The clinical course of low back pain: a meta-analysis comparing outcomes in randomised clinical trials (RCTs) and observational studies

Artus, Majid; van der Windt, Danielle; Jordan, Kelvin P; Croft, Peter R

doi:10.1186/1471-2474-15-68

Table 2 Characteristics of included RCTs (n 70)

From: The clinical course of low back pain: a meta-analysis comparing outcomes in randomised clinical trials (RCTs) and observational studies

Author and country	Setting	Treatment	Age, mean (y)	Female (%)	Duration of back pain, mean (weeks)	Sample size of trial arms
Albaladejo et al., Spain [36]	Primary care	Education & physiotherapy	51	68		100
		Education	51	63		139
		Usual GP care	53	72		109
Arribas et al., Spain [37]	National health centres	GDS physical therapy	39	64		78
		Electrotherapy	39	64		67
Bendix et al., Denmark [38]	General practice	Functional restoration (PT + OT + Psychological)	40	66		48
		Outpatient intensive physical training: Aerobics + strengthening exercises + fitness machines	43	69		51
Bronfort et al., USA [39]	College outpatient clinic	Spinal manipulation & trunk strengthening exercise	41	54	156	71
		NSAID & Trunk strengthening exercise	40	44	104	52
		Spinal manipulation & Stretching exercise	41	39	120	51
Bronfort et al., USA [40]	Physical therapy clinic	Supervised exercises	45	57	249	100
		Chiropractic	45	66	250	100
		Home exercises	46	58	250	101
Browder et al., USA [41]	Physical therapy clinics	Extension orientated exercises	40	31	9	26
		Strengthening exercises	38	32	9	22
Burton et al., UK [42]	General practice	The Back Book + usual care (GP & osteopathic care)		11		83
		The traditional Handy Hints & usual care (GP & osteopathic care)		12		79
Cambron et al., USA [43]	Chiropractic clinic + hospital clinic + General population	Chiropractic flexion distraction procedure	42	34		123
		Active trunk exercise program	41	41		112
Cecchi et al., Italy [44]	Rehabilitation department	Spinal manipulation	58	69		70
		Individual physiotherapy	61	61		70
		Back school	58	70		70
Chan et al., Hong Kong [45]	Physiotherapy	Aerobic training	47	79	54	24
		Usual physiotherapy	46	77	63	22
Chang et al., Taiwan [46]	General population	Piroxicam sachet	34	30		23
		Piroxicam tablets	34	26		19
Chok et al., Singapore [47]	Physiotherapy + Orthopaedic clinics + A/E	Physical therapy (endurance exercise at the PT department) + back hot pack	38	20	4	38
		Back hot pack (Home)	34	29	4	28
Costa et al., Australia [48]	Physical therapy clinics	Exercise	55	58	335	77
		Detuned diathermy and detuned USS	53	62	328	77
Constant et al., France [49]	General practice	Spa therapy & usual GP care				63
		Waiting list group & usual GP care				63
Critchley et al., UK [50]	Physiotherapy department	Individual physiotherapy	45	59	275	71
		Spinal stabilisation	44	71	346	72
		Pain management	44	62	348	69
Di Cesare et al., Italy [51]	Physical therapy clinics	Trigger point mesotherapy	53	55	22	29
		Acupuncture point mesotherapy	53	55	21	33
Djavid et al., Iran [52]	Occupational clinic	Low level laser (LLL)	40	56	118	20
		LLL + exercise	38	37	110	21
		Placebo LLL + exercise	36	17	106	20
Dufour et al., Denmark [53]	Rheumatology clinics	Group based multidisciplinary therapy	41	57	514	142
		Individual therapist assisted exercises	41	56	540	144
Dundar et al., Turkey [54]	Physical therapy clinics	Aquatic exercise	35	47		32
		Land based exercise	35	48		33
Fritz et al., USA [55]	Physical therapy clinics	Traction plus EOT	42	55		31
		Extension orientated therapy (EOT)	41	58		33
Frost et al., UK [56]	Physiotherapy	Routine physiotherapy & advice book	42	58		144
		Advice from physiotherapist & advice book	40	47		142
Geisser et al., USA [57]	University spinal programme	Manual therapy & Specific exercise (self corrections, stretching, strengthening)	39	67	284	26
		Sham Manual therapy & Specific exercise	39	56	370	25
		Manual Therapy & Non-specific exercise	37	80	370	24
		Sham Manual Therapy & non-specific exercise	46	61	284	25
George et al., USA [58]	Physical therapy	Standard care physical therapy	37	53	4	32
		Fear-avoidance based physical therapy	40	62	4	34
Glasov et al., Australia [59]	General population	Laser acupuncture	58	95		45
		Sham laser	49	62		45
Glomsrod et al., Norway [60]	Physicians clinics and General population	Active back school (Lectures and back exercises)	41	65		37
		Usual medical care	39	57		35
Goldby et al., UK [61]	General practice + hospital physicians	Spinal stabilisation & Attending the back school	43	68		84
		Manual therapy & Attending the back school	41	70		89
		Education (Booklet: Back in action) & Attending the back school	42	68		40
Hay et al., UK [62]	General practice	A brief programme of pain management (general fitness and exercise at clinic and home, explanation about pain mechanisms, distress, encouragement of positive coping strategies, overcoming fear of “hurt = harm”, and implementation of a graded return to usual activities)	40	50		201
		Physiotherapy including manual therapy techniques	41	55		201
Heymans et al., Netherlands [63]	Occupational healthcare	Usual Dutch occupational physician care	41	17	35	103
		Low intensity back school	41	22	35	98
		High intensity back school	40	23	35	98
Hseih et al., USA [64]	General population	Joint manipulation & myofascial therapy	48	33	12	52
		Joint manipulation	47	33	12	48
		Myofascial therapy	49	33	12	51
		Back school	48	40	11	48
Hurley et al., UK [65]	Physiotherapy + General practice + self referral	Manipulation therapy (Passively move intervertebral joint within or beyond its range)	40	57	8	80
		Interferential therapy (Electrical stimulation)	40	62	8	80
		Manipulation & interferential therapy	41	60	8	80
Hurwitz et al., USA [66]	Managed care facility	Chiropractic care only	52	49		169
		Chiropractic care & physical modalities (Heat/cold, USS)	54	58		172
		Medical care (excluding physical treatment) only	49	47		170
		Medical care & physical modalities (Heat/cold, USS)	49	54		170
Hurwitz et al., USA [67]	Network of healthcare	Chiropractic care only	52	49		340
		Chiropractic care & physical modalities (Heat/cold, USS)	53	58		340
Jellema et al., Netherlands [68]	General practice	Minimal intervention strategy (Assessing psychosocial risks, providing information on back pain and treatments & advice on self care)	43	48	2	143
		Usual GP care	42	47	2	171
Kaapa H., Finland [69]	Occupational healthcare	Multidisciplinary rehabilitation: guided, group programme. : CBT, relaxation, back school education & physical therapy	46	100	72	59
		Individual physiotherapy	47	100	63	61
Kankaanpaa, Finland [70]	Occupational healthcare	Active rehabilitation: guided exercises in a dept + behavioural support	40	34		30
		Passive treatment: which they considered as minor to the active arm, e.g. massage and thermal treatment	39	33		24
Kapitza et al., Germany [71]	General population	Contingent biofeedback	53	67	655	21
		Non-contingent biofeedback (placebo)	54	62	800	21
Karjalainen et al., 2003 & 2004, Finlands [72, 73]	General practice	Mini-intervention (Specific back exercises, reduce patient concerns & encourage physical activity)	44	59		56
		Mini-intervention & worksite visit	44	57		51
		Usual GP care	43	60		57
Kennedy et al., UK [74]	Primary care	Acupuncture + back book	47	46		24
		Sham acupuncture + back book	45	58		24
Kerr et al., UK [75]	General practice	Acupuncture	43	50	86	30
		Placebo TENS (non-functioning)	43	65	73	30
Kovacs et al., Spain [76]	Nursing home consulters	Back book education	80	66		233
		Back guide education	81	63		199
		Pamphlet with cardiovascular health advice	80	64		241
Kuukkanen et al., Finland [77]	Occupational healthcare	Intensive training: intensive progressive exercises guided at the gym + home exercises		62		29
		Home exercise only: same as intensive, but unguided		48		29
		Control: usual activities, no trial exercises		54		28
Leclaire et al., Canada [78]	Private physiatrist clinic	Standard care (rest, analgesics, physio) & Swedish back school	32	43		82
Leclaire et al., Canada [78]	Private physiatrist clinic	Standard care (rest, analgesics, physio)	32	41		86
Lindstrom et al., Sweden [79]	Occupational healthcare	Swedish back school & workplace visit + graded exercise (CBT approach)		24		51
		Usual care: rest& analgesics & physical treatment		38		52
Linton et al., Sweden [80]	General practice + general population	Back pain pamphlet	45	71		70
		Comprehensive information package	44	74		66
		CBT intervention	44	70		107
Luijsterburg et al., Netherlands [81]	Primary care	Physical therpay + GP care	42	57		67
		Usual GP care	43	40		68
Machado et al., Brazil [82]	Physiotherapy	Psychotherapy	45	81	356	16
		Exercise	42	59	206	17
Mannion et al., 1999 & 2001, Finland [83, 84]	General population	Modern active individual physiotherapy: strengthening, coordination and aerobics exercises, instructions on ergonomic principles + home exercises	46	61	520	46
		Muscle reconditioning on training devices (small groups)	45	54	504	47
		Low impact aerobic/stretching (groups)	44	55	676	44
Maul et al., Switzerland [85]	Occupational healthcare	Back school & exercise	38			97
		Back school	39			86
Mehling et al., USA [86]	General practice	Breath therapy	50	70	51	16
		Physical therapy: soft tissue mobilisation, joint mobilisation and exercises	49	58	57	12
Moseley L, Australia [87]	Physiotherapy + General practice	Physiotherapy	43	64		29
		Usual GP care	38	54		28
Niemisto et al., 2003 & 2005, Finland [88, 89]	General population	Manipulation, exercise & physician consultation	37	55	312	102
		Physician consultation only	37	53	312	102
Nordeman et al., Sweden [90]	General practice + physical therapy dept	Early access to physio (Individualised, exercise, advice, group education)	39	63		32
		Waiting list control	41	50		28
Paatelma et al., Finland [91]	Occupational clinic	Orthopaedic manual therapy	44	42		45
		McKenzie technique	44	29		52
		Advice only	44	35		37
Peloso et al., USA [92]	Outpatients	Tramadol & Acetamenophen combination tablets 375/325 2 PRN	58	64		167
		Placebo tablets 2 PRN	58	61		169
Rantonen et al., Finland [93]	Occupational clinic	Physical therapy	44	35	676	43
		Exercise	45	28	520	43
		Back book education	44	32	728	40
Rasmussen-Barr et al., Sweden [94]	Physiotherapy	Graded exercises	37	50	468	36
		Advice and walking	40	50	572	35
Rasmussen-Barr et al., Sweden [95]	Physiotherapy	Stabilizing training (Individual) (Cognitive + stabilisation of spinal muscles)	39	70		24
Rasmussen-Barr et al., Sweden [95]	Physiotherapy	Manual treatment (Individual) (Other muscles exercises, no manipulation)	37	78		23
Rittweger et al., Germany [96]	General population	Isodynamic lumbar extension	50	44	603	30
Rittweger et al., Germany [96]	General population	Vibration exercise (On a machine with a vibrating platform)	54	52	754	30
Ritvanen et al., Finland [97]	General population	Traditional chiropractic bone setting	41	45		33
		Physical therapy	42	43		28
Rossignol et al., Canada [98]	Workers compensation board	Coordination of primary healthcare program	37	33		54
Rossignol et al., Canada [98]	Workers compensation board	Usual GP care	38	23		56
Sahin et al., Turkey [99]	Physical therapy clinics	Back school	47	75	30	75
		Physical therapy	51	78	32	75
Soukup et al., Norway [100]	General practice + general population + referrals	Mensediesk exercise group intervention	40	53	676	34
		Waiting list group	40	49	578	35
Staal et al., & Hlobil et al., Netherlands [101, 102]	Occupational healthcare	Graded activity (Physiotherapy + OT)	39	5	9	67
		Usual OT care	37	8	8	67
Torstensen et al., Norway [103]	Social security offices	Medical exercise therapy (MET)	42	52		71
		Conventional physiotherapy (CP)	43	48		67
		Self exercise	40	51		70
Tsui et al., Hong Kong [104]	Physiotherapy	Electro-acupuncture & back exercise	40	76	39	14
		Electrical heat acupuncture + back exercise	39	71	54	14
		Back exercise only	41	62	50	14
Turner et al., USA [105]	General practice + physicians + general population	Relaxation training (group)				24
		Cognitive therapy (group)				23
		Cognitive therapy & Relaxation training (group)				25
		Waiting list control				30
Unsgaard-Tondel et al., Norway [106]	Primary care	Low load exercise	41	81	312	36
		High load sling exercise	43	64	468	36
		General exercise	36	65	312	37
van der Roer et al., Netherlands [107]	Physiotherapy	Intensive protocol training	42	55	54	60
		Guidelines based physiotherapy	42	48	47	54
Wand et al., UK [108]	General practice + A/E patients	Assess & Advice & Physiotherapy	34	44		43
		Assess & Advice & wait	35	55		51
Werners et al., Germany [109]	General practice	Interferential therapy: electrotherapy, to stimulate muscles fibres	38	43		68
		Motorised lumbar traction & massage	39	49		72
Yelland et al., Australia [110]	General practice	Glucose lignocaine injection	52	59	770	28
		Exercise (Alternating: flexion and extension of spine and hips)	49	55	718	26
		Saline injection	50	56	759	27
		Normal activity	51	58	733	29

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