive Exercise Plan, NeuromuscularElectricalStimulation(NMES) and Primary Care Management (PCM) in people with Subacute Low Back Pain, run by University of Tennessee 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 45 yearsHealthy volunteers can take part
Conditions the study is for: Subacute Low Back Pain
What is being tested?: Progressive Exercise Plan, NeuromuscularElectricalStimulation(NMES) and Primary Care Management (PCM)
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 133 participants
Where: 1 siteUnited States
Study dates: 17 Apr 2018to 28 May 2020
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

None listed.

Who cannot join

Those who might be at risk of adverse outcomes from the study interventions will be excluded. This includes individuals with
recurrence of LBP that is less than 3 months from prior episode;
a significant co-morbid medical condition (such as severe hypertension, neurological disorder or pacemaker/defibrillator) in which NMES strength training or unsupervised exercise is contraindicated and would pose a safety threat or impair ability to participate;
previous back surgeries;
inability or unwillingness to participate in an exercise or strengthening program;
clinical evidence of a lumbar radiculopathy;

Show all 11Show fewer

inability to speak and/or read English;
pregnancy;
vision impairment, where participant is classified as legally blind;
unwillingness to accept random assignment; or
a score >=23 on Center for Epidemiological Studies-Depression scale.

Trial locations and contacts

1 site in 1 country.

United States1 site

Blanchfield Army Community Hospital (BACH)
Fort Campbell North, Kentucky, 42223

Other trials in United States

About this study

Official title: Home-based Approaches for Subacute Low Back Pain in Active Duty: Randomized, Controlled Trial

Read the detailed description

The overall objective of this project is to compare three home-managed treatment regimens for subacute low back pain: Progressive Exercise Plan (PEP), NMES (neuromuscular electrical stimulation) core strength training and standard primary care management (PCM). The central hypothesis is that the NMES with PCM core strength training and PEP with PCM will show significantly greater improvements in muscle strength, pain, mobility/function, daily activity and quality of life (QOL) than PCM alone in military members with low back pain lasting three to eighteen weeks. The rationale for this study is that increasing torso muscle strength and decreasing pain through strength training exercises will significantly improve mobility, physical activity, QOL and reduce disability. Such outcomes could ultimately result in improved deployability, retention of military personnel and decreased economic costs in this population. The specific aims will be to determine whether the two treatment régimes are significantly more efficacious than standard PCM alone in improving lower back muscle strength, daily physical activity, physical function, quality of life, and symptoms associated with subacute LBP. After consent and baseline testing, active duty male and female subjects, ages 18 to <45, (n=135) with LBP will be randomly assigned to one of the three groups. Each of the two treatment arms will be supplemented by PCM and compared to a group receiving standard PCM alone. All groups will receive nine weeks of home therapy. Using longitudinal mixed regression models, differences in time trends for the outcome variables among controls and those in the treatment groups will be examined. In these regression analyses, the important primary measures will be expressed as a function of time, treatment group, and group-by-time interactions, while controlling for important covariates. Positive results could translate into accelerated rehabilitation, decreased symptoms and lower medical costs with better patient outcomes.

Conditions: Subacute Low Back Pain
Being tested: Progressive Exercise Plan, NeuromuscularElectricalStimulation(NMES), Primary Care Management (PCM)

