TITLE

Comparison between outcomes of Dry

Needling with conventional protocol and
Roods Approach with conventional
protocol on pain, strength and balance in
Knee Osteoarthritis
 INTRODUCTION
Osteoarthritis (OA) is considered to be one of the leading
causes of disability and the most frequent form of
arthritis. There exists an evidence that dry needling and
roods approach may be efficacious in reducing pain and
improving function in individuals with osteoarthritis
The purpose of this research is to compare the effectiveness of
combination of dry needling and conventional protocol
(strengthening and stretching) versus roods approach and
conventional protocol in patients with knee osteoarthritis
(OA).
 CONDITION INTERVENTIONS

Knee osteoarthritis Dry needling + conventional

protocol

Roods approach + conventional

protocol
 OBJECTIVES
To compare the effects of both interventions
(dry needling + conventional protocol and
roods approach + conventional protocol)
in patients with knee osteoarthritis on:
pain,
balance,
strength and
range of motion
deep tendon reflex
 HYPOTHESIS

EXPERIMENTAL HYPOTHESIS
There is significant difference between the outcomes of both
interventions.

NULL HYPOTHESIS
There is no significant difference between both interventions
 REVIEW OF LITERATURE
This is interventional study in which
Therapeutic knee taping is given by James Dunning, DPT, MSc,
FAAOMPT, Alabama Physical Therapy & Acupuncture and
Roods approach is proved by Rana S Hinman, Kay M Crossley,
Jenny McConnell, Kim L Bennell
which is an efficacious treatment for the management of pain
and disability in patients with knee osteoarthritis
 Article no. 1 - Efficacy of knee tape in the management of osteoarthritis
of the knee: blinded randomised controlled trial
Rana S Hinman, Kay M Crossley, Jenny McConnell, Kim L Bennell
Abstract
Objectives To test the hypotheses that therapeutic taping of the knee improves pain
and disability in patients with osteoarthritis of the knee and that benefits remain
after stopping treatment.
Design Randomised single blind controlled trial with three intervention arms
(therapeutic tape, control tape, and no tape) of three weeks duration and three
week follow up.
Setting Outcome assessment was performed in a university based laboratory. Taping
interventions were applied by eight physiotherapists in metropolitan private
practice.
Participants 87 patients with symptoms of knee osteoarthritis as defined by the
American College of Rheumatology.
Main outcome measures Primary outcome measure was pain as measured by visual
analogue scale and participant perceived rating of change. Secondary measures of
pain and disability included the Western Ontario and MacMaster Universities
osteoarthritis index, knee pain scale, and the SF-36.
Results The therapeutic tape group reported a greater reduction in pain on all primary
outcomes than either of the other two groups. A significant association was
evident between intervention andchange in pain at three weeks (P=0.000), with
73%
(21/29) of the therapeutic tape group reporting improvement compared with 49%
(14/29) of the control tape group and 10% (3/29) of the no tape group.
Significantly greater improvement in pain and disability was observed on most
secondary outcomes in the therapeutic tape group compared with the no tape
group. Benefits of therapeutic tape were maintained three weeks after stopping
treatment.
Conclusions Therapeutic knee taping is an efficacious treatment for the management
of pain and disability in patients with knee osteoarthritis.
Introduction
Osteoarthritis is a leading cause of pain and disability in elderly people worldwide and
accounts for a large proportion of visits to health professionals each year.14 Since
limited progress has been made towards curing the disease, management of
symptoms is the mainstay of treatment.5 Simple, inexpensive treatments that
increase the range of options for patients with the disease are warranted.
Physiotherapists tape the knee as short term or intermittent treatment for knee
pain. Knee taping is believed to relieve pain by improving alignment of the
patellofemoral joint and/or unloading inflamed soft tissues.6 The American
College of Rheumatology recommends knee taping for patients with osteoarthritis,
but there is little evidence to justify its use.5 7 One study of medial patellar tape
applied for four days in a small cohort with patellofemoral joint disease showed a
25% reduction in pain.8 We aimed to
establish the effect of therapeutic knee taping on pain and disability in patients with
symptoms of knee osteoarthritis and to determine if any benefits could be
maintained after stopping treatment
Methods
Participants and group assignment
Volunteers from the community responded to advertisements in local papers.
Inclusion criteria were based on the clinical and radiological classification criteria
of the American College of Rheumatology (presence of osteophytes, age over 50
years, and pain in the knee).9 Exclusion criteria were allergy to tape or history
of joint replacement, symptoms or signs suggestive of another cause of knee pain,
physiotherapy for the knee (previous six months), body mass index > 38 (owing to
difficulties of taping the knee effectively), rheumatoid arthritis, steroid injection or
knee surgery (previous six months), history of knee taping, and fragile skin
around the knee. All participants gave written informed consent. They were assigned
by block randomisation (blocks of three), stratified according to sex, to receive
either therapeutic tape, control tape, or no tape. An independent researcher not
involved in outcome assessment was responsible for group allocation, using a
computer generated random number table. Immediately after baseline
