Table 3: Characteristics of eligible trials of patient management post first-time spinal surgery
Trial / Design / Participants & indication / Intervention & setting / Outcome measures / Main results / CommentsAlaranta et al (1986)
(Finland) / RCT
2 groups:
A: comprehensive rehabilitation
B: normal care
Consecutive presenting patients
Randomisation with stratification on sex & age (≤40years, >40years) / First time disc prolapse & indication for surgery (including: cauda equina/massive paresis/intractable pain), aged under 55 years, not retired, within catchment area of 1 hospital
Pre-surgery values:
n=212)
A: n=106, mean age 40 years (SD 9), 49 F
B: n=106, mean age 39 years (SD 8), 52 F / A & B: out of bed day 1 post surgery; 2 X 1hour health education lessons; advice to sit after 3/52; follow-up check 1/12 post surgery
A: multifactorial rehabilitation 2/52 starting 1/12 post surgery; intensive back school training (knowledge, load on back, encourage physical activity, individual advice psychotherapy/social, multi-disciplinary, contact physiatrist at any point. Setting: rehabilitation centre.
B: normal care. Setting: outpatients or primary health care centre / 1. WHO: Occupational handicap scale (ordinal scale 0-5)
[cross tabulated to pre surgery perception. No pre or post surgery evaluation]
2. Subjective opinion of effects of surgery (5 point scale)
Assessment 12/12 post surgery /
- no significant between group differences at 12/12
Assumed statistical significance p<0.05 / Results expressed as perceived change in handicap since surgery.
n=8 lost to follow up.
No baseline post surgery measures.
Choi et al 2005
(Korea) / RCT
2 groups:
A: lumbar extension exercise programme
B: home based exercises
Consecutive presenting patients
Randomisation / First time lumbar discectomy, single level, non-responding unilateral radiating leg pain, no associated diseases
n=40 each group at initial randomisation
n=5 lost follow-up group A, & excluded from all analyses
A: n=35, mean age 51 years (SD 10); 15 F
B: n= 40; mean age 42years (SD 17); 22 F / A & B: posture advice, no strenuous activity, advice leaflet for home exercises from 2/52 post surgery
A: extensor muscle strengthening exercise (aerobic, limb strengthening, progressive resistance) for 12/52 starting 6/52 post surgery. Setting: outpatients but exact details unclear.
B: continue home-based exercises. Setting: home. / 1. ODI
2. VAS pain
3. CT
4. Mean lumbar extensor power
5. RTW
Assessments 1, 2 & 3 pre-surgery
1, 2 & 4 at 6/52 post surgery (i.e. baseline)
1, 2 & 3 at 18/52 post surgery
2. at 52/52 post surgery / 1. no significant difference between groups
2. significantly higher decrease in mean for group A at 18/52 (p<.05); no significant differences at 52/52
4. significantly higher mean improvement for group A at 18/52 (p<.05)
Statistical significance p<0.05 / Baseline values reported for mean lumbar extensor power only
Baseline differences apparent between groups (age and gender)
Danielsen et al 2000
(Norway) / RCT
2 groups:
A: standardised intensive training
B: control, mild exercises
Consecutive recruitment
Randomisation by random numbers, by independent person
Assessment by physiotherapist blinded to group allocation / First time surgery; patients offered lumbar operation in municipality of Rana; no other diseases that affect physical training; aged 20-60 years
n=65 eligible,
n=63 randomised
A: n=39; mean age 38years (range 22-58); 15 F
B: n=24; mean age 42years (range 28-57); 7 F
n=10, 16% loss to 12/12 follow-up / A & B: standard regimen for 3/52 post surgery; completion of pain journals
A: 3 X 40minutess per week for 8/52; start 4/52 post surgery. Medical exercises therapy-active exercise, no manual intervention; various apparatus; aim to strengthen back, abdomen ,lower extremities; individual parameters for exercises. Setting: outpatients but exact details unclear.
B: consultations every 2/52 to provide information re mild home exercises – relax & rest back; gradually resume activity; avoid heavy work. Setting: outpatients and home.
