The Neck Disability Index: State-of-the-Art, 1991-2008

STATE-OF-THE-ART PAPERS THE NECK DISABILITY INDEX: STATE-OF-THE-ART, 1991-2008 Howard Vernon, DC, PhD

ABSTRACT Background: Published in 1991, the Neck Disability Index (NDI) was the first instrument designed to assess self-rated disability in patients with neck pain. This article reviews the history of the NDI and the current state of the research into its psychometric properties—reliability, validity, and responsiveness—as well as its translations. Focused reviews are presented into its use in studies of the prognosis of whiplash-injured patients as well as its use in clinical trials of conservative therapies for neck pain. Special Features: The NDI is a relatively short, paper-pencil instrument that is easy to apply in both clinical and research settings. It has strong psychometric characteristics and has proven to be highly responsive in clinical trials. As of late 2007, it has been used in approximately 300 publications; it has been translated into 22 languages, and it is endorsed for use by a number of clinical guidelines. Summary: The NDI is the most widely used and most strongly validated instrument for assessing self-rated disability in patients with neck pain. It has been used effectively in both clinical and research settings in the treatment of this very common problem. (J Manipulative Physiol Ther 2008;31:491-502) Key Indexing Terms: Neck Pain; Treatment Outcome; Reliability and Validity; Outcome Assessment (Health Care); Spine; Cervical Vertebrae

HISTORY

OF THE

NECK DISABILITY INDEX

Before 1991, no instrument was available to assess the self-rated disability of patients with neck pain. In the previous decade, a few of such instruments for patients with low back pain had been developed, chiefly, the Oswestry Low Back Pain Index (OI)1 and the Roland-Morris Low Back Pain Questionnaire.2 Recognizing the deficiency with respect to neck pain, Vernon undertook to develop a similar instrument suitable for patients with neck pain. It was decided to model this instrument on the OI, so permission from its primary author, J. Fairbanks, was obtained for that purpose. Most of the items in the OI could be regarded as specific “activities of daily living.” The inclusion of this type of item distinguished the OI and similar instruments from the simpler measures of pain severity, location, or duration that were more commonly used at that time. The first phase in the development of the new instrument, later deemed the Neck Disability Index (NDI), consisted of

Professor, Canadian Memorial Chiropractic College, 6100 Leslie St., Toronto, Ontario, Canada. Submit requests for reprints to: Howard Vernon, DC, PhD, Canadian Memorial Chiropractic College, 6100 Leslie St., Toronto, Ontario, Canada M2H 3J1 (e-mail: [email protected]). Paper submitted March 27, 2008. 0161-4754/$34.00 Copyright © 2008 by National University of Health Sciences. doi:10.1016/j.jmpt.2008.08.006

item selection. First, items from the OI were reviewed for appropriateness and retained if deemed applicable to patients with neck pain. Six items were initially thought to be suitable: ‘pain intensity,’ ‘personal care,’ ‘lifting,’ ‘sleep,’ ‘driving,’ and ‘sex life.’ Descriptive studies on patients with neck pain experiencing chronic pain were reviewed to identify additional daily activities or health aspects reported to be importantly affected in these patients. Informal surveys of patients and a small consulting team of health practitioners supplemented this search for items upon which neck pain was considered to have a significant impact. The consulting team then provided consensus ratings that resulted in the addition of 4 new items: ‘headaches,’ ‘concentration,’ ‘reading,’ and ‘work.’ Rating scales for these items were then developed and refined. Drafts were submitted to patients and health practitioners for feedback, resulting in further revisions to the wording of the items. A pilot test was then launched using 5 whiplash-injured patients. This resulted in unanimous rejection of the OI item “sex life,” which was replaced by an item for ‘recreation.’ A final revision involved changes to the wording of 2 of the original OI items: pain intensity and sleep. In the original OI, these items were rated with respect to the “use of tablets” (ie, medication for pain or sleep). This was deemed unsuitable because many subjects might not be taking such medications. The wording of all the detractors in these 2 items was then revised to reflect either intensity, for pain, or duration, for sleep. This final version 491

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Table 1. Systematic review of studies of the psychometric properties of the NDI Author (first author)

NP/WAD

Sample

Knapp [5]

NP

46

Wallace [6]

NP

38

Reliability

Internal consistency

0.91 at 1 d

0.81

Factor analysis

Responsivity

12 wk ES = 1.35 (59% reduction)

Jette [7]

ES = 0.75

Hains [8]

NP

237

Item order has no effect

0.92

1

Westaway [9]

NP

Riddle [10]

NP

146

Stratford [11]

NP

48

Chok [12]

NP

46

0.9

pre-post tx: z = −3.88, P b .001

Ackelman [13]

