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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Emma Binns
+44 (0)113 3926234
emma.binns1@nhs.net


Dr Ganesan Baranidharan
+44 (0)113 3922075
g.baranidharan@nhs.net


Study Location:

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Be Part of Research - Trial Details - Can blocking the nerve to the back muscle predict the outcome of stimulating back muscles in managing pain due to muscle dysfunction?
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Can blocking the nerve to the back muscle predict the outcome of stimulating back muscles in managing pain due to muscle dysfunction?

Not Recruiting

Open to: All Genders

Age: Adult

Leeds

Medical Conditions

Chronic low back pain

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Chronic low back pain is a common disorder that can have a significant impact on the lives of patients. Treatment options include physiological therapy, psychological therapy and medication, which can have limited effectiveness. The multifidus muscle plays an important role in stabilising the lower back. The ReActiv8 device involves electrically eliciting contractions of the multifidus muscle to improve its strength over time and to help relieve pain. However, like most treatments, some patients respond more readily than others. This pilot study aims to explore whether responses to medial branch blocks help with predicting the benefit patients receive when treated with the ReActiv8 device.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Feb 2022 31 Dec 2024

Participants will be recruited from one medical centre to undergo two medial branch injections. Patients who then agree to go ahead with the ReActiv8 therapy will receive insertion of the device and be placed in one of three groups according to the amount of pain relief they experienced from the medial branch injections.
Group 1 Pain reduction of ≥60% within 6 hours after bilateral L2 Medial Branch block AND pain reduction of ≥ 60% within 6hrs after bilateral L2-L5 Medial Branch block
Group 2 Pain reduction of ≥60% within 6 hours after bilateral L2 Medial Branch block OR pain reduction of ≥ 60% within 6hrs after bilateral L2-L5 Medial Branch block
Group 3 Pain reduction of less than 60% within 6 hours after bilateral L2 Medial Branch block AND pain reduction of less than 60% within 6 hours after bilateral L2-L5 Medial Branch block
Patients will be followed up 1, 3, 6 and 12 months after the ReActiv8 device has been activated.


Patients aged 18 to 75 years with chronic low back pain

You can take part if:



You may not be able to take part if:


Current exclusion criteria as of 31/05/2024:1. BMI >35 kg/m²2. Any current indication for back surgery3. Leg pain worse than back pain or radiculopathy below the knee

Back pain exclusions:4. Any diagnosis or correction of scoliosis5. Neurological deficit (e.g., foot drop)6. Sacroiliac joint pain7. NRS of ≤5.0 and >9.0 at the Baseline Evaluation8. ODI score <25% and >60% at enrolment

Drug use exclusions:9. Baseline use >120 mg oral morphine equivalent per day of opioids10. Medications not at stable dose in prior 30 days

Surgical exclusions:11. Rhizotomy procedure of medial branch below T8 in <12 months12. Anaesthetic block of medial branch or epidural steroids for back pain in prior 30 days13. Previous back surgery below T814. Previous destructive thoracic or lumbar sympathectomy

Psycho-social exclusions:15. Current/pending litigation, claim or monetary settlement16. Closed claim in past five years, or financial incentive to remain impaired17. Current active depression

Previous exclusion criteria:1. BMI >35 kg/m²2. Any current indication for back surgery3. Leg pain worse than back pain or radiculopathy below the knee4. Any diagnosis or correction of scoliosis5. Neurological deficit (e.g. foot drop)6. Sacroiliac joint pain7. NRS ≤5.0 and >9.0 at baseline 8. ODI score <25% and >60% at enrolment9. PainDETECT score >19 at enrolment10. Baseline use >120 mg oral morphine equivalent per day of opioids 11. Medications not at stable dose in prior 30 days 12. Rhizotomy procedure of medial branch below T8 in < 12 months13. Anaesthetic block of medial branch or epidural steroids for back pain in prior 30 days 14. Previous back surgery below T815. Previous destructive thoracic or lumbar sympathectomy 16. Current/pending litigation, claim or monetary settlement 17. Closed claim in past five years, or financial incentive to remain impaired18. Current active depression


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Leeds General Infirmary
    Great George Street
    Leeds
    LS1 3EX

There are no direct benefits for participation. However, after some of the study treatments, participants may experience benefits including a reduction in their daily pain, a reduction in the amount of pain medication they need and an improvement in their quality of life. The information gathered in this study will add to the understanding of treatment options for patients suffering from similar chronic pain in the future.
Participants will have two spinal pain-killing injections and implantation of a ReActiv8 device. One of these spinal injections will be extra to those that patients would have if they did not take part in this study. In some countries it is a standard practice to do two diagnostic injections before a definitive treatment. This is a low-risk procedure, but like everything, there are some risks involved and side effects may occur. These are usually minor.
Side effects may include:
1. Mild local tenderness and/or bruising at the site of the injection that usually settles over the first few days
2. The local anaesthetic may spread causing some numbness and/or weakness in the legs and other areas. Should this occur, the effect is temporary and will rapidly resolve over minutes or sometimes hours.
3. Infection. This is rare. Medical help should be sought if there is warmth or redness over the site of injection with tenderness and/or feeling hot and unwell. This may require antibiotic treatment.
4. There are important nerves in the spine, but serious nerve injury is extremely rare (less than 1 in 10,000 cases).
5. Injection treatments are not always effective and may not help with the pain.
The spinal injections and implantation procedure of the ReActiv8 device all use x-rays, a type of ionising radiation, to form images of the body to guide the doctor during the procedures. Ionising radiation may cause cancer years or decades after the exposure. We are all at risk of developing cancer during our lifetime. 50% of the population is likely to develop one of the many forms of cancer at some stage during our lifetime. Taking part in this study may increase the chances of this happening to about 50.02%.
All other interventions and imaging that participants will receive are standard of care for the treatment of this particular condition with this device. The remainder of the study only requires participants to complete questionnaires and simple physical activity assessments, additional risks or side effects are not expected for participants in this study.

Ms Emma Binns
+44 (0)113 3926234
emma.binns1@nhs.net


Dr Ganesan Baranidharan
+44 (0)113 3922075
g.baranidharan@nhs.net



The study is sponsored by Leeds Teaching Hospitals NHS Trust and funded by Mainstay Medical, Inc..



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Read full details for Trial ID: ISRCTN12101415

Or CPMS 49291

Last updated 28 February 2025

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