Clinical trial NCT03060122: Combining CES Alpha-Stim and InterX for Optimized Rehabilitation Following Extremity Immobilization
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2017-02-23
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Once patients provide consent and we have determined that they meet inclusion criteria the process will occur as follows:

1. Participants will be administered baseline demographic and standard medical history questionnaires, including information about prescription medication use. In addition, participants will fill out baseline self-report outcomes and be administered the (LANSS) Pain Scale. Range of motion and temperature will also be assessed during the initial session. Some of these measurements are standard of care and would be filled out by the participant even if the participant were not participating in the study.

Usual CARE The usual care aspect of this study is the delivery of the pain treatment (NIN and CES) as is commonly used at the Center for the Intrepid. The experimental aspect is the combined delivery of the treatment, and the use of sham treatment as a control. The treatment (NIN and CES) will be delivered in a pragmatic fashion, with treatment delivered in conjunction with rehab visits and lasting approximately 4-weeks total. Each session will last approximately 20-40 minutes long, and will most often be delivered in conjunction with their rehab visit (physical therapy or occupational therapy) that occurs anywhere from 1 to 3 times each week.

STRICTLY RESEARCH The experimental aspect of the study will be the comparison of combined treatment (NIN + CES), standard NIN with sham CES, to standard care alone. Before initiation of treatment participants will be randomized to either NIN + CES, NIN + Sham CES, or standard care only immediately after the immobilization device (cast, brace, etc) has been removed. Randomization with be performed with a random number gerator. All groups will continue with their own rehabilitation as indicated throughout the entire course of the study treatment, and beyond as indicated by their therapist. The investigators will keep track of rehab appointments and visits, but not control for them.

3. At the 1-month follow-up, all participants will fill out the same self-report outcome measures from baseline, to include prescription pain medication and be administered the LANSS pain scale. Range of motion and temperature will also be assessed.

4. At the 2 and 4-month follow-up the same assessments will again be administered. If the participant has completed formal therapy prior to the 2 and 4 month follow-up time points the participant will be asked to return to the clinic to complete these assessments. Participants may be contacted by telephone or email, if agreeable, to provide a reminder for the return appointment(s).

5. Outcomes will be compared between the three groups at each time point (i.e., initial, one month, two months, four months).

6. All participants will be followed out to 4 months.

Although every attempt will be made to collect data at these specific times, due to the variability of participant and clinic schedules, the actual timing of collection may vary (+/- 1 week) and some of the proposed measures may not be collected at all time points.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Intensity
timeFrame: 4 months
Secondary outcomes:
measure: Temperature
timeFrame: 4 months
measure: Range of Motion (ROM)
timeFrame: 4 months
measure: Pain Medication
timeFrame: 4 months
measure: Global Rating of Change (GRC)
timeFrame: 4 months
measure: The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale
timeFrame: 4 months
measure: National Institutes of Health Patient Reported Outcomes Measurement Information Systems (PROMIS) 29
timeFrame: 4 months
measure: Lower Extremity Functional Scale(LEFS)
timeFrame: 4 months
measure: Quick Disabilities of the Arm, Shoulder, and Hand (Quick DASH
timeFrame: 4 months
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Jill Cancio, OTD
role: STUDY_DIRECTOR
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