| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Non-specific low back pain of more than three months' duration |
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| E.1.1.1 | Medical condition in easily understood language |
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| E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
To assess the feasibility of conducting a definitive study to evaluate the clinical- and cost-effectiveness of facet-joint injections compared to a sham procedure, in patients with non-specific low back pain of more than three months’ duration.
The definitive trial will be deemed feasible if we are successful in standardisation of the method of injection and the test-run of the sham procedure, and if we are able to recruit and retain patients to the proposed trial design. |
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| E.2.2 | Secondary objectives of the trial |
1. To assess the eligibility, recruitment and retention of patients in the two treatment arms (active versus sham procedure).
2. To assess the feasibility and acceptability of the two treatment arms from the point of view of patients and the pain team.
3. To assess the feasibility of the proposed definitive trial design including:
a. Testing of randomisation and blinding procedures.
b. Development of an appropriate active and sham procedure for FJIs.
c. Assessing the consistency of the trial sites to deliver the combined physical and psychological programme.
d. Assessing the feasibility of collecting the proposed outcome data (including pain, functioning, health-related quality of life, anxiety and depression, health care resource utilization, complications, and adverse events).
4. To assess the feasibility of diagnostic criteria to identify facet-joint disease (using clinical tests, and medial branch nerve blocks) to define patient subsets for evaluation in a |
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Patients aged 18 to 70 years attending pain clinics identified during routine clinical assessment of non-specific low back pain (clinical indicators for pain of facet-joint origin include tenderness over the facet-joints, referred leg pain above the knees, and worsening pain on extension, flexion and rotation).
2. Low back pain of greater than three months’ duration.
3. Average pain intensity score of 4/10 or more in the seven days preceding recruitment despite NICE-recommended treatment (NICE recommends providing patients with advice and information to promote self-management of their low back pain, and offering one of the following treatments, taking into account patient preference: an exercise programme, a course of manual therapy, or a course of acupuncture).
4. Dominantly paraspinal (not midline) tenderness at two bilateral lumbar levels.
5. At least two components of NICE-recommended best non-invasive care completed, including education and one of a physical exercise programme, acupuncture, and manual therapy (Dworkin et al. 2005).
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| E.4 | Principal exclusion criteria |
1. Patient refusal.
2. More than four painful lumbar facet-joints.
3. Patient has not completed at least two components of NICE-recommended best non-invasive care (Dworkin et al. 2005)
4. ‘Red flag’ signs (‘red flag’ signs are possible indicators of serious spinal pathology, and include thoracic pain, fever, unexplained weight loss, bladder or bowel dysfunction, progressive neurological deficit, and saddle anaesthesia).
5. Hypersensitivity to study medications or X-ray contrast medium.
6. Radicular pain (radicular pain is defined as pain perceived as arising in a limb or the trunk wall caused by ectopic activation of nociceptive afferent fibres in a spinal nerve or its roots or other neuropathic mechanisms. The pain is lancinating in quality and travels along a narrow band).
7. Dominantly midline tenderness over the lumbar spine.
8. Any other dominant pain.
9. Any major systemic disease or mental health illness that may affect the patient’s pain, disability and/or their ability to exercise and rehabilitate.
10. Any active neoplastic disease, including primary or secondary neoplasm.
11. Pregnant or breastfeeding patients.
12. Previous lumbar facet-joint injections.
13. Previous lumbar spinal surgery.
14. Patients with morbid obesity (body mass index of 35 or greater).
15. Major trauma or infection to the lumbar spine.
16. Participation in another clinical trial in the past thirty days.
17. Patients unable to commit to the six-month study duration.
18. Patients involved in legal actions or employment or benefit tribunals related to their low back pain.
19. Patients with a history of substance abuse.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
Qualitative endpoints
For the feasibility study, the outcome measures include assessing and documenting:
1. Progress, patient numbers and problems at each stage
2. Recruitment and retention of subjects
3. Randomisation
4. Acceptability of trial methods to patients and clinicians
5. Ability to maintain blinding to active procedure and sham injection (assessment of patients and research staff by ‘guess allocation’)
6. Consistency of CPP and acupuncture across the three main centres (their details will be collected as part of the clinical research form)
7. Monitoring and auditing of study conduct.
Quantitative endpoints
1. Feasibility of collecting potential candidate outcome data (number of completed outcomes at baseline and follow-up)
2. Outcome variability (with recruitment and retention figures) to inform sample size calculation for a full trial.
Primary outcome measures for the definitive trial
The primary outcome measure is the change in average pain scores taken at baseline, 6 weeks, 3 months and 6 months. This will be measured using an 11-point numerical rating scale (NRS).
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| The study will end when the last patient has completed the last set of questionnaires. The investigators will spend a further 3 months to analyse and report the data generated from the study. |
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| E.5.2 | Secondary end point(s) |
| As this is a feasibility study, we do not propose to formally inferentially test differences in outcomes or costs between or within the groups. Recruitment and attrition rates will be calculated with 95% confidence intervals. We shall report mean and standard deviations for primary and secondary outcomes for the two groups at baseline and all follow-up visits. |
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| This is not applicable to the study. |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | No |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
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| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 21 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 21 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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