Overnight use of continuous low-level heatwrap therapy for relief of low back pain.
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.
Nadler
Scott F
SF
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
Steiner
Deborah J
DJ
Petty
Sharon R
SR
Erasala
Geetha N
GN
Hengehold
David A
DA
Weingand
Kurt W
KW
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
D018712:Analgesics, Non-Narcotic; D007052:Ibuprofen