Subacute Low Back Pain
Conditions
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
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.
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).
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Lower Back Strength-Extension | 0, 3, 6, and 9 weeks | Torso extension muscle strength is measured with a modified version of the U of Michigan strength test system (Workability Systems, West Chester, Ohio) and a Chattanooga-Baseline® Hand Dynamometer - Digital LCD Gauge - ER™ 300 lb capacity (DJO Global, Chattanooga, Vista, CA USA). To measure trunk extension, the participant stands with their lower anterior abdomen against the padded board. The belt is placed around the posterior back and under the arms. Participants pull against the belt as forcefully as possible. Participants perform two maximal efforts maintaining each voluntary isometric exertion for 5 seconds, separated by 30-second rest; the highest value of the two trials will be accepted. |
| Lower Back Strength-Flexion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity | 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. |
| Mobility/Function Measured by the 2-minute Push-up Test | 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. |
| Current Pain Severity | 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. |
| Mobility/Function Measured by the 6-minute Walk Test | 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. |
| Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale | 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. |
| Mobility/Function Measured by the 2-minute Sit-up Test | 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. |
| Impact of Bodily Pain on Normal Work Measured by SF12v2 | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 4 | 5 |
| Overall Study | Withdrawal by Subject | 4 | 3 | 3 |
Baseline characteristics
| Characteristic | NeuromuscularElectricalStimulation(NMES) | Total | Primary Care Management (PCM) | Progressive Exercise Plan (PEP) |
|---|---|---|---|---|
| Age, Continuous | 25.47 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 Participants | 79 Participants | 27 Participants | 24 Participants |
| Mechanism of Injury Other | 7 Participants | 20 Participants | 7 Participants | 6 Participants |
| Mechanism of Injury Sports | 2 Participants | 3 Participants | 0 Participants | 1 Participants |
| Mechanism of Injury Work | 6 Participants | 26 Participants | 9 Participants | 11 Participants |
| Race/Ethnicity, Customized African American | 13 Participants | 37 Participants | 12 Participants | 12 Participants |
| Race/Ethnicity, Customized Amer. Indian/Alaska Native | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian/Pacific | 2 Participants | 6 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 24 Participants | 72 Participants | 24 Participants | 24 Participants |
| Race/Ethnicity, Customized Multi-racial | 3 Participants | 11 Participants | 3 Participants | 5 Participants |
| Rank Enlisted | 40 Participants | 121 Participants | 39 Participants | 42 Participants |
| Rank Officer | 1 Participants | 5 Participants | 4 Participants | 0 Participants |
| Rank Warrant Officer | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 7 Participants | 22 Participants | 8 Participants | 7 Participants |
| Sex: Female, Male Male | 36 Participants | 106 Participants | 35 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 43 | 0 / 42 |
| other Total, other adverse events | 0 / 43 | 0 / 43 | 0 / 42 |
| serious Total, serious adverse events | 0 / 43 | 0 / 43 | 0 / 42 |
Outcome results
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Care Management (PCM) | Lower Back Strength-Extension | Week 0 | 54.5 kg-Force | Standard Deviation 28.9 |