NP

59

2 d: 0.97 3 wk: 0.95 3 mo: 0.94 Modified NDI at 2 d: 0.97

NDI c/w DRI = 0.95 NDI c/w SF-36 Phys = −0.88 NDI c/w VAS activity = 0.86 NDI c/w VAS pain = 0.60

Wlodyka-Demaille [14]

NP

101

Hoving [15]

WAD

71

c/w NDI and Problem Elucidation Technique = 0.57

Bolton [16]

NP

102

ES = 0.80/0.88 4-6 wk

Wlodyka-Demaille [17]

NP

71

ES = 0.55 SRM = 0.55 c/w GPC = 0.48

Cook [18]

NP

203

Cleland [19]

Cervical radiculopathy

• c/w NDI and clinician's prediction of change = 0.54 • Positive for change • Equivalent to SF-36 Physical and Mental scales for most issues • MDC = 5 • MCIC = 5

0.93 at 1 d

0.92 at 1 d; 0.48 at 7 d

0.93 at 1 d

0.74

2 factors

1

• MDC= 10.2

38

• MCID = 7.0 • Change in stable patients: r = 0.68 Lee [20]

NP, controls

301

0.90

Vos [21]

WAD

187

0.90 at 1 wk

McCarthy [22]

NP

160

0.93 at 1-2 wk

0.92

ES = 1.04; SRM = 1.17 AUC re: GPE = 0.79 Baseline pats vs controls: 32.8 vs 9.1 P b .01 • Responsiveness Ratio = 1.82 • MDC = 1.66

0.86

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Table 1. (continued ) Author (first author)

NP/WAD

Sample

Stewart [23]

WAD

132

Mousavi [24]

NP

30

Pool [25]

NP

183

Trouli [26]

NP

65

Reliability

Internal consistency

Factor analysis

Responsivity • 6 wk: ES = 0.77, • Improved = 0.95, • SRM = 0.91, • Improved = 1.16; • AUC c/w GPE = 0.76

0.90

• c/w SF-36 • c/w pain VAS = 0.71

0.88

• MDC = 10.5 • AUC = 3.5⁎ ⁎ = preferred method 0.93 (0.84;0.97)

0.85

1 factor: EV = 4.48 Var. = 44.8%

• MDC = 1.78 • SEM = 0.64 • c/w GROC = 0.30

NP indicates neck pain; ES, effect size; c/w, correlated with; DRI, Disability Rating Index; tx, treatment; SRM, standardized response mean; GPE, global patient evaluation; pats, patients; GROC, global rating of change; GPC, global perceived change; EV, eigenvalue; Var, variance.

Fig 1. Translations of the NDI available on the MAPI Web site (www.proqolid.com). • English for Australia • English for the United States • English for the UK • Danish • Dutch • Finnish • French • French Canadian • French for Switzerland • German • German for Switzerland • Italian • Italian for Switzerland • Norwegian • Polish • Portuguese • Spanish for Spain • Spanish for the US

was submitted to the pilot group and was unanimously endorsed as relevant and easy to use. Since the original publication in 1991,3 only 1 small change has been made to the original English version, namely, the addition of the qualifier “neck” was added in all places where the sole term “pain” had been present, clarifying that the detractor was concerned with the patient's “neck pain” (items 1, 2, and 3).

SCORING

AND INTERPRETATION

Each item is scored out of 5 for a maximum total score of 50. Care should be taken in reporting the score as either out of 50 or as a percentage out of 100. Most studies have reported the scores out of 50. Several strategies for dealing with missing data or noncompliance with an item have been developed.

When only 1 item is missing, some authors have scored the NDI out of 45 and converted the score to a percentage. When several items are missing, some authors have used the mean value of the scored items and inserted this into the missing items. If 3 or more items are missing, the overall score may be suspect and, especially in research studies, may be invalid. The scoring interpretation for the NDI is slightly different than for the OI, as follows: 0-4 = none; 5-14 = mild; 15-24 = moderate; 25-34 = severe; over 34 = complete. These 5 categories have been revised by several authors in subsequent studies, especially in the effort to determine a dichotomous cutoff for “disabled” vs “not disabled” or “recovered” vs “not recovered” (see below).

THE ORIGINAL 1991 REPORT The original study reported on test-retest reliability over a 2-day period, obtaining a value of 0.89 (P b .05). Internal consistency was measured using Cronbach α, with a total index value of .80. The highest scoring items (average out of 5) were the following: headaches = 2.6; lifting = 2.2; recreation = 2.2; reading = 2.1; and driving = 2.0. The total index scores of the study sample were normally distributed, as follows: 0 to 4 (none) = 2%; 5 to 14 (mild) = 35%; 15 to 24 (moderate) = 48%; 25 to 34 (severe) = 15%; and greater than 35 (complete) = none. The convergent validity was assessed by comparing the NDI scores to the scores of the McGill Pain Questionnaire (MPQ)4: NDI/MPQ total score = 0.70; NDI/MPQ-number of words = 0.69. The responsiveness of the NDI was assessed by comparing, in a small group of patients who have whiplash undergoing chiropractic treatment, the change in NDI scores over 3 weeks to a Visual Analogue Scale (VAS) for “pain improvement” at 3 weeks. These scores were moderately strongly correlated (0.60). The average change in NDI score was 33.2%; the average VAS improvement score was 56%.

