Neuropathic Pain Clinical Trial
Official title:
The Clinical Feasibility of Combining Cranial Electrotherapy Stimulation (CES Alpha-Stim) and Non-invasive Interactive Neurostimulation (InterX) for Optimized Rehabilitation Following Extremity Immobilization
NCT number | NCT03060122 |
Other study ID # | C.2017.026 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2018 |
Est. completion date | August 7, 2019 |
Verified date | November 2019 |
Source | Brooke Army Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will be aimed at assessing the feasibility of a dual-device treatment prior to a rehabilitation session for an orthopaedic injury requiring immobilization, and its impact on improving outcomes and decreasing the risk for development of neuropathic pain. The investigators will evaluate the clinical feasibility and effectiveness of incorporating the Alpha-Stim and Inter-X treatment into a standard rehabilitation protocol to address risk factors associated with the development of neuropathic pain (i.e., pain, range of motion, and skin temperature) as well as its impact on reduced pain medication.
Status | Completed |
Enrollment | 35 |
Est. completion date | August 7, 2019 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. An orthopaedic/musculoskeletal postoperative injury that required cast or splint immobilization of the joint(s) to be treated of = 2 weeks and available for treatment and are coming in for physical or occupational therapy 2. Between the age of 18 - 65 years 3. Read and speak English well enough to provide informed consent and follow study instructions Exclusion Criteria: 1. Active infection, open sores, or open incisions (or anything that would inhibit the application of the stim) in the affected extremity. 2. Any contraindications to electrical stimulation including: any type of implanted demand type cardiac pacemakers, implanted defibrillators, or implanted functioning devices (i.e., insulin pump); active cancerous tissue or are undergoing chemotherapy; known pregnancy or breastfeeding or history of epilepsy or other seizures. 3. History of inflammatory skin diseases (psoriasis, dermatitis, etc.). 4. Contralateral extremity involvement resulting in less than normal range of motion, muscle strength, or daily pain greater than 1/10. |
Country | Name | City | State |
---|---|---|---|
United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Brooke Army Medical Center |
United States,
Brandt KD. Response of joint structures to inactivity and to reloading after immobilization. Arthritis Rheum. 2003 Apr 15;49(2):267-71. Review. — View Citation
Cook KF, Dunn W, Griffith JW, Morrison MT, Tanquary J, Sabata D, Victorson D, Carey LM, Macdermid JC, Dudgeon BJ, Gershon RC. Pain assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S49-53. doi: 10.1212/WNL.0b013e3182872e80. — View Citation
Gorodetskyi IG, Gorodnichenko AI, Tursin PS, Reshetnyak VK, Uskov ON. Non-invasive interactive neurostimulation in the post-operative recovery of patients with a trochanteric fracture of the femur. A randomised, controlled trial. J Bone Joint Surg Br. 2007 Nov;89(11):1488-94. — View Citation
Gorodetskyi IG, Gorodnichenko AI, Tursin PS, Reshetnyak VK, Uskov ON. Use of noninvasive interactive neurostimulation to improve short-term recovery in patients with surgically repaired bimalleolar ankle fractures: a prospective, randomized clinical trial. J Foot Ankle Surg. 2010 Sep-Oct;49(5):432-7. doi: 10.1053/j.jfas.2010.05.007. Epub 2010 Aug 5. — View Citation
Hortobágyi T, Dempsey L, Fraser D, Zheng D, Hamilton G, Lambert J, Dohm L. Changes in muscle strength, muscle fibre size and myofibrillar gene expression after immobilization and retraining in humans. J Physiol. 2000 Apr 1;524 Pt 1:293-304. — View Citation
Kirsch DL, Smith RB. The use of cranial electrotherapy stimulation in the management of chronic pain: A review. NeuroRehabilitation. 2000;14(2):85-94. — View Citation
Koltzenburg M. Neural mechanisms of cutaneous nociceptive pain. Clin J Pain. 2000 Sep;16(3 Suppl):S131-8. Review. — View Citation
Nigam AK, Taylor DM, Valeyeva Z. Non-invasive interactive neurostimulation (InterXâ„¢) reduces acute pain in patients following total knee replacement surgery: a randomised, controlled trial. J Orthop Surg Res. 2011 Aug 24;6:45. doi: 10.1186/1749-799X-6-45. — View Citation
Smith RB, Tiberi A, Marshall J. The use of cranial electrotherapy stimulation in the treatment of closed-head-injured patients. Brain Inj. 1994 May-Jun;8(4):357-61. — View Citation
Taylor AG, Anderson JG, Riedel SL, Lewis JE, Bourguignon C. A randomized, controlled, double-blind pilot study of the effects of cranial electrical stimulation on activity in brain pain processing regions in individuals with fibromyalgia. Explore (NY). 2013 Jan-Feb;9(1):32-40. doi: 10.1016/j.explore.2012.10.006. — View Citation
