NCT05696327

Brief Summary

The purpose of the study is to compare the effects of Tyler twist wrist extensor strengthening exercises in patients with lateral epicondylitis. A randomized control trial was conducted at Cina medical center Rawalpindi and Midland Doctors Medical institute. The sample size was 52 calculated through open-epi tool. The participants were divided into two groups: the treatment group and the control group. The study duration was 1 year. Sampling technique applied was non-probability purposive sampling. Only 20 to 40 years participants with diagnosed condition were included in the study. Tools used in this study are Jamar dynamometer for grip strength and PRTEE Questionnaire for pain and disability. Data was collected at baseline, mid and immediately after the application of interventions. Data analyzed through SPSS version 25

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2023

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

January 4, 2023

Last Update Submit

July 7, 2023

Conditions

Lateral Epicondylitis

Keywords

Lateral Epicondylitis, Tyler Twist Exercises, Elbow

Outcome Measures

Primary Outcomes (1)

  • Hand held dynamo-meter(Grip strength)

    To measure grip strength, Hand held dyanamo-meter is used as a tool to record readings in Kg.The device is hand held and displays grip force with a maximum range of 90kg.Maximum 3 readings are recorded and then a mean is calculated which is an actual value to be noted.Male to female ratio varies for the grip strengths and ranges from 35kg max in females and 60kg in male population.Strength also varies in old population as well.

    upto 24 weeks

Secondary Outcomes (1)

  • Patient rated tennis elbow evaluation questionnaire(PRTEE)

    upto 24 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

tyler twist wrist extensor strengthening exercises Treatment protocol will be followed for thrice a week for 4 weeks. The session will be of approximately 20 minutes. The initial Conventional therapy program will be the same as discussed in the control group except strengthening exercise which is excluded in experimental group because of Tyler twist exercise which is being used as a strengthening protocol.

Other: Tyler Twist Exercises

Control Group

ACTIVE COMPARATOR

Conventional physiotherapy (Ultrasound + Cross Friction Massage for 10 minutes + Wrist extensor stretching and Isotonic wrist extensor strengthening.) The treatment will continue for 4 weeks and 3 sessions/ week i.e. thrice a week. The session will be of approximately 20 minutes.

Other: conventional physical therapy

Interventions

Tyler Twist ExercisesOTHER

Tyler twist exercises are the group of exercises which are used to strengthen wrist ex tensors.The protocol consists of several steps using colored twist-able bands and patients are guided to actively perform the steps for their grip strength development.

Experimental Group
conventional physical therapyOTHER

Conventional physiotherapy (Ultrasound + Cross Friction Massage for 10 minutes + Wrist extensor stretching and Isotonic wrist extensor strengthening.)

Also known as: control group
Control Group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • both genders (male and female)
  • Age between 20yrs-40yrs
  • Tenderness on palpation over the lateral epicondyle of humerus.
  • Pain with gripping.
  • Pain with resisted wrist extension.
  • clinically diagnosed patients of lateral epicondylitis
  • did not take any kind of physiotherapy treatment.

You may not qualify if:

  • cervical spine disorder.
  • Peripheral neuropathy.
  • Previous Fracture/ trauma or surgery to the elbow region.
  • Steroid injections in last 6 months.
  • Tumor or wound.
  • Any other systemic/autoimmune disorders or congenital Participants who received any therapy for lumbar region past 3 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Lal Gul Khan, MScPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 25, 2023

Study Start

February 1, 2022

Primary Completion

January 20, 2023

Study Completion

January 20, 2023

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)