Ref no. (Year) Design [Grading] | CF-intervention | Comparison condition(s) | Between-group difference Mean (SD) Pain Intensity | Intervention’s influence: pain intensity | Between-group difference Mean (SD) Physical functioning | Intervention’s influence: Physical functioning |
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[35] (2011) RCT [Excellent] | Motivational Enhancement Treatment (MET) + PT: (n = 38) included proxy efficacy, treatment expectancy, therapeutic alliance, and empathy, combined with physical therapy | PT (n = 38): 30-min physical therapy (PT) sessions for 8 weeks, including 15 min of interferential therapy and a tailored back exercise programme. Dummy MET included general communication (non-counselling) skills | MET + PT Post: M = 3.3 (± 2.1) 1-month: M = 3.1 (± 2.1) PT only: Post: M = 3.6 (± 2.4) 1-month: M = 3.9 (± 2.5) | MET + PT ~ PT (p = .50) 95% C.I. [− 1.09 to 0.54] MET + PT larger reduction in pain intensity than PT-alone but non-significant | MET + PT Post: M = 6.3 (± 4.8) 1-month: M = 5.6 (± 4.5) PT only M = 7.2 (± 5.6) 1-month: M = 7.6 (± 6.4) | MET + PT ~ PT (p = .424) 95% C.I. [− 2.83 to 1.44] MET + PT larger reduction in physical disability than PT-alone but non-significant |
[36] (2013) RCT [Excellent] | Cognitive Functional Therapy (CFT) (n = 51): focuses on reframing back pain in a person-centred manner along with altering maladaptive/unhelpful behaviours to normalise movement | MT-EX (n = 43): consisted of manual therapy and exercise which included joint mobilisation or manipulation applied to the spine or pelvis; most patients (82.5%) were given exercises or a home exercise programme | CFT Post: M = 1.7 (± 1.7) 1-year: M = 2.3 (± 2.0) MT-EX Post: M = 3.8 (± 1.9) 1-year: M = 3.8 (± 2.1) | CFT > MT-EX Post: (p < .001) MDiff = − 2.1 95% C.I. [− 2.7 to − 1.4] 1-year: (p < .001) MDiff = − 1.3 95% C.I. [− 2.1 to − 0.5] Effect size unreported | CFT Post: M = 7.6 (± 6.7) 1-year: M = 9.9 (± 9.8) MT-EX Post: M = 18.5 (± 8.1) 1-year:M = 19.7 (± 11.7) | CFT > MT-EX Post: (p < .001) MDiff = − 9.7 95% C.I. [− 12.7 to − 6.7] 1-year: (p < .001) MDiff = − 8.2 95% C.I. [− 12.6 to − 3.8] Effect size unreported |
[37] (2014) RCT (2 × 2) [Excellent] | Enhanced versus limited therapeutic alliance (TA) following active or sham interferential current therapy (IFC) | Variation of CFs: Enhanced TA ( E ): AE: Active IFC (n = 29) SE: Sham IFC (n = 29) Limited TA ( L ): AL: Active IFC (n = 30) SL: Sham IFC (n = 29) | Significant differences between the SL and the AL, AE & SE groups Compared to SL (Sham IFC/Limited TA) mean differences were: AE: MΔ = 2.3 SE: MΔ = 1.19 AL: MΔ = 0.8 | ( p < .01) Dose response AE > SL: d = 2.51 Enhanced > Limited TA SE > SL: d = 1.73 AE > AL: d = 1.36 Active > Sham IFC AE > SE: d = 1.0 AL > SL: d = 0.89 | Not applicable | Not applicable |