Trescot AM, Helm S, Hansen H, Benyamin R, Glaser SE, Adlaka R, Patel S, Manchikanti L. Opioids in the management of chronic non-cancer pain: an update of American Society of the Interventional Pain Physicians' (ASIPP) Guidelines. Pain Physician. 2008 Mar;11(2 Suppl):S5-S62. Review. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Intensity | An 11-point verbalize NRS will be used to assess the subject's upper or lower extremity pain the day of each assessment as well as during therapy sessions. The 0 to 10 NPS has been found to be valid and reliable in many patient populations including the musculoskeletal population[37] and has been recommended for inclusion in the core NIH Toolbox for use with adults[38]. | 4 months | |
Secondary | Temperature | The temperature at three locations (different for upper and lower extremity) will be recorded with an infrared thermometer (Exergen DT-1001RS Infrared Dermal Thermometer with Remote Sensor, Exergen Corp, Watertown, Massachusetts) on both the involved and uninvolved extremities. | 4 months | |
Secondary | Range of Motion (ROM) | Active and/or passive ROM of the involved joints will be assessed using an electronic goniometer, and the reference of "normal" will be the non-involved limb. A measurement will be taken, but also the result will be dichotomously categorized as within 95% of opposite side - YES or NO. | 4 months | |
Secondary | Pain Medication | An 11-point verbalize NRS will be used to assess the subject's upper or lower extremity pain the day of each assessment as well as during therapy sessions. The 0 to 10 NPS has been found to be valid and reliable in many patient populations including the musculoskeletal population[37] and has been recommended for inclusion in the core NIH Toolbox for use with adults[38]. | 4 months | |
Secondary | Global Rating of Change (GRC) | The GRC, a self-report instrument, assesses subjective perception of the efficacy of a particular treatment and the significance of that change [39]. A 15-point Likert type scale ranging from 1 (very great deal worse) to 15 (a very great deal better) and a 6-point Likert type scale ranging from 1 (a tiny bit important) to 6 (a very great important) will be used. The GRC is used to determine the minimal clinically important differences and will be used in this study to assess the participants' perceived magnitude of changes following the 30 minute combined NIN/CES treatment and again after each physical therapy or occupational therapy session for range of motion and pain. | 4 months | |
Secondary | The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale | The LANNS assessment helps identify whether or not a patient exhibits neuropathic pain. The instrument consists of five self-report and two clinician administered sensory function items that assess dynamic mechanical allodynia and altered pin-prick threshold (PPT). Weighted scores for the seven items are binary (yes or no) and summed, giving a total score between 0 and 24. In terms of diagnostic validity, during the validation study this assessment yielded a sensitivity of 85% and specificity of 80%[ | 4 months | |
Secondary | National Institutes of Health Patient Reported Outcomes Measurement Information Systems (PROMIS) 29 | Emotional The PROMIS 29, a self-reported measure, assesses health-related quality of life (HRQOL) in seven domains (physical function, anxiety, depression, fatigue, sleep disturbance, social role satisfaction, pain interference, pain intensity). The instrument utilizes a 7-day recall period and consists of eight questions on a Likert-type scale, ranging from 1 to 5 , except for the pain intensity scale, which ranges from 0 to 10. | 4 months | |
Secondary | Lower Extremity Functional Scale(LEFS) | The LEFS, originally described by Binkley et al, provides global assessment of function related specifically to the lower extremities.[50] It is one self-report outcome measure that can capture adverse impact on function from multiple injuries or specific locations in the lower extremity. It consists of 20 questions total related to functional activities, each with a possible score ranging from 0 to 4, where 0 indicates that the activity cannot be performed at all and 4 indicates that the activity be performed with no limitations. The total maximum score is 80 points, indicating no limitations with any of the functional tasks. It has been shown to be valid, reliable, and responsive to change in various patient populations and in different body regions in the lower extremity (ankle, knee, and hip).[50-52] | 4 months | |
Secondary | Quick Disabilities of the Arm, Shoulder, and Hand (Quick DASH | The DASH is an 11-item self-report measure that assesses a subject's perceived ability to complete twenty-one upper extremity functional activities using a 5-point Likert scale. The cumulative Quick DASH score is scaled from 0 to 100, with higher scores indicating increased disability. The DASH is well tested and has been validated and found reliable in many different upper limb musculoskeletal disorders[45-48]. The Minimally Clinically Important Difference (MCID) for the Dash is 10.83 points, and for the QuickDash is 15.91 points. | 4 months |
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