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Table 2. Studies of prognosis in WAD using the NDI Author (first author)

Sample size

Baseline NDI

Follow-up time(s)

Results

Atherton [39]

480

N/A

1, 3, and 12 mo

1. NDI N 19 was 1 of only 5 factors in a multivariate model predicting persistent pain 2. Relative risk ratios NDI 0-14 = 1.0 15-22 = 1.6 (0.99-2.5) N22 = 2.8 (1.8-4.2)

Sterling [40]

65

6 mo = 17.67 (16.5) 24-36 mo = 15 (14.1)

2-3 y

1. NDI N 30 c/w: Hi autonomic measures Hi TSK Hi GHQ-28 - hi IES 2. Odds ratio for persistent pain at 2-3 y NDI N 30 = 1.0-1.1 (ss) 3. Predictive model of Initial NDI score Age Cold pain threshold IES score explained 56% of variability of follow-up NDI scores For moderate/severe group (at follow-up) this model had an 84.6% accuracy 4. Low initial NDI significantly predicted likelihood of recovery (only variable) 5. NDI is a better predictor of outcome than pain score alone

Crouch [41]

170

N/A

4-6 wk

1. At 4 wk (according to NDI score) No disability = 37% Mild disability = 37.6% Moderate = 21.2% Severe = 4.1% 2. Variables correlated to NDI score Seatbelt use = 0.038 x-ray obtained = 0.004 Midline tenderness = 0.008 Saw a GP = 0.001

Sterling [42]

76

34.15 (2.4)

6 mo

1. Significant corr. with NDI at follow-up High initial NDI Cold hyperalgesia Older age Acute stress

Bunketorp [43]

WAD =108 CON = 931

N/A

17 years

1. Persistent neck pain @ 17 yrs: WAD = 55% CON = 29%, P = .001 NDI scores at 17 y: WAD = 22 (21.7) CON = 10.6 (15.2), P = .001

Lankester [44]

277

N/A

9 mo-5 y

1. NDI score corr. with: GHQ = 0.58 (P b .01) Gargan/Bannister Scale = 0.72 (P b .01)

Joslin [45]

85

Sterling (from 2003 paper) [46]

76

1. NDI score is corr. with litigation status (P = .000) 6 mo

1. NDI score corr. with recovery categories: a. Recovered = b8 b. Mild disab. = 10-28 c. Mod/severe = N30

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Table 2. (continued ) Author (first author)

Sample size

Baseline NDI

Follow-up time(s)

Results

Nederhand [47]

82

24.4 (7.1)

24 wk

1. NDI scores at 24 wk: a. Recovered = 14.2 (4.6-25.4) b. Persistent pain = 27.9 (15.4-40). P b .000 2. Cutoff for recovery = b15 3. Initial NDI score predicted recovery status at 53% 4. Addition of TSK score predicted a further 29% = 83.3%

Miettinen [48]

144

3 years

1. Recovery cutoff = 20 2. Univariate OR for NDI N20 to predict non-recovery = 7.4 (P b .05) 3. Multivariate analysis = only NDI score signif. (P b .05) predicted poor outcome: OR = 11.2

Sterling [49]

76

6 mo

1. NDI scores used to create recovery categories: a. Recovered = 38% b. Mild disab. = 39% c. Mod/Severe = 23% 2. At 1 mo, all groups had signs of hypersensitivity. At 6 mo., only Mod/severe group showed these signs. So: Hi NDI scores c/w persisting hypersensitivity

Sterling [50]

66

3 mo

1. NDI scores used to create recovery categories: a. Recovered = 38% b. Mild disab. = 33% c. Mod/Severe = 29% 2. At 1 mo, all groups had signs of hi EMG, lo JPE. At 3 mo., only Mod/severe group showed So: Hi NDI scores c/w persisting motor dysfunction

Bunketorp [51]

108

17 y

1. Recovered vs persisting pain NDI: 8.5 (16) vs 32 (20), P = .000 2. NDI scores c/w radiating arm pain: r = 0.61

Moog [52]

43

6 mo

NDI score NOT c/w: litigation status presence of vibration-induced pain

22.4

N/A indicates not applicable; c/w, correlated with; TSK, Tampa Scale for Kinesiophobia; GHQ-28, Global Health Questionnaire-28; IES, Impact of Events Scale; ss, statistically significant; disab., disability; GP, general practitioner; corr., correlation; CON, control patient; Mod., moderate; OR, odds ratio; JPE, joint position error; EMG, electromyography.