[38] (2022) RCT [Excellent] | PRT (n = 50): Pain Reprocessing Therapy (PRT) aims to shift patients’ beliefs about the causes and threat value of pain | TAU (n = 50): Treatment as usual; Participants were given no additional treatment and agreed to continue their ongoing care as usual and not start new treatments before the post-treatment assessment | PRT Post: M = 1.18 (± 1.24) 1-year: M = 1.51 (± 1.59) TAU Post: M = 3.13 (± 1.45) 1-year: M = 3.0 (± 1.77) | PRT > TAU Post: (p < .001) g (SE) = − 1.75 (0.24) 1-year: (p < .001) g (SE) = − 1.05 (0.24) | PRT Post: M = 10.14 (± 10.6) 1-year: M = 11.16 (± 13.1) TAU Post: M = 20.68 (± 10.7) 1-year: M = 18.78 (± 12.6) | PRT > TAU Post: (p < .001) g (SE) = − 1.70 (0.26) 1-year: (p < .001) g (SE) = − 0.83 (0.24) |
[39] (2019) RCT [Excellent] | OLP (n = 63): Open-label placebo pills, social learning with TAU | TAU (n = 59): Treatment as usual (TAU) patients received no intervention (no further description provided) | OLP + TAU: Post: MΔ = –0.62 (± SE = 0.23) TAU: Post: MΔ = 0.11 (± SE = 0.17) | OLP + TAU > TAU Post: (p = .001) d = –0.44 | OLP + TAU: Post: MΔ = 23.21 (SE ± 1.59) TAU: Post: MΔ = 0.65 (± SE = 1.15) | OLP + TAU > TAU Post: (p = .02) d = –0.45 |
[40] (2016) RCT [Excellent] | OLP (n = 41): Open-label placebo pills, verbal suggestions, social learning with TAU | TAU (n = 42): Treatment as usual in an outpatient pain unit of a general public hospital (no further description of treatment provided) | OLP + TAU: MΔ = 1.49 (± 1.68) TAU: MΔ = 0.24 (± 1.61) | OLP + TAU > TAU Post: (p < .001) g = 0.76 | OLP + TAU: MΔ = 2.86 (± 3.91) TAU: MΔ = 0.02 (± 3.73) | OLP + TAU > TAU Post: (p < .001) g = 0.74 |
[41] (2017) RCT (Cluster) [Excellent] | Communication Style and Exercise Compliance in Physiotherapy (CONNECT) (n = 108): Enhancing physiotherapists’ communication skills to alter unhelpful patient beliefs and improve motivation | TAU (n = 99): Treatment as usual; publicly funded physiotherapy with no restrictions on the number of sessions or the type of treatment the physiotherapist administered | CONNECT Post: MΔ = − 1.53 (± 2.71) 24 weeks: MΔ = − 1.53 (± 2.78) TAU Post: MΔ = − 1.31 (± 2.36) 24 weeks: MΔ = − 1.18 (± 3.19) | CONNECT ~ TAU (p = .75) MDiff = − 0.10 95% C.I. [− 0.71 to 0.51] d = − 0.04 | CONNECT Post: MΔ = − 3.48 (± 5.72) 24 weeks: MΔ = − 4.87 (± 5.86) TAU Post: MΔ = − 2.82 (± 5.77) 24 weeks: MΔ = − 4.09 (± 5.95) | CONNECT a ~ TAU (p = .60) MDiff = − 0.36 95% C.I. [− 1.68–0.96] d = − 0.08 |
[42] (2010) RCT [Good] | ED (n = 18): Pain biology education for the management of cLBP | Variation of CFs: ED-EX (n = 20): Pain biology education plus six weekly exercise sessions (in a group format) | ED Post: MΔ = − 30.9 ED-EX Post: MΔ = − 4.2 | ED > ED-EX (p = .025) | ED Post: MΔ = − 7.5 ED-EX Post: MΔ = − 3.8 | ED ~ ED-EX (p = .127) |
