Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615001193561
Ethics application status
Approved
Date submitted
17/09/2015
Date registered
4/11/2015
Date last updated
7/10/2021
Date data sharing statement initially provided
7/10/2021
Date results information initially provided
7/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of dose schedules for pamidronate infusions in the management of non-specific low back pain
Scientific title
A pilot study comparing two dose schedules(two 90 mg doses on consecutive days versus two 90mg doses 28 days apart) for the delivery of intravenous pamidronate in the management of chronic non-specific low back pain.
Secondary ID [1] 287491 0
none
Universal Trial Number (UTN)
U1111-1170-4165
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
non-specific Low back Pain 296235 0
Condition category
Condition code
Anaesthesiology 296506 296506 0 0
Pain management
Musculoskeletal 296898 296898 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pamidronate infusion of 90mg.
Two doses given either on consecutive days or 28 days apart.
Each dose given over 4 hours in hospital ward.
Infusion monitored by study nurse or doctor.
Intervention code [1] 292874 0
Treatment: Drugs
Comparator / control treatment
Comparison of dose schedules of pamidronate in non specific low back pain.

Comparison of two 90 mg doses given on consecutive days and 28 days apart.

The dose given 28 days apart is the control dose.
Control group
Active

Outcomes
Primary outcome [1] 296133 0
Proportion of patients who show an improvement in Pain Scores measured on the Brief Pain Inventory (short form)
Timepoint [1] 296133 0
90 days post infusion- primary time point
180 days post infusion- secondary time point- completion of study
Secondary outcome [1] 317586 0
Global impression of change(Quality of life)
Timepoint [1] 317586 0
six months post first infusion dose

Eligibility
Key inclusion criteria
Patients referred to chronic pain clinic at Tauranga Hospital.
Chronic non specific low back pain of at least three months duration
Pain score greater than 4 on numerical rating scale
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Primary diagnosis of radicular or neuropathic pain
Vertebral compression fracture or cancer
Allergy to pamidronate
Significant other medical problems (renal, liver, cardiac, respiratory)
History of alcohol or drug abuse
Pending legal or compensation claim
Planned surgery or significant intervention in next six months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/11/2015
Actual
16/03/2016
Date of last participant enrolment
Anticipated
Actual
14/10/2019
Date of last data collection
Anticipated
Actual
17/03/2020
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 7173 0
New Zealand
State/province [1] 7173 0
Bay Of Plenty

Funding & Sponsors
Funding source category [1] 292067 0
Charities/Societies/Foundations
Name [1] 292067 0
BOP Medical Research Trust
Country [1] 292067 0
New Zealand
Primary sponsor type
Hospital
Name
Tauranga Hospital. Bay Of Plenty DHB
Address
Tauranga Hospital
Cameron Road
Private Bag 12024
Tauranga 3143
Country
New Zealand
Secondary sponsor category [1] 290742 0
None
Name [1] 290742 0
Address [1] 290742 0
Country [1] 290742 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293550 0
Health and Disability ethics comittee. Northern B
Ethics committee address [1] 293550 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
.
Ethics committee country [1] 293550 0
New Zealand
Date submitted for ethics approval [1] 293550 0
Approval date [1] 293550 0
11/08/2015
Ethics approval number [1] 293550 0
15\MTB\130

Summary
Brief summary
A randomized cohort pilot trial which will compare any significant statistical differences in either benefit or adverse effects on participants pain scores and quality of life when given a Pamidronate infusion(total dose 180mg) either on two consecutive days or 28 days apart to aid in the management of chronic non-specific low back pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57474 0
Dr Saad Anis
Address 57474 0
Chronic Pain Service
Tauranga Hospital
Private Bag 12024
Tauranga
3143
Country 57474 0
New Zealand
Phone 57474 0
+64 7 557 5038
Fax 57474 0
Email 57474 0
saad.anis@bopdhb.govt.nz
Contact person for public queries
Name 57475 0
Mrs Vicky Beveridge
Address 57475 0
Chronic Pain Service
Tauranga Hospital
Private Bag 12024
Tauranga
3143
Country 57475 0
New Zealand
Phone 57475 0
+64 7 557 5038
Fax 57475 0
Email 57475 0
vicky.beveridge@bopdhb.govt.nz
Contact person for scientific queries
Name 57476 0
Dr Saad Anis
Address 57476 0
Chronic Pain Service
Tauranga Hospital
Private Bag 12024
Tauranga
3143
Country 57476 0
New Zealand
Phone 57476 0
+64 7 557 5038
Fax 57476 0
Email 57476 0
saad.anis@bopdhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.