What participants receive

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

Progressive Exercise PlanBehavioural
The goal of PEP is to reduce back pain, disability, and improve trunk flexibility, strength and endurance through controlled, gradual, progressive back exercises. PEP teaches muscle strengthening exercises and self-management strategies to promote back fitness. PEP sessions provide a standardized self-management framework for performing the exercises at home. PEP is performed every other day/week for about ~1 hour over a period of 9 weeks. PEP consists of 3 sequential phases with each phase lasting 3 weeks. Exercises become progressively more difficult and intense, focusing on back stretching and strengthening that progressively load and unload the lumbar spine by means of flexion/extension exercises. The PEP group will perform 31 exercise sessions for 60 minutes on alternating days.
NeuromuscularElectricalStimulation(NMES)Device
The NMES treatment group will receive a portable battery-operated device, Recovery Back (Neurotech®, Minnetonka, MN) with a 2-garment site-specific system: back \& abdomen. NMES muscle contractions will be elicited by an electrical impulse generated by the Recovery Back system. The device delivers a pre-set program of NMES using a symmetrical biphasic square pulse waveform. (Moore SR, Shurman J, 1997) The garments are light-weight, breathable fabric that wraps around the waist with precise placements for the reusable electrodes. The controller uses a rechargeable battery with charger supplied. The NMES protocol consists of 30-minutes of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back training, next day Abdominal training).
Primary Care Management (PCM)Behavioural
All participants will receive standard primary care management for subacute LBP. Primary Care Management follows the clinical practice guidelines for low back pain.(Chou et al., 2007) Service members are to stay as active as possible and progressively increase their activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants will receive an information sheet on LBP advising them to remain active and use self-care options such as heat application. To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.

Study groups in NCT03502187
Study group	Role	What they receive
Primary Care Management (PCM)	Active comparator	Non-specific LBP, where the cause for the pain cannot be determined, accounts for ninety percent of LBP cases.(Koes, et al, 2006) Reducing pain and continuing daily activity to prevent deconditioning are the primary therapy goals of PCM. Traditional PCM treatment of LBP will include advice/information on self-care options, over-the-counter analgesics, heat application, and remaining active.(Chou, et al., 2007; Koes, et al, 2010) Despite evidence that physical activity is effective, limiting activity remains common; individuals cite pain or re-injury fear as a limiting factor.( Lethem, et al., 1983; Poirandeau, et al., 2006; Steenstra, et al., 2016) Receives: Behavioral: Primary Care Management (PCM)
NeuromuscularElectricalStimulation(NMES)	Experimental	Rehabilitation requires activation of deep stabilizing muscle groups in the lumbopelvic region. Traditional exercises specific for these muscles are hard to teach with poor compliance. NMES is effective in stimulating these muscles, (Porcari, et al., 2005; Glaser, et al., 2001) resulting in enhanced activation, and improved performance. (Coghlan, et al., 2011) NMES devices are programmed to exercise core muscles through a series of stimulated muscle contractions. Concurrent muscle stimulation of the abdominal wall and lumbar paraspinal area has been shown to be most effective to maximally activate deep lumbar stabilizers in LBP patients. (Baek, et al., 2016) NMES provides as much pain relief as transcutaneous electric nerve stimulation (TENS) in LBP subjects. (Moore SR, Shurman J, 1997) Receives: Device: NeuromuscularElectricalStimulation(NMES); Behavioral: Primary Care Management (PCM)
Progressive Exercise Plan (PEP)	Experimental	The literature suggests that this intervention may be of benefit in military personnel with subacute LBP. (Chou, et al., 2007;Marshall PW, Murphy BA, 2006) Meta-analysis showed evidence that graded-activity exercise improved patient outcomes in subacute LBP; however, evidence for other exercise programs were inconsistent. (Hayden, et al., 2005) A strengthening program involving the trunk and abdomen muscles showed clinical reductions in low back pain and disability with high adherence. (Kendall, et al., 2015) Systematic reviews were unable to support any one type of exercise over another. The use of pain-relieving modalities combined with muscle strengthening, such as home-based electrotherapy or progressive exercise, could reduce pain and improve function more rapidly. Receives: Behavioral: Progressive Exercise Plan; Behavioral: Primary Care Management (PCM)

