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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