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Does Trans-Cutaneous Electrical Nerve Stimulation (TENS) Alleviate The Pain Experienced During Bone Marrow Sampling?

NCT02005354 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-10-08

Study results available
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Summary

The approach of this study will be to answer the question does high-frequency stimulation Trans-Cutaneous Electrical Nerve Stimulation (TENS) alleviate the pain experienced during the bone marrow sampling procedure in addition to the standard analgesia given (ie. local anaesthetic with or without inhaled nitrous oxide).

Null hypothesis: TENS does not alleviate the pain experienced during the bone marrow sampling procedure in addition to the standard analgesia given

Conditions

Interventions

DEVICE

Trans-cutaneous Electrical Nerve Stimulation (TENS)

Patients in whom a bone marrow biopsy is planned will be randomised to one of two groups - a Placebo Comparator group where the TENS machine will be set at the lowest sensory threshold and an Active Comparator group where the TENS machine will be set at a recognised analgesic level (\>50Hz and below the pain threshold for the patient).

DRUG

Standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide)

All patients will receive standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide)

Sponsors & Collaborators

  • Torbay and South Devon NHS Foundation Trust

    collaborator OTHER

  • University Hospital Plymouth NHS Trust

    lead OTHER

Principal Investigators

  • Simon AJ Rule, MBChB, MPhil · University Hospital Plymouth NHS Trust

  • Sarah L Poplar, MB ChB · University Hospital Plymouth NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02005354 on ClinicalTrials.gov