NCT02235818

Brief Summary

The purpose of this study was to compare the immediate efficacy of Counterforce brace versus kinesiotaping on patients with lateral epicondylosis/tennis elbow with respect to a repetitive physical task. The investigators hypothesized that there would be difference in the outcomes with respect to interventions and activity. Patient came for one hour long Single occasion testing session and were not followed up after the testing was complete.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2013

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
Last Updated

September 10, 2014

Status Verified

September 1, 2014

Enrollment Period

5 months

First QC Date

July 4, 2013

Last Update Submit

September 8, 2014

Conditions

Keywords

tennis elbow, treatment, lateral epicondylitis, immediate effects

Outcome Measures

Primary Outcomes (1)

  • Pain free grip strength

    Pain free grip strength was recorded with J-tech medical dynamometer before and after five minutes of repetitive physical exposure with first control (no intervention) and then brace and kinesiotape assigned randomly in cross-over fashion.

    initial visit

Secondary Outcomes (1)

  • Pressure Pain Threshold

    initial visit

Other Outcomes (1)

  • Pain levels

    initial visit

Study Arms (2)

Kinesiotape (KT)

ACTIVE COMPARATOR

Kinesiotape was used only on the affected side as per the manufacturer instructions. With the elbow extended, wrist fully flexed and fingers pointed down 24, KT was applied with slight stretch (10-15%) and paper off tension to the lateral arm beginning just above the bony portion of lateral epicondyle. Once the top strand was anchored, KT was applied along the side of elbow such that hole in the tape was over lateral epicondyle of the elbow. Two strands of tape followed the lateral forearm and ended at around beginning of the distal one third of forearm. Once the support was applied, KT was gently rubbed to activate the glue.

Device: Kinesiotape

Counterforce elbow brace

ACTIVE COMPARATOR

The counterforce brace was approximately 5cm wide with velcro attachment for adjustable girth. It had gel pack for extra support on extensor muscle mass. With the elbow extended, brace was applied 2.5cms below the lateral epicondyle. A feeling of comfortable compression, as reported by the patients was used to adjust the brace.

Device: Counterforce elbow brace

Interventions

Pre-cut kinesiotape for tennis elbow, spidertech.com, applied on wrist extensors starting above elbow and ending at distal one third of forearm

Also known as: elastic tape, elastic therapeutic tape, kinesiotex tape
Kinesiotape (KT)

Applied over the wrist extensor muscle mass, had velcro for adjustment, comfortable grip as reported by patient was used to adjust the brace

Also known as: elbow strap, forearm brace, forearm strap
Counterforce elbow brace

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age (18-70 years)
  • Ability to provide written informed consent to participate
  • Were at least three weeks from onset of symptoms
  • Complaints of discomfort or pain at the lateral elbow region for a minimum of three weeks and tenderness with palpation of the lateral epicondyle
  • Provocation of lateral elbow pain with one of the following test - resisted middle finger extension, resisted wrist extension or passive stretch of wrist extensors

You may not qualify if:

  • History of surgery on affected elbow
  • History of cortisone injections on the affected elbow in the past 4 weeks
  • Any physical or mental limitations that precluded performance of the study testing
  • Allergy to adhesive tapes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hand and Upper Limb Centre, St. Joseph's Health Centre

London, Ontario, N6A 4L6, Canada

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Joy C Macdermid, PT, PhD

    Western University, Canada

    PRINCIPAL INVESTIGATOR
  • Pritika Gogia, MSc

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director HULC Clinical Research lab

Study Record Dates

First Submitted

July 4, 2013

First Posted

September 10, 2014

Study Start

January 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

September 10, 2014

Record last verified: 2014-09

Locations