| CTRI Number |
CTRI/2024/07/070453 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
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Public Title of Study
|
Effects of two different exercises on elbow pain. |
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Scientific Title of Study
|
Effects of eccentric training of wrist extensors versus digital lactching and lateral rotation of forearm in lateral epicondylities- A comparative randonized controlled trail. |
| Trial Acronym |
nil |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shraddha More |
| Designation |
Postgraduate student |
| Affiliation |
SDM College of physiotherapy |
| Address |
OPD number 5 ortho Physiotherpy Department SDM College of Physiotherapy, SDM College of Medical Science and Hospital Manjushree Nagar Sattur
Dharwad KARNATAKA 580009 India |
| Phone |
7892468220 |
| Fax |
|
| Email |
moresshraddha22@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shraddha More |
| Designation |
Postgraduate student |
| Affiliation |
SDM College of physiotherapy |
| Address |
OPD number 5 ortho Physiotherpy Department SDM College of Physiotherapy, SDM College of Medical Science and Hospital Manjushree Nagar Sattur
Dharwad KARNATAKA 580009 India |
| Phone |
7892468220 |
| Fax |
|
| Email |
moresshraddha22@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rajeev Kumar Lal |
| Designation |
Vice Principal, Professor and PG Guide, SDM College of Physiotherapy. |
| Affiliation |
SDM College of Physiotherapy. |
| Address |
OPD number 5 ortho Physiotherpy Department SDM College of Physiotherapy, SDM College of Medical Science and Hospital Manjushree Nagar Sattur
Dharwad KARNATAKA 580009 India |
| Phone |
9986202056 |
| Fax |
|
| Email |
lalrk@yahoo.com |
|
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Source of Monetary or Material Support
|
| SDM College of Medical sciences and hospital SDM College of Physiotherapy Manjushreee Nagar Sattur Dharwad
karnataka
580009
India
|
|
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Primary Sponsor
|
| Name |
Shraddha More |
| Address |
SDM College of Medical Sciences and hospital SDM College of Physiotherapy Manjushree Nagar Sattur Dharwad
Karnataka
580009
India |
| Type of Sponsor |
Other [Self] |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shraddha More |
Shri Dharmasthala Manjunatheshwar hospital |
Ortho physiotherapy department OPD number 5 manjushree nagar sattur
Dharwad
Karnataka
Dharwad KARNATAKA |
7892468220
moresshraddha22@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Medical Sciences and Hospital Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Digital latching and lateral rotation of forarm training |
The participants will be seated erect on armless chair with pillow on lap, shoulder maintained in neutral position, affected elbow in middle range of flexion, resting on pillow with the forearm pronation and the wrist in neutral position. The participant will, perform digital latching [flexion of PIP & DIP joints of four fingers and IP joint of thumb within pain free ROM] and then laterally rotates (supinate) forearm within pain free ROM. The participants seated as above with affected upper limb in same position and perform flexion of PIP and DIP joints of four fingers and IP joint of thumb to hold a notebook as resistance. The digits latched harder by pressing
notebook with pain free grip strength and then laterally rotate forearm within pain free ROM as progression.Twice in a day,10 repetitions of 3 sets with 1 min rest time.
|
| Comparator Agent |
Eccentric training of wrist extensor |
The participants will be seated erect on chair and forearm supported on the forearm rest or on an adjacent table. Painfree resistance will be checked prior to initiation of exercise. Participants will be instructed to hold water bottle (resistance as tolerated) with a clenched fist and forearm in pronation, hanging freely in front of the armchair or below the tabletop. The participant will be instructed to lower the weight by flexing the wrist of the affected arm downwards towards gravity and to lift it back passively with the unaffected arm.Progression by increasing the weights or increasing the quantity of water in bottle Twice in a day 10 repetition of 3 sets with 1 min rest time
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Inclusion Criteria
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| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject of either gender with lateral epicondylitis diagnosed by orthopedician.
2.Age limits from 35 to 60 years.
3.Subjects who did not receive any intra articular injections at elbow.
4.Unilateral / Bilateral involvement.
5.Cozens sign or Mill’s maneuver test positive |
|
| ExclusionCriteria |
| Details |
1.Individuals not willing to participate.
2.Any deformity in the affected upper limb.