| Primary Care Management (PCM) | Lower Back Strength-Extension | Week 3 | 57.5 kg-Force | Standard Deviation 33.1 |
| Primary Care Management (PCM) | Lower Back Strength-Extension | Week 6 | 68.2 kg-Force | Standard Deviation 36.9 |
| Primary Care Management (PCM) | Lower Back Strength-Extension | Week 9 | 69.4 kg-Force | Standard Deviation 30.7 |
| NeuromuscularElectricalStimulation(NMES) | Lower Back Strength-Extension | Week 9 | 69.3 kg-Force | Standard Deviation 39.3 |
| NeuromuscularElectricalStimulation(NMES) | Lower Back Strength-Extension | Week 0 | 50.2 kg-Force | Standard Deviation 25.4 |
| NeuromuscularElectricalStimulation(NMES) | Lower Back Strength-Extension | Week 6 | 69.0 kg-Force | Standard Deviation 33.4 |
| NeuromuscularElectricalStimulation(NMES) | Lower Back Strength-Extension | Week 3 | 61.4 kg-Force | Standard Deviation 34.6 |
| Progressive Exercise Plan (PEP) | Lower Back Strength-Extension | Week 9 | 55.1 kg-Force | Standard Deviation 23.6 |
| Progressive Exercise Plan (PEP) | Lower Back Strength-Extension | Week 3 | 54.6 kg-Force | Standard Deviation 31 |
| Progressive Exercise Plan (PEP) | Lower Back Strength-Extension | Week 6 | 53.1 kg-Force | Standard Deviation 30.1 |
| Progressive Exercise Plan (PEP) | Lower Back Strength-Extension | Week 0 | 49.2 kg-Force | Standard Deviation 27.2 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Care Management (PCM) | Lower Back Strength-Flexion | Week 0 | 51.6 kg-Force | Standard Deviation 29.7 |
| Primary Care Management (PCM) | Lower Back Strength-Flexion | Week 3 | 52.1 kg-Force | Standard Deviation 29.6 |
| Primary Care Management (PCM) | Lower Back Strength-Flexion | Week 6 | 65.6 kg-Force | Standard Deviation 39.9 |
| Primary Care Management (PCM) | Lower Back Strength-Flexion | Week 9 | 65.1 kg-Force | Standard Deviation 29.9 |
| NeuromuscularElectricalStimulation(NMES) | Lower Back Strength-Flexion | Week 9 | 60.9 kg-Force | Standard Deviation 30.9 |
| NeuromuscularElectricalStimulation(NMES) | Lower Back Strength-Flexion | Week 0 | 48.8 kg-Force | Standard Deviation 27.7 |
| NeuromuscularElectricalStimulation(NMES) | Lower Back Strength-Flexion | Week 6 | 63.7 kg-Force | Standard Deviation 29.6 |
| NeuromuscularElectricalStimulation(NMES) | Lower Back Strength-Flexion | Week 3 | 57.9 kg-Force | Standard Deviation 30.5 |
| Progressive Exercise Plan (PEP) | Lower Back Strength-Flexion | Week 9 | 47.9 kg-Force | Standard Deviation 22.5 |
| Progressive Exercise Plan (PEP) | Lower Back Strength-Flexion | Week 3 | 47.7 kg-Force | Standard Deviation 26.3 |
| Progressive Exercise Plan (PEP) | Lower Back Strength-Flexion | Week 6 | 44.4 kg-Force | Standard Deviation 26.3 |
| Progressive Exercise Plan (PEP) | Lower Back Strength-Flexion | Week 0 | 43.7 kg-Force | Standard Deviation 23.1 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Care Management (PCM) | Current Pain Severity | Week 0 | 4.43 score on a scale | Standard Deviation 2 |
| Primary Care Management (PCM) | Current Pain Severity | Week 3 | 3.88 score on a scale | Standard Deviation 2.6 |
| Primary Care Management (PCM) | Current Pain Severity | Week 6 | 4.03 score on a scale | Standard Deviation 2.5 |
| Primary Care Management (PCM) | Current Pain Severity | Week 9 | 3.28 score on a scale | Standard Deviation 2.6 |
| NeuromuscularElectricalStimulation(NMES) | Current Pain Severity | Week 9 | 4.07 score on a scale | Standard Deviation 3.1 |
| NeuromuscularElectricalStimulation(NMES) | Current Pain Severity | Week 0 | 4.57 score on a scale | Standard Deviation 2.2 |
| NeuromuscularElectricalStimulation(NMES) | Current Pain Severity | Week 6 | 3.96 score on a scale | Standard Deviation 2.9 |