[43] (2020) RCT [Good] | OLP (n = 26): Open-label placebo pills, verbal suggestions, with TAU (advice, education, reassurance, self-management) | TAU (n = 26): Treatment as usual included advice to remain active, along with education and reassurance in addition to a psychological education self-management strategy to improve pain-related disabilities | OLP + TAU: Post: MΔ = –0.9 (± 1.8) 12-weeks: MΔ = –1.1 (± 1.9) TAU: Post: MΔ = –0.2 (± 1.8) 12-weeks: MΔ = –0.8 (± 1.9) | OLP + TAU ~ TAU Post: (p = .19) d = 0.38 12-weeks: (p = .18) ηp2 = 0.04 | OLP + TAU: RMDQ: MΔ = –2.2 (± 2 .9) TUG: MΔ = –0.7 (± 1.0) 12-weeks: RMDQ: MΔ = –3.3 (± 3.2) TUG: MΔ = –0.62 (± 1.5) TAU: RMDQ: MΔ = –1.4 (± 3.6) TUG: MΔ = –0.7 (± 1.5) 12-weeks: RMDQ: MΔ = –2.3 (± 3.2) TUG: MΔ = –1.1 (± 1.1) | OLP + TAU ~ TAU RMDQ: (p = .40) d = 0.24 TUG: (p = .98) d = 0.01 12-weeks RMDQ: (p = .37) ηp2 = 0.02 TUG: (p = .28) ηp2 = 0.03 |
[44] (2021) RCT [Good] | ED + TA (n = 74): Patient education (ED) relating to return to daily activities, advice on coping with pain, a clear explanation of signs and symptoms with an emphasis on increasing empathy and therapeutic alliance (TA) | Variation of CFs: ED only (n = 74): the same structured patient education sessions (ED) but with no emphasis on enhancing the patient-practitioner relationship No ED (n = 74): Patients received no-education and were advised not to seek treatment in the first month after randomisation | ED + TA vs ED only Post: MDiff = 0.09 6-mo: MDiff = 0.61 1-year: MDiff = − 0.02 ED + TA vs No ED Post: MDiff = 0.06 6-mo: MDiff = − 0.05 1-year: MDiff = 1.40 ED only vs No ED: Post: MDiff = 0.15 6-mo: MDiff = 0.55 1-year: MDiff = 1.37 | ED + TA ~ ED only ns: (p-values unreported) ED + TA > No ED 1-year: (p < .05) Post & 6-months: ns ED only > No ED 1-year: (p < .05) Post & 6-months: ns Effect sizes unreported | M Diff PSFS/ODI ED + TA vs ED only Post: MDiff = 0.46/1.90 6-mo:MDiff = 0.52/1.27 1-yr: MDiff = 0.40/2.26 ED + TA vs No ED Post: MDiff = − 1.41/4.39 6-mo:MDiff = − 1.21/5.30 1-yr: MDiff = − 1.69/9.26 ED only vs No ED Post: MDiff = − 0.95/2.48 6-mo:MDiff = − 0.68/4.02 1-yr: MDiff = − 1.29/7.00 | ED + TA ~ ED only ns: (p-values unreported) ED + TA > No ED PSFS: ( p < .05) Post, 6-months, 1-year ODI: ( p < .05) 6-months, 1-year ED only > No ED PSFS: ( p < .05) Post, 1-year ODI: ( p < .05) 1-year Effect sizes unreported |
[45] (2017) RCT (2 × 2) [Good] | Manipulating patient’s pain expectations using an inert solution/labelling, verbal instructions, and classical conditioning (CC) | Variation of CFs: Opioid Instruction (OI) (Deceptive/Hidden) With CC: (n = 12) No CC: (n = 12) Placebo Instruction (PI) (Truthful/Open-Label) With CC: (n = 12) No CC: (n = 12) | Post: (Day 1) Opioid Instruction With CC: M = 1.92 (± 1.73) No CC: M = 3.00 (± 2.73) Placebo Instruction: With CC: M = 4.58 (± 2.31) No CC: M = 5.83 (± 1.95) | Deception > Truth ( p = < .01)* Dose–response: Deception (OI) With CC: d = 1.83* No CC: d = 0.83* Truthful (PI) With CC: d = 0.32; ns No CC: d = − 0.64* (nocebo effect) | Post: (Day 1) Opioid Instruction With CC: M = 77.22 (± 15.43) No CC: M = 67.78 (± 29.24) Placebo Instruction: With CC: M = 53.89 (± 24.03) No CC: M = 44.44 (± 15.66) | Deception > Truth ( p = < .01)* Dose–response: Deceptive: (OI) With CC: d = − 0.92* No CC: d = − 0.59* Truthful: (PI) With CC: d = − 0.17 No CC: d = 0.43 |
