Clinical and cost-effectiveness of PCF versus ACD in the treatment of cervical brachialgia (FORVAD trial)

Figures & data

Table 2. Data collection tools and schedule.

Variable	Instruments	Schedule	Comments
Functional Scores
General Function	Neck Disability Index (NDI)	Days 0 and 1 Weeks 6, 12, 26, 39, 52	Primary Outcome measure
Neurological Function	Restricted ASIA Score	Registration / Day 0 Day 1 Week 6	20 myotomes as in full ASIA C4, C5, C6, C7, C8, T1, T10, L2, L4 and S1 dermatomes
Pain
Neck Pain severity	Numbered Rating Scale	Days 0 and 1 Weeks 6, 12, 26, 39, 52
Arm Pain severity	Numbered Rating Scale	Days 0 and 1 Weeks 6, 12, 26, 39, 52
Pain type	PainDETECT	Day 0 Weeks 6, 12, 26, 39, 52	Used diagnostically to distinguish nociceptive and neuropathic pain
Voice / Swallowing
Hoarse Voice	GRBAS	Registration / Day 0 Day 1 Week 6	25% random sample Blind centralised expert assessment of recordings
Dysphagia	EAT-10 and GETS	Days 0 and 1 Weeks 6, 12, 26, 39, 52
Globus	VHI-10	Days 0 and 1 Weeks 6, 12, 26, 39, 52
Other
Health related Quality of Life	EQ-5D-3L	Days 0 and 1 Weeks 6, 12, 26, 39, 52
Health resource use		Weeks 6, 12, 26, 39, 52
Medical History		Registration	Demographics, non surgical interventions, co-morbidity, employment, depression, smoking
Operation details		At time of surgery	Including length of surgery, blood loss, use of plate (ACD), minimal access (PCF)
Post-op assessment		Day 1 Week 6
Analgesic use		Registration / Day 0 Day 1 Week 6
Complications		During surgery Day 1 Week 6
Discharge details		Week 6	Length of stay, wound problems

Table 1. Trial inclusion and exclusion criteria.

Exclusion Criteria 1) Cervical disc causing cord compression 2) Cervical myelopathy 3) Bilateral cervical brachialgia 4) Previous cervical spine surgery 5) Professionals where a hoarse voice would be exceptionally significant 6) Skin disease at surgical sites 7) Pregnancy 8) Cervical deformity 9) Not suitable for ACD (ACD) as assessed by the treating surgeon 10) Not suitable for PCF (PCF) as assessed by the treating surgeon

Inclusion Criteria 1) Aged ≥18-years old 2) Diagnosis of unilateral cervical brachialgia as confirmed by MRI or CT myelogram taken within the last 12 months 3) Symptoms of cervical brachialgia present for at least 6 weeks 4) Single level nerve entrapment 5) Postero-lateral disc and/or foraminal narrowing 6) Failed conservative management 7) Able and willing to comply with the terms of the protocol, including QoL questionnaires 8) Able to provide written informed consent

Figure 1. CONSORT diagram.

Table 3. Summary of minimisation factors at baseline by treatment group.

	PCF (N = 14)	ACD (N = 9)	Total (N = 23)
Site
The Royal Preston Hospital	0 (0.0%)	1 (11.1%)	1 (4.3%)
Sheffield Teaching Hospital NHS Foundation Trust	1 (7.1%)	0 (0.0%)	1 (4.3%)
Leeds Teaching Hospitals NHS Trust	11 (78.6%)	7 (77.8%)	18 (78.3%)
South Tees Hospital NHS Trust	1 (7.1%)	0 (0.0%)	1 (4.3%)
The Walton Centre NHS Foundation Trust	1 (7.1%)	1 (11.1%)	2 (8.7%)
Total	14 (100%)	9 (100%)	23 (100%)
Duration of upper limb symptoms
6 weeks to < 6 months	0 (0.0%)	0 (0.0%)	0 (0.0%)
= >6 months to < 12 months	6 (42.9%)	2 (22.2%)	8 (34.8%)
= > 12 months	8 (57.1%)	7 (77.8%)	15 (65.2%)
Total	14 (100%)	9 (100%)	23 (100%)
Smoking status in last 6 weeks
Smoker	5 (35.7%)	3 (33.3%)	8 (34.8%)
Non-smoker	9 (64.3%)	6 (66.7%)	15 (65.2%)
Total	14 (100%)	9 (100%)	23 (100%)

Table 4. Summary of participant characteristics at baseline in each treatment group.

