Trial Outcomes & Findings for Subacute Low Back Pain in Active Duty (NCT NCT03502187)

Last Updated: 2022-01-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

133 participants

Primary outcome timeframe

0, 3, 6, and 9 weeks

Results posted on

2022-01-25

Participant Flow

5 participants completed the consent but withdrew from the study prior to being assigned to a group.

Participant milestones

Participant milestones
Measure	Primary Care Management (PCM) Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application). To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.	NeuromuscularElectricalStimulation(NMES) NeuromuscularElectricalStimulation(NMES): The NMES treatment group received 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. It 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 wrapped around the waist with placements for reusable electrodes. The controller uses a rechargeable battery with charger supplied. The protocol consists of 30-min of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back/next day Abdominal). Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).	Progressive Exercise Plan (PEP) Progressive Exercise Plan: 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. Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).
Overall Study STARTED	43	43	42
Overall Study COMPLETED	34	36	34
Overall Study NOT COMPLETED	9	7	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Primary Care Management (PCM) Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application). To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.	NeuromuscularElectricalStimulation(NMES) NeuromuscularElectricalStimulation(NMES): The NMES treatment group received 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. It 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 wrapped around the waist with placements for reusable electrodes. The controller uses a rechargeable battery with charger supplied. The protocol consists of 30-min of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back/next day Abdominal). Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).	Progressive Exercise Plan (PEP) Progressive Exercise Plan: 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. Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).
Overall Study Withdrawal by Subject	4	3	3
Overall Study Lost to Follow-up	5	4	5

Baseline Characteristics

Subacute Low Back Pain in Active Duty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Primary Care Management (PCM) n=43 Participants Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application). To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.	NeuromuscularElectricalStimulation(NMES) n=43 Participants NeuromuscularElectricalStimulation(NMES): The NMES treatment group received 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. It 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 wrapped around the waist with placements for reusable electrodes. The controller uses a rechargeable battery with charger supplied. The protocol consists of 30-min of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back/next day Abdominal). Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).	Progressive Exercise Plan (PEP) n=42 Participants Progressive Exercise Plan: 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. Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).	Total n=128 Participants Total of all reporting groups
Age, Continuous	25.84 years STANDARD_DEVIATION 5.66 • n=93 Participants	25.47 years STANDARD_DEVIATION 5.22 • n=4 Participants	25.05 years STANDARD_DEVIATION 5.47 • n=27 Participants	25.5 years STANDARD_DEVIATION 5.4 • n=483 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	7 Participants n=4 Participants	7 Participants n=27 Participants	22 Participants n=483 Participants
Sex: Female, Male Male	35 Participants n=93 Participants	36 Participants n=4 Participants	35 Participants n=27 Participants	106 Participants n=483 Participants
Race/Ethnicity, Customized Caucasian	24 Participants n=93 Participants	24 Participants n=4 Participants	24 Participants n=27 Participants	72 Participants n=483 Participants
Race/Ethnicity, Customized African American	12 Participants n=93 Participants	13 Participants n=4 Participants	12 Participants n=27 Participants	37 Participants n=483 Participants
Race/Ethnicity, Customized Asian/Pacific	3 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	6 Participants n=483 Participants
Race/Ethnicity, Customized Amer. Indian/Alaska Native	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants
Race/Ethnicity, Customized Multi-racial	3 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants	11 Participants n=483 Participants
Mechanism of Injury Sports	0 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	3 Participants n=483 Participants
Mechanism of Injury Work	9 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants	26 Participants n=483 Participants
Mechanism of Injury Military Training	27 Participants n=93 Participants	28 Participants n=4 Participants	24 Participants n=27 Participants	79 Participants n=483 Participants
Mechanism of Injury Other	7 Participants n=93 Participants	7 Participants n=4 Participants	6 Participants n=27 Participants	20 Participants n=483 Participants
Rank Enlisted	39 Participants n=93 Participants	40 Participants n=4 Participants	42 Participants n=27 Participants	121 Participants n=483 Participants
Rank Warrant Officer	0 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants
Rank Officer	4 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	5 Participants n=483 Participants