What is being measured

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

Lower Back Strength-Extension
Torso extension muscle strength is measured with a modified version of the U of Michigan strength test system (Workability Systems, West Chester, Ohio) and a Chattanooga-Baseline® Hand Dynamometer - Digital LCD Gauge - ER™ 300 lb capacity (DJO Global, Chattanooga, Vista, CA USA). To measure trunk extension, the participant stands with their lower anterior abdomen against the padded board. The belt is placed around the posterior back and under the arms. Participants pull against the belt as forcefully as possible. Participants perform two maximal efforts maintaining each voluntary isometric exertion for 5 seconds, separated by 30-second rest; the highest value of the two trials will be accepted.
Measured: 0, 3, 6, and 9 weeks
Lower Back Strength-Flexion
Torso flexion muscle strength is measured with a modified version of the U of Michigan strength test system (Workability Systems, West Chester, Ohio) and a Chattanooga-Baseline® Hand Dynamometer - Digital LCD Gauge - ER™ 300 lb capacity (DJO Global, Chattanooga, Vista, CA USA). For trunk flexion, the participant stands in the apparatus, buttocks against the padded board, the superior edge level with the iliac crest. A canvas belt is around the chest and under the arms horizontal to the force-measuring dynamometer on the apparatus frame. Participants pull against the belt as forcefully as possible. Participants perform two maximal efforts maintaining each voluntary isometric exertion for 5 seconds, separated by 30-second rest; the highest value of the two trials will be accepted.
Measured: 0, 3, 6, and 9 weeks

Secondary outcomes (7)

Current Pain Severity
The Visual Analog Scale (VAS) of pain will be used to assess pain at rest and after activity. (Revill et al., 1976) Participants will complete this scale following the push-ups, sit-ups, 6-minute walk and the lumbar trunk muscle test. This VAS pain subscale is a 10-cm horizontal line index with descriptive anchors at each end. At the far left (0.0 cm) is "no pain" and at the far right (10 cm) is "worst possible pain". The participant is instructed to place a vertical line at some point between the anchors to describe their level of pain.
Measured: 0, 3, 6, 9 Weeks
Impact of Bodily Pain on Normal Work Measured by SF12v2
The Short Form Health Survey Version 2.0 (SF-12v2) Health Survey will be used to determine each participant's overall impact of bodily pain on normal work. The SF12v2 has a question that asks participants to assess the impact of pain on normal work during the previous 4 weeks using options ranging from Not at all to Extremely. Responses are translated to numerical scores ranging from 0 to 100. Higher scores indicate less impact of bodily pain.
Measured: 0, 3, 6, 9 Weeks
Physical Activity
Physical activity will be measured using the Fitbit Charge 2 (San Francisco, CA). The Charge 2 is a wrist-worn three-axis accelerometer that measures steps walked, distance traveled, energy expenditure and floors climbed. The unique feature of this device is a wireless function that automatically uploads data to designated mobile phone devices or computers. Physical Activity is reported as average Kcal expended during a seven day period.
Measured: 0, 3, 6, 9 Weeks
Mobility/Function Measured by the 2-minute Push-up Test
The 2-minute push-up test evaluates upper body endurance and strength as well as the stabilizing torso muscles of the abdomen and back. Starting in a prone position, the participant is positioned with their hands on the ground (shoulder width apart), toes in contact with the floor, spine parallel to the floor, elbows and hips in extension. The body moves as a single rigid unit and is lowered to the ground until elbows are at 90° angle. The body is then returned to the starting position by pushing the arms up to full extension. A push-up is counted if the elbows were brought to flexion of 90° or greater and then return to full extension, while keeping the body elevated on the toes. The number of push-ups performed in 2-minutes is recorded.
Measured: 0, 3, 6, 9 Weeks
Mobility/Function Measured by the 2-minute Sit-up Test
The 2-minute sit-up test measures trunk flexion and abdominal endurance. Starting in a supine position, the knee joints are flexed at a 90° angle, with fingers behind the head, soles of the feet and shoulder blades in contact with the floor. With the command to begin, the upper body is raised forward by flexing the abdominal muscles and then lowered. A sit-up is counted if the hands are behind the head, bringing the base of the spine to a vertical position and then returning the shoulder blades to the floor. The number of repetitions performed in 2 minutes is recorded.
Measured: 0, 3, 6, 9 Weeks
Mobility/Function Measured by the 6-minute Walk Test
The 6-Minute Walk Test (6-MWT) measures the distance a participant walks at a "fast" pace over a 6-minute period. Participants will "walk as quickly as you can" with the opportunity to stop and rest if required. This test measures functional capacity of walking. Healthy adults are expected to walk between 400 and 700 meters [1300-2300 feet] on the 6-minute walk test (Enright, 2003). Outcomes are reported in feet walked.
Measured: 0, 3, 6, 9 Weeks
Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale
The Center for Epidemiologic Studies Depression (CES-D) scale is a self-report questionnaire that contains 20 items. Participants were asked to rate how often over the past week they experienced symptoms associated with depression. Scores range from 0-60 with high scores denoting greater depressive symptoms. CES-D scores were recorded at baseline (0 weeks) and subsequent visits. If the baseline score was greater than 23 the participants were not randomized.
Measured: 0, 3, 6, 9 Weeks

