CompletedPhase 4ACTRN12612000354886

Benztropine for the relief of acute non-traumatic neck pain – a randomised trial

In patients presenting to the emergency department with acute non-traumatic neck pain, does benztropine compared to placebo relieve pain


Sponsor

St George Hospital

Enrollment

30 participants

Start Date

May 1, 2012

Study Type

Interventional

Conditions

Summary

Patients present to the Emergency department with acute cervical muscle spasm and pain, which may be spontaneous in onset or related to non-traumatic twisting events. In lay speech this may be referred to as a ‘wry neck’. Conventional analgesics such as paracetamol, NSAIDs and oral opoids are the mainstay of treatment for wry neck, but often provide inadequate pain relief. Centrally acting anti-cholinergic drugs are used for the relief of pain/spasm from the chronic condition of idiopathic cervical dystonia and from drug induced dystonic reactions. The use of these drugs for acute spasmodic neck pain has been poorly studied. There is a single study in the literature assessing the centrally-acting anti-cholinergic drug benztropine (trade name cogentin) in the relief of pain and spasm from this condition. This is a case series of 5 patients with acute pain and spasm of the neck and demonstrated remarkable relief of pain and improvement in range of motion in all patients following an intra-muscular injection of benztropine. Our hypothesis is that IM benztropine will provide relief of neck pain and improve range of neck movement in patients presenting with wry neck. We aim to compare the effect of 2mg IM benztropine with placebo on pain scores and range of motion in patients presenting to the ED with wry neck.


Eligibility

Sex: Both males and femalesMin Age: 16 YearssMax Age: 65 Yearss

Inclusion Criteria2

  • Non-traumatic neck pain of <24 hours duration
  • Age 16-65

Exclusion Criteria13

  • Use of drugs known to cause dystonic reactions in the 24 hours prior to the onset of pain (eg metoclopramide (maxalon), prochlorperazine (stemetil), promethazine (phenergan), haloperidol)
  • Clinical suspicion of a secondary cause for pain (eg neck-space infections, cervical osteomyelitis, discitis, epidural abscess, pathological cervical fractures, primary or secondary malignancies)
  • Past history of cervical spine fracture
  • Past history of chronic or recurrent neck pain
  • Past history of cervical spine surgery
  • Fever
  • Focal neurological deficit
  • Known allergy or adverse event to benztropine
  • Anti-coagulant medication (eg warfarin or enoxaparin) or clopidogrel
  • Known coagulation disorder (eg haemophilia) or platelet disorder (eg ITP, leukaemia, myelodysplastic disorder)
  • Parkinsons disease
  • Schizophrenia
  • Pregnant women

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Interventions

a single dose of 2mg by intra-muscular injection (IM) of benztropine (volume of 2ml) will be administered.

a single dose of 2mg by intra-muscular injection (IM) of benztropine (volume of 2ml) will be administered.


Locations(1)

NSW, Australia

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ACTRN12612000354886