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Subacute Low Back Pain in Active Duty

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03502187
Acronym
LBP
Enrollment
133
Registered
2018-04-18
Start date
2018-04-17
Completion date
2020-05-28
Last updated
2022-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subacute Low Back Pain

Brief summary

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). Each of the two treatment arms will be supplemented by Primary Care Management. The specific aim of the study is to determine whether the two treatment regimes 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.

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.

Interventions

BEHAVIORALProgressive 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.

DEVICENeuromuscularElectricalStimulation(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).

BEHAVIORALPrimary 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.

Sponsors

Blanchfield Army Community Hospital
CollaboratorFED
University of Tennessee
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

Diagnosed with low back pain, categorized as lumbago or unspecified backache; * greater than 3 weeks and less than 18 weeks since the onset of the episode of LBP; * active duty military service member at the time of diagnosis; * age ≥18 and \<45 years; * ability to provide freely given informed consent.

Exclusion criteria

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; * 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.

Design outcomes

Primary

MeasureTime frameDescription
Lower Back Strength-Extension0, 3, 6, and 9 weeksTorso 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-Flexion0, 3, 6, and 9 weeksTorso 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.

Secondary

MeasureTime frameDescription
Physical Activity0, 3, 6, 9 WeeksPhysical 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.
Mobility/Function Measured by the 2-minute Push-up Test0, 3, 6, 9 WeeksThe 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.
Current Pain Severity0, 3, 6, 9 WeeksThe 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.
Mobility/Function Measured by the 6-minute Walk Test0, 3, 6, 9 WeeksThe 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.
Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale0, 3, 6, 9 WeeksThe 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.
Mobility/Function Measured by the 2-minute Sit-up Test0, 3, 6, 9 WeeksThe 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.
Impact of Bodily Pain on Normal Work Measured by SF12v20, 3, 6, 9 WeeksThe 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.

Countries

United States

Participant flow

Pre-assignment details

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

Participants by arm

ArmCount
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.
43
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).
43
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).
42
Total128

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up545
Overall StudyWithdrawal by Subject433

Baseline characteristics

CharacteristicNeuromuscularElectricalStimulation(NMES)TotalPrimary Care Management (PCM)Progressive Exercise Plan (PEP)
Age, Continuous25.47 years
STANDARD_DEVIATION 5.22
25.5 years
STANDARD_DEVIATION 5.4
25.84 years
STANDARD_DEVIATION 5.66
25.05 years
STANDARD_DEVIATION 5.47
Mechanism of Injury
Military Training
28 Participants79 Participants27 Participants24 Participants
Mechanism of Injury
Other
7 Participants20 Participants7 Participants6 Participants
Mechanism of Injury
Sports
2 Participants3 Participants0 Participants1 Participants
Mechanism of Injury
Work
6 Participants26 Participants9 Participants11 Participants
Race/Ethnicity, Customized
African American
13 Participants37 Participants12 Participants12 Participants
Race/Ethnicity, Customized
Amer. Indian/Alaska Native
1 Participants2 Participants1 Participants0 Participants
Race/Ethnicity, Customized
Asian/Pacific
2 Participants6 Participants3 Participants1 Participants
Race/Ethnicity, Customized
Caucasian
24 Participants72 Participants24 Participants24 Participants
Race/Ethnicity, Customized
Multi-racial
3 Participants11 Participants3 Participants5 Participants
Rank
Enlisted
40 Participants121 Participants39 Participants42 Participants
Rank
Officer
1 Participants5 Participants4 Participants0 Participants
Rank
Warrant Officer
2 Participants2 Participants0 Participants0 Participants
Sex: Female, Male
Female
7 Participants22 Participants8 Participants7 Participants
Sex: Female, Male
Male
36 Participants106 Participants35 Participants35 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 430 / 430 / 42
other
Total, other adverse events
0 / 430 / 430 / 42
serious
Total, serious adverse events
0 / 430 / 430 / 42

Outcome results

Primary

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.