assessment by the blinded assessor, the treating physiotherapist accessed the
allocation schedule from a centrally located locked cabinet
Protocol
The trial comprised a three week intervention period and a three week follow up
(fig 1). Participants were assessed before treatment (baseline), after three weeks of
treatment (final assessment), and at six weeks (follow up).
Tape was applied by 12 trained physiotherapists at the university (n=4) and in private
practice (n=8) around the metropolitan region. The tape was worn for three weeks and
reapplied weekly. Skin was shaved before application. Therapeutic tape provided medial
glide, medial tilt, and anteroposterior tilt to the patella (fig 2). As
inflamed soft tissue is aggravated by stretch, tape was also applied to unload either the
infrapatellar fat pad or the pes anserinus (determined by clinical assessment
to ascertain the most tender).6 Hypoallergenic undertape (Fixomull stretch; Beiersdorf,
North Rhyde, NSW) was applied beneath the rigid tape (Leuko Sportstape Premium
Plus; Beiersdorf) to prevent irritation of the skin. Control tape aimed to provide sensory
input only. Hypoallergenic tape alone was laid over the same areas of skin as the
therapeutic tape. Participants allocated to the no tape group received no intervention.
All participants continued current treatments
but were instructed to refrain from starting new ones. Analgesic use was recorded in a
diary.
Masking
Participants were unaware of which taping technique was considered therapeutic.
Assessments were performed by one assessor (RH), who remained blinded to
treatment allocation until after statistical analyses. Participants were instructed not to
discuss groupallocation with the assessor, and the tape was removed by the participant
before final assessment.
Outcome measures
Primary outcome
The primary outcome was change in pain, measured on an 11 point, 10 cm horizontal
visual analogue scale, numbered in 1 cm increments.10 Participants rated the
average severity of knee pain, over the previous week, on movement and during an
aggravating activity nominated by the participant, by selecting an appropriate
whole number. Participant perceived rating of change in pain was recorded on a 5
point Likert scale ranging from 1 (much worse) to 5 (much better). Participants
with scores of 4 or 5 were considered improvers.
Secondary outcomes
Secondary measures of pain included the pain subscale of the Western Ontario and
MacMaster Universities osteoarthritis index, the knee pain scale, and the bodily
pain domain of the SF-36.1113 Disability was measured on a visual analogue
scale (average restriction of activity), the physical function subscale of the
osteoarthritis index, and the physical function and role domains of the SF-36.
Sample size and statistical analysis
A change in pain of 1.75 cm on the visual analogue scale has been recommended as
the minimum clinically important difference in trials of knee osteoarthritis.14 With
81 participants, our study had 80% power to detect a change in pain of 1.75 cm
between the therapeutic tape and no tape groups, assuming a change of 1 cm in the
control group and a standard deviation of 2 cm with a significance level of 5%. We
increased the numbers to 87 to allow for dropouts.
Analyses were performed with SPSS software on an intention to treat basis. Baseline
comparability between groups was determined with one way analysis of variance,
Kruskal-Wallis tests, or 2 tests. For each participant, change in scores from baseline
was calculated at three weeks (final assessment) and at six weeks (follow up).
Mean difference in change in scores and 95% confidence intervals were calculated
between groups at these time points.We analysed participant perceived rating of
change with the 2 statistic and determined the relative risk of being an improver.
The effect size of therapeutic tape (relative to no tape) was calculated.
Results
Between July 2001 and April 2002, we screened 325 volunteers from the community.
Of these, 87 met the selection criteria and were enrolled into our study. Twenty
nine participants were randomised to each of the three intervention groups. All
participants completed the intervention as allocated. One participant (no tape
group) withdrew to seek treatment for the knee and was unable to return for
follow up. Groups did not differ significantly at baseline for personal characteristics
or outcome measures (tables 1 and 2).
Secondary outcome measures
The therapeutic tape group experienced a significantly greater reduction in pain and
disability on most secondary outcomes than the no tape group. Although control
tape achieved small beneficial effects, most differences were not significantly
different from no tape. Although therapeutic tape seemed more effective than
control tape, differences were small for most outcomes and were not statistically
significant. However, at six weeks both tape groups showed significant
improvements from baseline compared with the no tape group.
Compliance, cointerventions, and adverse effects
Minor skin irritations affected eight (28%) participants in the therapeutic tape group
and one (3%) participant in the control tape group, but all participants continued
to wear the tape as prescribed. One participant (no tape group) underwent
corticosteroid injection for the knee during the intervention period, and one
participant (drop out from no tape group) sought alternative treatment after the
intervention period. No differences were found in analgesic use between groups
over the intervention period (28% no tape (eight participants), 14% control tape
(four), and 31% therapeutic tape (nine), 2 test P=0.27).
Discussion
Therapeutic knee tape reapplied weekly and worn continuously for three weeks
