Mangels (2009)

232 German patients with chronic low back pain

Inclusion criteria:

- musculoskeletal disease (ICD-10 M00-

99)

- ability to understand German

Exclusion criteria:

- surgeries during the previous 3 months - an intended length of treatment shorter than 3 weeks (eg, owing to

hospital or individual reasons)

- an unexpectedly short

admission process hindering the randomization process

Both groups (n=232): Patients received medical care (including analgetic medication if necessary), physiotherapy,

back school, and occupational therapy. The treatment took place in individual sessions or open groups. Further therapeutic elements were massages, electrotherapy, hydrotherapy,

thermotherapy, and nutritional and social advice. The participation at a progressive muscle relaxation group was

optional. The intended length of this treatment program was 3 weeks.

A group for psychologic pain management (according to cognitive behavioural principles) was introduced, which consisted of 9 group sessions of 90 minutes and was conducted by a

trained behavioural psychotherapist.

Furthermore, patients participated in a progressive muscle relaxation training program and had the opportunity to

engage in weekly individual sessions with the psychotherapist. The intended length of treatment was 4 weeks. In contrast to the traditional orthopaedic treatment, the behavioural-medical treatment was less individualized. For the most part,

therapies (physiotherapeutic and psychologic) were arranged

in groups with a group size from 10 to 12 patients.

Intervention (n=119): After the

termination of the inpatient rehabilitation treatment, they

additionally participated in 7 booster sessions, which were conducted by telephone within 12 months after discharge by 2 trained clinical psychologists. The interval between 2

sessions varied from 4 weeks in the beginning to 3 months at the end. Each session lasted 20 minutes on average.

Control (n=113): Patients in the control group did not participate in any booster sessions

Measurements: admission, discharge, at 1-year follow-up

Physical health status (SF12; mean scores 50±10)

Pre: I: 33.5±9.1 / C: 33.6±7.4

Post: I: 38.9±9.4 / C: 39.3±9.9

12mo: I: 38.4±10.4 / C: 38.4±9.7

F value (interaction group*time): 0.24 (p>0.05)

Mental health status (SF12; mean scores 50±10)

Pre: I: 43.9±12.1 / C: 44.0±11.1

Post: I: 48.9±12.1 / C: 50.8±10.5

12mo: I: 45.6±11.7 / C: 46.0±11.2

F value (interaction group*time): 0.95 (p>0.05)

Pain disability (PDI; 0-70)

Pre: I: 26.9±13.9 / C: 26.1±11.8

Post: I: 21.7±13.3 / C: 20.3±13.9

12mo: I: 22.6±16.0 / C: 22.0±14.0

F value (interaction group*time): 1.20 (p>0.05)

Self-efficacy (PSEQ; 0-60)

Pre: I: 41.3±11.8 / C: 42.1±10.6

Post: I: 45.1±10.8 / C: 46.0±10.1

12mo: I: 44.3±12.3 / C: 43.2±12.0

F value (interaction group*time): 1.05 (p>0.05)

Depression (BDI; 0-63)

Pre: I: 11.4±9.8 / C: 11.1±8.2

Post: I: 7.2±7.8 / C: 6.7±6.0

12mo: I: 10.7±8.8 / C: 10.4±7.8

F value (interaction group*time): 2.57 (p<0.05)

F value (BMR vs BMR+B pre-post): 0.05 (p>0.05)

F value (BMR vs BMR+B pre-follow-up): 0.00 (p>0.05)

For the behavioral-medical condition with subsequent booster sessions, 8 patients refused to participate in this

aftercare treatment program before commencement; they were, however, willing to participate at follow-up assessment. Reasons for refusal were having no time or no need for further support. Six patients dropped out after the first or second session owing to the same reasons as described

above.

The main analysis of overall treatment outcome was performed using 3 (treatment) x 3 (time points) ANOVAs.

Group differences between the 2

behavioral-medical conditions with and without subsequent booster sessions were analyzed using post hoc 2 (treatment) x 2 (time points) ANOVAs.

