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Varken Diklofenak eller manipulation har effekt på akut ryggskott

17 november 2007.

I en nyligen genomförd studie i Australien på 240 patienter med akut ryggskott (lumbago) har varken diklofenak (Voltaren) eller manipulation (kiropraktorbehandling) kunnat tillföra något utöver egenvård (undvikande av sängvila, fortsatt aktivitet, Alvedon) kunnat erbjuda.

Diclofenac or Spinal Manipulative Therapy Not Helpful for Acute Low Back Pain

News Author: Laurie Barclay, MD
CME Author: Désirée Lie, MD, MSEd

November 13, 2007 - Patients with acute low back pain receiving recommended first-line care did not recover more quickly with the addition of diclofenac or spinal manipulative therapy, according to the results of a randomized controlled trial in the November 8 issue of The Lancet.

"Present treatment guidelines for acute low back pain recommend that general practitioners should give advice (remain active, avoid bed rest, and reassurance of favourable prognosis) and paracetamol as the first line of care," write Mark J. Hancock, MAppSc, from the University of Sydney in Australia, and colleagues. "Non-steroidal anti-inflammatory drugs (NSAIDs) and spinal manipulative therapy are recommended as second-line management options for patients who have slow recovery. We do not know whether NSAIDs or spinal manipulative therapy, or both, in addition to advice and paracetamol as initial treatment results in quicker recovery for such patients."

In this community-based study, 240 patients with acute low back pain who had been given advice and paracetamol by their general practitioner were randomized to receive diclofenac 50 mg twice daily and placebo manipulative therapy (n = 60), spinal manipulative therapy and placebo drug (n = 60), diclofenac 50 mg twice daily and spinal manipulative therapy (n = 60), or double placebo (n = 60). The main endpoint was days to recovery from pain, evaluated with survival curves in an intent-to-treat analysis.

Compared with placebo drug or placebo manipulative therapy, neither diclofenac nor spinal manipulative therapy significantly decreased the number of days until recovery (diclofenac hazard ratio [HR], 1.09; 95% confidence interval [CI], 0.84 - 1.42; P = .516; spinal manipulative therapy HR, 1.01; 95% CI, 0.77 - 1.31; P = .955). By 12 weeks after randomization, 237 (99%) patients had either recovered or were censored.

Secondary analyses showed no significant effects on pain, disability, or global perceived effect at 1, 2, 4, or 12 weeks, when diclofenac or spinal manipulative therapy, or both, was added to baseline care.

Possible adverse reactions occurred in 22 patients; these included gastrointestinal tract disturbances, dizziness, and heart palpitations. Half of these patients were in the active diclofenac group, and the other half were taking placebo. One patient taking active diclofenac stopped treatment because of a suspected hypersensitivity reaction.

"Neither diclofenac nor spinal manipulative therapy gave clinically useful effects on the primary outcome of time to recovery," the study authors write. "We can reasonably assume that when quality baseline care is provided, previously effective treatments might no longer provide additional benefit."

Limitations of the study include cointerventions during the study period in 28 patients and imperfect compliance rates.

"These results are important because both diclofenac and spinal manipulative therapy have potential risks and additional cost for patients," the study authors conclude. "If patients have high rates of recovery with baseline care and no clinically worthwhile benefit from the addition of diclofenac or spinal manipulative therapy, then GPs [general practitioners] can manage patients confidently without exposing them to increased risks and costs associated with NSAIDs or spinal manipulative therapy."

Alphapharm donated the active diclofenac and Bill Rae provided the placebo tablets. Australia's National Health and Medical Research Council mainly funded the trial. One of the study authors had been a member of an advisory board about paracetamol for GlaxoSmithKline. Some of the study authors have obtained funding.

Lancet. 2007;370:1638-1643.

Clinical Context

Present treatment guidelines for acute low back pain include advice to remain active, avoidance of bed rest, reassurance, and paracetamol for pain as first-line therapy; second-line therapy includes use of NSAIDs and spinal manipulation. However, NSAIDs are associated with adverse effects, and manipulative therapy requires referral and may also be associated with adverse effects. Evidence of their efficacy is needed to recommend the treatments to patients with acute low back pain.