	PCF (N = 14)	ACD (N = 9)	Total (N = 23)
Age
Mean (s.d.)	54.5 (6.6)	53.3 (10.5)	54.0 (8.1)
Median (range)	53.5 (46.0, 67.0)	52.0 (34.0, 70.0)	52.0 (34.0, 70.0)
IQR	50.0, 58.0	47.0, 61.0	49.0, 61.0
Gender
Male	4 (28.6%)	4 (44.4%)	8 (34.8%)
Female	10 (71.4%)	5 (55.6%)	15 (65.2%)
Total	14 (100%)	9 (100%)	23 (100%)
BMI
Mean (s.d.)	30.1 (4.9)	30.2 (4.3)	30.1 (4.6)
Median (range)	30.2 (22.5, 40.8)	31.4 (24.3, 35.5)	30.2 (22.5, 40.8)
IQR	26.0, 33.2	26.0, 34.3	26.0, 34.3
Average number of cigarettes per day (smokers only)
Mean (s.d.)	13.6 (6.2)	18.3 (10.4)	15.4 (7.7)
Median (range)	12.0 (6.0, 20.0)	15.0 (10.0, 30.0)	13.5 (6.0, 30.0)
IQR	10.0, 20.0	10.0, 30.0	10.0, 20.0
N	5	3	8
Type of scan
MRI	14 (100.0%)	8 (88.9%)	22 (95.7%)
CT myelogram	0 (0.0%)	1 (11.1%)	1 (4.3%)
Cause of nerve root compression
Soft Disk	6 (42.9%)	5 (55.6%)	11 (47.8%)
Osteophyte	5 (35.7%)	3 (33.3%)	8 (34.8%)
Both	3 (21.4%)	1 (11.1%)	4 (17.4%)
Dominant hand
Left Handed	1 (7.1%)	0 (0.0%)	1 (4.3%)
Right Handed	13 (92.9%)	9 (100.0%)	22 (95.7%)
Ambidextrous	0 (0.0%)	0 (0.0%)	0 (0.0%)
Arm that participant has worse pain in?
Left Arm	6 (42.9%)	6 (66.7%)	12 (52.2%)
Right Arm	8 (57.1%)	3 (33.3%)	11 (47.8%)
Litigation pending for this complaint?
Yes	1 (7.1%)	1 (11.1%)	2 (8.7%)
No	12 (85.7%)	8 (88.9%)	20 (87.0%)
Missing	1 (7.1%)	0 (0.0%)	1 (4.3%)
Medications for this presentation?
Yes	13 (92.9%)	8 (88.9%)	21 (91.3%)
No	0 (0.0%)	1 (11.1%)	1 (4.3%)
Missing	1 (7.1%)	0 (0.0%)	1 (4.3%)
Other non-operative intervention for cervical brachialgia? *
Yes	3 (21.4%)	2 (22.2%)	5 (21.7%)
No	10 (71.4%)	7 (77.8%)	17 (73.9%)
Missing	1 (7.1%)	0 (0.0%)	1 (4.3%)
Does the participant have any comorbidities?
Yes	2 (14.3%)	0 (0.0%)	2 (8.7%)
No	11 (78.6%)	9 (100.0%)	20 (87.0%)
Missing	1 (7.1%)	0 (0.0%)	1 (4.3%)
Comorbidity list
Chronic obstructive pulmonary disease	1 (50%)	0 (0.0%)	1 (50%)
Peptic ulcer disease	1 (50%)	0 (0.0%)	1 (50%)
Depression in last 6 months?
Yes	4 (28.6%)	1 (11.1%)	5 (21.7%)
No	9 (64.3%)	8 (88.9%)	17 (73.9%)
Missing	1 (7.1%)	0 (0.0%)	1 (4.3%)

Figure 2. Box plot of percentage NDI score at each time point, by treatment group.

Figure 3. Box plot of NRS Upper limb pain score at each time point, by treatment group.

Data availability statement

Data supporting this study are available from the Clinical Trials Unit of the University of Leeds. Access to the data is subject to approval and a data-sharing agreement due to patient confidentiality.