Can blocking the nerve to the back muscle predict the outcome of stimulating back muscles in managing pain due to muscle dysfunction?

Not Applicable

• Conditions: Chronic low back pain; Musculoskeletal Diseases; Low back pain

• Registration Number: ISRCTN12101415
• Lead Sponsor: eeds Teaching Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-24
• Last Update Posted: 10 June 2024
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Age =18 years to =75 years
2. Chronic low back pain on the majority of days 12 weeks prior to enrolment
3. Continuing low back pain despite more than 90 days under medical management within last year

Exclusion Criteria

Current exclusion criteria as of 31/05/2024:
1. BMI >35 kg/m²
2. Any current indication for back surgery
3. Leg pain worse than back pain or radiculopathy below the knee

Back pain exclusions:
4. Any diagnosis or correction of scoliosis
5. Neurological deficit (e.g., foot drop)
6. Sacroiliac joint pain
7. NRS of =5.0 and >9.0 at the Baseline Evaluation
8. ODI score <25% and >60% at enrolment

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

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

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

Previous exclusion criteria:
1. BMI >35 kg/m²
2. Any current indication for back surgery
3. Leg pain worse than back pain or radiculopathy below the knee
4. Any diagnosis or correction of scoliosis
5. Neurological deficit (e.g. foot drop)
6. Sacroiliac joint pain
7. NRS =5.0 and >9.0 at baseline
8. ODI score <25% and >60% at enrolment
9. PainDETECT score >19 at enrolment
10. 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 months
13. Anaesthetic block of medial branch or epidural steroids for back pain in prior 30 days
14. Previous back surgery below T8
15. 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 impaired
18. Current active depression

Study & Design

• Study Type: Interventional
• Study Design: Not specified