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

Study Overview
=================
Brief 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

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Device: Trans-cutaneous Electrical Nerve Stimulation (TENS)
* Drug: Standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study. Male or Female, aged 18 years or above. Participants are those medical patients seen in the haematology outpatients clinic for whom a bone-marrow trephine biopsy is deemed necessary either for diagnosis, staging or disease monitoring purposes. Participants are either new patients or routine follow ups. Participant is able (in the Investigators opinion) and willing to comply with all study requirements. Participant is willing to allow his or her General Practitioner to be notified of participation in the study. Exclusion Criteria: Any known adverse reaction to high-frequency TENS or electrode gel pads Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trans-cutaneous Electrical Nerve Stimulation (TENS)<br>The Intervention-TENS group will have 2 electrodes applied proximal to the painful area along neuro-anatomical distribution (electrode-one placed 5cm superior and 2cm medial to the posterior superior iliac spine and electrode-two placed 5cm medial to the posterior superior iliac spine) in the same way as the control-TENS group. The concealed electrical parameter in this group will be within the therapeutic window, that is, well above the sensory detection threshold but below the pain threshold giving a strong but comfortable sensation. From previous studies, this is likely to be 50-110Hz. The device will be activated prior to entry into the treatment room and 2 minutes before administration of local anaesthetic and for 2 minutes after removal of the biopsy needle. This will cover the expected duration of pain as assessed in the pilot study. All patients will receive standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide) | Device: Trans-cutaneous Electrical Nerve Stimulation (TENS)<br>* 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).<br>Drug: Standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide)<br>* All patients will receive standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide)<br>|
| Placebo Comparator: Trans-cutaneous Electric Nerve Stimulation (TENS)<br>Patients in the CT group will have 2 gel-electrodes applied proximal to the sampling area (usually the right posterior superior iliac crest). The Control-TENS device will be identical in appearance to the Intervention-TENS device with a functioning display panel. The concealed electrical parameter in this group will be titrated to and set at the sensory detection. All patients will receive standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide) | Device: Trans-cutaneous Electrical Nerve Stimulation (TENS)<br>* 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).<br>Drug: Standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide)<br>* All patients will receive standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of Pain Will be Measured Using a Validated Numerical 0-10 Pain Scale Where 0 = no Pain and 10 = Worst Possible Pain | 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. | Post procedure and 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Bone marrow aspiration, trephine biopsy