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Table 2 Review of studies of manipulation and control or placebo comparison

From: Systematic review of clinical trials of cervical manipulation: control group procedures and pain outcomes

STUDY (First author name) PEDro REGION/COMPLAINT "PLACEBO" MANEUVER N (CONTROL GROUP) BLINDING CHECKED? PRIMARY OUTCOME MEASURE PRIMARY OUTCOME FOR CONTROL GROUP
Multi-session        
Sloop, 1982 [27] 8/11 Neck pain Diazepam (anamnestic) with no treatment 18 Yes For neck pain: - VAS VAS change @ 3 wks = 5 mm (±32 mm)
       - NVS NVS = 28% subjects reported treatment helped
Nilsson et al., 1997 [28] 9/11 Cervical: headache Low power laser light and deep friction massage 25 NR - headache hrs Avg HA (hrs/day ± inter4tile range) pre = 4.0; post = 2.4; Δ = -1.6 ± 2.5
       - headache intensity Avg HA intensity (mm ± inter4tile range) Pre = 41; post = 36; Δ = -4.2 ± 26
       - analgesic use Avg analgesics/day ± inter4tile range Pre = 1.0; post = 0.7; Δ = -0.3 ± 1
Bove and Nilsson, 1998 [29] 9/11 Cervical spine: Headache Low power laser light and deep friction massage (described as both an "active control" and as the "placebo" group) 37 NR pre = 2 wks post = 7 wks follow-up = 19 wks  
       -headache hrs Avg HA hrs/day (95% CI) Pre = 3.4 (2.4-4.4) post = 1.9 (0.9-2.9); Δ = -1.5 follow-up = 2.2 (1.2-3.2); Δ = -1.2
       -headache intensity (VAS) Avg HA intensity (95% CI) Pre = 37 mm (33-41) post = 34 mm (26-38); Δ = -3 follow-up = 26 mm (20-32); Δ = -11 *
       -analgesic use Avg analgesics/day (95% CI) Pre = 0.82 (0.5-1.14) post = 0.59 (0-1.49); Δ = -0.23 follow-up = 0.56 (0.22-0.9); Δ = -0.26
Tuchin et al., 2000 [15] 7/11 Cervical spine - migraines De-tuned interferential therapy 40 NR Headaches per month Avg HA/month (SD) Pre = 7.3 (6.53) post = 6.9 (6.6); ES = 0.06
       Headache intensity (VAS) Avg HA intensity VAS (SD) Pre = 7.89 (1.2) post = 6.2 (1.7); ES = 1.17 *
       Headache duration (hrs) analgesics/month Avg HA duration in hrs/episode (SD) Pre = 22.6 (27.4) post = 19.8 (17.7); ES = 0.12 Avg analgesics/month (SD) Pre = 20.1 (28.4) post = 16.2 (12.4); ES = 0.19
Alison et al., 2002 [16] 8/11 Neck and arm pain Waiting list 10 N/A -SF-MPQ Median SF-MPQ (inter4ile range) Pre = 10.0 (9.0)
       - NPQ - VAS Post = 7.5 (4.0); Δ = -2.5 * median NPQ (inter4tile range) Pre = 12.5 (4.0) Post = 11.5 (6.0); Δ = -1.0 median VAS (inter4tile range) Pre = 3.3 (3.5) Post = 3.8 (3.9); Δ = 0.5
Bakris et al., 2007 [33] 9/11 Cervical spine - hypertension Manual contact, Inappropriate direction of thrust 25 NR BP & pulse Systolic BP: Pre = 145.3; post = 142.1; Δ = -3.2 Diastolic BP: Pre = 91.0; post = 89.2; Δ = -1.8 Pulse rate Pre = 73.3; post = 73.8, Δ = -0.5
Vernon et al., 2009 [31] 9/11 Cervical spine: headache Sham manipulation with head thrust, but no segmental thrust + placebo meds 9 Yes## Reduction of headache days Outcome not reported for sham manipulation only
Borusiak et al., 2009 [34] 8/11 Cervical spine: pediatric headache Light touch/no thrust 28 Yes - % of days with HA % of days with HA (SD) Pre = 41.2 (28.5) Post = 31.8 (28.3); ES = 0.33 *
       - Duration of HA Duration of HA in hours (SD) Pre = 113.8 (115.1) Post = 107.2 (121.1); ES = 0.06
       - Intensity of HA Intensity of HA VAS (SD) Pre = 4.9 (1.8) Post = 5.0 (1.8); ES = 0.06
Haas et al., 2010 [35] 11/11 Cervical spine/cervicogenic headache Heat + light massage:   NR Numerical rating scales for: A - Headache intensity  
    Group 1- 8 sessions 20    Percentage score - Group 1: Pre = 56.8 (15.8) 12 wk = 42.0 (20.6); ES = 0.81 * 24 wk = 41.5 (18.2); ES = 0.90 *
    Group 2- 16 sessions 20   B - Neck pain Percentage score - Group 2: Pre = 58.7 (17.1) 12 wk = 49.4 (19.0); ES = 0.52 * 24 wk = 48.6 (21.4); ES = 0.52 *
        Percentage score - Group 1: Pre = 60.5 (21.4) 12 wk = 47.1 (24.2); ES = 0.59 * 24 wk = 47.2 (21.8); ES = 0.58 * Percentage score - Group 2: Pre = 48.5 (23.6) 12 wk = 42.8 (21.6); ES = 0.25 24 wk = 48.4 (23.1); ES = 0.004
Single session        
Pikula, 1999 [32] 6/11 Neck pain 1. SMT- contralateral 2. Detuned US 1-12 2-12 NR VAS neck pain 1. Contralateral manip VAS (SD) Pre = 44.1 (27.5) post = 41.4 (28.4) ES = 0.10