Timeline

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

17 Apr 201828 May 2020

First posted18 Apr 2018
Study start17 Apr 2018
Primary completion28 May 2020
Study completion28 May 2020

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 (31)Papers the sponsor has linked to this study.
Other trials for Subacute 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03502187
Sponsor's protocol ID: HU0001-17-1-TS05 (N17-B01)
Other IDs: 18-05885-DoD
Acronym: LBP
Status last verified: Feb 2020
First submitted: 29 Mar 2018
Last updated: 25 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Koes BW, van Tulder MW, Thomas S. Diagnosis and treatment of low back pain. BMJ. 2006 Jun 17;332(7555):1430-4. doi: 10.1136/bmj.332.7555.1430. No abstract available.
PubMed 16777886
Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. doi: 10.7326/0003-4819-147-7-200710020-00006.
PubMed 17909209
Koes BW, van Tulder M, Lin CW, Macedo LG, McAuley J, Maher C. An updated overview of clinical guidelines for the management of non-specific low back pain in primary care. Eur Spine J. 2010 Dec;19(12):2075-94. doi: 10.1007/s00586-010-1502-y. Epub 2010 Jul 3.
PubMed 20602122
Lethem J, Slade PD, Troup JD, Bentley G. Outline of a Fear-Avoidance Model of exaggerated pain perception--I. Behav Res Ther. 1983;21(4):401-8. doi: 10.1016/0005-7967(83)90009-8. No abstract available.
PubMed 6626110
Poiraudeau S, Rannou F, Baron G, Henanff LA, Coudeyre E, Rozenberg S, Huas D, Martineau C, Jolivet-Landreau I, Garcia-Mace J, Revel M, Ravaud P. Fear-avoidance beliefs about back pain in patients with subacute low back pain. Pain. 2006 Oct;124(3):305-311. doi: 10.1016/j.pain.2006.04.019. Epub 2006 Jun 5.
PubMed 16740362
Steenstra IA, Munhall C, Irvin E, Oranye N, Passmore S, Van Eerd D, Mahood Q, Hogg-Johnson S. Systematic Review of Prognostic Factors for Return to Work in Workers with Sub Acute and Chronic Low Back Pain. J Occup Rehabil. 2017 Sep;27(3):369-381. doi: 10.1007/s10926-016-9666-x.
PubMed 27647141
Coghlan S, Crowe L, McCarthypersson U, Minogue C, Caulfield B. Neuromuscular electrical stimulation training results in enhanced activation of spinal stabilizing muscles during spinal loading and improvements in pain ratings. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:7622-5. doi: 10.1109/IEMBS.2011.6091878.
PubMed 22256103
Porcari JP, Miller J, Cornwell K, Foster C, Gibson M, McLean K, Kernozek T. The effects of neuromuscular electrical stimulation training on abdominal strength, endurance, and selected anthropometric measures. J Sports Sci Med. 2005 Mar 1;4(1):66-75. eCollection 2005 Mar 1.
PubMed 24431963
Coghlan S, Crowe L, McCarthyPersson U, Minogue C, Caulfield B. Electrical muscle stimulation for deep stabilizing muscles in abdominal wall. Annu Int Conf IEEE Eng Med Biol Soc. 2008;2008:2756-9. doi: 10.1109/IEMBS.2008.4649773.
PubMed 19163276
Glaser JA, Baltz MA, Nietert PJ, Bensen CV. Electrical muscle stimulation as an adjunct to exercise therapy in the treatment of nonacute low back pain: a randomized trial. J Pain. 2001 Oct;2(5):295-300. doi: 10.1054/jpai.2001.25523.
PubMed 14622808
Baek SO, Cho HK, Kim SY, Jones R, Cho YW, Ahn SH. Changes in deep lumbar stabilizing muscle thickness by transcutaneous neuromuscular electrical stimulation in patients with low back pain. J Back Musculoskelet Rehabil. 2017;30(1):121-127. doi: 10.3233/BMR-160723.
PubMed 27341642
Moore SR, Shurman J. Combined neuromuscular electrical stimulation and transcutaneous electrical nerve stimulation for treatment of chronic back pain: a double-blind, repeated measures comparison. Arch Phys Med Rehabil. 1997 Jan;78(1):55-60. doi: 10.1016/s0003-9993(97)90010-1.
PubMed 9014958
Marshall PW, Murphy BA. Evaluation of functional and neuromuscular changes after exercise rehabilitation for low back pain using a Swiss ball: a pilot study. J Manipulative Physiol Ther. 2006 Sep;29(7):550-60. doi: 10.1016/j.jmpt.2006.06.025.
PubMed 16949944
Kendall KD, Emery CA, Wiley JP, Ferber R. The effect of the addition of hip strengthening exercises to a lumbopelvic exercise programme for the treatment of non-specific low back pain: A randomized controlled trial. J Sci Med Sport. 2015 Nov;18(6):626-31. doi: 10.1016/j.jsams.2014.11.006. Epub 2014 Nov 13.
PubMed 25467200
Hayden JA, van Tulder MW, Malmivaara AV, Koes BW. Meta-analysis: exercise therapy for nonspecific low back pain. Ann Intern Med. 2005 May 3;142(9):765-75. doi: 10.7326/0003-4819-142-9-200505030-00013.
PubMed 15867409

