Clinical trial NCT04774965: The Effects of SlumberCurve™ Following Rotator Cuff Surgery: a Randomized Control Trial
Official title: The Effects of SlumberCurve™ Following Rotator Cuff Surgery: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Rotator Cuff Tears
Surgery
Pain, Postoperative
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Eight28, LLC
First posted: 2021-03-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the effects of a novel sleep aid known as SlumberCurve™, which serves as an adjustable form of a wedge pillow, on sleep quality and pain management following rotator cuff repair. The researchers hypothesize that SlumberCurve™ will significantly improve sleep quality and reduce night-time pain.

Detailed description: Poor sleep quality is prevalent among patients undergoing rotator cuff repair surgery, and negatively affects the potential for proper healing. Without adequate sleep, the production of anabolic steroids and inflammatory cytokines are diminished. These anabolic steroids and inflammatory cytokines play a key role in postoperative healing, resulting in adequate pain regulation and increased patient satisfaction. Therefore adequate sleep quality is important not only for quality of life, but for postoperative healing. A recent systematic review revealed that some studies reported varying degrees in both the time and magnitude of change in return to adequate sleep quality following rotator cuff repair. This study hopes to address this gap in the literature by investigating a novel sleep aid, SlumberCurve, and its effect on sleep quality and night-time pain relief. SlumberCurve is a Class I Medical Device and is currently advocated to relieve tension and diminish pain in patients undergoing rotator cuff repair surgery. The device provides adjustable elevation of the torso as well as concave positioning, placing the shoulder in a more forward position. This novel sleep aid has the potential to increase sleep quality, and therefore enhance both patient satisfaction and postoperative recovery from rotator cuff repair surgery.

Eligibility criteria: Inclusion Criteria:

• Any male or nonpregnant female aged 18 years or older with a full-thickness rotator cuff tear undergoing rotator cuff repair surgery

Exclusion Criteria:

* Patients who receive workers' compensation benefits
* Patients with irreparable tears
* Patients undergoing revision surgery
* Patients with concomitant severe glenohumeral arthritis or concurrent adhesive capsulitis
* Sleep apnea disorder or other diagnosed sleep disorder
* Neuropsychiatric disease
* Use of sleep medication
* Prior shoulder surgery
* Rotator cuff arthropathy with pseudo paralysis
* Acute fractures involving the proximal humerus or shoulder girdle

Primary outcomes:
measure: Fitbit Sleep Data - Time spent awake, restless, and asleep
timeFrame: 90 days
measure: Fitbit Sleep Data - Sleep Stages
timeFrame: 90 days
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 90 days
measure: Visual Analog Scale (VAS)
timeFrame: 90 days
measure: Single Assessment Numeric Evaluation (SANE)
timeFrame: 90 days
measure: Postoperative Oral Morphine Equivalents
timeFrame: 90 days
measure: Simple Shoulder Test (SST)
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kunze KN, Movasagghi K, Rossi DM, Polce EM, Cohn MR, Karhade AV, Chahla J. Systematic Review of Sleep Quality Before and After Arthroscopic Rotator Cuff Repair: Are Improvements Experienced and Maintained? Orthop J Sports Med. 2020 Dec 29;8(12):2325967120969224. doi: 10.1177/2325967120969224. eCollection 2020 Dec.