| NeuromuscularElectricalStimulation(NMES) | Current Pain Severity | Week 3 | 4.54 score on a scale | Standard Deviation 2.3 |
| Progressive Exercise Plan (PEP) | Current Pain Severity | Week 9 | 3.93 score on a scale | Standard Deviation 2.7 |
| Progressive Exercise Plan (PEP) | Current Pain Severity | Week 3 | 4.47 score on a scale | Standard Deviation 2.2 |
| Progressive Exercise Plan (PEP) | Current Pain Severity | Week 6 | 4.70 score on a scale | Standard Deviation 2.6 |
| Progressive Exercise Plan (PEP) | Current Pain Severity | Week 0 | 4.78 score on a scale | Standard Deviation 2 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Care Management (PCM) | Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale | Week 0 | 6.84 score on a scale | Standard Deviation 6.29 |
| Primary Care Management (PCM) | Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale | Week 3 | 7.78 score on a scale | Standard Deviation 6.1 |
| Primary Care Management (PCM) | Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale | Week 6 | 6.13 score on a scale | Standard Deviation 6.31 |
| Primary Care Management (PCM) | Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale | Week 9 | 5.70 score on a scale | Standard Deviation 6.11 |
| NeuromuscularElectricalStimulation(NMES) | Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale | Week 9 | 6.20 score on a scale | Standard Deviation 7.28 |
| NeuromuscularElectricalStimulation(NMES) | Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale | Week 0 | 6.05 score on a scale | Standard Deviation 6.07 |
| NeuromuscularElectricalStimulation(NMES) | Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale | Week 6 | 6.55 score on a scale | Standard Deviation 6.4 |
| NeuromuscularElectricalStimulation(NMES) | Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale | Week 3 | 6.46 score on a scale | Standard Deviation 4.72 |
| Progressive Exercise Plan (PEP) | Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale | Week 9 | 7.63 score on a scale | Standard Deviation 7.25 |
| Progressive Exercise Plan (PEP) | Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale | Week 3 | 7.12 score on a scale | Standard Deviation 7.25 |
| Progressive Exercise Plan (PEP) | Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale | Week 6 | 8.06 score on a scale | Standard Deviation 6.96 |
| Progressive Exercise Plan (PEP) | Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale | Week 0 | 6.26 score on a scale | Standard Deviation 5.5 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Care Management (PCM) | Impact of Bodily Pain on Normal Work Measured by SF12v2 | Week 0 | 53.6 score on a scale | Standard Deviation 22.5 |
| Primary Care Management (PCM) | Impact of Bodily Pain on Normal Work Measured by SF12v2 | Week 3 | 59.0 score on a scale | Standard Deviation 24 |
| Primary Care Management (PCM) | Impact of Bodily Pain on Normal Work Measured by SF12v2 | Week 6 | 59.2 score on a scale | Standard Deviation 23.2 |
| Primary Care Management (PCM) | Impact of Bodily Pain on Normal Work Measured by SF12v2 | Week 9 | 72.0 score on a scale | Standard Deviation 23.2 |
| NeuromuscularElectricalStimulation(NMES) | Impact of Bodily Pain on Normal Work Measured by SF12v2 | Week 9 | 72.1 score on a scale | Standard Deviation 21.1 |
| NeuromuscularElectricalStimulation(NMES) | Impact of Bodily Pain on Normal Work Measured by SF12v2 | Week 0 | 44 score on a scale | Standard Deviation 27.5 |
| NeuromuscularElectricalStimulation(NMES) | Impact of Bodily Pain on Normal Work Measured by SF12v2 | Week 6 | 61.4 score on a scale | Standard Deviation 26.6 |
| NeuromuscularElectricalStimulation(NMES) | Impact of Bodily Pain on Normal Work Measured by SF12v2 | Week 3 | 58.8 score on a scale | Standard Deviation 22.2 |
