Plymouth Hospitals NHS Trust
Plymouth, Devon, PL6 8DH, United Kingdom
NCT Number: NCT02005354
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Plymouth, Devon, PL6 8DH, United Kingdom
Patients in whom a bone marrow biopsy is planned will be randomised to one of two groups - a control-TENS group where the TENS machine will be set at the lowest sensory threshold and an intervention-TENS group where the TENS machine will be set at a recognised analgesic level (>50 Hertz (Hz) and below the pain threshold for the patient) (Bennett et al. 2011). The identity of the TENS type will be concealed from both the patient and the doctor performing the biopsy. The primary outcome will be pain and this will be recorded by the patient immediately after the procedure using a validated numerical scale (0-10). All patients will receive standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide).
The benefit of this study is to establish whether or not TENS can benefit patients as an additional, safe, non-invasive and inexpensive method of pain relief during this frequently painful procedure.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
All patients will receive standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide)
Time frame: Post procedure and 24 hours
To establish the effect of high-frequency stimulation TENS on the pain experienced by patients undergoing a bone-marrow biopsy, using standard technique with local anaesthetic.
The perception of pain will be measured using a pain scale directly after and 24 hours after bone-marrow sampling in patients randomly allocated and blinded to the use of intervention-TENS (IT) or control-TENS (CT) in addition to local anaesthesia.
University Hospital Plymouth NHS Trust
Other
Does Trans-Cutaneous Electrical Nerve Stimulation (TENS) Alleviate The Pain Experienced During Bone Marrow Sampling in Addition to Standard Techniques?A Randomised, Double-Blinded, Controlled Trial
Acronym: TENS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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