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 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Home-based Approaches for Subacute Low Back Pain in Active Duty: Randomized, Controlled Trial
ClinicalTrials.gov ID: NCT03502187
Acronym / sponsor ID: LBP / HU0001-17-1-TS05 (N17-B01)
Conditions: Subacute Low Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: University of TennesseeUniversity, hospital or other
Collaborators: Blanchfield Army Community Hospital
Study start: 17 Apr 2018 (actual)
Primary completion: 28 May 2020 (actual)
Study completion: 28 May 2020 (actual)
First posted: 18 Apr 2018 (actual)
Results: Posted 25 Jan 2022

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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Primary Care Management (PCM)	Active comparator	Behavioral: Primary Care Management (PCM)Non-specific LBP, where the cause for the pain cannot be determined, accounts for ninety percent of LBP cases.(Koes, et al, 2006) Reducing pain and continuing daily activity to prevent deconditioning are the primary therapy goals of PCM. Traditional PCM treatment of LBP will include advice/information on self-care options, over-the-counter analgesics, heat application, and remaining active.(Chou, et al., 2007; Koes, et al, 2010) Despite evidence that physical activity is effective, limiting activity remains common; individuals cite pain or re-injury fear as a limiting factor.( Lethem, et al., 1983; Poirandeau, et al., 2006; Steenstra, et al., 2016)
NeuromuscularElectricalStimulation(NMES)	Experimental	Device: NeuromuscularElectricalStimulation(NMES), Behavioral: Primary Care Management (PCM)Rehabilitation requires activation of deep stabilizing muscle groups in the lumbopelvic region. Traditional exercises specific for these muscles are hard to teach with poor compliance. NMES is effective in stimulating these muscles, (Porcari, et al., 2005; Glaser, et al., 2001) resulting in enhanced activation, and improved performance. (Coghlan, et al., 2011) NMES devices are programmed to exercise core muscles through a series of stimulated muscle contractions. Concurrent muscle stimulation of the abdominal wall and lumbar paraspinal area has been shown to be most effective to maximally activate deep lumbar stabilizers in LBP patients. (Baek, et al., 2016) NMES provides as much pain relief as transcutaneous electric nerve stimulation (TENS) in LBP subjects. (Moore SR, Shurman J, 1997)
Progressive Exercise Plan (PEP)	Experimental	Behavioral: Progressive Exercise Plan, Behavioral: Primary Care Management (PCM)The literature suggests that this intervention may be of benefit in military personnel with subacute LBP. (Chou, et al., 2007;Marshall PW, Murphy BA, 2006) Meta-analysis showed evidence that graded-activity exercise improved patient outcomes in subacute LBP; however, evidence for other exercise programs were inconsistent. (Hayden, et al., 2005) A strengthening program involving the trunk and abdomen muscles showed clinical reductions in low back pain and disability with high adherence. (Kendall, et al., 2015) Systematic reviews were unable to support any one type of exercise over another. The use of pain-relieving modalities combined with muscle strengthening, such as home-based electrotherapy or progressive exercise, could reduce pain and improve function more rapidly.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (0 listed)

