Clinical Trials Logo

Clinical Trial Summary

The study aims to study the impact on different surgical approaches for lumbar active discopathy. This inflammatory disease of the disc and adjacent vertebral endplates can induce low back pain with inflammatory-like features. Lumbar fusion is proposed to the patient when conservative management is not enough. This fusion can be obtained by an anterior muscle sparring approach or by a posterior muscle decaying approach.

The goal with this single center retrospective study is to identify the surgical approach that offers to the patient the better long term functional outcome. A phone call would allow us to ask patients a few questions:

- Mcnab's criteria

- Roland Morris Disability Questionnaire

The patients medical file review would also allow us to identify:

- the length of hospital stay for the discectomy (in days)

- incidence of Failed Back Surgery Syndrome

- incidence of redo surgeries

- incidence of adjacent level diseases

- incidence of dural tears and eventual complications (meningitis, orthostatic headaches,...)

- incidence of iliac vessels injuries and eventual complications (thrombosis, need for revascularisation,...)


Clinical Trial Description

1) The Roland-Morris Disability Questionnaire

When your back hurts, you may find it difficult to do some of the things you normally do.

This list contains sentences that people have used to describe themselves when they have back pain. When you read them, you may find that some stand out because they describe you today.

As you read the list, think of yourself today. When you read a sentence that describes you today, put a tick against it. If the sentence does not describe you, then leave the space blank and go on to the next one. Remember, only tick the sentence if you are sure it describes you today.

1. I stay at home most of the time because of my back.

2. I change position frequently to try and get my back comfortable.

3. I walk more slowly than usual because of my back.

4. Because of my back I am not doing any of the jobs that I usually do around the house.

5. Because of my back, I use a handrail to get upstairs.

6. Because of my back, I lie down to rest more often.

7. Because of my back, I have to hold on to something to get out of an easy chair.

8. Because of my back, I try to get other people to do things for me.

9. I get dressed more slowly then usual because of my back.

10. I only stand for short periods of time because of my back.

11. Because of my back, I try not to bend or kneel down.

12. I find it difficult to get out of a chair because of my back.

13. My back is painful almost all the time.

14. I find it difficult to turn over in bed because of my back.

15. My appetite is not very good because of my back pain.

16. I have trouble putting on my socks (or stockings) because of the pain in my back.

17. I only walk short distances because of my back.

18. I sleep less well because of my back.

19. Because of my back pain, I get dressed with help from someone else.

20. I sit down for most of the day because of my back.

21. I avoid heavy jobs around the house because of my back.

22. Because of my back pain, I am more irritable and bad tempered with people than usual.

23. Because of my back, I go upstairs more slowly than usual.

24. I stay in bed most of the time because of my back.

Note to users:

This questionnaire is taken from: Roland MO, Morris RW. A study of the natural history of back pain. Part 1: Development of a reliable and sensitive measure of disability in low back pain. Spine 1983; 8: 141-144

The score of the RDQ is the total number of items checked - i.e. from a minimum of 0 to a maximum of 24.

It is acceptable to add boxes to indicate where patients should tick each item.

The questionnaire may be adapted for use on-line or by telephone.

2) Modified Macnab Criteria:

Excellent: No pain, No restriction of mobility, Return to normal work and level of activity

Good: Occasional nonradicular pain, Relief of presenting symptoms, Able to return to modified work

Fair: Some improved functional capacity, Still handicapped and/or unemployed

Poor: Continued objective symptoms of root involvement, Additional operative intervention needed at index level irrespective of length of postoperative follow-up ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04086199
Study type Observational
Source Centre Hospitalier Régional de la Citadelle
Contact Thibault Remacle, MD
Phone +3243217170
Email thibaultremacle@gmail.com
Status Recruiting
Phase
Start date January 1, 2020
Completion date April 2, 2020

See also
  Status Clinical Trial Phase
Completed NCT01914666 - An Open Label Extension Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain Phase 3
Completed NCT01761617 - Yoga Dosing Study for Chronic Low Back Pain N/A
Completed NCT03338192 - Examining Racial and SocioEconomic Disparities (ERASED) in Chronic Low Back Pain Study
Completed NCT03106740 - Evaluating the Role of Neuroinflammation in Low Back Pain Phase 2
Completed NCT02960269 - Interprofessional Management of Chronic Back Pain in Rural and Remote Setting: Use of Telehealth vs. Secure Laptop-based Videoconferencing N/A
Completed NCT04203888 - Personalized Trial for Chronic Lower Back Pain N/A
Not yet recruiting NCT05704751 - EVOKE ECAP-Controlled Lead Placement and Programming in Chronic Pain Patients
Completed NCT06351774 - Project AdaPT: An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain N/A
Completed NCT01855919 - A Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain Phase 3
Terminated NCT01865539 - Efficacy of Foot Orthotics in Veterans With Chronic Lower Back Pain N/A
Enrolling by invitation NCT05386212 - The Impact of an Instructional Web-based Healthcare App for Relieving Back Pain From Spinal Compression Fractures
Completed NCT03299192 - Tai Chi for Chronic Low Back Pain in Older Adults N/A
Completed NCT01081912 - Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain Phase 3
Completed NCT04468074 - Virtual Reality Treatment for Adults With Chronic Back Pain N/A
Completed NCT01343927 - Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations N/A
Completed NCT01329861 - Internet-based Cognitive Behavioural Treatment for Chronic Back Pain N/A
Terminated NCT01125917 - Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015 Phase 3
Enrolling by invitation NCT05413070 - Quality Improvement re: Choosing Wisely Back Pain Measures
Not yet recruiting NCT06401499 - The Effect of Pregabalin and Etoricoxib on Pain Alone Versus in Combination Phase 4
Recruiting NCT04893720 - The SPINUS II Study: Spinal Fusion for Multilevel SPECT/CT Positive Lumbar Degeneration