Time frame: 0, 3, 6, and 9 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Primary Care Management (PCM)Lower Back Strength-ExtensionWeek 054.5 kg-ForceStandard Deviation 28.9
Primary Care Management (PCM)Lower Back Strength-ExtensionWeek 357.5 kg-ForceStandard Deviation 33.1
Primary Care Management (PCM)Lower Back Strength-ExtensionWeek 668.2 kg-ForceStandard Deviation 36.9
Primary Care Management (PCM)Lower Back Strength-ExtensionWeek 969.4 kg-ForceStandard Deviation 30.7
NeuromuscularElectricalStimulation(NMES)Lower Back Strength-ExtensionWeek 969.3 kg-ForceStandard Deviation 39.3
NeuromuscularElectricalStimulation(NMES)Lower Back Strength-ExtensionWeek 050.2 kg-ForceStandard Deviation 25.4
NeuromuscularElectricalStimulation(NMES)Lower Back Strength-ExtensionWeek 669.0 kg-ForceStandard Deviation 33.4
NeuromuscularElectricalStimulation(NMES)Lower Back Strength-ExtensionWeek 361.4 kg-ForceStandard Deviation 34.6
Progressive Exercise Plan (PEP)Lower Back Strength-ExtensionWeek 955.1 kg-ForceStandard Deviation 23.6
Progressive Exercise Plan (PEP)Lower Back Strength-ExtensionWeek 354.6 kg-ForceStandard Deviation 31
Progressive Exercise Plan (PEP)Lower Back Strength-ExtensionWeek 653.1 kg-ForceStandard Deviation 30.1
Progressive Exercise Plan (PEP)Lower Back Strength-ExtensionWeek 049.2 kg-ForceStandard Deviation 27.2
Primary

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.

Time frame: 0, 3, 6, and 9 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Primary Care Management (PCM)Lower Back Strength-FlexionWeek 051.6 kg-ForceStandard Deviation 29.7
Primary Care Management (PCM)Lower Back Strength-FlexionWeek 352.1 kg-ForceStandard Deviation 29.6
Primary Care Management (PCM)Lower Back Strength-FlexionWeek 665.6 kg-ForceStandard Deviation 39.9
Primary Care Management (PCM)Lower Back Strength-FlexionWeek 965.1 kg-ForceStandard Deviation 29.9
NeuromuscularElectricalStimulation(NMES)Lower Back Strength-FlexionWeek 960.9 kg-ForceStandard Deviation 30.9
NeuromuscularElectricalStimulation(NMES)Lower Back Strength-FlexionWeek 048.8 kg-ForceStandard Deviation 27.7
NeuromuscularElectricalStimulation(NMES)Lower Back Strength-FlexionWeek 663.7 kg-ForceStandard Deviation 29.6
NeuromuscularElectricalStimulation(NMES)Lower Back Strength-FlexionWeek 357.9 kg-ForceStandard Deviation 30.5
Progressive Exercise Plan (PEP)Lower Back Strength-FlexionWeek 947.9 kg-ForceStandard Deviation 22.5
Progressive Exercise Plan (PEP)Lower Back Strength-FlexionWeek 347.7 kg-ForceStandard Deviation 26.3
Progressive Exercise Plan (PEP)Lower Back Strength-FlexionWeek 644.4 kg-ForceStandard Deviation 26.3
Progressive Exercise Plan (PEP)Lower Back Strength-FlexionWeek 043.7 kg-ForceStandard Deviation 23.1
Secondary

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.