METHODS The search strategy for the current report for articles using or referring to the NDI was conducted as a citation search of the 1991 publication using Science Citation Index, through the Scholar's Portal Web of Science. Articles were retrieved from 1991 to December 2007. Articles were reviewed to insure that the instrument used in assessing the self-rating of disability by patients with neck pain was actually the NDI. This resulted in 287 qualified citations. These articles were then classified according to the following categories: psychometric studies, diagnosis, prognosis, treatment designs (clinical trials, case series, and case studies), treatment type (surgical, conservative, injections), patients with whiplash, patients experiencing chronic pain, translation studies, and systematic reviews/ practice guidelines. Various subsets of articles on specific topics have been reviewed systematically by conducting quality reviews (see

Table 3. Cutoff or category values for the NDI Study

Findings

Atherton et al [39], 2006

• NDI N 18: 1 of only 5 factors in a multivariate model predicting persistent pain at 1 and 3 and 12 mo. • relative risk ( RR) for persisting pain: ▪ 0-14 = 1.0 ▪ 15-22 = 1.6 (0.99;2.5) ▪ N22 = 2.8 (1.8;4.2)

Sterling et al • Established recovery categories: [40], 2003-2005 ▪ Recovered = b4 ▪ Mild disability = 5-14 ▪ Moderate/Severe disability = N15 Nederhand et al [47], 2004

At 24 wk, cutoff value of 15 (0-14 vs 15N) strongly correlates with outcome

Miettinen et al [48], 2004

At 24 wk cutoff value of 20 strongly correlates with outcome

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Table 4. RCTs of manipulation + NDI (high quality) Author (first name/group) n

QS Tx

Age % M % F T1

SD

T2

SD

ch

ES

T3

Bronfort-A [56] Bronfort-B [56] Evans-A [57] Evans-B [57] Giles-A [58] Hurwitz-A [59,60] Hurwitz-A [59,60] Cleland-A [61] Cleland-B [61] Muller-A [62] Giles-B [63]

89 89 89 89 84 74 71 68 68 58 58

45 44.3 45 44.3 39 46 46 36 35 39 42.5

8.5 10.3 8.4 10.2 16, 42 6.2 6.2 11.9 14.2 18, 44

18.6 20.2 15.5 19.5 17

9.2 11.5 10.5 12.9 0, 36

7.8 7.6 10.8 8.4 9.0 10.0

0.89 0.70 1.4 0.72

14.1 8.7 12.3 1.43 15.8 12.3 12.0 1.06 15.6 11.8 10.7 1.06 20.5 13.5 7.4 0.65

20 22

8, 40 8.0 18, 28 10.0

64 64 64 64 35 171 171 19 17 23 20

SMT + low tech exer SMT + sham elec SMT + rehab exer SMT + sham elec SMT SMT ± heat SMT ± elec SMT (thor) SMT (sham thor) SMT SMT

41 42 41 42 51 32 32 26 26 48 53

59 58 59 58 49 68 68 74 74 52 47

26.4 27.8 26.3 27.9 26 13.1 13.1 28.4 33.6 28 32

SD

ch

ES

QS indicates quality score; Tx, treatment; M, male; F, female; T1, T2, T3, mean scores at times 1, 2, and 3; ch, change scores; ES, effect size; SMT, spinal manipulative therapy; tech, technical; exer, exercise; elec, electrical therapy; thor, thoracic spine.

Table 5. RCTs of manipulation + NDI (low quality) Author (first name)

n

QS

Tx

Age

M

F

1

SD

2

SD

ch

ES

3

SD

Cilliers-A [64] Cilliers-B [64] Parkin-Smith -A [65] Parkin-Smith-B [65] Van Schalwyk-A [66] Van Schalkwyk -B [66] Wood -A [67] Wood-B [67]

15 15 13 17 15 15 15 15

50 50 47 47 50 50 50 50

SMT (super. seg) SMT (both segs) SMT (cerv) SMT (cerv and thor) SMT (ipsil.) SMT (cont.) SMT (instr.) SMT

33 29.3 33.8 37 33.1 27.7

53 27 54 71 80 53 33 40

47 73 46 29 20 47 67 60

18.2 17.6 22.5 16.4 31.8 26.8

9.7 8.2 8.1 15.9 14.1 13.3

6.9 4.7 6 6.13 13.5 11.0

8.1 5.7 5.7 18.4 11.0 9.8

11.4 12.9 16.5 10.3 18.3 15.8

6.0 6.13

6.8 8

16.5 10.3

ch

ES

QS indicates quality score; Tx, treatment; M, male; F, female; T1, T2, T3, mean scores at times 1, 2, and 3; ch, change scores; ES, effect size; super. seg., superior segment; segs, segments; cerv, cervical; ipsil., ipsilateral; cont., contralateral; instr., instrumented manipulation; thor, thoracic spine; SMT, spinal manipulative therapy.

below for details for each category) and then extracting the relevant data, summarizing these into evidence tables.