| Progressive Exercise Plan (PEP) | Impact of Bodily Pain on Normal Work Measured by SF12v2 | Week 9 | 65.8 score on a scale | Standard Deviation 23.2 |
| Progressive Exercise Plan (PEP) | Impact of Bodily Pain on Normal Work Measured by SF12v2 | Week 3 | 55.9 score on a scale | Standard Deviation 22.2 |
| Progressive Exercise Plan (PEP) | Impact of Bodily Pain on Normal Work Measured by SF12v2 | Week 6 | 58.6 score on a scale | Standard Deviation 25.1 |
| Progressive Exercise Plan (PEP) | Impact of Bodily Pain on Normal Work Measured by SF12v2 | Week 0 | 47.6 score on a scale | Standard Deviation 19 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Care Management (PCM) | Mobility/Function Measured by the 2-minute Push-up Test | Week 0 | 46.9 Number of push-ups | Standard Deviation 14.4 |
| Primary Care Management (PCM) | Mobility/Function Measured by the 2-minute Push-up Test | Week 3 | 46.0 Number of push-ups | Standard Deviation 16.3 |
| Primary Care Management (PCM) | Mobility/Function Measured by the 2-minute Push-up Test | Week 6 | 45.9 Number of push-ups | Standard Deviation 14.6 |
| Primary Care Management (PCM) | Mobility/Function Measured by the 2-minute Push-up Test | Week 9 | 46.2 Number of push-ups | Standard Deviation 18.1 |
| NeuromuscularElectricalStimulation(NMES) | Mobility/Function Measured by the 2-minute Push-up Test | Week 9 | 46.0 Number of push-ups | Standard Deviation 22.9 |
| NeuromuscularElectricalStimulation(NMES) | Mobility/Function Measured by the 2-minute Push-up Test | Week 0 | 41.1 Number of push-ups | Standard Deviation 18.2 |
| NeuromuscularElectricalStimulation(NMES) | Mobility/Function Measured by the 2-minute Push-up Test | Week 6 | 42.3 Number of push-ups | Standard Deviation 18.7 |
| NeuromuscularElectricalStimulation(NMES) | Mobility/Function Measured by the 2-minute Push-up Test | Week 3 | 40.3 Number of push-ups | Standard Deviation 20.4 |
| Progressive Exercise Plan (PEP) | Mobility/Function Measured by the 2-minute Push-up Test | Week 9 | 46.3 Number of push-ups | Standard Deviation 17.2 |
| Progressive Exercise Plan (PEP) | Mobility/Function Measured by the 2-minute Push-up Test | Week 3 | 47.4 Number of push-ups | Standard Deviation 16.8 |
| Progressive Exercise Plan (PEP) | Mobility/Function Measured by the 2-minute Push-up Test | Week 6 | 42.2 Number of push-ups | Standard Deviation 18.7 |
| Progressive Exercise Plan (PEP) | Mobility/Function Measured by the 2-minute Push-up Test | Week 0 | 43.7 Number of push-ups | Standard Deviation 18.4 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Care Management (PCM) | Mobility/Function Measured by the 2-minute Sit-up Test | Week 0 | 44.4 Number of sit-ups | Standard Deviation 17.6 |
| Primary Care Management (PCM) | Mobility/Function Measured by the 2-minute Sit-up Test | Week 3 | 44.9 Number of sit-ups | Standard Deviation 18.8 |
| Primary Care Management (PCM) | Mobility/Function Measured by the 2-minute Sit-up Test | Week 6 | 45.6 Number of sit-ups | Standard Deviation 18.4 |
| Primary Care Management (PCM) | Mobility/Function Measured by the 2-minute Sit-up Test | Week 9 | 51.0 Number of sit-ups | Standard Deviation 14.5 |
| NeuromuscularElectricalStimulation(NMES) | Mobility/Function Measured by the 2-minute Sit-up Test | Week 9 | 43.5 Number of sit-ups | Standard Deviation 18.2 |
| NeuromuscularElectricalStimulation(NMES) | Mobility/Function Measured by the 2-minute Sit-up Test | Week 0 | 35.5 Number of sit-ups | Standard Deviation 21.4 |
| NeuromuscularElectricalStimulation(NMES) | Mobility/Function Measured by the 2-minute Sit-up Test | Week 6 | 43.2 Number of sit-ups | Standard Deviation 15.2 |
| NeuromuscularElectricalStimulation(NMES) | Mobility/Function Measured by the 2-minute Sit-up Test | Week 3 | 38.7 Number of sit-ups | Standard Deviation 21.5 |