3.Patient who has/had neurological problems affecting the involved upper limb.
4.Earlier episodes of lateral epicondylitis of elbow treated surgically / intra articular injections at elbow.
5.Any fracture in the affected upper limb / limbs within past 6 months.
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
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Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1.Visual analog scale(VAS)
2.Patient rated tennis elbow evaluation flow(PRTEE)
3.Pain free grip test (PFGT) 2nd and 3rd setting.
|
At 0th day and 4th week
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
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Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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Runge first reported on a disorder that was linked to pain in the
humeral lateral condylar region and trouble
writing in 1873. Morris later coined the term "lawn tennis arm" for
this condition in 1882.1 It has been referred to by several
different names, such as angiofibroblastic hyperplasia, lateral epicondylitis(LE), and tendinosis. Trauma to the
lateral elbow can occur, however it is usually
considered an overuse injury.2 Approximately 40% of people
experience LE at some point
in their life. In general population the prevalence
of LE is 1-3%. In a population based study by Sanders et al, the annual
incidence of tennis elbow was reported to be 4.5 per 1000 people.3
This condition is primarily a degenerative overuse
process of the extensor carpi
radialis brevis (ECRB)
and the common extensor tendon. Aside from degenerative changes, the
histological findings include granulation
tissue, micro-rupture, an abundance
of fibroblasts, vascular hyperplasia, unstructured collagen, and a notable lack of traditional inflammatory cells (macrophages, lymphocytes, neutrophils) within the tissue.2
The majority of the patients complain pain located just
anterior to, or in, the bony surface of the upper half of the lateral epicondyle, usually radiating in line
with the common extensor mass. The pain can
vary from intermittent and low-grade to continuous and severe which
may cause sleep disturbance. It is typically produced by wrist
and finger extensor muscle
contraction against resistance. 4
Stability of a joint depends upon congruency of articular surfaces,
thickness of articular cartilage, orientation
of fibers in ligaments, capsule and direction of muscular pull, which
together facilitate free and
controlled joint movements. The stability of the PRUJ (Proximal Radio Ulnar
Joint) is excellent because the
radial head is enclosed in a very strong osteoligamentous cavity, made of the
radial notch of the ulna and the
annular ligament, which is a very resistant ligament. The total range of
pronation- supination is roughly
180°, but the motion
must be measured from a reference position (0)-elbow flexed
at right angle and hand included in a vertical plane, the thumb being
directed upward. From this position,
the pronation is 90°, rotating the palm downward and the thumb medially. In
the inverse motion-supination,
normally 90°the palm is directed upward and the thumb is directed laterally. Supination, is the most important movement because it cannot
be compensated by the shoulder, whereas a lack of pronation can be replaced by its abduction.8
In an elliptical radial head, the orientation of the long axis is
perpendicular to the radial notch with the
forearm in neutral rotation. The “non-circular shape†radial head does
not rotate precisely around a specific
centre in full pronation and supination. With pronation the radial head
translates anteriorly, placing the
posterior annular ligament under tension while in supination the radial head
translates posteriorly, placing the anterior
portion of the annular
ligament under tension. 6
The longitudinal axis of the forearm rotation runs from the center of
radial head and capitellum proximally
to the base of the styloid process of the distal ulna distally. Therefore, it
is oblique to the longitudinal axes
of both the radius and the ulna
and rotation is independent of elbow position. The axis of rotation shifts slightly ulnar and
volar in supination and radial and dorsal during pronation. The radius has been shown to move proximally by 1
to 2 mm with pronation.7
During pronation, radius crosses over ulna as a result its anterior
concavity of sagittal plane now faces posteriorly.
Flexor muscles which lie anterior to both bones during supination come and
lie between them as “mattressâ€
softening their contact, displacing ulna posteriorly with respect to radius.
Also cupped radial
head and cylindrical
radial head rim rotate medially over humeral capitulum and in fibro-
osseous ring respectively. Hence plane of proximal surface of radial
head tilts dorsally, distally & laterally
(as great axis of radial head comes to lie transversely so that long axis of
radius displaces laterally by 2 mm). During
supination cupped radial
head and cylindrical radial head rim rotate laterally over humeral capitulum and in fibro-osseous ring respectively so that radius
now lies parallel
to ulna.