Reneman (2020)

201 Dutch patients with chronic musculoskeletal pain

Inclusion criteria:

- admitted for a 12, 16 or 20 week pain rehabilitation program

- chronic musculoskeletal pain for more than three months without

a specific pathological care as usual se;

- chronic musculoskeletal pain induced disability

- social and psychological

factors were assumed to be relevant in maintaining chronic musculoskeletal pain induced disability

- willing

to stop other treatments for chronic musculoskeletal pain during

pain rehabilitation program (except pain medication)

- 18 years or older

- motivated to participate in pain

rehabilitation program

Exclusion criteria:

- referred to the 8 week pain rehabilitation program

- unable to understand the Dutch language

- comorbidities

such as heart failure, rheumatoid arthritis, or psychiatric disorders

preventing a pain rehabilitation program

Intervention: Short form interdisciplinary care (n=54)

Patients allocated to the short form group received a pain rehabilitation program that was 4 weeks shorter

than proposed (which will result in approximately 10 contact hours less on average). Thus, patients in short form received 4 weeks/10 contact hours less than proposed after intake.

Control: Interdisciplinary care as usual (n=58)

Patients allocated to the care as usual group received 12, 16 or

20 weeks of pain rehabilitation program as proposed after the intake procedure.

Both groups:

The objectives of care as usual and short form were the same and

the content was similar; both treatments were outpatient, interdisciplinary

pain rehabilitation programs aimed to decrease chronic musculoskeletal

pain related disability, optimise participation, and

increase the quality of life. Pain rehabilitation program is intended to

coach patients to self-manage their pain and disability.

The rehabilitation team consisted of rehabilitation physicians, occupational

therapists, physiotherapists, and psychologists.

The patient’s team determined the required duration of treatment, which could be 8, 12, 16 or 20 weeks. This was based on the assessment of the complexity of the physical, social and personal situation of the patient, motivation, and ability to change behaviour.

Pain rehabilitation

program was based on cognitive behavioural principles, and

consisted pain education, for example regarding differences between

acute and chronic pain.

Patients were counselled to reflect on their pain management strategies and how these strategies

could be changed into other management strategies. Each patient set individual treatment goals. Activities included exercise programmes and sport activities, education (including work participation) by an occupational therapist, and coaching by psychologists.

Measurements: baseline and 1–3 weeks after discharge

Euroqol 5D-5L (EQ 5D-5L) (-0.329 to 1.000), mean±SD

Pre: I: 0.54 (0.21) / C: 0.56 (0.19)

Post: I: 0.70 (0.20) / C: 0.70 (0.17)

ES between group difference: 0.19

EQ-5D-VAS (0-100), mean±SD

Pre: I: 54.4 (17.7) / C: 54.5 (17.8)

Post: I: 67.6 (18.7) / C: 67.5 (16.1)

ES between group difference: 0

Pain Disability Index (PDI) (0-70), mean ±SD

Pre: I: 37.9 (14.2) / C: 36.1 (12.5)

Post: I: 26.6 (17.7) / C: 25.1 (15.0)

ES between group difference: 0.20

Non-inferiority design. Because large

pain rehabilitation program dosage variations exist, without evidence

that higher dosage leads to better results, the authors hypothesised

that short form would be non-inferior to care as usual in an outpatient

pain rehabilitation setting.

Both groups improved significantly over time.

The duration of 26% of all programs (36% within short form and 17% within care as usual) was extended to achieve a

desired outcome.

The study was stopped prematurely because of an a-priori stopping rule. The study had to be discontinued prematurely because too many programs in the short form group were extended. This caused lack of included patients and lack of contrast regarding dosage between the care as usual and short

form groups, which may partly explain the inconclusiveness of the results.

The reduction of PDI scores was 2.5 points larger in the care as usual group compared to the short form group (Figure 1). The mean difference of 2.5 points lies within the non-inferiority margin from 0.0 to 4.0. Because the CI of this difference exceeded the upper and lower limit of the non-inferiority margin, the results were inconclusive.

