Subacute Low Back Pain in Active Duty

NCT03502187 | Completed Results FDA Device

• 2 other identifiers: HU0001-17-1-TS05 (N17-B01)18-05885-DoD
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacute Low Back Pain

Outcome Measures

Primary Outcomes (2)

• 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.

  0, 3, 6, and 9 weeks

• Lower Back Strength-Flexion

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

  0, 3, 6, and 9 weeks

Secondary Outcomes (7)

• Current Pain Severity

  0, 3, 6, 9 Weeks

• Impact of Bodily Pain on Normal Work Measured by SF12v2

  0, 3, 6, 9 Weeks

• Physical Activity

  0, 3, 6, 9 Weeks

• Mobility/Function Measured by the 2-minute Push-up Test

  0, 3, 6, 9 Weeks

• Mobility/Function Measured by the 2-minute Sit-up Test

  0, 3, 6, 9 Weeks

Study Arms (3)

Primary Care Management (PCM)

ACTIVE COMPARATOR

Non-specific LBP, where the cause for the pain cannot be determined, accounts for ninety percent of LBP cases.(Koes, et al, 2006) Reducing pain and continuing daily activity to prevent deconditioning are the primary therapy goals of PCM. Traditional PCM treatment of LBP will include advice/information on self-care options, over-the-counter analgesics, heat application, and remaining active.(Chou, et al., 2007; Koes, et al, 2010) Despite evidence that physical activity is effective, limiting activity remains common; individuals cite pain or re-injury fear as a limiting factor.( Lethem, et al., 1983; Poirandeau, et al., 2006; Steenstra, et al., 2016)

Behavioral: Primary Care Management (PCM)

NeuromuscularElectricalStimulation(NMES)

EXPERIMENTAL

Rehabilitation requires activation of deep stabilizing muscle groups in the lumbopelvic region. Traditional exercises specific for these muscles are hard to teach with poor compliance. NMES is effective in stimulating these muscles, (Porcari, et al., 2005; Glaser, et al., 2001) resulting in enhanced activation, and improved performance. (Coghlan, et al., 2011) NMES devices are programmed to exercise core muscles through a series of stimulated muscle contractions. Concurrent muscle stimulation of the abdominal wall and lumbar paraspinal area has been shown to be most effective to maximally activate deep lumbar stabilizers in LBP patients. (Baek, et al., 2016) NMES provides as much pain relief as transcutaneous electric nerve stimulation (TENS) in LBP subjects. (Moore SR, Shurman J, 1997)

Device: NeuromuscularElectricalStimulation(NMES); Behavioral: Primary Care Management (PCM)

Progressive Exercise Plan (PEP)

EXPERIMENTAL

The literature suggests that this intervention may be of benefit in military personnel with subacute LBP. (Chou, et al., 2007;Marshall PW, Murphy BA, 2006) Meta-analysis showed evidence that graded-activity exercise improved patient outcomes in subacute LBP; however, evidence for other exercise programs were inconsistent. (Hayden, et al., 2005) A strengthening program involving the trunk and abdomen muscles showed clinical reductions in low back pain and disability with high adherence. (Kendall, et al., 2015) Systematic reviews were unable to support any one type of exercise over another. The use of pain-relieving modalities combined with muscle strengthening, such as home-based electrotherapy or progressive exercise, could reduce pain and improve function more rapidly.

Behavioral: Progressive Exercise Plan; Behavioral: Primary Care Management (PCM)

Interventions

Progressive Exercise Plan BEHAVIORAL

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.

Progressive Exercise Plan (PEP)

NeuromuscularElectricalStimulation(NMES) DEVICE

The NMES treatment group will receive a portable battery-operated device, Recovery Back (Neurotech®, Minnetonka, MN) with a 2-garment site-specific system: back \& abdomen. NMES muscle contractions will be elicited by an electrical impulse generated by the Recovery Back system. The device delivers a pre-set program of NMES using a symmetrical biphasic square pulse waveform. (Moore SR, Shurman J, 1997) The garments are light-weight, breathable fabric that wraps around the waist with precise placements for the reusable electrodes. The controller uses a rechargeable battery with charger supplied. The NMES protocol consists of 30-minutes of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back training, next day Abdominal training).

NeuromuscularElectricalStimulation(NMES)

Primary Care Management (PCM) BEHAVIORAL

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.

NeuromuscularElectricalStimulation(NMES); Primary Care Management (PCM); Progressive Exercise Plan (PEP)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Tennessee: lead
• Blanchfield Army Community Hospital: collaborator

Study Sites (1)

Blanchfield Army Community Hospital (BACH)

Fort Campbell North, Kentucky, 42223, United States

Location

Related Publications (31)

• Koes BW, van Tulder MW, Thomas S. Diagnosis and treatment of low back pain. BMJ. 2006 Jun 17;332(7555):1430-4. doi: 10.1136/bmj.332.7555.1430. No abstract available.

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• Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. doi: 10.7326/0003-4819-147-7-200710020-00006.

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Results Point of Contact

• Title: Dr. Laura Talbot
• Organization: University of Tennessee Health Science Center

ltalbot@uthsc.edu

901-448-3630

Study Officials

• Laura A Talbot, PhD, EdD, RN

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 18, 2018
• Study Start: April 17, 2018
• Primary Completion: May 28, 2020
• Study Completion: May 28, 2020
• Last Updated: January 25, 2022
• Results First Posted: January 25, 2022

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)