significantly improved pain and disability in patients with osteoarthritis of the
knee. This effect was greater than that observed with control tape and was of a
magnitude considered clinically significant.14 Furthermore, benefits may be
maintained three weeks after stopping treatment
Primary outcome measures
After intervention the therapeutic tape group showed a significantly greater reduction
in pain than the control and no tape groups (table 2). Effect sizes were large. A
small, although non-significant, benefit of control tape was observed. On most
comparisons at six weeks, a significantly greater reduction in pain from baseline
was evident in the therapeutic tape group. This indicates a prolonged effect of
therapeutic tape three weeks after stopping treatment (fig 3). An association was
evident between group and perceived improvement in pain after three weeks (2
test P=0.000; fig 4), with 21 (73%) participants in the therapeutic tape group reporting
improved pain compared with three (10%) in the no tape group (95% confidence
interval of difference 42% to 82%), and corresponding to a number needed to treat of
2 ( 1.8 to 2.2). Compared with no tape group, the therapeutic tape group was
seven times more likely to report improved pain (relative risk 7.00, 2.34 to 20.92),
and the control tape group was four and a half times more likely (4.67, 1.50 to
14.53).
Only one previous study evaluated the effects of knee tape in a population with
osteoarthritis.8 Despite the limitations of that trial (small sample, lack of untaped
control group, short intervention period, and limited outcome measures), a 25%
reduction in pain was observed in patients with patellofemoral joint disease after
taping of the patella medially for four days.8 We achieved a greater reduction in
pain (38-40%) with therapeutic tape, probably because of our different protocol.
Our study expands on previous findings by showing improvements in both pain
and physical function using a battery of outcome measures.
Morem importantly, we observed beneficial effects of knee taping in people with
generalised, non-specific degeneration of the knee joint. Our cohort comprised
patients with both varied severity of disease, as shown by radiography, and varied
involvement of the patellofemoral joint. Contrary to the previous trial, some of our
participants had only tibiofemoral joint disease, highlighting the generalisability of this
intervention to the wider population with osteoarthritis.8 Our study provides the
first evidence of the prolonged effects of knee taping in the short term, once
treatment has stopped.
Strengths and limitations of study
A strength of our study is the general applicability of the therapeutic taping technique.
Numerous physiotherapists, of varying ages and skill level, representative of those
working in private practice, applied the intervention. The results suggest that
specialist physiotherapists are not required for this intervention to be effective.
The effect sizes were generally medium to large for most outcome measures,
comparable with those reported for exercise programmes, physiotherapy
regimens, and drug therapies.7 1618 Patients may be taught to tape their own
knee, providing them with a self management strategy. Further research is needed
to confirm the effectiveness of such management. The main limitation of our study
was its short duration, although in clinical practice taping is viewed as a short term
and intermittent treatment strategy, generally used as an adjunct to exercise and
drug therapies in knee osteoarthritis. Taping is particularly useful for patients
pursuing potentially aggravating activities. Nevertheless, as knee osteoarthritis is a
chronic disease, studies evaluating the long termeffects of knee taping are also
required.
Our cohort comprised volunteers from the community, which explains the large number
excluded. Participants had moderately severe osteoarthritis, as assessed by radiography, and
reported moderate levels of pain and disability. More women than men were enrolled. We
believe that our cohort reflects patients with knee osteoarthritis presenting to health
practitioners. Although patients who volunteer for research may be more motivated than
those recruited from waiting lists, and thus more likely to report positive outcomes, the lack
of significant change in the control tape group suggests that benefits with therapeutic tape
were owing to the intervention. We cannot generalise our results to some patient subgroups.
These include obese individuals and those with fragile skin or allergies to tape. It is not
known how taping relieves pain. Our three way randomisation protocol represents an
advance on previous methods, allowing specific effects of tape to be compared with both the
placebo effects of the intervention and the clinical course of knee osteoarthritis. Although a
placebo effect was evident on secondary outcomes at six weeks, the superiority of
therapeutic tape over control tape on primary outcomes at both time points showed that
therapeutic tape has a direct effect on knee pain that cannot be attributed to placebo
(attention by physiotherapist, close monitoring, novel treatment) or cutaneous stimulation
alone. Subtle changes in patellar position may alter the magnitude or distribution of
patellofemoral joint pressures or stress on joint structures.6 Unloading the fat pad may
reduce strain on this often inflamed soft tissue.19 Changes in proprioceptive acuity,
quadriceps strength, and neuromotor control of the knee with taping have been described in
other populations.
 Article no.2- Dry Needling Versus Conventional Physical
Therapy in Patients With Knee Osteoarthritis
Further study details as provided by James Dunning, DPT, MSc,
FAAOMPT, Alabama Physical Therapy & Acupuncture

