Trial Outcomes & Findings for Does Trans-Cutaneous Electrical Nerve Stimulation (TENS) Alleviate The Pain Experienced During Bone Marrow Sampling? (NCT NCT02005354)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

Post procedure and 24 hours

Results posted on

2019-10-08

Participant Flow

70 patients were randomised, thirty five patients received TENS impulses at a strong but comfortable amplitude (intervention group) and 35 patients received TENS impulses just above the sensory threshold (control group)

Participant milestones

Participant milestones
Measure	TENS Intervention 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)	TENS Placebo Comparator 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). Standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide): All patients will receive standard pain
Overall Study STARTED	35	35
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TENS Intervention n=35 Participants 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)	TENS Placebo Comparator n=35 Participants 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). Standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide): All patients will receive standard pain	Total n=70 Participants Total of all reporting groups
Age, Continuous	68 years n=5 Participants	69 years n=7 Participants	69 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	18 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	17 Participants n=7 Participants	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TENS Intervention n=35 Participants 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)	TENS Placebo Comparator n=35 Participants 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). Standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide): All patients will receive standard pain
Perception of Pain Will be Measured Using a Validated Numerical 0-10 Pain Scale Where 0 = no Pain and 10 = Worst Possible Pain Mean Pain Score immediately post procedure	5.6 Numerical Pain Severity Scale (0-10) Interval 4.8 to 6.4	5.7 Numerical Pain Severity Scale (0-10) Interval 4.8 to 6.6
Perception of Pain Will be Measured Using a Validated Numerical 0-10 Pain Scale Where 0 = no Pain and 10 = Worst Possible Pain Mean pain score 24 hours post procedure	1.9 Numerical Pain Severity Scale (0-10) Interval 1.2 to 2.6	1.9 Numerical Pain Severity Scale (0-10) Interval 1.1 to 2.6

Adverse Events

TENS Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TENS Placebo Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr David Tucker

Plymouth Hospitals NHS Trust

Phone: 01752 432595

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place