NCT05698108

Brief Summary

This study aimed to find the effects of Instrument Assisted Soft Tissue Mobilization (IASTM) using Ergon Tools on pain, grip strength and functional activity among patients diagnosed with Lateral epicondylitis. The study concluded that IASTM is effective in improving pain, grip strength and functional activity in patients with lateral epicondylitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

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

March 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

November 26, 2022

Last Update Submit

January 13, 2023

Conditions

Keywords

IASTMLateral Epicondylitistennis elbowpaingrip strengthfunctional activity

Outcome Measures

Primary Outcomes (3)

  • Pain (mild to severe)

    Visual Analogue Scale The score is calculated by measuring the distance (mm) between the "no pain" anchor and the patient's mark on a 10-cm line with a ruler, yielding a range of 0-100. A higher score implies that the pain is more intense and a lower score suggests the intensity of pain to be milder. VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain

    4 weeks

  • Grip Strength

    Digital Hand Held Dynamometer The best result from several trials for each hand is recorded, with at least 15 seconds recovery between each effort. The values listed below (in kg and lbs) give a guide to expected scores for adults. These values are the average of the best scores of each hand. See more Hand Grip Strength Norms. Other protocols will just use the score from the dominant hand, or compare the left and right hand results. See also examples of some actual athlete results.

    4 weeks

  • Functional Activity

    Patient Rated Tennis Elbow Evaluation It consists of pain subscale and functional subscale, total score is calculated by adding Pain Subscale and Function Subscale then calculated as, Best Score= 0 Worst Score = 100 (pain and disability contribute equally to score)

    4 weeks

Study Arms (2)

Conventional Physcial Therapy Group

ACTIVE COMPARATOR

All participants received treatment 2 times a week for 4 weeks. Pre-treatment included a Moist hot pack for 10 minutes and traditional physical therapy included Cyriax Deep Friction Massage (DFM), Ultrasound therapy as well as strengthening and stretching exercises

Other: Conventional Physical Therapy

IASTM Group

EXPERIMENTAL

Participants received Instrument Assisted Soft Tissue Mobilization Treatment 2 times a week for 4 weeks using Ergon IASTM tools.

Device: Instrument Assisted Soft Tissue Mobilization (IASTM)

Interventions

Tools designed for soft tissue mobilization

Also known as: Ergon Tools
IASTM Group

Moist Hot pack, Ultrasound, Deep Friction Massage, Stretching and Strengthening Exercises.

Also known as: Traditional Physical Therapy
Conventional Physcial Therapy Group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both Male and Female Patients
  • Patients between the age group 20-50 years
  • Sub-acute Patients having symptoms for \> 6 weeks and \< 3 months.
  • Patients who had pain rating from 5 to 9 in VAS will be included
  • Patients with Positive Cozens test, Mill's test

You may not qualify if:

  • Patients with any surgical or trauma history of the elbow
  • Rheumatoid Arthritis and Malignancies
  • Cervical Radiculopathy patients who have referred pain in the elbow
  • Loss of Passive ROM in extension
  • Active infections such as, Bursitis, Calcification of the soft tissues, Fragile skin, Hyper Mobility \& Joint Effusion
  • Hemophilic Patients
  • Osteoporosis
  • Patients with history of getting treatment with Steroid Injections will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sikander Medical Complex

Gujranwala, Pujab, 52250, Pakistan

Location

MeSH Terms

Conditions

Tennis ElbowPain

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shazal Nazir, DPT

    University of Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study was single-blinded as the assessor was blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2022

First Posted

January 26, 2023

Study Start

March 1, 2022

Primary Completion

September 30, 2022

Study Completion

November 1, 2022

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations