Guideline appendix Appendix H

1232 Pages·2016·10.37 MB·English

by  Mikaela Bartlett

National Clinical Guideline Centre

Draft
Low back pain and sciatica
Low back pain and sciatica: management of non-
specific low back pain and sciatica
NICE guideline <number>
Appendices H
February 2016
Draft for consultation

Commissioned by the National Institute for
Health and Care Excellence

LLooww bbaacckk ppaaiinn aanndd sscciiaattiiccaa

Contents

Disclaimer
Healthcare professionals are expected to take NICE clinical guidelines fully into account when
exercising their clinical judgement. However, the guidance does not override the responsibility of
healthcare professionals to make decisions appropriate to the circumstances of each patient, in
consultation with the patient and, where appropriate, their guardian or carer.
Copyright
National Clinical Guideline Centre, 2016
Funding
National Institute for Health and Care Excellence

National Clinical Guideline Centre, 2016
Low back pain and sciatica

Contents
Contents
Appendices .................................................................................................................................. 5
Appendix H: Clinical evidence tables ............................................................................................... 5
References .............................................................................................................................. 1189

National Clinical Guideline Centre, 2016
4
CL
Nation 1 Appendices linical eow bac
a vk
l Clin 2 Appendix H: Clinical evidence tables idenc pain
ical Guid H.31 Clinical examination e tables and scia
e t
lin 4 None. ica
e
C
e
n
tre H.52 Risk assessment tools and stratification
, 2
0
1 6
6
Study APELDOORN 2012B trial: Apeldoorn 201212,13
Study type RCT (Clusters randomised; Parallel)
Number of studies (number of participants) 1 (n=156)
5

Countries and setting Conducted in Netherlands; Setting: private physical therapy clinics in Amsterdam and surrounding rural areas (<50 km
radius)
Line of therapy Unclear
Duration of study Intervention + follow-up: 1 year
Method of assessment of guideline condition Adequate method of assessment/diagnosis
Stratum Overall: low back pain with/without sciatica
Subgroup analysis within study Not applicable
Inclusion criteria Low back pain as the primary complaint, with or without associated leg pain, age between 18-65 years, current
episode longer than 6 weeks and ability to read and write Dutch
Exclusion criteria Known or specific low back pain (e.g cauda equina compression, fractures), severe radiculopathy, spondylolisthesis
(grade 2 or more), serious co-morbidity 9e.g metastases, AIDS)psychopathology, lumbar spinal surgery in the previous
year, more than 1 low back operation, pregnancy,, inability to attend 6 or more regular physical therapy
appointments, moderate complaints about 1 or more items of the UDI-6 or inability to demonstrate any low back pain
symptoms during mechanical examination
CL
Nationa RAegcer, ugietmndeenrt /asnedle ectthionnic oitfy p atients prAuagrteai el- n aMtrsee awasne ( r<(eS5 Dr0e) :kc 4mru3 i.rt2ae dd(1i ub1sy.)7 p) hiny scilcaasls tifhicearatipoinst gs rforoump a 2n1d p 4r2iv.0at (e1 0p.h9y)s iinc atlh teh uersaupayl ccalirnei cgsr oinu Ap.m Gsetenrddearm (M a:nFd): s 6u7r:r8o9u.n ding linical evow back
l Clin Ethnicity: idenc pain
ical Guid FEuxtrrtah ecro mpompuenlattsi on details B(OaDseI)l iwnea sP a1i8n. 1(N (1R1S.)5 w) ians t6h.e0 c(1la.7ss)i ifnic athtieo ncl agsrsoiufipca atniodn 2 g1r.o9u (p1 4a.n5d) i6n. 2th (e1 .u8s) uina lt chaer eu sguraolu cpa.r Bea gsreoliunpe. PBCaSse slcinoere F uonf tchtieo nS F- e tables and scia
e 36 was 43.7 (8.3) in the classification group and 40.2 (8.7) in the usual care group. Baseline MCS score of the SF-36 t
lin was 52.3 (8.5) in the classification group and 51.1 (10.6) in the usual care group. ica
e
C
e Indirectness of population No indirectness
n
t
r Interventions (n=74) Intervention 1: Risk assessment tools + treatment - Delitto/Childs/Flynn/Hancock/O’Sullivan. Patients assigned
e
, 2 to the classification group were treated according to their primary classification category i.e direction specific
0
1 exercises, spinal manipulation or stabilisation exercise for a minimum of 4 weeks. After this period, the physical
6
therapist was allowed to exchange treatment strategy according to the current low back pain Dutch guidelines..
Duration 1 year. Concurrent medication/care: 8.1 % in the classification group were taking medication for low back
pain whereas 14.6% were taking medication in the usual care group
Further details: 1. Validated and non-validated risk tools: Not applicable / Not stated / Unclear
6

(n=82) Intervention 2: Unstratified treatment et – Unstratified treatment. Patients assigned to usual physical therapy
care received individually tailored treatment according to the current low back pain Dutch guidelines.. Duration 1
year. Concurrent medication/care: 8.1 % in the classification group were taking medication for low back pain whereas
14.6% were taking medication in the usual care group
Further details: 1. Validated and non-validated risk tools:

Funding Academic or government funding (The Netherlands Organisation for Health Research and Development grant funds
were received to support this work)

RESULTS (NUMBERS ANALYSED) AND RISK OF BIAS FOR COMPARISON: CLASSIFICATION GROUP versus USUAL THERAPY GROUP

Protocol outcome 1: Quality of life at ≤ 4 months
- Actual outcome: SF-36-Physical Component Score (PCS) at 1 year; Risk of bias: Very high; Indirectness of outcome: No indirectness
- Actual outcome: SF-36-Physical Component Score (MCS) at 1 year; Risk of bias: Very high; Indirectness of outcome: No indirectness

Protocol outcome 2: Pain severity (VAS/NRS) at ≤ 4 months
Nation - P rAocttoucaol lo ouutctcoommee: N3:R PSa,0in-1 s0e vaet r8it wy e(VeAksS;/ NRiRskS )o aft b >ia4s m: Voenrtyh hs i-g 1h ;y Ienadri rectness of outcome: No indirectness Clinical eLow bac
al Clin - Actual outcome: NRS,0-10 at 52 weeks; Risk of bias: Very high; Indirectness of outcome: No indirectness videnck pain
ical Guid P- rAocttoucaol lo ouutctcoommee: O4:D FIu,0n-c1t0io ant (8d wisaebeiklist;y R sicsok roefs b) iaats ≤: V4e mryo hnitghhs; Indirectness of outcome: No indirectness e tables and scia
e Protocol outcome 5: Function (disability scores) at >4 months - 1 year t
lin - Actual outcome: ODI,0-10 at 52 weeks; Risk of bias: Very high; Indirectness of outcome: No indirectness ica
e
C
e
n Protocol outcome 6: Responder criteria at ≤ 4 months
t
re - Actual outcome: NRS (>30 % improvement from baseline) at 8 weeks; Risk of bias: Very high; Indirectness of outcome: No indirectness
, 2 - Actual outcome: ODI (>30 % improvement from baseline) at 8 weeks; Risk of bias: Very high; Indirectness of outcome: No indirectness
0
1
6
Protocol outcome 7: Responder criteria at >4 months - 1 year
- Actual outcome: NRS (>30 % improvement from baseline) at 52 weeks; Risk of bias: Very high; Indirectness of outcome: No indirectness
- Actual outcome: ODI (>30 % improvement from baseline) at 52 weeks; Risk of bias: Very high; Indirectness of outcome: No indirectness
7

Protocol outcomes not reported by the study Quality of life at >4 months - 1 year; Psychological distress (HADS/GHQ/BDI/STAI) at ≤ 4 months; Psychological distress
(HADS/GHQ/BDI/STAI) at >4 months - 1 year; Healthcare utilisation (prescribing, investigations, hospitalisation or
health professional visit) at ≤ 4 months; Healthcare utilisation (prescribing, investigations, hospitalisation or health
professional visit) at >4 months - 1 year; Adverse events (morbidity) at ≤ 4 months; Adverse events (morbidity at >4
months - 1 year; Adverse events (mortality) at >4 months - 1 year; Adverse events (mortality) at ≤ 4 months

Study Beneciuk 201329,29
Study type Prospective cohort study
Number of participants 146 patients enrolled and provided baseline information.
Country and setting USA
Funding Brooks health system, primary author supported by the National institute of health T32 neuromuscular plasticity
research training fellowship grant.
Duration of study 6 months
CL
Nationa BPaatsieelninte c hchaararactceterirsitsitcisc s A4In9gc.el3u,% smi,o elnoa wncr (ibSteaDcr)ik:a 4 p1a.i1n (a1n3d.5 lo),w feemr laelge :1 671.1%%, ,s syymmpptotomm l odcuartaiotino:n l:o awcu btaec (k< p9a0i nd aoynsl)y 5 313%.6, %ch, rloowni cb (a≥c9k0 p daainy sa)n 4d9 b%u. t tock/thigh linical evow back
nl Cli AT1d2u lotsr bloewtwere,e innc tlhued iangge rsa odfi a1t8in agn pda 6in5 iynetoa rtsh see beukitntog cpkhs yasnicda llo twheerra epxyt rfeomr liotyw) ,b aabclke ptoa irne (adde afinnde ds paesa hka tvhineg E snygmlispht oms at idenc pain
ical Guid l anguage. e tables and scia
e Exclusion criteria: t
lin Presence of systemic involvement related to metastatic or visceral disease, recent spinal fracture, osteoporosis, or ica
e
C pregnancy.
e
n
t
r
e
, 2 Risk assessment tool Fear avoidance beliefs questionnaire (FABQ) physical activity scale: 4 item scale (0-24) and FABQ work scale: 7 item
0 scale (0-42). Higher levels indicating higher levels of fear avoidance beliefs.
1
6

Pain catastrophizing scale: 13 item questionnaire (potential range of scores 0-52) higher scores indicating higher levels
of pain catastrophizing.
8

Eleven-item version of the tempa scale kinesophobia: used to measure degree of fear on movement and injury or re-
injury in individuals with low back pain (potential scores ranging 11-44), with higher scores indicating greater fear on
movement and injury or re-injury due to pain.

