Skip to main content

Table 2 Summary of randomised clinical trials included in this review

From: Management of patellofemoral joint osteoarthritis using biomechanical device therapy: a systematic review with meta-analysis

Author

Type of study

Sample size

Participants

Intervention

Comparator

Outcome measure

Results

Callaghan et al. [13]

Randomised controlled trial

n = 126

M=54 (43%)

F=72 (57%)

PFJ OA.

Mean age 55.5 years (SD 7.5).

K-L score 2/3.

PFJ symptoms (stairs/ rising from chair).

3 months of daily pain scoring >40/100 on VAS. Painful palpation of patella facets.

BMI=31

Brace with or without strap (participants preference) worn for mean 7.4 hours a day for 6 weeks.

No brace.

VAS (knee pain in last 7 days during nominated activity).

Change in PF BML.

Secondary: KOOS-pain and KOOS-ADL.

At 6 weeks, between groups adjusted mean differences

(VAS: −1.3 cm (95%CI −2.0 to −0.7; p<0.001)

PF BML volume: −490.6 mm3, 95%CI −929.5 to −51.7; p = 0.03)

KOOS-pain 5.7 (95% CI: 0.6 to10.8, p = 0.03

KOOS-ADL 4.5, (95%CI; 0.5 to 8.5, p = 0.03)

Callaghan et al. [14]

Within subjects crossover design with randomised order.

n = 30

M=13 (43%)

F=17 (57%)

PFJ OA

Mean age 57 years (SD 7.8).

Mean BMI 27.8 (SD 4.2)

K-L score 2/3

PFJ symptoms (stairs/ rising from chair)

3 months of daily pain scoring 40/100 on VAS. Painful palpation of patella facets.

Weight-bearing MRI with brace.

Weight-bearing MRI with no brace.

Patella position measured on MRI.

Mean difference between groups

Lateral PFJ contact area: (0.94 cm2, 95%CI 0.07 to 1.8

p=0.04)

PFJ lateral distance −0.06 cm 95%CI-0.12, to -0.01

(p=0.03).

Callaghan et al. [15]

Randomised controlled trial

n = 108

M=49 (45%)

F=59 (55%)

PFJ OA

Mean age 55.5 years

K-L score 2/3

PFJ symptoms (stairs/ rising from chair)

3 months of daily pain VAS >40/100.

BMI=30.7

Brace worn for 7.4 hours a day on average for 6 weeks.

No brace

Isometric MVC to assess quadriceps muscle strength and AMI.

At 6 weeks: between group difference in MVC

(9.09 Nm; 95%CI: −4.89 to 23.07) between group difference in AMI −8.62%; 95% CI: -13.90% to -3.33%)

Crossley et al. [16]

Within subject design with randomised order.

n = 14

M=2 (14%)

F=12 (86%)

Predominant PFJ OA.

Mean age 56.9 (SD 7.4).

Mean BMI 27.6 (SD 3.4).

Anterior knee pain with stairs, squatting, rising from sitting. Tenderness peripatellar region. Radiographic evidence of osteophytes or severity grade ≥2

Tape

No tape

Patella position on MRI.

VAS (pain on performing single leg squat x5).

Immediate pre post rape within groups mean differences

patella lateral displacement (2.94% 95%CI: 0.37 to 5.51 p=0.028)

Bisect offset: 0.58% (95%CI: -3.35 to 4.5 p=0.757)

patellar lateral tilt angle: -3.570 (95%CI: 2.14 to 4.19 p<0.001)

VAS pain: -15.3mm, 95%CI: 0.4 to 30.3 p=0.045).

Crossley et al. [17]

Randomised Controlled Trial.

n = 92

M=39 (42%)

F=53 (58%)

PFJ OA.

Mean age: 54.5 (SD 10 years).

BMI: 27.6

3/10 pain VAS during PFJ loading activities (using stairs/rising from sitting or squatting) and on most days in the past month.

Evidence of PFJ osteophytes on radiograph.

PFJ targeted programme that combined exercise, education, manual therapy and taping.

8 treatments of 60-minute duration over a 12-week period.

Control group: physiotherapist delivered, single-patient osteoarthritis education.

8 treatments of 60-minute duration over a 12-week period + home exercises

Perceived GRoC,

VAS pain during aggravating activity.

KOOS

At 3 months: superior GRoC outcomes intervention group (much improved n = 20/44): control (much improved: n = 5/48).

VAS (mean difference -15.2mm 95% CI: -27 to -3.4)

KOOS –ADL (mean difference 5.8; 95% CI: −0.6–12.1)

KOOS pain (mean difference 6; 95%CI: 0.1 to 12.6)

KOOS symptoms (mean difference

3;96%CI -3.1 to 8.9)

KOOS sport (mean difference 8.7; 95% CI -1.2 to 18.6)

KOOS QoL (mean difference -0.1; 95% CI: -7.1 to 7)

No significant VAS or KOOS differences at 9 months.

Cushnaghan et al. [18]

Within subjects crossover trial with randomised order

N = 14

F=10

M= 4

Anterior knee pain on walking and with using

steps and stairs.

Radiographic PFJ OA predominant in lateral facet. Concomitant TFJ OA in all subjects.