Key exclusion criteria (11 listed)

Those who might be at risk of adverse outcomes from the study interventions will be excluded. This includes individuals with
recurrence of LBP that is less than 3 months from prior episode;
a significant co-morbid medical condition (such as severe hypertension, neurological disorder or pacemaker/defibrillator) in which NMES strength training or unsupervised exercise is contraindicated and would pose a safety threat or impair ability to participate;
previous back surgeries;
inability or unwillingness to participate in an exercise or strengthening program;

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
Progressive Exercise PlanThe goal of PEP is to reduce back pain, disability, and improve trunk flexibility, strength and endurance through controlled, gradual, progressive back exercises. PEP teaches muscle strengthening exercises and self-management strategies to promote back fitness. PEP sessions provide a standardized self-management framework for performing the exercises at home. PEP is performed every other day/week for about ~1 hour over a period of 9 weeks. PEP consists of 3 sequential phases with each phase lasting 3 weeks. Exercises become progressively more difficult and intense, focusing on back stretching and strengthening that progressively load and unload the lumbar spine by means of flexion/extension exercises. The PEP group will perform 31 exercise sessions for 60 minutes on alternating days.	Behavioural	Progressive Exercise Plan (PEP)
NeuromuscularElectricalStimulation(NMES)The NMES treatment group will receive a portable battery-operated device, Recovery Back (Neurotech®, Minnetonka, MN) with a 2-garment site-specific system: back \& abdomen. NMES muscle contractions will be elicited by an electrical impulse generated by the Recovery Back system. The device delivers a pre-set program of NMES using a symmetrical biphasic square pulse waveform. (Moore SR, Shurman J, 1997) The garments are light-weight, breathable fabric that wraps around the waist with precise placements for the reusable electrodes. The controller uses a rechargeable battery with charger supplied. The NMES protocol consists of 30-minutes of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back training, next day Abdominal training).	Device	NeuromuscularElectricalStimulation(NMES)
Primary Care Management (PCM)All participants will receive standard primary care management for subacute LBP. Primary Care Management follows the clinical practice guidelines for low back pain.(Chou et al., 2007) Service members are to stay as active as possible and progressively increase their activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants will receive an information sheet on LBP advising them to remain active and use self-care options such as heat application. To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.	Behavioural	NeuromuscularElectricalStimulation(NMES), Primary Care Management (PCM), Progressive Exercise Plan (PEP)