DISCUSSION Psychometric Properties Since 1991, 22 additional publications have reported on the psychometric properties of the NDI.5-26 Eight of these were published before 20025-12 and most of these were included in the only systematic review to date.27 In that review, it was acknowledged that (1) the NDI was the most widely used of the several scales for self-rating disability in patients with neck pain, which had been developed since 1991, and (2) the NDI was the most well-validated of these instruments. Table 1 displays the results of 21 studies with original data on the psychometric properties of the NDI up to 2007. With regard to reliability, 8 studies in addition to the original paper have reported test-retest correlations between 0.90 and 0.93.5,12,14,18,20,21,22,24,26 Hains et al8 reported that item order did not affect the responses. The internal consistency has been reported in 7 additional studies, with Cronbach α values ranging from .74 to .93.5,14,18,20,22,24,26 Four studies have calculated the factor structure of the NDI,8,14,18,26 with 3 agreeing that only 1 factor—physical disability—is present. The reliability, internal consistency, and factor structure of the NDI are now considered to be well described in the literature and to be of very high quality.

With regard to responsiveness, the minimum detectable change (MDC) reported in 2 studies of patients with neck pain is less than 2 points (out of 50, b4%),21,26 although Pool et al25 reported an MDC of 10.4 points. Cleland et al19 reported on a small sample of patients with cervical radiculopathy finding a much larger MDC; however, because the NDI was not specifically designed for use in this clinical group, these findings do not reflect on the NDI in usual use. The minimum clinically important difference or change (MCID/C) has been reported in 3 studies.11,19,25 Stratford et al11 determined an MDC and MCIC of 5 (5/ 50) points by comparing NDI change scores with a physician-rated change scale. Cleland et al19 reported an MCID of 10 points in the small sample of radiculopathy patients. This clinical problem is generally more refractive to treatment, so a larger MCID is not surprising. Pool et al's25 value of the area under the curve (AUC) comparing NDI change vs global perceived change was 3.5 points. This was deemed by these authors to be the more appropriate value for MCIC. Effect sizes, standardized response means and responsiveness ratios have been reported by 7 studies, with the findings ranging from 0.80 to 1.82, all of which are large by usual standards.28 These studies report on variable treatments over variable times and doses. The data on treatment studies reviewed below is more precise for the effect sizes for different treatment approaches.

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Table 6. RCTs of exercise + NDI Author (first name)

n

QS

Tx

Age

M

F

1

SD

2

SD

Ch

ES

3

SD

ch

ES

Bronfort-A [56] Evans-B [57] Hoving-B [68] Kjellman-A [69] Kjellman-B [69] Ylinen-B [70] Ylinen-C [70] Hoving-B [71] Nikander-A [72] Nikander-B [72] Ylinen-A [73] Kietrys-A [74] Ylinen-A [75] Ylinen-B [75]

63 63 59 20 25 59 60 59 60 58 59 72 57 59

89 89 84 68 68 82 82 89 82 82 82 61 84 84

Hi Int MedX Hi Int MedX Active exer Active exer McKen Endur Streng Active exer Streng Endur Streng Active exer Endur Streng

43.6 43.6 45.9 46.8 45.4 46 45 45.9 45 45 46 41.2 46 45

40 40 30 20 28 0 0 30 0 0 0 22 0 0

60 60 70 80 72 100 100 70 100 100 100 78 100 100

26.7 26.4 13.9 16.5 15 22 21 13.9 17.5 19 22 5.1 20 22

10.4 10.2 6.8 8 6 16, 28 16, 26 6.8 6.5 7 16, 30 4.4 16, 28 16, 26

17.1 15 7.9 10.5 8 14 12 7.5

10.3 11.6 7.9 8 6 11, 16 10, 14 7.2

9.6 11.4 6 6 7 8 9 6.4

0.93 1.05 0.81 0.75 1.17

12.4 16.6

9.9 12.4

14.3 9.8

1.42 0.87

8.5 7.5

8.5 6

8 7.5

0.98 1.25

0.91

7.4

5.9

6.5

1.02

19 4.6 14 14

17, 22 3.6 6, 20 6,20

13

10, 16

9

14 12

6, 20 4, 22

6 10

3 .52 6 8

0.13

QS indicates quality score; Tx, treatment; M, male; F, female; T1, T2, T3, mean scores at times 1, 2, and 3; ch, change scores; ES, effect size; Hi, high; int, intensity; MedX, brand of exercise equipment; exer, exercise; McKen, McKenzie protocol; endur, endurance; streng, strength.