| Progressive Exercise Plan (PEP) | Mobility/Function Measured by the 2-minute Sit-up Test | Week 9 | 45.0 Number of sit-ups | Standard Deviation 13 |
| Progressive Exercise Plan (PEP) | Mobility/Function Measured by the 2-minute Sit-up Test | Week 3 | 43.2 Number of sit-ups | Standard Deviation 15.3 |
| Progressive Exercise Plan (PEP) | Mobility/Function Measured by the 2-minute Sit-up Test | Week 6 | 40.8 Number of sit-ups | Standard Deviation 14.9 |
| Progressive Exercise Plan (PEP) | Mobility/Function Measured by the 2-minute Sit-up Test | Week 0 | 41.5 Number of sit-ups | Standard Deviation 15.2 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Care Management (PCM) | Mobility/Function Measured by the 6-minute Walk Test | Week 0 | 1940 Number of feet | Standard Deviation 253 |
| Primary Care Management (PCM) | Mobility/Function Measured by the 6-minute Walk Test | Week 3 | 2020 Number of feet | Standard Deviation 245 |
| Primary Care Management (PCM) | Mobility/Function Measured by the 6-minute Walk Test | Week 6 | 1996 Number of feet | Standard Deviation 280 |
| Primary Care Management (PCM) | Mobility/Function Measured by the 6-minute Walk Test | Week 9 | 2041 Number of feet | Standard Deviation 271 |
| NeuromuscularElectricalStimulation(NMES) | Mobility/Function Measured by the 6-minute Walk Test | Week 9 | 1883 Number of feet | Standard Deviation 427 |
| NeuromuscularElectricalStimulation(NMES) | Mobility/Function Measured by the 6-minute Walk Test | Week 0 | 1868 Number of feet | Standard Deviation 335 |
| NeuromuscularElectricalStimulation(NMES) | Mobility/Function Measured by the 6-minute Walk Test | Week 6 | 1925 Number of feet | Standard Deviation 237 |
| NeuromuscularElectricalStimulation(NMES) | Mobility/Function Measured by the 6-minute Walk Test | Week 3 | 1889 Number of feet | Standard Deviation 320 |
| Progressive Exercise Plan (PEP) | Mobility/Function Measured by the 6-minute Walk Test | Week 9 | 1924 Number of feet | Standard Deviation 283 |
| Progressive Exercise Plan (PEP) | Mobility/Function Measured by the 6-minute Walk Test | Week 3 | 1882 Number of feet | Standard Deviation 235 |
| Progressive Exercise Plan (PEP) | Mobility/Function Measured by the 6-minute Walk Test | Week 6 | 1904 Number of feet | Standard Deviation 257 |
| Progressive Exercise Plan (PEP) | Mobility/Function Measured by the 6-minute Walk Test | Week 0 | 1858 Number of feet | Standard Deviation 225 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Care Management (PCM) | Physical Activity | Week 0 | 2733 Kcal | Standard Deviation 1024 |
| Primary Care Management (PCM) | Physical Activity | Week 6 | 2599 Kcal | Standard Deviation 843 |
| Primary Care Management (PCM) | Physical Activity | Week 9 | 2605 Kcal | Standard Deviation 942 |
| Primary Care Management (PCM) | Physical Activity | Week 3 | 2691 Kcal | Standard Deviation 955 |
| NeuromuscularElectricalStimulation(NMES) | Physical Activity | Week 6 | 2955 Kcal | Standard Deviation 942 |
| NeuromuscularElectricalStimulation(NMES) | Physical Activity | Week 0 | 3005 Kcal | Standard Deviation 932 |
| NeuromuscularElectricalStimulation(NMES) | Physical Activity | Week 9 | 2922 Kcal | Standard Deviation 1107 |
| NeuromuscularElectricalStimulation(NMES) | Physical Activity | Week 3 | 2950 Kcal | Standard Deviation 854 |
| Progressive Exercise Plan (PEP) | Physical Activity | Week 9 | 2559 Kcal | Standard Deviation 700 |
| Progressive Exercise Plan (PEP) | Physical Activity | Week 6 | 2609 Kcal | Standard Deviation 934 |
| Progressive Exercise Plan (PEP) | Physical Activity | Week 3 | 2809 Kcal | Standard Deviation 1040 |
| Progressive Exercise Plan (PEP) | Physical Activity | Week 0 | 2912 Kcal | Standard Deviation 1019 |