Primary outcome

Lower Back Strength-Extension
Time frame: 0, 3, 6, and 9 weeks
Torso extension muscle strength is measured with a modified version of the U of Michigan strength test system (Workability Systems, West Chester, Ohio) and a Chattanooga-Baseline® Hand Dynamometer - Digital LCD Gauge - ER™ 300 lb capacity (DJO Global, Chattanooga, Vista, CA USA). To measure trunk extension, the participant stands with their lower anterior abdomen against the padded board. The belt is placed around the posterior back and under the arms. Participants pull against the belt as forcefully as possible. Participants perform two maximal efforts maintaining each voluntary isometric exertion for 5 seconds, separated by 30-second rest; the highest value of the two trials will be accepted.
Lower Back Strength-Flexion
Time frame: 0, 3, 6, and 9 weeks
Torso flexion muscle strength is measured with a modified version of the U of Michigan strength test system (Workability Systems, West Chester, Ohio) and a Chattanooga-Baseline® Hand Dynamometer - Digital LCD Gauge - ER™ 300 lb capacity (DJO Global, Chattanooga, Vista, CA USA). For trunk flexion, the participant stands in the apparatus, buttocks against the padded board, the superior edge level with the iliac crest. A canvas belt is around the chest and under the arms horizontal to the force-measuring dynamometer on the apparatus frame. Participants pull against the belt as forcefully as possible. Participants perform two maximal efforts maintaining each voluntary isometric exertion for 5 seconds, separated by 30-second rest; the highest value of the two trials will be accepted.

7 secondary outcomes

Current Pain Severity
Time frame: 0, 3, 6, 9 Weeks
Impact of Bodily Pain on Normal Work Measured by SF12v2
Time frame: 0, 3, 6, 9 Weeks
Physical Activity
Time frame: 0, 3, 6, 9 Weeks
Mobility/Function Measured by the 2-minute Push-up Test
Time frame: 0, 3, 6, 9 Weeks
Mobility/Function Measured by the 2-minute Sit-up Test
Time frame: 0, 3, 6, 9 Weeks
Mobility/Function Measured by the 6-minute Walk Test
Time frame: 0, 3, 6, 9 Weeks
Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale
Time frame: 0, 3, 6, 9 Weeks

Results and safety

Results posted to the registry on 25 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Primary Care Management (PCM)	43	34
NeuromuscularElectricalStimulation(NMES)	43	36
Progressive Exercise Plan (PEP)	42	34

Primary outcome: Lower Back Strength-Extension

Time frame: 0, 3, 6, and 9 weeks. Mean (Standard Deviation). Unit: kg-Force

Measure	Primary Care Management (PCM) n = 43	NeuromuscularElectricalStimulation(NMES) n = 43	Progressive Exercise Plan (PEP) n = 42
Week 0	54.5 (28.9)	50.2 (25.4)	49.2 (27.2)
Week 3	57.5 (33.1)	61.4 (34.6)	54.6 (31.0)
Week 6	68.2 (36.9)	69.0 (33.4)	53.1 (30.1)
Week 9	69.4 (30.7)	69.3 (39.3)	55.1 (23.6)