Exs start 4/52 post surgery / Primary:
1. RMDQ
2. VASpain
Others:
3. sick leave (mean wks)
4. pre-surgery clinical exam
5. myelogram
6. CT
7. st. pain drawing
8. WONCA fn status
All assessments pre-surgery
1 & 2 also reported at 6/12 & 12/12 post surgery / 1. Significantly higher mean improvement for group A at 6/12 (p=.02) & 12/12 (p=.03)
2. signif larger decrease in mean scores for group A at 6/12 (p=.04); no signif diff at 12/12 (p=.09)
Group A signif younger (p=.05) & signif higher mean scores pre-surgery on RMDQ (p=.03) & sick leave (wks) (p=.01); no diff in results from covariate analyses adjusting for age & sick leave / No primary end point identified
Baseline assessment pre-surgery
ITT analyses reported here, same conclusion using analyses on completers-only
Clinical importance taken as between group difference of 50% reduction on VASpain or on reported disability RMDQ, alpha 5%, power 80%
Dolan et al 2000
(UK) / RCT
2 groups:
A: strength & endurance ex prog
B: normal care
Single-blind randomisation / First time surgery, patients lumbar microdiscectomy, radiologic evidence of disc prolapse, sciatica<12months typical root nerve distn, no inflammatory disease, no tumour, no infection; aged 18-60yrs
Group A: n=9, mean age 39yryears, 0 F
B: n=11, mean age 43years, 3 F / A & B: normal care for 6/52 post surgery, physiotherapy advice on exercise & return to normal activity
A: 2 X 60 minutes per week for 4/52 exercise programme, start 6/52 post surgery. Experienced physiotherapist led sessions, patient’s own pace. Aerobic, stretching, strength & endurance. Aim to improve strength & endurance of back & abdominal muscles, & mobility of spine & hips. Setting: outpatients but exact details unclear.
B: no further treatment / 1a. VAS pain
1b. pain diary (4Xdaily)
- LBOS
3b. MSPQ
3c. Zung
4a. posture & mobility using Isotrak system
4b surface EMG of paraspinal muscle activity
4c. fatigue using Biering-Sorensen test
Assessments pre-surgery & at 6/52, 10/52,26/52, 52/52 post surgery / Comparable improvement in both groups 6/52 post surgery, all outcomes.
At 52/52:
1a. no significant difference between group mean scores (p=.08)
1b. significantly lower mean scores group A (p<.05)
2. significantly higher mean score for group A (p<.05).
Statistical significance p<0.05
. / Reported preliminary results on first 20 participants at 52/52. Focus of results within groups across time not across groups
Donaldson et al 2006
(New Zealand) / RCT
2 groups:
A: 26 week, non-aggressive, progressive rehabilitation programme
B: control; only contact with blind assessor for sending and receiving outcome measures
Recruitment from list of surgical patients for 1 spinal surgeon
Randomised by blind assessor, computer-generated allocation / In good health; lumbar discectomy; no central neurological disorder; no communication difficulties; no major medical problems; no condition making gym-based exercise unsafe; no indication of lumbar surgery due to spinal infection; no inflammatory disease or tumour; aged 17-65 years;.
A: n=47, mean age 42 years, 21 F
B: n=46, mean age 41 years, 18 F / A: gym-based programme, starting 6/52 post surgery; progressive conditioning exercises for 8/52; 3 X 3/52 progressive hypertrophy exercises; 3 X 3/52 progressive strength exercises. Setting: outpatients gym.
B: usual rehabilitation advice from surgeon
Compliance with A: 77% (n=36) completed full programme / 1. RDQ
2. OLBI
3. SF-36: physical & mental components
4.return to work (using a specific questionnaire)
5. number of doctor visits
6. visits to other therapists
7. amount of medication
Assessments 6/52 & 58/52 post surgery; 3-year follow-up planned / 1 thr’ 7. No significant difference between groups on change from 6/52 at 58/52 on any outcome
No significant differences between groups on baseline characteristics except group A had significantly more ‘heavy’ work than group B. No difference in findings when work heaviness used as covariate. / Sample size (n=40) based on Stratford et al (1996) – 80% power, 2 tailed α=0.05, between group differences of 4 units on RMDQ at 58/52
26 week intervention
Erdogmus et al 2007
(Austria) / RCT
3 groups:
A: comprehensive physiotherapy
B: sham physiotherapy
C: Control – no treatment
Block randomisation, sealed opaque envelopes, independent of research team
Consecutive recruitment, outpatient clinic
Baseline data collected by study physician prior to randomisation; blind assessors at other assessments
Baseline = mean 6.4 days post surgery / First-time, uncomplicated spinal surgery at 1 hospital; pre-surgery history < 6/12; no local complication; no post-surgery leg muscle weakness (>Grade 2/5); LBP-RS ≤100; no neurologic diseases; no orthopaedic condition; no musculoskeletal chronic pain or psychiatric disorders
A: n=40, mean age 40 years, 19 F
B: n=40, mean age 42 years, 19 F,
C: n=40, mean age 42 years, 15 F, / ALL patients pre-enrolment: minimal Information leaflet plus physiotherapeutic intervention comprising instructions on ergonomics, lifestyle changes, isometric back extension exercises – 2 per day.