Nine-item patient health questionnaire: used to assess degree to which depressive symptoms have on a patient with
low back pain (scores range from 0-27), high scores indicate elevated depressive symptoms.

STarT Back: overall score (0-9)determined by summing all positive responses
STarT Back: psychosocial subscale score (0-5) based on bothersomeness, fear, catastophizing, anxiety and depression.
High risk ≥4: high levels of psychosocial prognostic factors are present with or without physical factors present,
Medium risk >3: physical and psychosocial factors are present but not a high levels of psychosocial factors,
Low risk 0-3: few prognostic factors are present.
Target condition Predicting 6 months follow-up pain intensity using the numeric pain rating scale (0-10)
Predicting 6 months follow-up disability scores using the Roland Morris disability questionnaire (0-24)
Results:
CL
Nation Aolotdwhjue bsra tpecsdky pc%ha oRinl2o v (gaMirciaValbA tl oeaosd,lj sua,s ndtdien mpgs ofyogcrrh aaopllloh tgihci ceaa nl d PFFAAaiBBnQQ ( NppRhhSyy)ss iiccaall awcotirvki tsyc asclea:l e1:8 1.97 .6 linical eow bac
a vk
l Clinical Guid m easures) PTPSTaaaamitnire pTcn aaBt t sahaccesaktal reslotc hopr fehq ekiuzinineniesngtsg iiso otcnopanohlealo :io br1evi7ae (. r9(1a1- li1lt e-sicmteosnr)e :v (1e08r-s.96io) :n 1):7 1.77 .8 idence tables pain and scia
elin STarT Back screening tool psychological score (0-5): 8.2 tica
e
C
e Disability (RMDQ)
n
t
r FABQ physical activity scale: 39.6
e
, 2 FABQ physical work scale: 41.4
0
1 Pain catastrophizing scale: 41.2
6

Tampa scale of kinesiophobia (11-iten version): 40.4

Patient health questionnaire: 41.2

STarT Back screening tool overall score: 42.3
9
STarT Back screening tool psychological score: 44.3

General limitations (according to PROBAST) Limited outcome data reported (R² only adjusted for other tools/covariates); high rate of missing data with analyses
indicating significant differences between completers an non-completers

Study Beneciuk 201429,30
Study type Prospective cohort study
Number of participants 123
Country and setting USA
Funding Brooks health system, main author funded by national institutes of health T32 neuromuscular plasticity
Duration of study 6 months
Baseline characteristics Age [mean (SD)] 42.6 (13.1); female 61%, symptom duration-chronic (91days or more) 45.5%
Patient characteristics Inclusion criteria
Adults between the ages of 18 and 65 years seeking physical therapy for low back pain (defined as having symptoms at
Nation Tl a1n2g uoar gloew. er, including radiating pain into the buttocks and lower extremity), able to read and speak the English Clinical eLow bac
a vk
l Clin EPxreclsuesniocen ocrf isteyrsitae:m ic involvement related to metastatic or visceral disease, recent spinal fracture, osteoporosis, or idenc pain
ical Guid Risk assessment tool pSdTreeategrTnrm aBniancciykn.:g c whahnegthe einr poavretricailpl ascnotsre w (e0r-e9 )i mdeptreorvmeidn e(SdT baryT s Buamcmk Sincgre aelln pinogs iTtiovoel r(eSsBpTo) ncsaetes gaot rbizaasteiolinne c haanndg aetd 4 f-rwoeme ks and e tables and scia
e t
lin medium to low, high to low, or high to medium risk), stable (SBT categorization remained low or medium risk), or ica
e
C worsened (SBT categorization changed from low to medium, low to high, medium to high, or remained high risk).
e
n
t
r
e Thresholds for each category as follows:
, 2
0 High risk ≥4: high levels of psychosocial prognostic factors are present with or without physical factors present,
1
6 Medium risk >3: physical and psychosocial factors are present but not a high levels of psychosocial factors,

Low risk 0-3: few prognostic factors are present.
Target condition 6 months outcome for numeric pain rating scale and Oswestry disability score
1
0 Results:

R2 (adjusted for demographics, low back Pain: 16.8%
pain symptom duration and variation in Disability: 46.3%
initial STarT Back categorisation)

General limitations (according to PROBAST) Limited outcome data reported (R² only adjusted for other tools/covariates); high rate of missing data with analyses
indicating significant differences between completers an non-completers

Study Beneciuk 201531
Study type RCT (Patient randomised; Parallel)
Number of studies (number of participants) 1 (n=109)
Countries and setting Conducted in USA; Setting: Outpatient clinic setting.
Line of therapy Not applicable
Duration of study Intervention time: 4 weeks
Method of assessment of guideline Adequate method of assessment/diagnosis: Diagnosis by a physician.
condition