Time frame: 0, 3, 6, 9 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Primary Care Management (PCM)Current Pain SeverityWeek 04.43 score on a scaleStandard Deviation 2
Primary Care Management (PCM)Current Pain SeverityWeek 33.88 score on a scaleStandard Deviation 2.6
Primary Care Management (PCM)Current Pain SeverityWeek 64.03 score on a scaleStandard Deviation 2.5
Primary Care Management (PCM)Current Pain SeverityWeek 93.28 score on a scaleStandard Deviation 2.6
NeuromuscularElectricalStimulation(NMES)Current Pain SeverityWeek 94.07 score on a scaleStandard Deviation 3.1
NeuromuscularElectricalStimulation(NMES)Current Pain SeverityWeek 04.57 score on a scaleStandard Deviation 2.2
NeuromuscularElectricalStimulation(NMES)Current Pain SeverityWeek 63.96 score on a scaleStandard Deviation 2.9
NeuromuscularElectricalStimulation(NMES)Current Pain SeverityWeek 34.54 score on a scaleStandard Deviation 2.3
Progressive Exercise Plan (PEP)Current Pain SeverityWeek 93.93 score on a scaleStandard Deviation 2.7
Progressive Exercise Plan (PEP)Current Pain SeverityWeek 34.47 score on a scaleStandard Deviation 2.2
Progressive Exercise Plan (PEP)Current Pain SeverityWeek 64.70 score on a scaleStandard Deviation 2.6
Progressive Exercise Plan (PEP)Current Pain SeverityWeek 04.78 score on a scaleStandard Deviation 2
Secondary

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.

Time frame: 0, 3, 6, 9 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Primary Care Management (PCM)Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) ScaleWeek 06.84 score on a scaleStandard Deviation 6.29
Primary Care Management (PCM)Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) ScaleWeek 37.78 score on a scaleStandard Deviation 6.1
Primary Care Management (PCM)Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) ScaleWeek 66.13 score on a scaleStandard Deviation 6.31
Primary Care Management (PCM)Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) ScaleWeek 95.70 score on a scaleStandard Deviation 6.11
NeuromuscularElectricalStimulation(NMES)Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) ScaleWeek 96.20 score on a scaleStandard Deviation 7.28
NeuromuscularElectricalStimulation(NMES)Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) ScaleWeek 06.05 score on a scaleStandard Deviation 6.07
NeuromuscularElectricalStimulation(NMES)Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) ScaleWeek 66.55 score on a scaleStandard Deviation 6.4
NeuromuscularElectricalStimulation(NMES)Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) ScaleWeek 36.46 score on a scaleStandard Deviation 4.72
Progressive Exercise Plan (PEP)Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) ScaleWeek 97.63 score on a scaleStandard Deviation 7.25
Progressive Exercise Plan (PEP)Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) ScaleWeek 37.12 score on a scaleStandard Deviation 7.25
Progressive Exercise Plan (PEP)Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) ScaleWeek 68.06 score on a scaleStandard Deviation 6.96
Progressive Exercise Plan (PEP)Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) ScaleWeek 06.26 score on a scaleStandard Deviation 5.5
Secondary

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.

Time frame: 0, 3, 6, 9 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Primary Care Management (PCM)Impact of Bodily Pain on Normal Work Measured by SF12v2Week 053.6 score on a scaleStandard Deviation 22.5
Primary Care Management (PCM)Impact of Bodily Pain on Normal Work Measured by SF12v2Week 359.0 score on a scaleStandard Deviation 24
Primary Care Management (PCM)Impact of Bodily Pain on Normal Work Measured by SF12v2Week 659.2 score on a scaleStandard Deviation 23.2
Primary Care Management (PCM)Impact of Bodily Pain on Normal Work Measured by SF12v2Week 972.0 score on a scaleStandard Deviation 23.2
NeuromuscularElectricalStimulation(NMES)Impact of Bodily Pain on Normal Work Measured by SF12v2Week 972.1 score on a scaleStandard Deviation 21.1
NeuromuscularElectricalStimulation(NMES)Impact of Bodily Pain on Normal Work Measured by SF12v2Week 044 score on a scaleStandard Deviation 27.5
NeuromuscularElectricalStimulation(NMES)Impact of Bodily Pain on Normal Work Measured by SF12v2Week 661.4 score on a scaleStandard Deviation 26.6
NeuromuscularElectricalStimulation(NMES)Impact of Bodily Pain on Normal Work Measured by SF12v2Week 358.8 score on a scaleStandard Deviation 22.2
Progressive Exercise Plan (PEP)Impact of Bodily Pain on Normal Work Measured by SF12v2Week 965.8 score on a scaleStandard Deviation 23.2
Progressive Exercise Plan (PEP)Impact of Bodily Pain on Normal Work Measured by SF12v2Week 355.9 score on a scaleStandard Deviation 22.2
Progressive Exercise Plan (PEP)Impact of Bodily Pain on Normal Work Measured by SF12v2Week 658.6 score on a scaleStandard Deviation 25.1
Progressive Exercise Plan (PEP)Impact of Bodily Pain on Normal Work Measured by SF12v2Week 047.6 score on a scaleStandard Deviation 19
Secondary

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.

