None listed
Conditions
Brief summary
Low back pain commonly occurs in the general population, making it an important target for intervention. ThermaCare HeatWraps may prevent and relieve pain in regions such as the low back through continuous, low-level, direct heat therapy. The objective of this Investigator Initiated study is to evaluate the effectiveness of ThermaCare HeatWraps in improving flexibility and low back muscle relaxation, and in patients experiencing pain, reducing pain during movement. This study is an intervention trial on two discrete subject samples; (1) people with recent back pain, and (2) people who regularly play sport. ViMove wearable sensors provide precise objective measurements of low back muscle activity and movement in real time and can capture a patient’s reporting of pain during movement. Outcomes will be assessed through standard ViMove protocols in conjunction with multiple validated measures of pain, perception of change, and function.
Interventions
ThermaCare Low-back HeatWraps provide continuous, low-level, direct heat therapy and will be evaluated in two population samples:
Group 1: participants with low back pain occuring for > 3 week,
Group 2: participants who engage in moderate-to-high intensity exercise 3 times a week or more as assessed by the Borg Perceived Exertion Scale
Efficacy of ThermaCare HeatWraps (Pfizer Consumer Healthcare) will be assessed using reliable and valid subjective measures of pain and disability, in conjunctio
ThermaCare Low-back HeatWraps provide continuous, low-level, direct heat therapy and will be evaluated in two population samples: Group 1: participants with low back pain occuring for > 3 week, Group 2: participants who engage in moderate-to-high intensity exercise 3 times a week or more as assessed by the Borg Perceived Exertion Scale Efficacy of ThermaCare HeatWraps (Pfizer Consumer Healthcare) will be assessed using reliable and valid subjective measures of pain and disability, in conjunction with objective movement and function data (ViMove sensors, dorsaVi Ltd.) The study will occur across two consecutive days. The first day will provide a baseline assessment of the participant, and will require the following from both groups: Fitment of ViMove Sensors, followed by a ViMove in-clinic assessment of movement in the "start interview" of day 1 The participant will then leave the clinic whilst wearing the sensors, and will go about their day. This provides a baseline assessment of movement and activity. The participant will return to the clinic after approximately 8-hours for an "end-of-day interview", and will be required to complete questionnaires assessing pain and disability. This will be followed by a 2nd ViMove in-clinic assessment. Sensors will then be removed for the day. The second day will assess the efficacy of ThermaCare HeatWraps. The procedure is almost identical to the first day, with the difference being the additional application of the HeatWrap during the "start interview". The HeatWrap will be worn outside of the clinic for the 8-hour period, and will be removed following the completion of the "end-of-day interview". These Heatwraps are wrapped around the low back of the participant and worn for 8 hours. They will be applied by the treating physician according to the manufacturer's instructions. Each heat wrap is designed to heat to about 40 degrees Celsius (104 F). Intervention adherence will be assessed by the treating clinician during the end-of-day interview. No strategies will be utilised to improve adherence, other than the recommendations outlined by the clinician (i.e that the Wrap should be worn for the 8-hours unless you feel extremely uncomfortable etc.)
Sponsors
dorsaVi Ltd.
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 54 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria for recent low back pain patients: 1. Adults between the age of 21-54 inclusive, male and female. 2. Low back pain is the primary source of pain over the last 3 weeks. 3. Have experienced and received treatment for muscle related low back pain with an average score of at least 3/10 on a 10-point VAS scale over the past 3 weeks. 4. Must be able to communicate fluently in English. 5. Must provide written informed consent. 6. Must agree to confidentiality. Inclusion criteria for people who are active in sports: 1. Adults between the age of 21-54 inclusive, male and female. 2. Participate in 30 min of moderate to high intensity exercise 3 times per week as determined by the Borg Perceived Exertion Scale. 3. Must be able to communicate fluently in English. 4. Must provide written informed consent. 5. Must agree to confidentiality.
Exclusion criteria
1. The subject is pregnant. 2. The subject has a severe hearing impairment or an inability to follow verbal instructions in English. 3. The subject is cognitively impaired. 4. Known allergic skin reaction to tapes and plasters. 5. Co-morbidities of neoplasm, infection, fracture, inflammatory or metabolic disorder that has potential to affect the lumbo-pelvic region. 6. Preceding chronic myelopathy, specific neurological disease or neurological changes. 7. Person who is currently enrolled in another investigational drug or device study.
Outcome results
None listed