None listed
Conditions
Brief summary
The primary aim of this study is to test the feasibility of a clinical trial comparing TENS alone to TENS combined with self-selected music, in patients with persistent spinal pain. The results of this feasibility study will be used to inform a larger trial of these interventions in patients with persistent spinal pain. A secondary aim is to study the analgesic effects of each intervention over the course of the TENS treatment, impact of participant's function and mood and adverse outcomes.We hypothesise that administration of TENS combined with music will be equally feasible compared to TENS alone, and will be well tolerated by participants. Secondly, we hypothesise that participants will have superior analgesia when TENS is combined with music treatment will have improved analgesia compared to TENS alone.
Interventions
This will be a prospective, randomised controlled pilot study to compare Transcutaneous Electric Nerve stimulation(TENS) alone (control and standard treatment) versus TENS combined with patient self-selected music (intervention). The TENS unit consists of a hand-held device connected to electrodes which are attached to the skin. The device when switched on delivers low-voltage impulses to the electrodes the frequency and intensity of which can be controlled by the participant. Participants are f
This will be a prospective, randomised controlled pilot study to compare Transcutaneous Electric Nerve stimulation(TENS) alone (control and standard treatment) versus TENS combined with patient self-selected music (intervention). The TENS unit consists of a hand-held device connected to electrodes which are attached to the skin. The device when switched on delivers low-voltage impulses to the electrodes the frequency and intensity of which can be controlled by the participant. Participants are free to select from available mode of delivery of the impulses which include Burst, Continuous or Modulate. The impulses will be felt as a tingling. The electrodes are usually placed on the back near the area that is painful. The patients will be randomised to receive 2 weeks of TENS therapy and 2 weeks of TENS with music. The order in which this is delivered will be determined by randomisation. Thus one group will receive standard TENS for 2 weeks followed by TENS with music for 2 weeks. This order will be reversed in the other group. The participants will be compared against themselves for the outcomes thus reducing the number of participants to power the study. There is no washout period. The TENS will be self administered. Administration of TENS will be for the duration of 1 hour at a time, up to a maximum of 6 times during each 24 hours, for 2 weeks and with music from a self selected play list from a set of genres Classical, Easy listening, Pop, Rhythm & Blues, Vocal and Musical. We will use a participant diary to record the duration of TENS each day and the type of music listened to. The pulse intensity that can be set in the TENS machine can vary from 0-80milliAmpere, pulse frequency between 2Hz-150Hz .
Sponsors
Westmead Hospital, Department of Anaesthesia
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients 18 years and over presenting with spinal pain with or without radicular limb pain attending pain clinic at Westmead Hospital will be eligible
Exclusion criteria
Those who have used TENS or Music therapy in the past to manage their pain, those with a significant hearing impairment, lack of technical ability to play music through Spotify, or an inability to communicate in English
Outcome results
None listed