A: 20 X 30mins 1-1 physiotherapy sessions over 12/52 strengthening & stretching exercises, ergonomics, general mobility of spine, muscle coordination & response time. Aimed at re-integration into work or usual activities. Setting: outpatient physiotherapy department, commencing 1 week post op.
B: 20 X 30 minutes 1-1 sham neck massage sessions from masseur specialist over 12/52. Setting: outpatients but exact details unclear.
C: no treatment; patients asked to wait & see.
All participants allowed analgesia on-demand / Primary outcome:
1. LBPRS (pain, disability, physical impairment)
Secondary outcomes:
2. Patient’s overall satisfaction with treatment outcome#
3. Compliance with back exercise training at home
4. socioeconomic parameters
5. Psychologic parameters
outcome 1. assessed baseline, 6/52, 12/52 & 18/12 post baseline
Others at baseline & 18/12 post baseline.
Primary endpoint 12/52
# 5 point likert scale / 1. LBPRS mean sum score significantly better group A compared with group C (p=.005), at 12/52.
Significantly lower mean scores at 6/52 and 12/52 for group A compared with group C on LBPRS physical impairment (p=.006 and 017, respectively); & at 12/52 on pain (p=.026), & disability (p=.047). No other significant differences between groups.
2. thr’ 5. No other significant differences at 12/52
1. thr’ 5. No significant differences between groups at 18/12 post baseline
No apparent (sic) baseline differences across groups / Primary analysis between group comparisons of changes (from baseline) on mean LBPRS at 12/52; ITT analysis; per-protocol analysis conducted as sensitivity analysis
Sample size calculated to detect between group differences <10 on mean change LBPRS sum scores at 12/52, common SD=15, power 80%, alpha =.05 – clinical relevance assumed = 10 points diff < 15% baseline mean LBPRS
Filiz et al 2005
(Turkey) / RCT
3 groups:
A: back education + intensive exercise programme
B: back education + home exercise programme
C: control – no education or exercise
Consecutive recruitment referrals at out patients
Random allocation by therapist draw of opaque sheet giving treatment
Single (assessor) blind study / First time, single level discectomy; no neurological deficits, cardiovascular pathology, respiratory or other pathologies preventing exercising; aged 20-50 years.
Baseline (1/12) post surgery:
A: n=20, mean age 38 years, 10 F
B: n=20, mean age 41 years, 8 F;
C: n=20, mean age 40 years, 11 F / Exercise programme started 30 days post surgery
A & B: back school education programme; 8 patients/group, twice weekly for 4/52; use of body mechanics & back protection methods
A: 90 minutes three times per week for 8/52; relaxation & stretching exercise, followed by “dynamic lumbar stabilization exercises”; 3 sets X 5 repetitions increasing to 3 sets X 15 repetitions; taught 1-1, performed in groups of 5 patients. Setting: outpatient clinical Dept of Physical Medicine and Rehabilitation.
B: classical exercises – McKenzie & Williams exercise; taught in clinic, then performed at home three times per week for 8/52; patients telephoned weekly. Setting: outpatient clinical Dept of Physical Medicine and Rehabilitation.