Time frame: 0, 3, 6, 9 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Primary Care Management (PCM)Mobility/Function Measured by the 2-minute Push-up TestWeek 046.9 Number of push-upsStandard Deviation 14.4
Primary Care Management (PCM)Mobility/Function Measured by the 2-minute Push-up TestWeek 346.0 Number of push-upsStandard Deviation 16.3
Primary Care Management (PCM)Mobility/Function Measured by the 2-minute Push-up TestWeek 645.9 Number of push-upsStandard Deviation 14.6
Primary Care Management (PCM)Mobility/Function Measured by the 2-minute Push-up TestWeek 946.2 Number of push-upsStandard Deviation 18.1
NeuromuscularElectricalStimulation(NMES)Mobility/Function Measured by the 2-minute Push-up TestWeek 946.0 Number of push-upsStandard Deviation 22.9
NeuromuscularElectricalStimulation(NMES)Mobility/Function Measured by the 2-minute Push-up TestWeek 041.1 Number of push-upsStandard Deviation 18.2
NeuromuscularElectricalStimulation(NMES)Mobility/Function Measured by the 2-minute Push-up TestWeek 642.3 Number of push-upsStandard Deviation 18.7
NeuromuscularElectricalStimulation(NMES)Mobility/Function Measured by the 2-minute Push-up TestWeek 340.3 Number of push-upsStandard Deviation 20.4
Progressive Exercise Plan (PEP)Mobility/Function Measured by the 2-minute Push-up TestWeek 946.3 Number of push-upsStandard Deviation 17.2
Progressive Exercise Plan (PEP)Mobility/Function Measured by the 2-minute Push-up TestWeek 347.4 Number of push-upsStandard Deviation 16.8
Progressive Exercise Plan (PEP)Mobility/Function Measured by the 2-minute Push-up TestWeek 642.2 Number of push-upsStandard Deviation 18.7
Progressive Exercise Plan (PEP)Mobility/Function Measured by the 2-minute Push-up TestWeek 043.7 Number of push-upsStandard Deviation 18.4
Secondary

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.

Time frame: 0, 3, 6, 9 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Primary Care Management (PCM)Mobility/Function Measured by the 2-minute Sit-up TestWeek 044.4 Number of sit-upsStandard Deviation 17.6
Primary Care Management (PCM)Mobility/Function Measured by the 2-minute Sit-up TestWeek 344.9 Number of sit-upsStandard Deviation 18.8
Primary Care Management (PCM)Mobility/Function Measured by the 2-minute Sit-up TestWeek 645.6 Number of sit-upsStandard Deviation 18.4
Primary Care Management (PCM)Mobility/Function Measured by the 2-minute Sit-up TestWeek 951.0 Number of sit-upsStandard Deviation 14.5
NeuromuscularElectricalStimulation(NMES)Mobility/Function Measured by the 2-minute Sit-up TestWeek 943.5 Number of sit-upsStandard Deviation 18.2
NeuromuscularElectricalStimulation(NMES)Mobility/Function Measured by the 2-minute Sit-up TestWeek 035.5 Number of sit-upsStandard Deviation 21.4
NeuromuscularElectricalStimulation(NMES)Mobility/Function Measured by the 2-minute Sit-up TestWeek 643.2 Number of sit-upsStandard Deviation 15.2
NeuromuscularElectricalStimulation(NMES)Mobility/Function Measured by the 2-minute Sit-up TestWeek 338.7 Number of sit-upsStandard Deviation 21.5
Progressive Exercise Plan (PEP)Mobility/Function Measured by the 2-minute Sit-up TestWeek 945.0 Number of sit-upsStandard Deviation 13
Progressive Exercise Plan (PEP)Mobility/Function Measured by the 2-minute Sit-up TestWeek 343.2 Number of sit-upsStandard Deviation 15.3
Progressive Exercise Plan (PEP)Mobility/Function Measured by the 2-minute Sit-up TestWeek 640.8 Number of sit-upsStandard Deviation 14.9
Progressive Exercise Plan (PEP)Mobility/Function Measured by the 2-minute Sit-up TestWeek 041.5 Number of sit-upsStandard Deviation 15.2
Secondary

