Clinical trial NCT05968274: The Effect of Rebox Current in Pain Management
Official title: The Effect of Rebox Current in Pain Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Electric Stimulation Therapy
Keywords: Rebox therapy
electrotherapy
pain treatment
Rebox currents
Lead sponsor: Rebox Therapy s.r.o.
Sponsor class: INDUSTRY
Collaborators: name: F.D. Roosevelt University Hospital in Banská Bystrica, Slovakia
First posted: 2023-08-01
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This post-marketing monocentric double-blind sham controlled crossover study will assess the efficacy of Rebox electrotherapy in the treatment of pain. Totally 72 patients will be treated with both real and sham Rebox device in a crossover design with a 1:1 ratio over a 6-week period. The degree of pain intensity reduction after the real Rebox stimulation will be evaluated in comparison with the sham stimulation. Moreover, differences in multidimensional aspects of pain will be compared between the real and sham stimulation.


Eligibility criteria: Inclusion Criteria:

* Patient with pain based on the following diagnoses:

  * Myofascial musculoskeletal pain
  * Vertebrogenic algic syndrome in the cervical, thoracic and lumbosacral regions
  * Sacroileitis with sacroiliac joint block
  * Cervicocranialgia
  * Frozen shoulder syndrome
  * Arthrosis
  * Epicondylitis
  * Pain in tendons, ligaments and other enthesopathies
  * Postoperative pain
  * Post-traumatic pain
  * Postherpetic neuralgia
* Duration of pain (de novo or exacerbation of chronic pain) prior to study inclusion ranges from 2 weeks to 3 months
* The average pain intensity in a given period of 2 weeks to 3 months prior to study inclusion must be NRS (Numerical Rating Scale) \>3
* The patient may be concurrently treated with analgesics and may be undergoing manual physiotherapy (rehabilitation)

Exclusion Criteria:

* Age \<18 years
* Local contraindications:

  * Impaired skin integrity at the site of application (open wound, skin ulcer, burns), Note: the area around the postoperative scar is not an exclusion criterion
  * Acute inflammation of the skin or subcutaneous tissue at the application site
  * Deep vein thrombosis (diagnosed or suspected)
* General contraindications:

  * Implanted electrical device (pacemaker, implantable cardioverter-defibrillator, deep brain stimulator, cochlear implant, etc.)
  * Pregnancy
  * Epilepsy
  * Malignant cancer (diagnosed or suspected)
  * Acute potentially life-threatening conditions
* Concomitant other physical therapy (electrotherapy, magnetotherapy, laser therapy, ultrasound therapy, mechanotherapy, etc.)
* The Rebox device was administered to the subject for any indication in the last 12 months prior to the study inclusion date
* A recent change in analgesic medication (i.e., new agent or change in agent dose less than 1 week prior to the first stimulation session) or a planned change in analgesic medication during the course of the study (change in agent, change in dose), Note: modification of analgesic medication during the study is possible but must be recorded
* Ongoing acute infection, surgery or trauma during the study
* Concurrent subject participation in another clinical study
* Subject is unable to sign informed consent

Primary outcomes:
measure: Change in pain intensity
timeFrame: 1. at baseline (day of randomization); 2. after 8th session (at the end of week 2.5 from randomization); 3. before 9th session (at the end of week 3.5 from randomization); 4. after 16th session (at the end of week 6 from randomization)
Secondary outcomes:
measure: Immediate analgesic effect
timeFrame: At each stimulation session, total 16 times (at 8 weekdays every other day from randomization up to week 2.5 + at 8 weekdays every other day from week 3.5 up to week 6)
measure: Change in multidimensional aspects of pain
timeFrame: 1. at baseline (day of randomization); 2. after 8th session (at the end of week 2.5 from randomization); 3. before 9th session (at the end of week 3.5 from randomization); 4. after 16th session (at the end of week 6 from randomization)
measure: Tolerability outcome
timeFrame: At each stimulation session, total 16 times (at 8 weekdays every other day from randomization up to week 2.5 + at 8 weekdays every other day from week 3.5 up to week 6)
Other outcomes:
Locations:
city: Banská Bystrica
country: Slovakia
facility: F.D. Roosevelt University Hospital
Study officials:
affiliation: F.D. Roosevelt University Hospital in Banská Bystrica, Slovakia
name: Igor Martuliak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Low J, Reed A. Electrotherapy Explained, Principles and Practice, 3rd Edition. Butterworth-Heinemann. 2000; 121-122.
citation: Johannsen F, Gam A, Hauschild B, Mathiesen B, Jensen L. Rebox: an adjunct in physical medicine? Arch Phys Med Rehabil. 1993 Apr;74(4):438-40.
citation: Trudel D, Duley J, Zastrow I, Kerr EW, Davidson R, MacDermid JC. Rehabilitation for patients with lateral epicondylitis: a systematic review. J Hand Ther. 2004 Apr-Jun;17(2):243-66. doi: 10.1197/j.jht.2004.02.011.
citation: Daut RL, Cleeland CS, Flanery RC. Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain. 1983 Oct;17(2):197-210. doi: 10.1016/0304-3959(83)90143-4.
citation: Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16.