Table 7. RCTs of mobilization + NDI Author (first name)

n

QS

Tx

Age

M

F

1

SD

2

SD

Hoving-A [68] Hurwitz-B [60] Korthals de Bos-A [76] Hurwitz-B [59] Hoving-A [71]

60 165 60 165 60

84 71 79 74 89

Mobs Mobs w/w.o heat Mobs Mobs w/w.o elec Mobs

44.6 46 44.6 46 44.6

43 30 43 30 43

57 70 57 70 57

13.6 13.3

7 6.3

5.8

5.8

13.3 13.6

6.3 7

ch

7.5 6.4

ES

3

SD

ch

6.4

6.1

7.2

ES

7.2

6.9

QS indicates quality score; Tx, treatment; M, male; F, female; T1, T2, T3, mean scores at times 1, 2, and 3; ch, change scores; ES, effect size; mobs, mobilization; w/w.o, with or without; elec, electrical therapy.

Table 8. RCTs of physiotherapy + NDI Author (first name)

n

QS

Tx

Age

M

F

1

SD

2

SD

ch

Korthals de Bos-B [76] Gustavsson-B [77]

59 16

79 71

Physio Physio (indiv)

45.9 36

30 6

70 94

14

10, 24

14.5

8 8, 20

6.3 −0.5

ES

3

SD

ch

14

6.8, 23

0

ES

QS indicates quality score; Tx, treatment; M, male; F, female; T1, T2, T3, mean scores at times 1, 2, and 3; ch, change scores; ES, effect size; physio, physiotherapy; indiv, indivualized.

The NDI change scores correlate well with measures of global change, with r values ranging from 0.30 to 0.76.9,20,23,26 Finally, the NDI has been employed in numerous studies of other instruments designed to evaluate patients with neck pain. In the following list, the NDI was used as one of the primary measures for determining the construct validity of these new instruments. As all of these studies reported acceptably high correlation coefficients, these studies provide evidence for the convergent validity of the NDI with other instruments whose purpose is more or less equivalent (the reference cited is the first one to use the NDI for comparison): • The Copenhagen Neck Functional Disability Scale (Jordan et al29) • The Patient-Specific Scale (Neck) (Riddle and Stratford10) • The Neck Pain and Disability Scale (Wheeler et al30) • The Functional Rating Index (Feise et al31) • The Aberdeen Back Scale (Neck) (Williams et al32)

• The Cervical Spine Outcomes Questionnaire (BenDebba et al33) • The Bournemouth Questionnaire—Neck (Bolton et al34) • The Whiplash-Specific Disability measure (Pinfold et al35) • The Core Outcomes for Neck Pain (White et al36) • The Whiplash Disability Questionnaire (Willis et al37) • The NHANES-ADL (neck) (Cook et al38)

Translations As of late 2007, there were 6 published translations of the NDI into French,14 Dutch,15 Swedish,13 Korean,20 Brazilian Portuguese,18 and Iranian.24 In addition to these published translations, the author has worked with the MAPI Company of France to produce the numerous translations (Fig 1) that are available at the MAPI website (www.proqolid.com). All of the MAPI translations were conducted using standardized methodologies of linguistic validation, including forward and backward translations by linguistic experts, pilot testing

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Table 9. RCTs of acupuncture + NDI Author (first name)

N

QS

Tx

Age

M

F

1

SD

2

SD

ch

ES

Zhu-A [78] Giles-B [58] White-A [79] Muller-B [62]

14 34 70 20

80 84 89 89

Acup + Wash + Sham Acup Acup Acup

50 37.5 53.9 38

64 56 34 55

36 44 66 45

10.2 18 16.8 18

4.7 10, 25 6.34 11, 25

6 14 11.8 12

4.5 7, 21 6.59 0, 16

4.2 8 5.06 12

0.91 0.79

3

SD

ch

ES

6.1

4.8

4.1

0.85

10.9

6.27

5.82

0.92

QS indicates quality score; Tx, treatment; M, male; F, female; T1, T2, T3, mean scores at times 1, 2, and 3; ch, change scores; ES, effect size; Acup, acupuncture; wash, washout period.

Table 10. RCTs of medication + NDI Author (first name)

n

QS

Tx

Age

M

F

1

SD

2

SD

ch

Hoving-C [68] Giles-C [58] Korthals de Bos-C [76] Muller-C [62] Hoving-C [71]

64 40 64 19 64

84 84 79 89 89

Meds + adv Meds Meds + adv Meds Meds + adv

45.9 39 45.9 39 45.9

44 58 28 58 44

56 42 72 42 56

15.9 23

7.1 16, 27

10 21

21 15.9

6, 25 7.1

18 9.4

7.2 10, 25 7.4 8,25 8.8

5.6 5 8.5 3 6.5

ES

3

SD

ch

ES

QS, quality score; Tx, treatment; M, male; F, female; T1, T2, T3, mean scores at times 1, 2, and 3; ch, change scores; ES, effect size; meds, medication; adv, advice.