C: advised to be as active as possible with their daily routines / 1. PILE
a. floor– waist
b. waist– shoulder
2. Body endurance test:
a. back muscles
b. abdominal muscles
3. Lumbar Schober (mobility)
4. VAS pain
5a. Modified ODI
5b. LBPRS(sum)
6. BDI
7. Time to return to work or daily activities (post surgery)
Assessments at 1/12 (baseline) & 3/12 post surgery / At 12/52 post surgery:
2a, 2b, 5b, 7. Significantly better mean outcome scores for group A than groups B or C, and for group B than group C (p<.001, all instances)
4. significantly better mean outcome scores for group A than groups B or C (p<.001)
3, 5a. significantly better mean outcome scores for group A than group C, & for group B than group C (p<.001)
6. significantly better mean outcome scores for group A than group C (p<.001)
No significant differences between groups at baseline / Primary end point 3/12 post surgery
No loss to follow-up
NOTE: Authors report unreliability of outcome 7: Time to return to work or daily activities
Häkkinen et al 2005 (2003)
(Finland)
[associated study Häkkinen et al 2003] / RCT
2 groups:
A: combined strength & stretching exercises for 12/12
B: conventional stretching exercises for 12/12
Consecutive recruitment at 2/12 post surgery clinic assessment
Random assignment
Impendent assessor blind to allocation / Single level, first time lumbar discectomy; VAS pain ≥10m at 2/12 post surgery; no re-operation; no referral for severe pain; no spondylodesis of lumbar spine; no other condition likely to affect training;
Baseline (2/12) post surgery:
A: n=65, mean age 39 years, 29 F;
B: n=61, mean age 39 years, 26 F / All patients received usual care for 6-8/52 post surgery; given written instructions for restricted physical activities.
A & B: At 2/12 post surgery, verbal & written information from physiotherapist about home exercises & exercise diary for 12/12; stretching exercises three times per week for 12/12 – included active SLR, trunk flexion in supine, & passive extension of lumbar spine in prone, muscle stretches in supine – 3 repetitions each exercise AMBIGUOUS
A: exercises practiced under supervision for 1 session per week for 8 weeks; strengthening exercise using body weight or individually adjusted dumbbells (8-12 repetitions); 2 series per exercise, twice per week for 12/12. Setting: Outpatient physiotherapy department.
B: Continued training programme at home. Setting: home. / 1. VAS pain
a. back
b. leg
2. OLBDQ
3. Million’s Disability Index
4. Leisure time activities (minutes/week)
5. Isometric strength:
a. trunk flexion
b. trunk extension
6. Endurance strength:
a. trunk flexion
b. trunk extension
c. squat
d. alternate single-arm dumbbell press
7. mobility (flexion: Schober test)
8. Compliance with exercises
Assessments 2/12 (start of intervention) & 14/12 post surgery; compliance at 4/12 & 14/12 post surgery / At 14/12 post surgery, n=46, 47 in group A, B respectively
1, 2, 3, 5, 6 & 7: no significant differences between groups at 14/12 post surgery / Conducted ITT analyses
Adjusted for baseline values (ANCOVA or median regression analysis
Johannsen et al 1994
(Denmark) / RCT
2 groups:
A: intensive supervised training (clinic-based)
B: conventional rehabilitation programme (home-training)
Recruitment from consecutive patients post surgery`
Randomisation by minimisation; stratified on sex, age (<40years, >40years), pre-surgery hospitalisation (yes, no)
Same assessor at all assessments / First time lumbar discectomy within previous 4-6 weeks; classic nerve root compression symptoms but no caudia equina; confirmatory CT/myelography; employed; no evidence of spondylolisthesis, osteoporosis, painful hip arthosis, inflammatory rheumatic disease or neoplastic disorder; aged 18-65 years
Baseline (4-6)/52 post surgery:
A: n=20
B: n-20
Baseline data for completers only:
A: n=11, median age 39 years, 4 F
B: n=16, median age 36 year,; 4 F / A & B: start programme approx 6/52 post surgery
A: supervised training 1hour twice per week for 3/12; group size ≤10; dynamic endurance exercises for low & high back, buttock & abdominal muscles with increasing ventral flexion & extension over (4 to 8)/52; 100 repetition of each exercise, own speed, 30s pause each 10 repetitions; 10mins warm-up each session & 10mins stretching exercise at end. All movements checked by physiotherapist. Setting: outpatients but exact details unclear.
