Bolus versus continuous study

Comparison of the effects of intermittent boluses to simple continuous infusion on patient global perceived effect in intrathecal therapy for pain

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN21659064

Enrollment

Registered

2012-07-30

Start date

2011-05-09

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal diseases Musculoskeletal Diseases

Interventions

The study is a randomised double blind two period crossover study. Two different modes of administration of the usual daily dose divided into 6 intermittent boluses and the second with the same dose a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Are implanted with a programmable Intrathecal Therapy Drug Device (ITDD) 2. Have achieved stable pain relief on continuous flow 3. Are capable of giving informed consent 4. Are willing to sign the Informed Consent form 5. Are male or female 6. Aged between 18 years and 65 years of age

Exclusion criteria

Exclusion criteria: 1. Fail to give informed consent 2. Are incapable of answering the questionnaires: PGIC, EQ5D, VAS Score for physical or psychological reasons 3. Have non-Programmable Device ITDD 4. Have Patient Therapy Manager devices (PTM's) 5. Are using Ziconotide Intrathecal Therapy 6. Are programmed with bolus doses (flex doses) 7. Have severe limitation in function and mobility 8. Are pregnant or lactating 9. Are not practising a safe method of birth control

Design outcomes

Primary

Measure	Time frame
The Patient Global Impression of Change (PGIC), is a self-evaluation of the patient?s overall change since the start of the study will be completed at the end of each 2 week period using a 7-point Likert scale Since the last visit to the pain clinic my overall pain control is We chose the PGIC as a primary outcome measure as it will allow the patient to balance a potential improvement in pain relief with a potential worsening in side effects.	—

Measure

Time frame

The Patient Global Impression of Change (PGIC), is a self-evaluation of the patient?s overall change since the start of the study will be completed at the end of each 2 week period using a 7-point Likert scale Since the last visit to the pain clinic my overall pain control is We chose the PGIC as a primary outcome measure as it will allow the patient to balance a potential improvement in pain relief with a potential worsening in side effects.

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Secondary

Measure	Time frame
These will be measured at baseline and the end of each 2-week period. Visual Analogue Scale of pain relief patients will score their pain on a 10cm line anchored with no pain at the 0cm end and Worst Pain Imaginable at the 10cm end. This will be measured by means of a 5 day pain diary to be completed 5 days before each visit EQ-5D is a health related quality of life questionnaire which is divided into 5 dimensions: mobility, self ?care, usual activity, pain/discomfort and anxiety/depression, and will be measured at visit 2, visit 3 and visit 4.	—

Measure

Time frame

These will be measured at baseline and the end of each 2-week period. Visual Analogue Scale of pain relief patients will score their pain on a 10cm line anchored with no pain at the 0cm end and Worst Pain Imaginable at the 10cm end. This will be measured by means of a 5 day pain diary to be completed 5 days before each visit EQ-5D is a health related quality of life questionnaire which is divided into 5 dimensions: mobility, self ?care, usual activity, pain/discomfort and anxiety/depression, and will be measured at visit 2, visit 3 and visit 4.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026