Table 11. RCT of cervical pillow + NDI Author (first name) Erfanian-A [80]

n 14

QS 55

Tx Pillow

Age 34.1

M 14

F 86

1 14.2

SD 7.8

2 14

SD 7.1

ch 0.18

ES

3 11.9

SD 5.5

ch 3.1

ES

QS indicates quality score; Tx, treatment; M, male; F, female; T1, T2, T3, mean scores at times 1, 2, and 3; ch, change scores; ES, effect size.

with clinicians and nonexperts in multiple iterations, final confirmation by the original author, and standard formatting and proof-reading. No separate psychometric studies were conducted by the MAPI group on any of these translations. Overlap exists between the separate French and Dutch studies14,15 which did conduct psychometric testing in their respective languages. As of December 2007, 2 other translations involving the author are in preparation: Greek26 and Gujarati (personal communication, Sabapathy, 2007).

orders. Leigh et al, 2004. British Columbia Physiotherapy Association http://www.bcphysio.org/pdfs/wad.pdf 5. Clinical Practice Guidelines for Physical Therapy in Patients with Whiplash-Associated Disorders. Bekkering et al, 2003, Royal Dutch Society for Physical Therapists. http://www.ifomt.org/pdf/Guidelines/WhiplashGln.pdf

Whiplash-Associated Disorder: Prognosis Studies Using the NDI Clinical Guidelines The NDI is explicitly endorsed as the instrument of choice in the following guidelines for the treatment of whiplashassociated disorder (WAD): 1. NHS Library: - Clinical Knowledge Summaries - Prodigy Guidelines http://www.cks.library.nhs.uk/neck_pain 2. Transport Accident Commission, Victoria State, Australia http://www.tac.vic.gov.au/jsp/corporate/homepage/ home.jsp 3. New South Wales Motor Accidents Authority, Guidelines for the Management of Acute Whiplash-Associated Disorders, 2nd Edition, 2007. https://www.cebp.nl/media/m393.pdf 4. Clinical Practice Guidelines for the Physiotherapy treatment of Patients with Whiplash-Associated Dis-

There have been 41 studies involving patients with WAD that have used the NDI. Seventeen of these involved the prognosis of patients with whiplash, 14 of which reported original data.39-52 These studies were rated according to Sackett et al.53 Studies rated in categories 3-5/5 were excluded. The quality of these studies ranged from 2b-2c according to the classification by Sackett et al (all were acceptable for inclusion). Data retrieval included numbers of subjects, baseline NDI scores, follow-up NDI scores, prognostic indicators, and where applicable, correlation scores between NDI and other variables. The groups within these reports were classified according to categories by Cote et al,54 as follows: source of data—emergency department (n = 11), general practice (3), insurance database (2), population study (1); study design—univariate (9), multivariate (7), or explanatory (modeling) (1). The median follow-up time in these studies was 6 months (1-204 months) (Table 2). The mean (SD) sample

Journal of Manipulative and Physiological Therapeutics Volume 31, Number 7

Vernon The Neck Disability Index

Table 12. RCT of laser + NDI Author (first name)

n

QS

Tx

Age

M

F

1

SD

2

SD

ch

Dundar-A [81]

32

29

Low-level laser

40.8

16

84

14.7

6.1

9.4

5.5

5.3

ES

3

SD

ch

ES

QS indicates quality score; Tx, treatment; M, male; F, female; T1, T2, T3, mean scores at times 1, 2, and 3; ch, change scores; ES, effect size.

Table 13. RCT of relaxation therapy + NDI Author (first name)

n

QS

Tx

Age

M

F

1

SD

2

SD

ch

Gustavsson-A [77]

13

71

Relaxation

43

0

100

17

9, 25

15

7, 22

2

ES

3

SD

ch

14

10, 22.5

3

ES

QS indicates quality score; Tx, treatment; M, male; F, female; T1, T2, T3, mean scores at times 1, 2, and 3; ch, change scores; ES, effect size.