Schmidt (2020)

165 Danish patients with chronic low back pain

Inclusion criteria:

Patients were eligible if they had chronic low back pain for more than 12 months (with or without sciatica and/or with or without widespread pain) and if they were 18 years or older.

Exclusion criteria:

The exclusion criteria were (1) severe systemic diseases (American Society of Anesthesiologists physical status classification system ⩾3) (2) a diagnosis of axial spondyloarthritis, (3) spinal fracture within the last three months, (4) severe osteoporosis, (5)

active cancer, (6) severe psychiatric disease, (7) pregnancy, (8) lack of fluency in Danish, and (9) minimal back-specific disability (Oswestry Disability Index score <21).

Both groups (n=165)

The rehabilitation programmes encompassed the four actions characterising the process of rehabilitation: (1) assessment, (2)

goal setting, (3) intervention, and (4) evaluation. Activities included 38 clinical activities targeting the biopsychosocial factors driving disability. There were offered in a combination of group lecture and dialogue, group sessions (supervised and non-supervised), individual counselling and unsupervised individual exercise. The multidisciplinary team consisted of six physiotherapists, three occupational therapists, three nurses (educated as coaches and primarily focusing on the psychologic aspect of the programme), a rheumatologist, and a nutritional counsellor. The programs were partially standardised and partially tailored, the latter to ensure a degree of person-centredness.

Existing programme

(1) Four-week inpatient stay, (2) Six-month follow-up visit. In total, 21 inpatients days.

Based on the biopsychosocial approach.

Integrated programme

(1) pre-admission day, (2) two weeks of home-based activities, (3) two-week inpatient stay, (4) four weeks of home-based activities, (5) initial two-day inpatient booster session, (6) six weeks of home-based activities, (7) second two-day inpatient booster session, (8) Six-month follow-up visit. In total, 15 inpatient days.

Based on the biopsychosocial approach and the Chronic Care Model.

Measurements: baseline (I: n=82 / C: n=83) and one year after the start of the rehabilitation program (I: n=65 / C: n=67)

HRQoL (EQ-5D 5L; -0.624-1), mean±SD

Pre: I: 0.567±0.157 / C: 0.603±0.118

12mo: I: 0.610±0.163 / C: 0.626±0.165

MD (95%CI): 0.02 (–0.04 to 0.07)

Back specific disability (ODI; 0-100) mean±SD (range)

Pre: I: 42±10 (20-68) / C: 43±11, (24-72)

12mo: I: 37±16 (8-73) / C: 38±17 (6-72)

MD (95%CI): −0.53 (–4.08 to 3.02)

Pain self-efficacy (PSEQ; 0-60) mean±SD

Pre: I: 28±11 / C: 27±10

12mo: I: 33±15 / C: 32±15

MD (95%CI): 0.01 (–3.34 to 3.37)

Back pain intensity (NRS; 0-10) mean±SD

Pre: I: 6±2 / C: 6±2

12mo: I: 6±2 / C: 5±2

MD (95%CI): −0.10 (–0.68 to 0.48)

Depression (MDI; 0-50), mean±SD

Pre: I: 20±12 / C: 20±11

12mo: I: 17±12 / C: 18±11

MD (95%CI): 1.67 (−1.52 to 4.85)

Study reference

(first author, publication year)

Was the allocation sequence adequately generated? ^a

Definitely yes

Probably yes

Probably no

Definitely no

Was the allocation adequately concealed?^b

Definitely yes

Probably yes

Probably no

Definitely no

Blinding: Was knowledge of the allocated

interventions adequately prevented?^c

Were patients blinded?

Were healthcare providers blinded?

Were data collectors blinded?

Were outcome assessors blinded?

Were data analysts blinded?