[46] (2019) RCT (2 × 2) [Good] | Manipulating patient’s pain expectations using an inert drain dressing infusion with mirrors/labelling, verbal instructions, and either placebo or nocebo conditioning (PC or NC) | Variation of CFs: Sham “Opioid” Infusion: Placebo Conditioning (PC): (n = 17) Sham only (SO): (n = 21) Nocebo Conditioning (NC): (n = 21) Natural History (NH): (n = 14) no sham infusion (waiting only) nor any classical conditioning | Post infusion: (Day 1) PC: M = 3.24 (± 2.48) SO: M = 2.43 (± 1.88) NC: M = 3.57 (± 2.27) NH: M = 5.00 (± 2.35) Post infusion: (Day 8) PC: M = 3.41 (± 2.52) SO: M = 2.57 (± 2.22) NC: M = 3.48 (± 2.18) NH: M = 5.36 (± 1.98) | Sham Infusion > NH PC & SO ( p = < .001) NC ( p = < .01) PC: η2 = 0.38 SO: η2 = 0.56 NC: η2 = 0.21 NH: ( p = .92) NH: η2 = 0.01 | Post infusion: (Day 1) PC: M = 72.54 (± 29.2) SO: M = 77.46 (± 21.4) NC: M = 73.33 (± 23.2) NH: M = 54.76 (± 23.7) Post infusion: (Day 8) PC: M = 76.86 (± 29.2) SO: M = 78.73 (± 22.5) NC: M = 78.73 (± 18.0) NH: M = 53.86 (± 23.0) | Sham Infusion > NH SO ( p = < .01) PC & NC ( p = < .05) PC: η2 = 0.15 SO: η2 = 0.27 NC: η2 = 0.20 NH: ( p = .63) NH: η2 = 0.03 |
[47] (2017) CCT [Excellent] | Enhanced Transtheoretical Model Intervention (ETMI) (n = 94): focusing on therapists’ communication skills; improving TA using empathy, active listening; addressing low motivation, self-efficacy, and addressing maladaptive beliefs/behaviours | Conventional physical therapy (PT (n = 95)) treatments: mobilisation, manipulation, back exercises, postural training, back school, electrical stimulation, shortwave diathermy, cooling, and stretching | Average Pain Post: MΔ = 0.6 95% C.I. [− 0.2 to 1.4] Follow-up: MΔ = 0.9 95% C.I. [− 0.03 to 1.8] Worst Pain Post: MΔ = 0.10 95% C.I. [− 0.8 to 1.2] Follow-up: MΔ = 1.2 95% C.I. [0.05 to 2.3] | ETMI ~ PT Post: (p = .10) Follow-up: (p = .06) Worst pain ETMI > PT Post: (p = .70) Follow-up: (p = .04) Effect size unreported | Post: MΔ = 1.3, 95% C.I. [− 0.3 to 3.0] Follow-up: MΔ = 2.7 95% C.I. [0.9 to 4.5] | ETMI ~ PT Post: (p = .10) ETMI > PT Follow-up: (p = .004) d = 0.54 |
[48] (2012) CCT [Good] | Intervention (n = 93) focused on patient’s illness and treatment beliefs and their information needs | TAU (n = 95): Treatment as usual; inpatient musculoskeletal rehabilitation which is typically multimodal and multidisciplinary | Intervention M = 42.91 (± 21.50) TAU M = 42.26 (± 20.77) | Intervention ~ TAU (p = .319) | Intervention M = 30.98 (± 15.70) Control M = 31.46 (± 16.19) | Intervention ~ TAU (p = .412) |
[49] (2018) CCT [Fair] | Adding one weekly group-based physical therapy session in a rehabilitation setting compared to home treatment alone | Variation of CFs: Rehab (n = 13): Weekly group-based physical therapy session involving exercises Home (n = 17): No physical therapy supervision | Post-treatment MDiff = − 0.9 95% C.I. [− 2.3 to 0.5] | Rehab ~ Home (p = .655) | Post-treatment MDiff = − 0.2 95% C.I. [− 3.8 to 3.3] | Rehab ~ Home (p > 0.999) |