Table 14. Change scores (/50) for various treatment modalities Treatment (n)

Mean change

SD

SEM

Manipulation: NDI 2 (9) NDI 3 (4)

8.8 10.6

1.2 1.1

.39 2.2

Exercise: NDI (12) NDI 3 (8)

7.8 10.8

3.8 3.8

1.09 1.36

Mobilization NDI 2 (3)

7.4

Acupuncture NDI 2 (5)

7.05

3.1

1.38

Medication NDI 2 (6)

5.02

3.1

1.39

size was 137 (120). One case control study51 included 931 controls. Several recovery categorizations were reported, all of which correlated with the original NDI categories (Table 3). Recovery cutoffs range from 10-20/ 50, with the average being 15/50. Odds or relative risk ratios for high initial NDI and poor recovery were reported from 1.1 to 11.2. Several predictive models including high initial NDI scores were reported, accounting for up to 84.6% of variability in recovery status. Several studies reported that NDI score was the best predictor of outcome: low initial NDI predicts recovery; high initial NDI recovery predicts chronicity. The NDI has been shown to be highly useful in the prognostication of outcome after WAD injury either alone or within multivariable models. The NDI appears better than ‘pain level’ as a measure of symptom/disability status for prognostic purposes. High NDI scores (N15/50) at 3 to 36 months postaccident are strongly correlated with several important measures of physiologic dysfunction and physical impairment, indicating that psychosocial and accidentrelated factors are not the only correlates of high self-rated disability in patients who have chronic WAD and that attention to pathophysiologic factors such as muscular dysfunction and central sensitization is warranted.

The NDI in Random Clinical Trials (RCTs) of Conservative Treatment In nonsurgical treatment studies, treatment groups were classified as follows: manipulation, mobilization, physiotherapy, exercise, acupuncture, medication, cervical pillow, laser, and relaxation therapy. Each trial report was rated for quality by 2 raters using the Maastricht-Amsterdam Rating Scale,55 which gives a score out of 19. Studies attaining a score of 50% or more were considered of high quality. Tables 4 to 13 display data on the different groups reported in trials of conservative treatments for neck pain,56-83 which employed the NDI as an outcome measure (no. of groups N no. of trials). Table 14 shows the mean (SD) and the SEM of change scores at various intervals postbaseline for several of these treatment modalities. This review has only focused on those treatment studies that have used the NDI; the purpose was not to conduct a systematic review of all RCTs of conservative treatments for neck pain. The primary purpose of this review was to describe (not systematically analyze) the responsiveness of the NDI as an outcome measure in these trials. The mean changes obtained in the categories shown in Table 14 all exceed the MCIC reported by Stratford et al,11 although the groups receiving medications appear to improve the least. These mean changes range from 5 to 10 points or from 10% to 20%. By way of interpreting these changes, Farrar et al82 have reviewed the change scores on the 11-point pain scale in 10 clinical trials for a variety of chronic pain complaints (2724 subjects) and have determined that a 2-point or 20 out of 100 mm change (20%) is clinically relevant for chronic pain patients. It could be argued that these change scores represent the natural history of chronic neck pain or the placebo effect within a trial and therefore do not reflect the influence of the treatments provided. Vernon et al83 investigated the average change in pain scores in a separate group of controlled clinical trials of conservative treatments for chronic neck pain and found that these are not generally greater than 15 mm on a 100-mm VAS (around 15% improvement). In several of these studies, there was no change at all in pain scores in the control groups over up to 10 weeks posttreatment. Considering the findings of Farrar et al82 and Vernon et al83 with respect to changes in pain scores of patients with chronic pain, the

499

500

Vernon The Neck Disability Index

changes in disability/NDI scores obtained in this descriptive review would appear to exceed what could be ascribed to either the natural history or the placebo effect.

Other Treatment Modalities The NDI has been used as a primary outcome measure in 57 surgical trials and 3 trials of injection-type therapies (references available from author on request).

Journal of Manipulative and Physiological Therapeutics September 2008

7. 8. 9.

10.

CONCLUSION The current “state-of-the-art” of the NDI has been reviewed here. The NDI is the oldest and most widely used instrument for self-reporting of disability due to neck pain. Its internal psychometric properties have been well established in numerous cultural groups with neck pain: it is highly reliable, strongly internally consistent, and with a 1factor structure for “physical disability.” It has strong and well-documented convergent and divergent validity with other instruments used in the evaluation of patients and subjects with neck pain. Clinicians can confidently apply a “minimum clinically important change” value of 3 to 5 points in their practice settings,11 whereas researchers can make use, in future clinical trials, of the large number of reports of the responsiveness of the instrument to various therapies over various time frames and according to various indices of responsiveness. The NDI has been translated into 22 languages, with 6 published reports and 1 large Web-based resource with 18 readily available versions. It has been used in 52 surgical clinical trials and 3 trials of injection therapies as well as RCTs of numerous conservative therapies, chiefly manipulation and exercise. In this regard, it has served to expand the range of outcome measurements of neck pain patients beyond the limited use of pain scales and has enriched the yield of these clinical trials.

11.

12. 13. 14.

15.

16. 17.

18.

19.

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