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Completed

NCT Number: NCT00758017

Efficacy of Different Acupuncture Methods for Chronic Low Back Pain

The aim of the study is to evaluate pain intensity over 8 weeks in acupuncture patients with chronic low back pain and to compare 2 different groups of patients which differ in the acupuncture method used to treat the pain.

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Key information

Conditions

Chronic Low Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ambulatory practice Yang-Strobel

Berlin, 13581, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of chronic low back pain (for at least 3 months) confirmed by a consultant
  • indication for treatment of low back pain with acupuncture confirmed by a consultant
  • at least 40 mm on a VAS pain scale

Exclusion criteria

  • acupuncture during the last 6 months
  • start of a new therapy for low back pain within the last 4 weeks
  • pregnancy
  • substance or drug abuse

Treatment and study plan

Acupuncture 1

Other

Application of individualised acupuncture

Acupuncture 2

Other

Application of standardised acupuncture

Primary outcomes

  1. Pain intensity over 8 weeks (area under the curve)

    Time frame: 8 weeks

Secondary outcomes

  1. Intensity of back pain at week 8 and week 26

    Time frame: baseline, week 8, week 26

  2. Back function (FFbH-R)

    Time frame: baseline, week 8, week 26

  3. QoL

    Time frame: baseline, week 8, week 26

  4. Days with medication intake

    Time frame: baseline to end of week 8

  5. Days with physical therapy because of back pain

    Time frame: baseline to end of week 8

  6. Sick leave days

    Time frame: baseline, at week 8, at week 26

  7. Number of therapy sessions

    Time frame: baseline to expected time frame 3 months

  8. Duration of therapy

    Time frame: baseline to expected time frame 3 months

  9. Adverse effects and severe adverse effects

    Time frame: baseline to expected time frame 3 months

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 23, 2008
Registry last updated
Jun 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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