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.

Time frame: 0, 3, 6, 9 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Primary Care Management (PCM)Mobility/Function Measured by the 6-minute Walk TestWeek 01940 Number of feetStandard Deviation 253
Primary Care Management (PCM)Mobility/Function Measured by the 6-minute Walk TestWeek 32020 Number of feetStandard Deviation 245
Primary Care Management (PCM)Mobility/Function Measured by the 6-minute Walk TestWeek 61996 Number of feetStandard Deviation 280
Primary Care Management (PCM)Mobility/Function Measured by the 6-minute Walk TestWeek 92041 Number of feetStandard Deviation 271
NeuromuscularElectricalStimulation(NMES)Mobility/Function Measured by the 6-minute Walk TestWeek 91883 Number of feetStandard Deviation 427
NeuromuscularElectricalStimulation(NMES)Mobility/Function Measured by the 6-minute Walk TestWeek 01868 Number of feetStandard Deviation 335
NeuromuscularElectricalStimulation(NMES)Mobility/Function Measured by the 6-minute Walk TestWeek 61925 Number of feetStandard Deviation 237
NeuromuscularElectricalStimulation(NMES)Mobility/Function Measured by the 6-minute Walk TestWeek 31889 Number of feetStandard Deviation 320
Progressive Exercise Plan (PEP)Mobility/Function Measured by the 6-minute Walk TestWeek 91924 Number of feetStandard Deviation 283
Progressive Exercise Plan (PEP)Mobility/Function Measured by the 6-minute Walk TestWeek 31882 Number of feetStandard Deviation 235
Progressive Exercise Plan (PEP)Mobility/Function Measured by the 6-minute Walk TestWeek 61904 Number of feetStandard Deviation 257
Progressive Exercise Plan (PEP)Mobility/Function Measured by the 6-minute Walk TestWeek 01858 Number of feetStandard Deviation 225
Secondary

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.

Time frame: 0, 3, 6, 9 Weeks

ArmMeasureGroupValue (MEAN)Dispersion
Primary Care Management (PCM)Physical ActivityWeek 02733 KcalStandard Deviation 1024
Primary Care Management (PCM)Physical ActivityWeek 62599 KcalStandard Deviation 843
Primary Care Management (PCM)Physical ActivityWeek 92605 KcalStandard Deviation 942
Primary Care Management (PCM)Physical ActivityWeek 32691 KcalStandard Deviation 955
NeuromuscularElectricalStimulation(NMES)Physical ActivityWeek 62955 KcalStandard Deviation 942
NeuromuscularElectricalStimulation(NMES)Physical ActivityWeek 03005 KcalStandard Deviation 932
NeuromuscularElectricalStimulation(NMES)Physical ActivityWeek 92922 KcalStandard Deviation 1107
NeuromuscularElectricalStimulation(NMES)Physical ActivityWeek 32950 KcalStandard Deviation 854
Progressive Exercise Plan (PEP)Physical ActivityWeek 92559 KcalStandard Deviation 700
Progressive Exercise Plan (PEP)Physical ActivityWeek 62609 KcalStandard Deviation 934
Progressive Exercise Plan (PEP)Physical ActivityWeek 32809 KcalStandard Deviation 1040
Progressive Exercise Plan (PEP)Physical ActivityWeek 02912 KcalStandard Deviation 1019

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026