This is a 4-week urban community-based, prospective, double-blind, placebo-controlled study examining the addition of either diclofenac or spinal manipulation, or both, to usual first-line therapy for acute low back pain.

Study Highlights

  • Included were adults with acute low back pain with or without leg pain of less than 6 weeks' duration presenting to 40 general practitioners in Australia.
  • Patients complained of moderate pain between the 12th rib and buttock crease and had moderate disability as measured by items 7 and 8 of the Short Form Health Survey with 36 questions.
  • Excluded were pain not preceded by 1 month without pain, taking NSAIDs or undergoing spinal manipulation, spinal surgery within 6 months, and contraindication to treatments used.
  • All patients were given paracetamol 1 g 4 times daily until recovery for a maximum of 4 weeks and advice form their general practitioners.
  • 240 patients were randomized to 4 groups of 60 each: control (placebo drug with placebo manipulation), NSAID (diclofenac with placebo manipulation), spinal manipulation (placebo drug with spinal manipulation), and spinal manipulation with NSAID (diclofenac with spinal manipulation).
  • Spinal manipulation was performed by 15 physiotherapists at 13 private clinics who had a graduate diploma in manipulation and who practiced it on a regular basis.
  • Sessions were offered 2 to 3 times weekly for a maximum of 12 sessions in 4 weeks.
  • Therapy was stopped if recovery occurred before 4 weeks.
  • Mobilization or high-velocity thrust procedures were permitted to produce motion at the lumbar spine, thoracic spine, sacroiliac joint, pelvis, and hip.
  • Placebo manipulative therapy comprised pulsed ultrasound, which matched the treatment in duration and frequency (30 - 40 minutes for initial and 20 minutes for follow-up sessions).
  • Patients were asked not to seek other treatment during the study.
  • Primary outcome was time to recovery, with recovery defined as either the first pain-free day (pain score 0 or 1) and the first of 7 consecutive pain-free days with a pain score of 0 or 1 of 10.
  • Patients kept a daily pain diary.
  • Secondary outcomes were pain score, function with use of the 10-point Patient-Specific Functional Scale, disability with use of the Roland Morris Disability Questionnaire, and overall perceived effect.
  • Patients were assessed at baseline and at weeks 1, 2, 4, and 12.
  • Adherence to manipulative therapy was defined by the percentage of planned sessions completed, and adherence to medication was by self-report and unused pill count.
  • Mean age of the patients was 41 years, 44% were women, duration of current symptoms was 9 days, and mean number of previous episodes was 4.
  • 48% attended at least 1 follow-up appointment, and 26% had 2 follow-up appointments.
  • Patients typically took two thirds of the prescribed doses of paracetamol.
  • They took 72% of the prescribed dose of diclofenac or placebo.
  • Median number of spinal manipulations was 2.3 per week for all patients; 97% had low-velocity thrust vs 5% having high-velocity thrust techniques.
  • 12% of patients took additional interventions, and crossover was similar in the 2 groups.
  • Adverse reactions were similar in the groups for diclofenac and placebo and the spinal manipulation groups.
  • Median days to recovery were 13 for patients taking diclofenac and 16 for those taking placebo, with an HR of 1.09 (no significant difference).
  • Median days to recovery were 15 for both spinal and placebo manipulation groups.
  • There was no interaction between diclofenac and spinal manipulation.
  • Neither diclofenac nor spinal manipulation had significant effects on pain, disability, function, or global perceived pain at any point.

Pearls for Practice

  • Use of diclofenac in addition to first-line therapy for 4 weeks for acute low back pain is not associated with shorter time to recovery or improvement in pain, function, disability, or global perceived pain.
  • Use of spinal manipulation in addition to first-line therapy for acute low back pain is not associated with shorter time to recovery or improvement in pain, function, disability, or global perceived pain; diclofenac and manipulation do not interact.

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