The aim is to study and compare the effects of shockwave therapy versus ultrasonic therapy and deep friction massage in patients with tennis elbow.
Design
double Blind Parallel Arm Study. Randomized Controlled Trial.
Settings and conduct
This double blind (patient ad outcome assessor will be blinded) parallel assignment study will be conducted in approximately five months at 2 settings;
1- Physiotherapy Department Syed Medical Complex, Sialkot
2- Physiotherapy Department Sialkot College of Physical Therapy, Amin welfare & Teaching Hospital, Sialkot.
Participants/Inclusion and exclusion criteria
Both male and female patients of 30-60 years of age with pain in twisting and turning movements of forearm. Patients with any history of trauma, surgery or presence of metal implant in elbow complex region, neurological deficits, radiculopathies and sensory impairments will be excluded.
Intervention groups
Group-A will be receiving shockwave therapy, Group-B will be administered Ultrasonic Therapy along with deep friction massage.
Main outcome variables
Patient Rated Tennis Elbow Evaluation Questionnaire, NPRS and SF-36
General information
Reason for update
Acronym
SWT
IRCT registration information
IRCT registration number:IRCT20201031049207N4
Registration date:2020-12-25, 1399/10/05
Registration timing:registered_while_recruiting
Last update:2020-12-25, 1399/10/05
Update count:2
Registration date
2020-12-25, 1399/10/05
Registrant information
Name
Wajida Perveen
Name of organization / entity
Sialkot college of Physical Therapy, Amin Welfare &Teaching Hospital, defence Road, Sialkot Pakistan
Country
Pakistan
Phone
+92 52 3250520
Email address
drwajidaperveenpt@scptamc.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-15, 1399/09/25
Expected recruitment end date
2021-05-14, 1400/02/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Extra Corporeal Shock Wave Therapy versus Ultrasonic Therapy and deep friction message in the management of Lateral Epicondylitis.
Public title
Shockwave Therapy in Tennis Elbow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both Males and Females.
Age between 30-60 years.
pain in twisting and turning movements of forearm.
Difficulty in holding weight in the affected side and walk.
Range of wrist extension complete but painful
Strength of extensor muscles Grade-IV
Exclusion criteria:
History of trauma in the region of Elbow complex.
Presence of any metal implant.
Any Neurological Deficits on the treatment sides
Symptoms of Cervical Radiculopathies.
Any sensory deficits.
strength of extensors less than Grade-IV
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
1
Any patient may have a bilateral problem.
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups. In Group A (Experimental group) patients will have shock wave treatment and in patients Group B (Control) will have ultrasonic therapy and deep friction massage using coin toss method and allocation sequence will be concealed through sealed envelopes.
Concealment of allocation: will be achieved with sequentially numbered, opaque, sealed, envelopes (SNOSE). SNOSE will be used according to guidelines of Doig and Simpson (25). An independent researcher with no clinical involvement in the trial will make the concealed envelopes. 60 Envelopes will be prepared. Half envelops will contain folded papers with Treatment A written on them and the remaining half will contain folded papers with Treatment B written on them. A carbon paper will be inserted in each envelop with carbon side facing the paper so the allocation sequence, patient name, date of birth of participant and other information can be transferred onto allocation paper inside the envelope. A piece of tin foil is also inserted into envelop so the treatment card cannot be read against light. Envelops will be sealed and signed by the maker. A unique randomized number will be allocated to these envelops and shuffled vigorously. Then the envelops will be arranged sequentially and handed over to another independent researcher. Assessor will pretest the participant and if eligible envelope will be allocated to subject. Therapist will record the information on the envelope and open it afterwards to maintain the concealment. Assessor will record the post treatment findings and another independent analyst will analyze the data. This allocation of concealment will ensure the unpredictability of treatment allocation by investigators and patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
In these patients assessor will be blinded to allocation of treatment groups in this study. Patient will be blinded to treatment allocation as treatment will be given in separate rooms for each group. Therapist who is not blinded will not take the outcome measurements.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
SCPT-IRB
Street address
Umer Street
City
Sialkot
Postal code
51310
Approval date
2020-11-16, 1399/08/26
Ethics committee reference number
IRB-SCPT-DPT-140-2020
Health conditions studied
1
Description of health condition studied
Lateral Epicondylitis or Tennis Elbow
ICD-10 code
M77.10
ICD-10 code description
Lateral epicondylitis, unspecified elbow
Primary outcomes
1
Description
Patient Rated Tennis Elbow Evaluation
Timepoint
one Pre-Treatment, one after 3rd visit and 3rd after 7th visit
Method of measurement
subjective assessment of the patient
2
Description
Pain
Timepoint
before 1st treatment session, after 3rd treatment session and after 7th session
Method of measurement
Numeric Pain Rating scale
Secondary outcomes
1
Description
Quality of Life
Timepoint
before 1st treatment session and after last treatment session
Method of measurement
questionnaire SF-36
Intervention groups
1
Description
Intervention group: Group-A shock wave therapy group will be administered shockwave therapy with decompression on lateral side of elbow, with frequency 1Hz, energy level 2.0, for 7 sessions with gap of 4 days in each session.
Category
Treatment - Devices
2
Description
Intervention group: Group-B Ultrasonic therapy and deep friction massage group. patients will be provided with ultrasonic therapy 2.5w/sec2 (intermittent) 3 times a week for four weeks. deep friction massage will be an adjunct to ultrasonic therapy.
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
there is no further information.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Effects of Shockwave therapy versus ultrasonic and deep friction massage in the management of Lateral Epicondylitis. outcomes of the effects of treatment modality will be shared after completion of the study.
When the data will become available and for how long
after completion of study (January 2022).
To whom data/document is available
further information can be requested to principal investigator by those who are working in academic institutions and are interested to apply extra corporeal shockwave in tennis elbow.
Under which criteria data/document could be used
the data may be used as a reference after the study has been completed and published. Principal investigator will review the requests himself on predefined review criteria and respond accordingly.
From where data/document is obtainable
Any applicant can contact Principle investigator/ person responsible for scientific inquiries via email to request the sharing of data.
What processes are involved for a request to access data/document
The data can be accessed by direct request via email to the Principal investigator/ person responsible for scientific inquiries. He will respond in 10 working days positively.