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WithdrawnNCT01263652Updated May 27, 2020

Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients

An interventional study of Diclofenac hydroxyethylpyrrolidine and orphenadrine in Pain Relief, sponsored by Western Galilee Hospital-Nahariya. Withdrawn. Open to participants aged 15 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-05-27.

Sponsored by Western Galilee Hospital-Nahariya · Not applicable, Interventional, and Treatment

Why this study was withdrawn
inability to complete recruitment as planned
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
15 Years to 100 Years
Sex
All
01

Study summary

The investigators will conduct a randomized double blind study, to determine whether patient analgesic delivery mode preference affects pain reduction quality in non-surgical spine patients.

The patients will receive both intra-muscular and oral non-narcotic analgesics and placebo. During the study period, pain reduction parameters will be collected. At the end of the study period, the investigators will attempt to find a correlation between pre-study patient preferences and the quality of the pain reduction achieved.

02

Conditions studied

  • Pain Relief

Keywords

  • Pain
  • intramuscular
  • oral
  • spine
  • preference
03

In context

Lead sponsor

Western Galilee Hospital-Nahariya is the lead sponsor of 87 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with chronic and acute back pain

Exclusion criteria

Exclusion Criteria:

  • Recent Spine Surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    IMmed

    Patients receiving intra-muscular medication and oral placebo

    Drug: Diclofenac hydroxyethylpyrrolidine · Drug: orphenadrine · Drug: Tramadol · Drug: Dipyrone

  • Active comparator
    POmed

    Patients receiving intra-muscular placebo and oral medication

    Drug: Diclofenac hydroxyethylpyrrolidine · Drug: orphenadrine · Drug: Tramadol · Drug: Dipyrone

Interventions

  • DrugDiclofenac hydroxyethylpyrrolidine

    IM/PO

    Also known as: Voltaren, Abitren

  • Drugorphenadrine

    IM/PO orphenadrine

    Also known as: Flexin

  • DrugTramadol

    IM/PO tramadol

    Also known as: Tramadex, Tramal

  • DrugDipyrone

    PO/IM Dipyrone

    Also known as: Optalgin, Phanalgin

06

What researchers measure

Primary outcomes

  1. pain scores on visual analog scale

    up to 7 days for each patient per hospitalization

    Time frame: visual analog scale will be mesuered before and one hour following every pain medication delivery

Secondary outcomes

  1. Patient Questionnaire assessing pain and pain relief

    A questionnaire will be filled immediately before and one hour following analgesic administration

    Time frame: Before administaration of pain control medication and one hour following analgesic administration

  2. patient preference Questionnaire

    every patient will be asked for his prefered analgesic delivery method

    Time frame: before first analgesic administration at the current hositalization

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01263652
Lead sponsor
Western Galilee Hospital-Nahariya
Responsible party
Nimrod Rahamimov (Investigator, Western Galilee Hospital-Nahariya) — Principal investigator
First posted
Dec 21, 2010
Start date
Dec 31, 2010 (estimated)
Primary completion
Jun 1, 2019
Completion
Jun 1, 2019
Last update
May 27, 2020

Study contacts

Nimrod Rahamimov, M.D.
principal investigator · Western Galilee Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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