        2. Placebo UltraSound VAS (SD) Pre = 50.4 (22.5) post = 46.5 (21.8) ES = 0.18
Haas et al 2003 [30] 11/11 Neck pain Alternate site manipulation 52 NR Pain (VAS) Measured immediately after and later that evening (~ 6 hours) Pain VAS (SD) Pre = 40.4 (20.9) post = 24.7 (19.5); ES = 0.78 * follow-up = 28.7 (19.6); ES = 0.58 *
Buchmann et al., 2005 [17] 6/11 Cervical spine Manual contact, no rotation, no thrust 8 NR Dysfunctional motion segments Pre contact = 13 dysfunctional segments
        Post contact = 13 dysfunctional segments
Martinez-Segura et al., 2006 [18] 8/11 Cervical spine - Neck pain Manual contact, cervical rotation, no thrust 37 NR Resting neck pain (VAS) Resting neck pain VAS (SD) Pre = 5.5 (1.7) post = 5.1 (1.9) ES = 0.22
Fernandez De Las Penas et al., 2007 [19] 7/11 Cervical spine - healthy subjects Manual contact, cervical rotation, no thrust 15 NR PPT at elbow both ipsi and contral. Ipsi elbow PPT Pre = 2.3(0.4); post = 2.3 (0.5); ES = 0 Contra elbow PPT Pre = 2.3(0.5); post = 2.3 (0.6); ES = 0
Ruiz-Saez et al., 2007 [20] 8/11 Cervical spine - trapezius MTrP's Manual contact, cervical rotation, no thrust 36 NR PPT at trapezius trigger points Pre = 1.34 (0.4) Post = 1.27 (0.4); ES = -0.18 Post 5 min = 1.15 (0.4); ES = 0.48 * Post 10 min = 1.1 (0.5); ES = 0.53 *
Fernandez-Carnero et al., 2008 [21] 8/11 Cervical spine - tennis elbow Manual contact, cervical rotation, no thrust 10 NR - PPT Affected elbow PPT Pre = 314.4 (11.6); post = 327.7 (18.6) ES = 0.88 * Contralateral elbow PPT Pre = 475.2 (78.5); post = 481.2 (84.6) ES = 0.07
       - Thermal pain threshold (TPT) Affected elbow TPT ( o C) Pre = 41.1 (3.4); post = 41.8 (1.3) ES = 0.3 Contralateral elbow TPT ( o C) Pre = 44.3 (1.5); post = 43.4 (0.9) ES = 0.75
       - Pain free grip strength (PFG) PFG (KG) affected side Pre = 14.7 (6.0); post = 13.6 (6.2) ES = 0.18
Fernandez De Las Penas et al., 2008 [22] 8/11 Cervical spine- healthy subjects Manual contact, cervical rotation, no thrust 10 NR C5-C6 Z-joint tenderness (PPT) Left Z-joint PPT Pre = 316.4 (30.5); post = 311.8 (32.8) ES = 0.15 Right Z-joint PPT Pre = 315.0 (43.8); post = 312.3 (47.7) ES = 0.06
Tuttle et al., 2008 [23] 7/10 1 Cervical spine - neck pain Mobilization applied to non-symptomatic level 20 NR AROM stiffness NS decrease in flex/ext AROM NS increase in lat flex and rotation NS decrease in stiffness (data not reported; only graphic data)
Dunning and Rushton, 2009 [24] 6/10 1 Cervical spine - EMG of biceps muscle Manual contact, cervical rotation, no thrust 54 NR Biceps resting EMG 21.12% (±5%) increase in resting EMG of right bicep after sham
        17.15% (±7%) increase in resting EMG of left bicep after sham
Mansila-Ferragut et al., 2009 [25] 8/11 Upper cervical spine - neck pain Manual contact, cervical rotation, no thrust 19 NR - PPT at the sphenoid PPT (95% CI) Pre = 0.8 (0.7 - 0.9) Post = 0.7 (0.5 - 0.9); Δ = -0.1
       - Active mouth opening Active mouth opening in mm (95% CI) Pre = 36.2 (34.3 - 38.2) Post = 35.9 (33.7 - 38.0); Δ = -0.3
Sterling et al., 2010 [26] 8/11 Neck pain findings Manual contact 17 NR - PPT at C6 PPT at C6 (SD) Pre = 216.1 (103.2) Post = 253.4 (114.2); ES = 0.34 *
       - Nociceptive Flexion Reflex (NFR) threshold NFR threshold (SD) Pre = 8.0 (5) Post = 7.9 (5.4); ES = -0.02
       - VAS pain from NFR VAS pain from NFR (SD) Pre = 4.5 (3.8) Post = 3.6 (2.8); ES = 0.27
  1. VAS = visual analogue scale; NVS = numerical verbal scale; HA = headache; avg = average; inter4tile = interquartile; US = ultrasound; NR = not reported; SF-MPQ = Short-form McGill Pain Questionnaire; NPQ = Neck Pain Questionnaire; PPT = pressure pain threshold; ipsi = ipsilateral; contra = contralateral; MTrP's = myofascial trigger points; BP = blood pressure; z-joint = zygapophyseal joint; AROM = active range of motion; EMG = electromyogram.
  2. # # Reported on double placebo registration (not just for sham manipulation)
  3. * Clinically important change
  4. 1In these two studies, subjects received all treatments; intention-to-treat was not applicable: PEDro score out of 10