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Clinical Trials/ISRCTN54009836
ISRCTN54009836
Completed
Not Applicable

The effectiveness of three forms of physiotherapy for sleep disturbance in chronic low back pain: a pilot single-blinded randomised controlled trial

Health Research Board (HRB) (Ireland)0 sites60 target enrollmentSeptember 23, 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic low back pain
Sponsor
Health Research Board (HRB) (Ireland)
Enrollment
60
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 23, 2009
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Health Research Board (HRB) (Ireland)

Eligibility Criteria

Inclusion Criteria

  • 1\. Males/females aged between 18 \- 70 years
  • 2\. Patients with chronic (greater than or equal to 3 months) or recurrent (greater than or equal to three episodes in the previous 12 months) low back pain (LBP) of mechanical origin with/without radiation to the lower limb
  • 3\. No spinal surgery within the previous 12 months
  • 4\. Patients deemed suitable by their GP/hospital consultant to carry out an exercise programme
  • 5\. Patients willing to attend for an 8\-week treatment programme of exercise classes
  • 6\. Fluency in English (verbal and written)
  • 7\. Access to a telephone (for follow\-up support)

Exclusion Criteria

  • 1\. Clinically diagnosed primary sleep disorder, e.g., sleep apnoea, insomnia
  • 2\. Currently on sleeping medication
  • 3\. Currently or having received treatment for CLBP within previous 3 months
  • 4\. Patients with minimum disability on the Oswestry Disability Index (less than 10\)
  • 5\. Red flags indicating serious spinal pathology, e.g., cancer, cauda equina lesion
  • 6\. Radicular pain indicative of nerve root compression
  • 7\. Patients diagnosed with severe spinal stenosis, spondylolisthesis, fibromyalgia
  • 8\. History of systemic/inflammatory disease, e.g., rheumatoid arthritis
  • 9\. Patients with any confounding conditions such as a neurological disorder or currently receiving treatment for cancer
  • 10\. Patients with acute (less than 6 weeks) or subacute LBP (6 \- 12 weeks), provided that they have experienced less than three LBP episodes during previous 12 months

Outcomes

Primary Outcomes

Not specified

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