Definitely yes

Probably yes

Probably no

Definitely no

Was loss to follow-up (missing outcome data) infrequent?^d

Definitely yes

Probably yes

Probably no

Definitely no

Are reports of the study free of selective outcome reporting?^e

Definitely yes

Probably yes

Probably no

Definitely no

Was the study apparently free of other problems that could put it at a risk of bias?^f

Definitely yes

Probably yes

Probably no

Definitely no

Overall risk of bias

If applicable/necessary, per outcome measure^g

LOW

Some concerns

HIGH

Mangels (2009)

Probably no;

Reason: Randomization was carried out by an administration secretary of the rehabilitation hospital

who received random numbers from the study center. No further details about how these random numbers were generated and groups were unequal sizes (I: 113 / I+B: 119/ C:131)

Definitely yes;

Reason: Randomization was carried out by an administration secretary of the rehabilitation hospital

who received random numbers from the study center, and

who was not involved in further treatment decisions. Therefore, treatment was allocated in a blind way. A list of a random sequence was prepared at the beginning of the

study specifying the sequence of the 3 treatment conditions;

subsequent patients fulfilling the inclusion criteria were

allocated to the condition indicated on the list.

Definitely no;

Reason: patients were not blinded and statistical analyses were not performed blind to treatment condition

Probably yes;

Reason: drop out was low and comparable between the groups (6 or 7%)

Probably yes;

Reason: all outcomes described in the Methods section are reported, no trial registration or study protocol available.

Probably no;

Reason: For the behavioral-medical condition with subsequent booster sessions, 8 patients refused to participate in this

aftercare treatment program before commencement; they were, however, willing to participate at follow-up assessment. Reasons for refusal were having no time or no need for further support. Six patients dropped out after the first or second session owing to the same reasons as described

above.

HIGH (Comparison:
 inter vs inter)

Reneman (2020)

Definitely yes;

Reason: Patients were stratified on work status (paid work or unpaid/no

work), resulting in two strata. For each stratum, blocks of six were

used. Randomisation was generated by using a computer random

generator.

Definitely yes;

Reason: Sequentially numbered, sealed, opaque envelopes

were used for each stratum. Patients were sequentially and

randomly assigned to the two groups by an independent person.

Probably yes;

Reason: Patients were blinded for allocation. They were unaware of the treatment duration they were supposed to receive in care as usual, and, therefore, they were blinded for allocation to care as usual or short form. Patients were an outcome assessor for outcome measurements

since they filled in the PDI and other questionnaires.

They were blinded for baseline scores. Clinicians could not be blinded for intervention for the 20 weeks duration because this part only

exists in the care as usual group.

Definitely no;

Reason: 72/99 patients (73%) in the short form group and 81/102 patients (79%) in the usual care group received the allocated intervention

54 patients in the short form group and 58 patients in the usual care group with complete data were included in the analysis

Probably yes;

Reason: disability and QoL were included in the trial registration.

Work productivity was also included in the trial registration but was not reported in this paper.

Probably no;

The trial was stopped prematurely because of an a-priori stopping rule.

HIGH

Schmidt (2020)

Definitely yes;

A computer-generated randomization with 1:1

allocation in random blocks of six ensuring allocation concealment was performed by the research assistant. Randomization was stratified on the basis

of disability at baseline using the Oswestry

Disability Index score with cutoff at 41 in order to achieve approximate balance in mean disability levels

in the arms of the trial.

Probably yes;

Reason: The research assistant

informed patients about intervention allocation and

the dates for their allocated rehabilitation programme.

Probably no;

Reason: Blinding of patients and providers was not possible due to the nature of the interventions. In

order to ensure patients had equal expectations about each rehabilitation programme, we attempted to blind participants to the hypothesis by informing them that the trial aimed to compare two rehabilitation programmes that meet current recommendations.

The researcher who performed the statistical analysis was blinded.

Definitely no;

Reason: only 65/82 patients (79%) in the existing rehabilitation programme and 67/83 patients (81%) in the integrated rehabilitation programme were included in the analysis

Definitely yes;

Reason: outcomes in line with the Methods section and the trial registration

No information;

Some concerns