PRIMARY outcome

Timeframe: 0, 3, 6, and 9 weeks

Outcome measures

Outcome measures
Measure	Primary Care Management (PCM) n=43 Participants Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application). To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.	NeuromuscularElectricalStimulation(NMES) n=43 Participants NeuromuscularElectricalStimulation(NMES): The NMES treatment group received 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. It 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 wrapped around the waist with placements for reusable electrodes. The controller uses a rechargeable battery with charger supplied. The protocol consists of 30-min of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back/next day Abdominal). Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).	Progressive Exercise Plan (PEP) n=42 Participants Progressive Exercise Plan: 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. Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).
Lower Back Strength-Extension Week 0	54.5 kg-Force Standard Deviation 28.9	50.2 kg-Force Standard Deviation 25.4	49.2 kg-Force Standard Deviation 27.2
Lower Back Strength-Extension Week 3	57.5 kg-Force Standard Deviation 33.1	61.4 kg-Force Standard Deviation 34.6	54.6 kg-Force Standard Deviation 31.0
Lower Back Strength-Extension Week 6	68.2 kg-Force Standard Deviation 36.9	69.0 kg-Force Standard Deviation 33.4	53.1 kg-Force Standard Deviation 30.1
Lower Back Strength-Extension Week 9	69.4 kg-Force Standard Deviation 30.7	69.3 kg-Force Standard Deviation 39.3	55.1 kg-Force Standard Deviation 23.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Primary Care Management (PCM) n=43 Participants Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application). To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.	NeuromuscularElectricalStimulation(NMES) n=43 Participants NeuromuscularElectricalStimulation(NMES): The NMES treatment group received 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. It 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 wrapped around the waist with placements for reusable electrodes. The controller uses a rechargeable battery with charger supplied. The protocol consists of 30-min of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back/next day Abdominal). Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).	Progressive Exercise Plan (PEP) n=42 Participants Progressive Exercise Plan: 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. Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).
Lower Back Strength-Flexion Week 0	51.6 kg-Force Standard Deviation 29.7	48.8 kg-Force Standard Deviation 27.7	43.7 kg-Force Standard Deviation 23.1
Lower Back Strength-Flexion Week 3	52.1 kg-Force Standard Deviation 29.6	57.9 kg-Force Standard Deviation 30.5	47.7 kg-Force Standard Deviation 26.3
Lower Back Strength-Flexion Week 6	65.6 kg-Force Standard Deviation 39.9	63.7 kg-Force Standard Deviation 29.6	44.4 kg-Force Standard Deviation 26.3
Lower Back Strength-Flexion Week 9	65.1 kg-Force Standard Deviation 29.9	60.9 kg-Force Standard Deviation 30.9	47.9 kg-Force Standard Deviation 22.5

SECONDARY outcome

Timeframe: 0, 3, 6, 9 Weeks

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.

Outcome measures

Outcome measures
Measure	Primary Care Management (PCM) n=43 Participants Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application). To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.	NeuromuscularElectricalStimulation(NMES) n=43 Participants NeuromuscularElectricalStimulation(NMES): The NMES treatment group received 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. It 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 wrapped around the waist with placements for reusable electrodes. The controller uses a rechargeable battery with charger supplied. The protocol consists of 30-min of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back/next day Abdominal). Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).	Progressive Exercise Plan (PEP) n=42 Participants Progressive Exercise Plan: 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. Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).
Current Pain Severity Week 0	4.43 score on a scale Standard Deviation 2.0	4.57 score on a scale Standard Deviation 2.2	4.78 score on a scale Standard Deviation 2.0
Current Pain Severity Week 3	3.88 score on a scale Standard Deviation 2.6	4.54 score on a scale Standard Deviation 2.3	4.47 score on a scale Standard Deviation 2.2
Current Pain Severity Week 6	4.03 score on a scale Standard Deviation 2.5	3.96 score on a scale Standard Deviation 2.9	4.70 score on a scale Standard Deviation 2.6
Current Pain Severity Week 9	3.28 score on a scale Standard Deviation 2.6	4.07 score on a scale Standard Deviation 3.1	3.93 score on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: 0, 3, 6, 9 Weeks

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.

Outcome measures

Outcome measures
Measure	Primary Care Management (PCM) n=43 Participants Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application). To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.	NeuromuscularElectricalStimulation(NMES) n=43 Participants NeuromuscularElectricalStimulation(NMES): The NMES treatment group received 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. It 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 wrapped around the waist with placements for reusable electrodes. The controller uses a rechargeable battery with charger supplied. The protocol consists of 30-min of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back/next day Abdominal). Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).	Progressive Exercise Plan (PEP) n=42 Participants Progressive Exercise Plan: 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. Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).
Impact of Bodily Pain on Normal Work Measured by SF12v2 Week 0	53.6 score on a scale Standard Deviation 22.5	44 score on a scale Standard Deviation 27.5	47.6 score on a scale Standard Deviation 19.0
Impact of Bodily Pain on Normal Work Measured by SF12v2 Week 3	59.0 score on a scale Standard Deviation 24.0	58.8 score on a scale Standard Deviation 22.2	55.9 score on a scale Standard Deviation 22.2
Impact of Bodily Pain on Normal Work Measured by SF12v2 Week 6	59.2 score on a scale Standard Deviation 23.2	61.4 score on a scale Standard Deviation 26.6	58.6 score on a scale Standard Deviation 25.1
Impact of Bodily Pain on Normal Work Measured by SF12v2 Week 9	72.0 score on a scale Standard Deviation 23.2	72.1 score on a scale Standard Deviation 21.1	65.8 score on a scale Standard Deviation 23.2

SECONDARY outcome

Timeframe: 0, 3, 6, 9 Weeks

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.

Outcome measures

Outcome measures
Measure	Primary Care Management (PCM) n=43 Participants Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application). To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.	NeuromuscularElectricalStimulation(NMES) n=43 Participants NeuromuscularElectricalStimulation(NMES): The NMES treatment group received 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. It 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 wrapped around the waist with placements for reusable electrodes. The controller uses a rechargeable battery with charger supplied. The protocol consists of 30-min of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back/next day Abdominal). Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).	Progressive Exercise Plan (PEP) n=42 Participants Progressive Exercise Plan: 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. Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).
Physical Activity Week 0	2733 Kcal Standard Deviation 1024	3005 Kcal Standard Deviation 932	2912 Kcal Standard Deviation 1019
Physical Activity Week 3	2691 Kcal Standard Deviation 955	2950 Kcal Standard Deviation 854	2809 Kcal Standard Deviation 1040
Physical Activity Week 6	2599 Kcal Standard Deviation 843	2955 Kcal Standard Deviation 942	2609 Kcal Standard Deviation 934
Physical Activity Week 9	2605 Kcal Standard Deviation 942	2922 Kcal Standard Deviation 1107	2559 Kcal Standard Deviation 700

SECONDARY outcome

Timeframe: 0, 3, 6, 9 Weeks

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.

Outcome measures

Outcome measures
Measure	Primary Care Management (PCM) n=43 Participants Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application). To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.	NeuromuscularElectricalStimulation(NMES) n=43 Participants NeuromuscularElectricalStimulation(NMES): The NMES treatment group received 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. It 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 wrapped around the waist with placements for reusable electrodes. The controller uses a rechargeable battery with charger supplied. The protocol consists of 30-min of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back/next day Abdominal). Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).	Progressive Exercise Plan (PEP) n=42 Participants Progressive Exercise Plan: 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. Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).
Mobility/Function Measured by the 2-minute Push-up Test Week 0	46.9 Number of push-ups Standard Deviation 14.4	41.1 Number of push-ups Standard Deviation 18.2	43.7 Number of push-ups Standard Deviation 18.4
Mobility/Function Measured by the 2-minute Push-up Test Week 3	46.0 Number of push-ups Standard Deviation 16.3	40.3 Number of push-ups Standard Deviation 20.4	47.4 Number of push-ups Standard Deviation 16.8
Mobility/Function Measured by the 2-minute Push-up Test Week 6	45.9 Number of push-ups Standard Deviation 14.6	42.3 Number of push-ups Standard Deviation 18.7	42.2 Number of push-ups Standard Deviation 18.7
Mobility/Function Measured by the 2-minute Push-up Test Week 9	46.2 Number of push-ups Standard Deviation 18.1	46.0 Number of push-ups Standard Deviation 22.9	46.3 Number of push-ups Standard Deviation 17.2

SECONDARY outcome

Timeframe: 0, 3, 6, 9 Weeks

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.

Outcome measures

Outcome measures
Measure	Primary Care Management (PCM) n=43 Participants Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application). To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.	NeuromuscularElectricalStimulation(NMES) n=43 Participants NeuromuscularElectricalStimulation(NMES): The NMES treatment group received 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. It 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 wrapped around the waist with placements for reusable electrodes. The controller uses a rechargeable battery with charger supplied. The protocol consists of 30-min of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back/next day Abdominal). Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).	Progressive Exercise Plan (PEP) n=42 Participants Progressive Exercise Plan: 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. Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).
Mobility/Function Measured by the 2-minute Sit-up Test Week 0	44.4 Number of sit-ups Standard Deviation 17.6	35.5 Number of sit-ups Standard Deviation 21.4	41.5 Number of sit-ups Standard Deviation 15.2
Mobility/Function Measured by the 2-minute Sit-up Test Week 3	44.9 Number of sit-ups Standard Deviation 18.8	38.7 Number of sit-ups Standard Deviation 21.5	43.2 Number of sit-ups Standard Deviation 15.3
Mobility/Function Measured by the 2-minute Sit-up Test Week 6	45.6 Number of sit-ups Standard Deviation 18.4	43.2 Number of sit-ups Standard Deviation 15.2	40.8 Number of sit-ups Standard Deviation 14.9
Mobility/Function Measured by the 2-minute Sit-up Test Week 9	51.0 Number of sit-ups Standard Deviation 14.5	43.5 Number of sit-ups Standard Deviation 18.2	45.0 Number of sit-ups Standard Deviation 13.0

SECONDARY outcome

Timeframe: 0, 3, 6, 9 Weeks

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.

Outcome measures

Outcome measures
Measure	Primary Care Management (PCM) n=43 Participants Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application). To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.	NeuromuscularElectricalStimulation(NMES) n=43 Participants NeuromuscularElectricalStimulation(NMES): The NMES treatment group received 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. It 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 wrapped around the waist with placements for reusable electrodes. The controller uses a rechargeable battery with charger supplied. The protocol consists of 30-min of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back/next day Abdominal). Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).	Progressive Exercise Plan (PEP) n=42 Participants Progressive Exercise Plan: 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. Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).
Mobility/Function Measured by the 6-minute Walk Test Week 0	1940 Number of feet Standard Deviation 253	1868 Number of feet Standard Deviation 335	1858 Number of feet Standard Deviation 225
Mobility/Function Measured by the 6-minute Walk Test Week 3	2020 Number of feet Standard Deviation 245	1889 Number of feet Standard Deviation 320	1882 Number of feet Standard Deviation 235
Mobility/Function Measured by the 6-minute Walk Test Week 6	1996 Number of feet Standard Deviation 280	1925 Number of feet Standard Deviation 237	1904 Number of feet Standard Deviation 257
Mobility/Function Measured by the 6-minute Walk Test Week 9	2041 Number of feet Standard Deviation 271	1883 Number of feet Standard Deviation 427	1924 Number of feet Standard Deviation 283

SECONDARY outcome

Timeframe: 0, 3, 6, 9 Weeks

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.

Outcome measures

Outcome measures
Measure	Primary Care Management (PCM) n=43 Participants Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application). To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.	NeuromuscularElectricalStimulation(NMES) n=43 Participants NeuromuscularElectricalStimulation(NMES): The NMES treatment group received 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. It 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 wrapped around the waist with placements for reusable electrodes. The controller uses a rechargeable battery with charger supplied. The protocol consists of 30-min of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back/next day Abdominal). Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).	Progressive Exercise Plan (PEP) n=42 Participants Progressive Exercise Plan: 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. Primary Care Management (PCM): All participants received 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 activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants received an information sheet on LBP advising to remain active and use self-care options (e.g., heat application).
Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale Week 0	6.84 score on a scale Standard Deviation 6.29	6.05 score on a scale Standard Deviation 6.07	6.26 score on a scale Standard Deviation 5.50
Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale Week 3	7.78 score on a scale Standard Deviation 6.10	6.46 score on a scale Standard Deviation 4.72	7.12 score on a scale Standard Deviation 7.25
Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale Week 6	6.13 score on a scale Standard Deviation 6.31	6.55 score on a scale Standard Deviation 6.40	8.06 score on a scale Standard Deviation 6.96
Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale Week 9	5.70 score on a scale Standard Deviation 6.11	6.20 score on a scale Standard Deviation 7.28	7.63 score on a scale Standard Deviation 7.25

Adverse Events

Primary Care Management (PCM)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NeuromuscularElectricalStimulation(NMES)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Progressive Exercise Plan (PEP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Laura Talbot

University of Tennessee Health Science Center

Phone: 901-448-3630

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place