Mean age 70.4yrs (range 55–84)

Disease duration 12.5yrs

1. Medial directed patellar taping

2. lateral directed patellar taping

4 days for each tape condition

Neutral taping

4 days for each tape condition

VAS knee pain

At day 4:

Mean difference neutral v medial tape =15.5mm (95%CI 2.4 to 28.6, p=0.023)

Mean difference neutral v lateral tape at day 4 = -8mm (95%CI -22.5 to 6.5)

Kumar & Ganesh [20]

Randomised trial

n = 60

M/F not stated

Radiographic PFJ OA with anterior knee pain

VAS knee pain equal and greater than 3cm

Age not stated

Short wave diathermy + joint mobilisations + isometric exercises + medial patellar taping

Short wave diathermy + joint mobilisations + isometric exercises + lateral patellar taping

Knee pain VAS

WOMAC

Lateral taping group “highly significant” compared to medial taping group for VAS and WOMAC (p=0.0001)

Hunter et al. [19]

Randomised crossover trial

n = 80

M=17 (21%)

F=63 (79%)

Lateral PFJ OA or mixed lateral PFJ with concomitant TFJ OA but demonstrates source of symptoms is PFJ with anterior knee symptoms on most days with stair climbing and/ or rising from a chair and patellar mobilisations.

Mean age: 60.5 (SD 9 years)

BMI 27.6

Active treatment (Treatment B):

BioSkin Q Brace with realigning T-strap for 6 week duration and mean of 4.8 hours/day, followed by a washout period (6 weeks) and then crossover to 6 weeks of brace with no strap (Treatment A).

Control (Treatment A):

BioSkin Q Brace without realigning T-strap for 6 week duration and mean of 4.3 hours a day, followed by a washout period (6 weeks) followed by 6 weeks of wearing a brace with strap (Treatment B).

Primary: VAS (average pain over previous week).

Secondary: WOMAC (pain, function, stiffness subscales).

At 6 weeks:

No significant brace treatment effect (VAS −0.68, 95% CI: −6.2 to 4.8 p= 0.81)

No significant difference between the groups for WOMAC pain, function or stiffness subscales.

Quilty et al. [21]

Randomised controlled trial

n = 87

M/F not stated

Chronic knee pain with predominant PFJ OA on radiographs (PFJ osteophytes).

Mean age: 66.8 years (SD 9.5)

BMI:30

Physiotherapy delivered treatments (exercises, patellar taping, footwear and postural advice).

9 x sessions, 30-minute duration over 10 weeks.

Control (no treatment)

Primary: VAS (overall pain during past month).

WOMAC function sub-score.

Secondary: MVC to assess quadriceps strength.

At 5 months: adjusted between means differences:

VAS -6.4mm (95% CI: -15.3 to 2.4)

WOMAC -0.6 (95% CI: -3.7 to 2.4)

no significant differences between groups at 12 months

quadriceps muscle strength at 5 months 11.7Nm (95% CI: 4.5 to 19; p = 0.002)

but not 12 months (p=0.08).

Tan et al. [22]

Randomised controlled trial

N = 26

F 16

Clinical diagnosis of PFJ OA based on NICE guidelines.

Mean age 60 (SD8)yrs

Commercially available foot orthotics

6 weeks continuous wear

Sham foot orthotic inserts

6 weeks continuous wear

Primary: feasibility of full RCT

Secondary

KOOS

AKPS

VAS

GRoC

Adjusted mean difference

(95% CI) 6 weeks:

KOOS pain: 8.1 (-6.9 to 23.1)

KOOS symptoms: 4.4 (-6.6 to 15.5)

KOOS ADL: 13.7 (0.2 to 27.2)

KOOS Sport: 25.7 (-1.7 to 53)

KOOSQoL: 11.3 (-1.4 to 24)

AKPS: 9.1

(− 8.6 to 26.8)

VAS most aggravating activity: 21.9mm (2.1 to 46.0)

Average VAS on most aggravating activity: 15.8mm (− 4.9 to 36.6)

GRoC foot orthoses group: median value 2.5(min= -1; max = 6)

GRoC sham group: median value 3(min=0; max= 6)

Tan et al. [23]

within-subject, cross-over design with randomised order

N = 21

F=14

Clinical diagnosis of PFJ OA based on NICE guidelines

mean age 58 (SD8) yrs

BMI 27.0 (SD 4.8)

Commercially available foot orthotic

Sham inserts

Primary outcome: biomechanical motion effects

Secondary outcome VAS pain

No significant immediate effects of foot orthotics compared to sham inserts on VAS pain scores

VAS mean differences (95% CI)

Level walking 4.2 (-2.9, 11.2)

Stair ascent −3.4 (-13.1 to 6.3)

Stair descent 0.7 (-11.5 to 12.9)

  1. Abbreviations: AMI arthrogenous muscle inhibition, MRI magnetic resonance imaging, OA osteoarthritis, PFJ patellofemoral joint, BMI body mass index, MVC maximum voluntary contraction, GRoC perceived global rating of change, SD standard deviation, K-L Kellgren-Lawrence, VAS visual analogue scale, KOOS-(ADL) knee injury and osteoarthritis outcome score (Activities of Daily Living), WOMAC Western Ontario and McMaster Universities Osteoarthritis Index, M males, F females, KOOS QoL knee injury and osteoarthritis outcome score (Quality of Life), NICE National Institute for Clinical Excellence