Combining CES Alpha-Stim and InterX for Optimized Rehabilitation Following Extremity Immobilization

NCT03060122 | Completed

• 1 other identifier: C.2017.026
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Temperature

  4 months

• Range of Motion (ROM)

  4 months

• Pain Medication

  4 months

• Global Rating of Change (GRC)

  4 months

• The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale

  4 months

Study Arms (3)

Standard Care

NO INTERVENTION

Patient's randomized to this arm will receive standard post operative/post immobilization physical therapy or occupational therapy rehabilitation care without the use of NIN or CES.

NIN (InterX) and CES (Alpha-Stim)

EXPERIMENTAL

The Alpha-Stim Cranial Electrical Stimulation device applies a micro-current trans-cranially via electrodes attached to the ear.The electrical current is controlled through a handheld device. Standard treatment sessions lasting approximately 20-60 minutes. InterX Therapy (non-invasive) has been developed specifically for the treatment of acute and chronic pain. It is delivered on the skin of the involved area. The device will be applied by a trained therapist along the course of the dermatomes in the affected area. Electrical current is controlled through a handheld device. Standard treatment sessions last approx 20-45 min. The treatment will be delivered in conjunction with the rehab visit (physical or occupational therapy)

Device: NIN; Device: CES

NIN (InterX) and sham CES

ACTIVE COMPARATOR

The Alpha-Stim Cranial Electrical Stimulation device intensity will be preset and locked by the manufacturer at its lowest therapeutic dose at 100 mA, a sub-sensory level that serves as a sham treatment. InterX Therapy (non-invasive) has been developed specifically for the treatment of acute and chronic pain. It is delivered on the skin of the involved area. The device will be applied by a trained therapist along the course of the dermatomes in the affected area.Electrical current is controlled through a handheld device. Standard treatment sessions last approx 20-45 min. The treatment will be delivered in conjunction with the rehab visit (physical or occupational therapy)

Device: NIN; Device: Sham CES

Interventions

NIN DEVICE

The InterX device will be applied by a trained therapist along the course of the dermatomes in the affected area, paying special attention to the location of major cutaneous nerves ensuring optimal treatment points are identified and treated within the neurologically related area.

Also known as: InterX

NIN (InterX) and CES (Alpha-Stim); NIN (InterX) and sham CES

Sham CES DEVICE

The sham CES is identical to the regular device but ear clips will emit a dose at 100 mA, a sub-sensory level.

Also known as: Alpha-Stim Sham

NIN (InterX) and sham CES

CES DEVICE

Cranial Electrical Stimulation (CES) Alpha-Stim is a noninvasive medical treatment device that delivers a microcurrent (100 to 500 microamperes) via ear clip electrodes connected to a handheld device.

Also known as: Alpha-Stim

NIN (InterX) and CES (Alpha-Stim)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Between the age of 18 - 65 years
• Read and speak English well enough to provide informed consent and follow study instructions

You may not qualify if:

• Active infection, open sores, or open incisions (or anything that would inhibit the application of the stim) in the affected extremity.
• 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.
• History of inflammatory skin diseases (psoriasis, dermatitis, etc.).
• Contralateral extremity involvement resulting in less than normal range of motion, muscle strength, or daily pain greater than 1/10.

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 75234, United States

Location

Related Publications (13)

• Koltzenburg M. Neural mechanisms of cutaneous nociceptive pain. Clin J Pain. 2000 Sep;16(3 Suppl):S131-8. doi: 10.1097/00002508-200009001-00004.

  PMID: 11014457 BACKGROUND

• 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.

  PMID: 18443640 BACKGROUND

• Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002 Jun;3(3):159-80. doi: 10.1054/jpai.2002.123652. No abstract available.

  PMID: 14622770 BACKGROUND

• Webster BS, Verma SK, Gatchel RJ. Relationship between early opioid prescribing for acute occupational low back pain and disability duration, medical costs, subsequent surgery and late opioid use. Spine (Phila Pa 1976). 2007 Sep 1;32(19):2127-32. doi: 10.1097/BRS.0b013e318145a731.

  PMID: 17762815 BACKGROUND

• Hortobagyi 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(Pt 1):293-304. doi: 10.1111/j.1469-7793.2000.00293.x.

  PMID: 10747199 BACKGROUND

• Brandt KD. Response of joint structures to inactivity and to reloading after immobilization. Arthritis Rheum. 2003 Apr 15;49(2):267-71. doi: 10.1002/art.11009. No abstract available.

  PMID: 12687522 BACKGROUND

• Nigam AK, Taylor DM, Valeyeva Z. Non-invasive interactive neurostimulation (InterX) 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.

  PMID: 21864362 BACKGROUND

• 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. doi: 10.1302/0301-620X.89B11.19352.

  PMID: 17998187 BACKGROUND

• 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.

  PMID: 20688546 BACKGROUND

• Kirsch DL, Smith RB. The use of cranial electrotherapy stimulation in the management of chronic pain: A review. NeuroRehabilitation. 2000;14(2):85-94.

  PMID: 11455071 BACKGROUND

• 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. doi: 10.3109/02699059409150986.

  PMID: 8081350 BACKGROUND

• 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.

  PMID: 23294818 BACKGROUND

• 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.

  PMID: 23479545 BACKGROUND

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jill Cancio, OTD

  Brooke Army Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pain Psychologist

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: February 23, 2017
• Study Start: March 1, 2018
• Primary Completion: July 31, 2019
• Study Completion: August 7, 2019
• Last Updated: November 25, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)