Primary outcome: Lower Back Strength-Flexion

Time frame: 0, 3, 6, and 9 weeks. Mean (Standard Deviation). Unit: kg-Force

Measure	Primary Care Management (PCM) n = 43	NeuromuscularElectricalStimulation(NMES) n = 43	Progressive Exercise Plan (PEP) n = 42
Week 0	51.6 (29.7)	48.8 (27.7)	43.7 (23.1)
Week 3	52.1 (29.6)	57.9 (30.5)	47.7 (26.3)
Week 6	65.6 (39.9)	63.7 (29.6)	44.4 (26.3)
Week 9	65.1 (29.9)	60.9 (30.9)	47.9 (22.5)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 9 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Primary Care Management (PCM)	0 of 43 (0%)	0 of 43 (0%)	0 of 43
NeuromuscularElectricalStimulation(NMES)	0 of 43 (0%)	0 of 43 (0%)	0 of 43
Progressive Exercise Plan (PEP)	0 of 42 (0%)	0 of 42 (0%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16777886Koes BW, van Tulder MW, Thomas S. Diagnosis and treatment of low back pain. BMJ. 2006 Jun 17;332(7555):1430-4. doi: 10.1136/bmj.332.7555.1430. No abstract available.
Background: PubMed 17909209Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. doi: 10.7326/0003-4819-147-7-200710020-00006.
Background: PubMed 20602122Koes BW, van Tulder M, Lin CW, Macedo LG, McAuley J, Maher C. An updated overview of clinical guidelines for the management of non-specific low back pain in primary care. Eur Spine J. 2010 Dec;19(12):2075-94. doi: 10.1007/s00586-010-1502-y. Epub 2010 Jul 3.
Background: PubMed 6626110Lethem J, Slade PD, Troup JD, Bentley G. Outline of a Fear-Avoidance Model of exaggerated pain perception--I. Behav Res Ther. 1983;21(4):401-8. doi: 10.1016/0005-7967(83)90009-8. No abstract available.
Background: PubMed 16740362Poiraudeau S, Rannou F, Baron G, Henanff LA, Coudeyre E, Rozenberg S, Huas D, Martineau C, Jolivet-Landreau I, Garcia-Mace J, Revel M, Ravaud P. Fear-avoidance beliefs about back pain in patients with subacute low back pain. Pain. 2006 Oct;124(3):305-311. doi: 10.1016/j.pain.2006.04.019. Epub 2006 Jun 5.
Background: PubMed 27647141Steenstra IA, Munhall C, Irvin E, Oranye N, Passmore S, Van Eerd D, Mahood Q, Hogg-Johnson S. Systematic Review of Prognostic Factors for Return to Work in Workers with Sub Acute and Chronic Low Back Pain. J Occup Rehabil. 2017 Sep;27(3):369-381. doi: 10.1007/s10926-016-9666-x.
Background: PubMed 22256103Coghlan S, Crowe L, McCarthypersson U, Minogue C, Caulfield B. Neuromuscular electrical stimulation training results in enhanced activation of spinal stabilizing muscles during spinal loading and improvements in pain ratings. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:7622-5. doi: 10.1109/IEMBS.2011.6091878.
Background: PubMed 24431963Porcari JP, Miller J, Cornwell K, Foster C, Gibson M, McLean K, Kernozek T. The effects of neuromuscular electrical stimulation training on abdominal strength, endurance, and selected anthropometric measures. J Sports Sci Med. 2005 Mar 1;4(1):66-75. eCollection 2005 Mar 1.
Background: PubMed 19163276Coghlan S, Crowe L, McCarthyPersson U, Minogue C, Caulfield B. Electrical muscle stimulation for deep stabilizing muscles in abdominal wall. Annu Int Conf IEEE Eng Med Biol Soc. 2008;2008:2756-9. doi: 10.1109/IEMBS.2008.4649773.
Background: PubMed 14622808Glaser JA, Baltz MA, Nietert PJ, Bensen CV. Electrical muscle stimulation as an adjunct to exercise therapy in the treatment of nonacute low back pain: a randomized trial. J Pain. 2001 Oct;2(5):295-300. doi: 10.1054/jpai.2001.25523.
Background: PubMed 27341642Baek SO, Cho HK, Kim SY, Jones R, Cho YW, Ahn SH. Changes in deep lumbar stabilizing muscle thickness by transcutaneous neuromuscular electrical stimulation in patients with low back pain. J Back Musculoskelet Rehabil. 2017;30(1):121-127. doi: 10.3233/BMR-160723.
Background: PubMed 9014958Moore SR, Shurman J. Combined neuromuscular electrical stimulation and transcutaneous electrical nerve stimulation for treatment of chronic back pain: a double-blind, repeated measures comparison. Arch Phys Med Rehabil. 1997 Jan;78(1):55-60. doi: 10.1016/s0003-9993(97)90010-1.
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.

Laura A Talbot, PhD, EdD, RN principal investigator

University of Tennessee

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

Questions about this trial

What is this clinical trial studying?

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 0 inclusion and 11 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 25 Jan 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?

Yes. Results are posted in the registry (first posted 25 Jan 2022). 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?

Lower Back Strength-Extension (time frame: 0, 3, 6, and 9 weeks). The study lists 2 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 NCT03502187, which also lists 31 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 25 Jan 2022.