B: Initial 2 hour instruction and then unsupervised, individual training at home; 1hour twice per week for 3/12; 2hours instruction by physiotherapist in outpatients, written instructions & diagrams for each exercise; muscle exercises on floor for back, abdomen, hip abductors & adductors; standing exercise for quadriceps; 10mins warm-up & 10 minutes stretching exercises at end. Setting: home. / 1. Isokinetic muscle
strength :
a. trunk extension
b. trunk flexion
2. spinal mobility –summated score, cm
3a. Back pain now – 5-pt scale
3b. Average back pain over last week – 5-pt scale
4. Disability (0-12; no. of impaired daily tasks out of 12)
5. Drug therapy for pain (0 =good, 3=bad; patients overall assessment of disability days & sick leave post-surgery)
Assessments at baseline (4-6/52 post surgery), 3/12, 6/12 / 1a: significantly greater median strength for group B at 6/12 (p<.05)
No other significant differences between groups at 3/12 or 6/12 (p>.05)
No significant differences between groups in drop-out rate or training side-effects
A: 11/20 completed supervised training for 3/12
B: 16/20 reported completing home-training for 3/12 / Completers only analyses - no ITT analyses conducted
Johannson et al 2009
(Sweden) / RCT
2 groups:
A: clinic-based behaviour oriented physiotherapy
B: home-based training
Recruitment from scheduled surgery attendees at 2 neighbouring hospitals
Computer generated random allocation – blocks of 4, stratified by hospital; blinded allocation during post-operative stay / Scheduled for first-time lumbar disc surgery; MRI confirmation of lumbar disc herniation; no comorbidity affecting daily activities; fluent in Swedish; aged 18-60 years
Baseline = pre-surgery
A: n=29, median age 43 years, 12 F
B: n=30, median age 38 years, 12 F / A& B oral & written information on training from ward physiotherapist starting 1 day post surgery for 3/52; trunk stabilisation, back & hip mobility, & activation of back, abdominal & buttock muscles; + written exercise programme at least once daily; + encouraged to increase activities gradually, including walking. Physiotherapy assessment at 3/52 post surgery & change in daily training to focus on strengthening & stretching, increase & extension of daily activities to return to normal, & no heavy lifting for 3/12 post surgery.
A: daily home programme as above + supervised training at physiotherapy department once per week for 8/52 starting from physiotherapist assessment on 3/52 post surgery. Training aimed to reduce fear & avoidant behaviour through a behavioural operant approach – mobility, stability, stretching, strengthening & condition training; weight resistance exercises introduced gradually. Setting: physiotherapy outpatient clinic.
B: daily home programme as above. At 3/52 assessment, recommended to gradually increase no. of repetitions of exercises & future physical activity encouraged. No additional instructions from physiotherapist, but allowed to contact to ask questions about training programme. Setting: home. / Primary outcome
1. ODI
Other outcomes
2. physical activity level
3. TSK*
4a. CSQ: self-statement
4b. CSQ catastrophising
5a. VAS back pain
5b. VAS leg pain
6a. EuroQoL – 5D
6b. EuroQol - VAS
6c. SF-36
7. Patient satisfaction
8. Therapies given by other caregivers
* modified TSK – 5 items omitted
Assessments at baseline pre surgery, 3/12, 12/12 post surgery
Home exercise group by phone at 3/12 for compliance to exercise / 2. Significantly more in group A reported training regularly at 12/12 post surgery (p=.02)
5a. Significantly higher median change score in group B at 12/12 post surgery (p=.04)
6b. Significantly higher median change score in group B at 12/12 post surgery (p=.03).
7. Significantly more in group A reported sufficient help from physiotherapist (p=023) & would recommend treatment received (p=.023) at 3/12 post surgery
8. 1/29 in group A & 4/30 in group B had visited another caregiver at 3/52 post surgery
No other significant differences between groups at 3/12 or 12/12
Only significant difference between groups at baseline was on age (median age group A: 43years, group B: 38years (p=.016) / ITT analysis conducted.
Adjusted for age (signif diff between groups at baseline, p=.016). Adjustment had little effect on results, unadjusted summaries reported
Compliance at 3/12 post surgery: group A: 25/29 attended all 8 clinic sessions; group B: 24/30 trained 3-7 times/week, 2/30 once/week or occasionally, & 3/30 did no training
Kjellby-Wendtet al 1998
(Sweden) / RCT
2 groups: