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Table 3 Exclusion themes and subthemes

From: Inclusion and exclusion criteria used in non-specific low back pain trials: a review of randomised controlled trials published between 2006 and 2012

Themes

Subthemes

n (%)

1

Back-related condition

Spondylolisthesis

35 (21)

Spinal stenosis

31 (18)

Spondylolysis

13 (8)

Ankylosing spondylitisa

8 (5)

Structural deformity

7 (4)

Osteoporotic fracture

6 (4)

Congenital deformation

6 (4)

Disc disease

3 (2)

Sacroiliitis

3 (2)

Severe structural deformity

3 (2)

Scoliosis

2 (1)

Active structural deficit

2 (1)

Severe postural abnormality

2 (1)

2

Specified, unspecified, implied systemic, rheumatologic or immunologic conditions

Inflammatory disease

37 (22)

Osteoporosis

27 (16)

Rheumatological disease

13 (8)

Rheumatoid arthritis

12 (7)

Fibromyalgia

9 (5)

Autoimmune disease

4 (2)

Reactive arthritisb

2 (1)

Bone disease

2 (1)

Osteoarthritis

2 (1)

Inflammatory arthritis

1 (1)

Arthritis

1 (1)

Systemic Lupus Erythematosus

1 (1)

Myofascial pain syndrome

1 (1)

Articular impairment

1 (1)

3

Psychological

Psychiatric disorders

35 (21)

Depression

11 (6)

Severe psychiatric disorder

8 (5)

Impaired cognition

7 (4)

4

Other systemic, unspecified

Systemic disease

15 (9)

Metabolic disease

10 (6)

Visceral disease

9 (5)

Endocrine disorder

2 (1)

Uterine disease

1 (1)

Thyroid dysfunction

1 (1)

5

Trauma

 

63 (37)

6

Malignancy

 

78 (46)

7

Infectious

Infection

42 (25)

Infectious spondylopathy

5 (3)

Infectious disease

4 (2)

Previous infection

1 (1)

Abscess

1 (1)

8

Cardiovascular

Cardiac disease /insufficiency

32 (19)

Vascular disease /insufficiency

13 (8)

Hypertension

6 (4)

Ischemic heart attack

2 (1)

Claudication

2 (1)

Aortic aneurysm

1 (1)

9

Haematological

Bleeding disorders

5 (3)

Blood coagulation disorder

2 (1)

10

Respiratory

Respiratory disease /insufficiency

14 (8)

11

Gastrointestinal, liver or renal

Severe renal or hepatic disorder

5 (3)

Liver disease

2 (1)

Gastrointestinal disease

2 (1)

Abdominal hernia

2 (1)

Gastritis

1 (1)

Gastric ulcer

1 (1)

Crohn’s disease

1 (1)

Inguinal hernia

1 (1)

12

Neurological, systemic

Myelopathy

2 (1)

Epilepsy

2 (1)

Seizure disorders

1 (1)

Muscular disease

1 (1)

Muscular dystrophy

1 (1)

13

General indications of spinal pathology

Pathology or disease “such as” / “e.g”

22 (13)

Specific cause “such as” / “e.g”

22 (13)

Red flags indicating serious spinal pathology

21 (12)

Specific cause identified

14 (8)

Known or suspected serious pathology

10 (6)

Non-mechanical low back pain

1 (1)

14

Neurological related to the back (symptoms or signs or specific conditions referable to involvement of the spinal cord or nerve roots)

Nerve root compromise

44 (26)

Neurological signs

34 (20)

Disc herniation

30 (18)

Sciatica

17 (10)

Radicular symptoms

16 (9)

Signs of nerve root irritation

15 (9)

Cauda equina syndrome

14 (8)

Radiation below knee

13 (8)

Radiculopathy

10 (6)

Progressive neurological signs

4 (2)

Radicular pain

4 (2)

Widespread neurological signs

3 (2)

Leg symptoms

3 (2)

Spondylolisthesis with radiculopathy

1 (1)

Cord compression

1 (1)

Paralysis

1 (1)

15

Previous or scheduled surgery

 

84 (50)

16

Pregnancy-related

Pregnancy

81 (48)

Pre-eclampsia

1 (1)

17

Medico-legal issues

 

39 (23)

18

Comorbidities

Comorbidities

2 (1)

Urine or faecal incontinence

1 (1)

19

Exclusion for feasibility

Not understanding language

28 (17)

Other current treatment

18 (11)

Previous specific treatment

17 (10)

Medication

13 (8)

Contraindications for intervention

8 (5)

Cardiac pacemaker

6 (4)

Current alcohol abuse

3 (2)

Unable to commit to home-exercises

3 (2)

Fever on the day of examination

3 (2)

History of psychosis

2 (1)

History of alcohol abuse

2 (1)

Presence of yellow flags

1 (1)

20

Miscellaneous

Obesity

 

 Body Mass Index ≥30

4 (2)

 Body Mass Index ≥40

3 (2)

 Obesity (not specified)

2 (1)

 Body Mass Index ≥35

1 (1)

 Body Mass Index ≥28

1 (1)

Menstruation

1 (1)

Unable to sit on a stationary bike

1 (1)

Bad balance between trunk flexors and extensors

1 (1)

Inability to walk at least 100 m without interruption

1 (1)

Neurologic impairment

1 (1)

Behaviour precluding participation in group therapy

1 (1)

Evidence of distress

1 (1)

Patients unable to accurately locate the area of pain

1 (1)

Patient unable to walk without a walking aid

1 (1)

Suspected non-compliance

1 (1)

21

Patient-reported outcome measures with score thresholds for exclusion

Visual Analogue Scale (0 to 100)c

 

 ≥ 60 mm

2 (1)

 ≥ 80 mm

2 (1)

Beck Depression Inventory (0 to 63)

 

 ≥ 20 points

1 (1)

 ≥ 29 points

1 (1)

Bothersomeness scale (0 to 10)

 

 ≤ 3 points

1 (1)

Numeric Rating Scale (0 to 10)

 

 ≥ 80 points

1 (1)

  1. aBechterew is an eponymous term for ankylosing spondylitis, and was reported in two trials; bTwo trials used a banned eponymous term to refer to reactive arthritis. cVisual Analogue Scale transformed to mm