Purpose
The purpose of this research is to compare the effectiveness of conventional physical
therapy (manual physical therapy, exercise, range of motion, and stretching) versus
conventional physical therapy combined with dry needling in patients with knee
osteoarthritis (OA). Physical therapists commonly use conventional physical
therapy techniques and dry needling to treat knee OA, and this study is attempting
to find out if the addition of dry needling to conventional physical therapy has an
equal, greater, or lesser effect than conventional physical therapy alone.
condition intervention
Knee Osteoarthritis Other: Dry Needling, Conventional PT
Other: Conventional PT
Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment

Official Title:
Dry Needling Versus Conventional Physical Therapy in Patients With Knee
Osteoarthritis: a Multi-center Randomized Clinical Trial
Primary Outcome Measures:
Change in Knee Pain Intensity (NPRS) [ Time Frame: Baseline, 2 Weeks, 6 Weeks, 3
Months ]
Change in Knee Osteoarthritis Index (Pain) [ Time Frame: Baseline, 2 Weeks, 6
Weeks, 3 Months ]
5 Questions each worth 0-4 points with a maximum score of 20 points possible
Change in Knee Osteoarthritis Index (Stiffness) [ Time Frame: Baseline, 2 Weeks, 6
Weeks, 3 Months ]
2 Questions each worth 0-4 points with a maximum score of 8 points possible
Change in Knee Osteoarthritis Index (Physical Function) [ Time Frame: Baseline, 2
Weeks, 6 Weeks, 3 Months ]
17 Questions each worth 0-4 points with a maximum score of 68 points possible
Change in Knee Osteoarthritis Index (Total) [ Time Frame: Baseline, 2 Weeks, 6
Weeks, 3 Months ]
24 Questions each worth 0-4 points with a maximum score of 96 points possible

Secondary Outcome Measures:

Change in Global Rating of Change Score (GROC) [ Time Frame: 2 Weeks, 6 Weeks,
3 Months ]
Change in Medicine Intake (Frequency of medication intake)
[ Time Frame: Baseline, 3 months ]
Frequency of medication intake (narcotics and over-the-counter) for knee pain
Arms Assigned Interventions
Experimental: Other: Dry Needling, Conventional PT
Dry Needling, Conventional PT
Dry needling to the knee and conventional
physical therapy (stretching, ROM,
strengthening), 1-2 treatments per week X6
weeks (up to 10 sessions total)