Hence plane of proximal surface
of radial head tilts ventrally, proximally and medially altering tension
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in annular ligament and therefore the lateral ligament complex which in turn reduces stress on common
extensor origin.8
Forearm supination is performed by two main muscles, the
biceps brachii and supinator muscles9 and forearm pronation is performed by pronator teres
and pronator quadratus. Supinator is wrapped around
the neck of radius whereas biceps are inserted into the apex of the
“supinator bend†that is the radial tuberosity. The pronator quadratus is wrapped around
the distal end of the ulna, so that the
radius moves around the ulna whereas the pronator
teres inserted into the apex of the “pronator bend†of the radius.8 At proximal radio ulnar joint
transverse stability is mainly due to annular ligament and to a lesser extend,
quadrate/squared ligament. Annular
ligament, not like conventional ligaments inserts on anterior and posterior rims of radial
notch of ulna, winds around radial head. Its inner aspect is lined with fibrocartilage that makes radial
head easier to move during forearm rotation. Quadrate/squared ligament is present at inferior part, it
tightens in pronation and supination by wrapping around radial neck,
thereby drawing radial
head closer to ulna hence,
providing transverse stability and also longitudinal stability by limiting
vertical migration of radius. In most cases, the lesion will
involve the junctional tissue at
the common extensor muscle origin of the lateral epicondyle, specifically,
the ECRB. If the ECRB
is involved, extension of the wrist will be more painful
if resistance is given at the heads of the metacarpals rather than at
the fingertips.8 Radial extension will more specifically indicate the ECRB or ECRL. Tenderness above the
epicondyle will indicate that the ECRL is involved, while anterolateral
tenderness would arise from
ECRB tissue inflammation. 2
Once a muscle
fatigues the tendon
accepts the kinetic forces
hence the reason
tendinopathy injuries are
observed in overuse
repetitive type athletes. Main components comprising tendinopathy are angiofibroblastic hyperplasia which is
an internal misalignment of collagen fibers. Each time the degenerative tendon is further worked
it restarts the
fibroblastic phase of healing laying
down new Type
III collagen which further
degenerate the components of
a normal tendon. 11
The onset of pain is usually gradual. The simple diagnostic tests can include the forced elbow
extension test,
which is usually positive. The forearm is held fully
pronated and the wrist palmarly flexed; passive elbow extension then produces lateral
elbow pain, which may limit full extension of the joint. Grip strength
is limited by pain,
as measured by dynamometry. As opposed to
tenderness to palpation of the
lateral epicondyle and isometrically resisted extension of the wrist,
signifying true LE.2
Majority of treatment protocol for the management of LE ranges from
Anti-Inflammatory Medication, Corticosteroid
Injection, Electrical stimulation, LASER, acupuncture, counterforce Bracing
or Splint, Ergonomics, Ultrasound, Iontophoresis, Phonophoresis, exercises (Flexibility, Strengthening and Endurance
training), Manual therapy techniques, (e.g., Transverse Frictions, Joint
mobilization and manipulation, Myofascial release, strain and counter
strain techniques) etc.5
Therapeutic exercise programs reduce pain and improve function.
Literature has found connections between
eccentric loading and positive outcomes in tendinopathy patients by inducing
hypertrophy, increasing tensile strength and decreasing neovascularization. Eccentric contraction can create
a greater stimulus for the cells of the tendon,
producing collagen and resulting in the tendon being able to withstand greater forces. It is believed
that neovascularization is a causing factor of pain in LE and other
tendinopathies. Eccentric execution results in greater
force production with less energy
expenditure and less oxygen consumption compared to concentric execution.13Recent
evidence suggests that eccentric actions may be more
effective, but must
be used with
caution due to the common
effect of muscle soreness.1,10,14
Based mainly on clinical experience, supinator weakness in LE patients
is commonly addressed as increasing pain,
and decreasing functional ability and hand-grip strength. This means that the causes of LE may not be Limited to the ECRB. Functional impingement of
the supinator due to altered joint mechanism and
muscle imbalance can
impair the stabilization of
the elbow resulting in
overcompensation
of the ECRB. Changes in supinator may lead to altered and compensatory changes
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in the ECRB that may overload the ECRB during
repetitive movements. This
may lead to micro trauma
of the soft tissue
structures present at the lateral epicondyle thus causing symptoms of LE.10
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