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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06456268
Other study ID # AAAU3696
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 30, 2024
Est. completion date July 15, 2025

Study information

Verified date June 2024
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this project is to test the effects of the VibraCool mechanical stimulation neuromodulatory therapeutic device on post-operative pain and opioid use following ACLR, and thus residual opioids in circulation.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date July 15, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Underwent ACL reconstruction Exclusion Criteria: - Pediatric IT band ACL reconstruction (known to cause significantly more pain) - Non-english speakers (limitations of our study group)

Study Design


Intervention

Device:
VibraCool mechanical stimulation and neuromodulatory therapeutic device
Multiple studies have shown that vibration sources applied to muscles prior to exercise reduced soreness and lactate dehydrogenase production, and increased range of motion at 48 and 72 hours [5-11]. Acute pain results from fast A nerves transmitting nociceptive information to the dorsal column, where the substantia gelatinosa's interneurons prioritize competing A mechanoreceptor and C-fibers to slow pain transmission. Melzack and Wall observed that stimulation of A mechanoreceptors "shut the gate" on pain transmission, an inhibitory mechanism known as "gate control" [5]. Multiple physical methodologies leverage gate control physiology for pain relief, such as vibratory massage therapy and electrical stimulation to varying degrees [7]. However, the use of vibratory massage to improve pain control and reduce opioid use following ACLR has not been well studied, and to our knowledge there are no RCTs evaluating the use of this modality compared to standard ice or cryocompression.
Game Ready cryotherapy device
Cryotherapy has also been used as an adjunctive post-operative therapy to reduce pain and inflammation following UCLR. It has been shown to decrease local metabolism, resulting in reduced pain and inflammation [cite Crystal et al]. Multiple studies have shown the benefits of using cryotherapy after ACLR [cite Raynor et al, Blakeley et al], and more recently dynamic intermittent compression has been shown to improve circulation while reducing the risk of skin necrosis associated with static permanent compression [cite Khanna et al, McGuire et al]. A recent meta-analysis including ten RCTs found significant reductions in post-operative VAS pain scores and breakthrough opioid consumption when using cryotherapy, such as Game Ready ice therapy, following ACLR [cite Davey et al].
Standard ice packs
Cold also provides peripheral gate-control relief via small, slow C-Fibers that transmit low level pain. In addition to local pain relief [5], intense cold can raise the A pain threshold distant to the location. The mechanism has been called descending or diffuse noxious inhibitory relief, or more recently conditioned pain modulation (CPM) [20, 21]. Injections, aches, and infiltration of local anesthesia and dermal fillers are relieved by applying cold [20, 22, 23]. For acute injury, near freezing cold relieves pain by suppressing the local metabolic production of inflammation and concomitant tissue ischemia from hypoxia due to the increased metabolic rate [24-26].

Locations

Country Name City State
United States Columbia University Medical Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary VAS pain Scale of 0 to 10, with 10 being the worst pain and 0 being no pain. Will record daily mean VAS pain scores over the first seven post-operative days First 7 post-operative days
Primary Opioid use Percent of patients discontinuing opioid use by or on post-operative day three, compared to those who continue after day three First 3 post-operative days
Secondary Mean reduction in opioid use in mg of morphine equivalents per day mean reduction in opioid use in milligrams of morphine equivalents per day (MMOD) of 30% from patients not using the device over the 7-day period First 7 post-operative days
Secondary PROMIS Pain Interference score PROMIS is a computerized adaptive patient-reported test to measure interference of pain in everyday functioning. The raw score is converted to a T-score metric in which 50 is the mean and 10 is the standard deviation. Higher T-scores represent increased pain interference. First 7 post-operative days
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