Active Comparator: Other: Conventional PT

Conventional PT
Conventional physical therapy to include
knee stretching, range of motion, and
strengthening exercises,1-2 treatments per
week X6 weeks (up to 10 sessions total)
Detailed Description: Patients with knee OA will be randomized to receive 1-
2 treatments per week for 6 weeks (up to 10 sessions total) of either: (1)
Dry Needling and conventional physical therapy or the (2) Conventional
physical therapy (manual physical therapy, exercise, range of motion and
stretching)
Eligibility
Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Criteria
Inclusion Criteria:
1 ) Report of knee pain of at least 2/10 per NPRS (0--10 scale) for >3 months
2 ) Report of at least 3 of the following per Altman et al. (1986)
o Over 50 Years of age
o Less than 30 minutes of morning stiffness
o Crepitus on active motion
o Bony tenderness
o Bony enlargement
o No palpable warmth of synovium
Exclusion Criteria:
Report of red flags to manual physical therapy to include: hypertension,
infection, diabetes, peripheral neuropathy, heart disease, stroke, chronic
ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged
steroid use, fracture, RA, osteoporosis, severe vascular disease,
malignancy, etc.
History of previous surgery to the knee
History of physical therapy, massage therapy, chiropractic treatment, or
injections for knee pain in the last 4 weeks
History of a surgical procedure on either lower extremity in last 6 months
Two or more positive neurologic signs consistent with nerve root
compression, including any two of the following:
Weakness involving a major muscle group of the lower extremity.
Diminished patella or achilles tendon reflex
Diminished or absent sensation to pinprick in lower extremity
dermatome
Involvement in litigation or worker's compensation regarding knee pain.
Any condition that might contraindicate the use of electro-needling
The patient is pregnant.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with
your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study
research staff using the Contacts provided below.
 METHODOLOGY
1- ROODS APPROACH + CONVENTIONAL
PROTOCOL

INCLUSION CRITERIA EXCLUSION CRITERIA

based on the clinical and Allergic skin or history

radiological classification criteria of joint replacement, another
of the American College of cause of knee pain, body mass
Rheumatology index > 38, rheumatoid arthritis,
steroid injection or knee surgery,
history of knee taping, and fragile
skin around the knee.
Characteristic No tape Control tape Therapeutic tape
(n=29) (n=29) (n=29)
Mean (SD) age (years) 69 (9) 71 (8) 66 (8)
Mean (SD) height (m) 1.64 (0.01) 1.64 (0.09) 1.64 (0.01)
Mean (SD) weight (kg) 81.1 (13.4) 78.8 (16.4) 79.1 (10.8)
Mean (SD) body mass index (kg/m2) 30.1 (4.0) 29.3 (4.9) 29.3(4.0)
Mean (SD) duration of symptoms (years) 9 (11) 9 (10) 9 (8)
Men 10 (34) 10 (34) 10 (34)
Women 19 (66) 19 (66) 19 (66)

Radiographic severity*:
Grade I/II 7 (24) 9 (31) 9 (30)
Grade III/IV 22 (76) 20 (69) 20 (70)
Presence of osteophytes in patellofemoral joint 23 (79) 23 (79) 21 (72)
Narrowing of patellofemoral joint 10 (35) 5 (17) 6 (21)

*Kellgren and Lawrence grading system; higher grade indicates more severe disease.15
2- DRY NEEDLING + CONVENTIONAL PROTOCOL
INCULSION CRITERIA EXCLUSION CRITERIA

Over 50 Years of age red flags to manual physical therapy

Less than 30 minutes of morning History of previous surgery to the knee
stiffness History of physical therapy
Crepitus on active motion condition that might contraindicate the
Bony tenderness use of electro-needling
Bony enlargement The patient is pregnant.
No palpable warmth of synovium Two or more positive neurologic signs
consistent with nerve root compression,
including any two of the following:
Weakness involving a major muscle
group of the lower extremity.
Diminished patella or achilles tendon
reflex.
Diminished or absent sensation to
pinprick in lower extremity dermatome
Arms Assigned Interventions
Experimental: Other: Dry Needling,Conventional PT
Dry Needling, Conventional PT
Dry needling to the knee and
conventional physical therapy
(stretching, ROM, strengthening),
1-2 treatments per week X6 weeks
(up to 10 sessions total)
Active Comparator:Conventional PT Other: Conventional PT
Conventional physical therapy to include
knee stretching, range of motion, and
strengthening exercises,1-2 treatments
per week X6 weeks
(up to 10 sessions total)
 Other details about both technique
CRITERIA DRY NEEDLING ROODS APPROACH

Age Adults and seniors over 50 years

Gender All All

Duration 1-2 treatments per week X 3 interventional week +

6 weeks (up to 10 sessions 3 follow up week= 6 weeks
total)
 CONCLUSION
This study attempting to find most effective exercise protocol
among both protocols : dry needling and roods approach
with the combination of conventional protocols on different
variables with the help of using different scales, instruments,
applying tests or performing activities.