A pilot study of dose schedules for pamidronate infusions in the management of non-specific low back pain

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001193561

Enrollment

Registered

2015-11-04

Start date

2016-03-16

Completion date

2019-10-14

Last updated

2021-10-11

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

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

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

Outcome results