title: Overnight use of continuous low-level heatwrap therapy for relief of low back pain.
abstract: OBJECTIVE
  To evaluate of the efficacy and safety of 8 hours of continuous, low-level heatwrap therapy administered during sleep.
  
  
  METHODS
  Prospective, randomized, parallel, single-blind (investigator), placebo-controlled, multicenter clinical trial.
  
  
  METHODS
  Two community-based research facilities.
  
  
  METHODS
  Seventy-six patients, aged 18 to 55 years, with acute, nonspecific low back pain.
  
  
  METHODS
  Subjects were stratified by baseline pain intensity and gender and randomized to one of the following treatments: evaluation of efficacy (heatwrap, n=33; oral placebo, n=34) or blinding (unheated wrap, n=5; oral ibuprofen, n=4). All treatments were administered for 3 consecutive nights with 2 days of follow-up.
  
  
  METHODS
  Primary: morning pain relief (hour 0) on days 2 through 4 (0-5-point verbal response scale). Secondary: mean daytime pain relief score (days 2-4, hours 0-8), mean extended pain relief score (day 4, hour 0; day 5, hour 0), muscle stiffness, lateral trunk flexibility, and disability (Roland-Morris Disability Questionnaire).
  
  
  RESULTS
  Heatwrap therapy was significantly better than placebo at hour 0 on days 2 through 4 for mean pain relief (P=.00005); at hours 0 through 8 on days 2 through 4 for pain relief (P<.001); at hour 0 on day 4 and at hour 0 on day 5 for mean pain relief (P<.001); on day 4 in reduction of morning muscle stiffness (P<.001); for increased lateral trunk flexibility on day 4 (P<.002); and for decreased low back disability on day 4 (P=.005). Adverse events were mild and infrequent.
  
  
  CONCLUSIONS
  Overnight use of heatwrap therapy provided effective pain relief throughout the next day, reduced muscle stiffness and disability, and improved trunk flexibility. Positive effects were sustained more than 48 hours after treatments were completed.
authors.affiliation: Department of Physical Medicine and Rehabilitation, University of Medicine and Dentistry of New Jersey--New Jersey Medical School, Newark, NJ 07103, USA. sfnadler@cs.com
authors.forename: Scott F
authors.initials: SF
authors.lastname: Nadler
authors.forename: Deborah J
authors.initials: DJ
authors.lastname: Steiner
authors.forename: Sharon R
authors.initials: SR
authors.lastname: Petty
authors.forename: Geetha N
authors.initials: GN
authors.lastname: Erasala
authors.forename: David A
authors.initials: DA
authors.lastname: Hengehold
authors.forename: Kurt W
authors.initials: KW
authors.lastname: Weingand
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use; D003710:Demography; D004185:Disability Evaluation; D005260:Female; D006358:Hot Temperature / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use; D017116:Low Back Pain / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D018482:Muscle, Skeletal / Q000503:physiopathology; D010147:Pain Measurement; D026741:Physical Therapy Modalities / Q000009:adverse effects / Q000379:methods*; D011446:Prospective Studies; D016059:Range of Motion, Articular; D016037:Single-Blind Method; D012890:Sleep; D016896:Treatment Outcome
chemical_list: D018712:Analgesics, Non-Narcotic; D007052:Ibuprofen