Assessment of effectiveness of percutaneous adhesiolysis and caudal epidural injections in managing post lumbar surgery syndrome: 2-year follow-up of a randomized, controlled trial

Figures & data

Figure 1 Schematic presentation of patient flow at 2-year follow-up.

Table 1 Demographic characteristics and clinical data

	Group I (n = 60)	Group II (n = 60)	P-value
Gender
Male	42% (25)	42% (25)	1.00
Female	58% (35)	58% (35)
Age
Mean ± standard deviation	52 ± 13.9	52 ± 12.5	0.962
Height (inches)
Mean ± standard deviation	67 ± 4.3	67 ± 4.0	0.807
Weight (lbs)
Mean ± standard deviation	185 ± 44.0	178 ± 50.1	0.458
Duration of pain (months)
Mean ± standard deviation	186 ± 121.7	196 ± 109.4	0.642
Mode of onset of pain
Nontraumatic	55% (33)	57% (34)	0.540
Traumatic	45% (27)	43% (26)
Back pain distribution
Bilateral	72% (43)	65% (39)	0.40
Left or right	28% (17)	35% (21)
Leg pain distribution
Bilateral	39% (23)	35% (21)	0.926
Left or right	61% (37)	65% (39)
Pain ratio
Back pain only	2% (1)	0%	0.46
Back worse than leg	63% (38)	57% (34)
Leg worse than back	3% (2)	8% (5)
Both equal	32% (19)	35% (21)
Surgical history (number of interventions)
One	50% (30)	47% (28)	0.603
Two	30% (18)	23% (14)
Three	10% (6)	17% (10)
More than three	10% (6)	13% (8)

Note: Unless otherwise stated, data expressed as % (n).

Table 2 Therapeutic procedural characteristics with procedural frequency, average relief per procedure, and average total relief in weeks over a period of 1 year and 2 years

	Back pain		Leg pain
	Group I (n = 60)	Group II (n = 60)	Group I (n = 59)	Group II (n = 58)
Average number of procedures per year	2.2* ± 1.08	3.5 ± 1.03	2.2* ± 1.09	3.4 ± 1.03
Average number of procedures per 2 years	2.4* ± 1.44	6.4 ± 2.35	2.4* ± 1.45	6.4 ± 2.35
Average relief per procedure (weeks)	4.9* ± 4.00	11.7 ± 2.97	5.1* ± 3.90	11.5 ± 3.34
Average total relief per year (weeks)	13.2* ± 14.20	40.7 ± 14.92	12.9* ± 13.71	39.7 ± 15.87
Average total relief per 2 years (weeks)	14.8* ± 19.77	78.5 ± 32.36	15.0* ± 19.77	77.7 ± 33.07

Note:

* Significant difference with Group II (P < 0.05).

Table 3 Comparison of the numeric rating scale for pain and Oswestry Disability Index score summaries at six time points

Time points	Mean ± standard deviation
	Numeric pain rating score		Oswestry Disability Index
	Group I (n = 60)	Group II (n = 60)	Group I (n = 60)	Group II (n = 60)
Baseline	7.9 ± 0.8	8.1 ± 0.8	28.6 ± 4.1	31.2 ± 4.1
3 months	4.9* ± 1.6	3.4* ± 0.8	20.2* ± 6.6	15.2* ± 4.1
6 months	5.8* ± 1.5	3.7* ± 1.1	22.3* ± 6.1	15.2* ± 5.2
12 months	6.1* ± 1.4	4.0* ± 1.2	23.3* ± 5.8	15.8* ± 5.6
18 months	6.1* ± 1.4	3.6* ± 1.2	23.3 ± 5.7	14.6 ± 4.6
24 months	6.2* ± 1.4	3.6* ± 1.1	23.2 ± 6.7	13.9 ± 5.1
Group difference	0.001		0.001
Baseline versus follow-up points	0.001		0.001
Group by time interaction#	0.001		0.001

Notes:

* Significant difference with baseline values (P < 0.05);

# there was significant difference between groups at 3 months, 6 months, 12 months, 18 months, and 24 months.

Figure 2 Proportion of patients with significant relief (≥50%) in average pain score (Numeric Rating Scale and Oswestry Disability Index).

Table 4 Employment characteristics

	Group I			Group II
	Baseline	12 months	24 months	Baseline	12 months	24 months
Employment status
Employed part-time	3	3	3	1	1	1
Employed full-time	6	6	6	4	4	4
Unemployed	3	3	3	0	0	0
Total employed	9	9	9	5	5	5
Eligible for employment	12	12	12	5	5	5
Housewife	4	4	4	1	1	1
Disabled	28	28	28	42	41	41
>65 years of age	16	16	16	12	13	13
Total number of patients	60	60	60	60	60	60

Notes: There were no changes in Group I; one disabled became >65 years of age in Group II.

Table 5 Daily opioid (morphine equivalents)

	Group I	Group II
Baseline	69.6 ± 106.8	99.0 ± 117.1
3 months	68.0 ± 91.4	76.6* ± 99.8
6 months	67.9 ± 91.4	75.1* ± 97.5
12 months	67.9 ± 91.4	78.2* ± 103.7
18 months	67.9 ± 91.4	76.3* ± 96.5
24 months	67.9 ± 91.4	76.3* ± 96.5
Group difference	0.149
Baseline versus follow-up points	0.089
Group by time interaction#	0.485

Notes:

* Significant difference with baseline values (P < 0.05);

# there was significant difference between groups at 3 months, 6 months, 12 months, 18 months, and 24 months.

Table 6 Characteristics of weight monitoring

Weight (lbs)	n = 60		P-value
	Group I	Group II
Weight at beginning	185.1 ± 44.0	177.6 ± 49.1	0.377
Weight at 1 year	184.1 ± 42.8	175.9 ± 48.1	0.324
Change	−1.0 ± 6.7	−1.7 ± 12.7	0.713
Lost weight	33% (20)	42% (25)
No change	45% (27)	22% (13)	0.021
Gained weight	22% (13)	37% (22)
Weight at 2 years	184.4 ± 42.4	176.2 ± 49.0	0.332
Change	−0.7 ± 7.2	−1.3 ± 16.6	0.798
Lost weight	33% (20)	45% (27)
No change	44% (26)	17% (10)	0.006
Gained weight	23% (14)	38% (23)

Notes: Data expressed as mean ± standard deviation or % (n); bold indicates significance.