NCT03848117

Brief Summary

Lateral epicondylitis (LE) is a pain causing musculoskeletal disease which mainly occurs due to the over exertion or over use of extensors of wrist mainly ECRB and pain is felt at the origin of common extensor tendon. This study was focused to assess the effectiveness of cyriax approach and mulligan approach to improve the functional status of sub acute lateral epicondylitis patients through patient related tennis elbow evaluation form.

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 Mar 2019

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

First Submitted

Initial submission to the registry

January 26, 2019

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2019

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

7 months

First QC Date

January 26, 2019

Last Update Submit

November 12, 2019

Conditions

Keywords

Patient Rated Tennis Elbow Evaluation (PRTEE)Mobilization with movementDeep Transverse friction massage

Outcome Measures

Primary Outcomes (2)

  • Patient related tennis elbow evaluation pain scale

    Pain associated with daily tasks is measured through Patient related tennis elbow evaluation pain scale with categories as "0" for no pain and "10" for worst imaginable pain.

    Upto 4 weeks

  • Patient related tennis elbow evaluation functional disability scale

    Degree of difficulty in performing daily tasks associated with elbow joint is measured through Patient related tennis elbow evaluation functional disability scale in categories as "0" for no difficulty in task and "10" for unable to do a task.

    Upto 4 weeks

Secondary Outcomes (1)

  • Hand grip strength chart index

    Upto 4 weeks

Study Arms (2)

(DTF massage & Mill's manipulation)(Group 1)

ACTIVE COMPARATOR

For any given subject in group 1, PRTEE pain and functional disability evaluations and Hand grip strength were completed on the same day. Then each subject in 1st group completed 4 weeks of physical therapy sessions which were aimed to decrease pain, increase functional activity level, and improve hand grip strength. Each subject was evaluated for changes in symptoms on 1st week, 2nd week, 3rd week and 4th week.

Other: Cyriax approach i.e. DTF massage and Mill's manipulation

( Taping & MWM) (Group 2).

ACTIVE COMPARATOR

For any given subject in group 2, PRTEE pain and functional disability evaluations and Hand grip strength were completed on the same day. Then each subject in second group completed 4 weeks of physical therapy sessions which were aimed to decrease pain, increase functional activity level, and improve hand grip strength. Each subject was evaluated for changes in symptoms on 1st week, 2nd week, 3rd week and 4th week.

Other: Mulligan approach i.e. Taping and MWM

Interventions

Each patient in group I i.e. Cyriax group was given 20-minute session. Each session started in sitting position and initially deep transverse friction massage was done at lateral compartment of the elbow joint and immediately after that mill's manipulation at elbow joint with flexion at wrist joint in pronated arm position. This session was repeated three times a week for one month (Total 12 sessions/ one month).

(DTF massage & Mill's manipulation)(Group 1)

Each patient in group II i.e. Mulligan group was given 30 to 45-minute session. Each session started in sitting position and it included mobilization with movement which was given in such a way that initially lateral glide at elbow joint was performed and after holding it, I asked the patient to make a fist and open the fist. In this way, I repeated this procedure 36 times and after 12 repetitions, a short rest period was given. Taping was applied after mobilization around the elbow joint over extensor carpi radialis muscles. This session was repeated three times a week for one month (Total 12 sessions/ one month).

( Taping & MWM) (Group 2).

Eligibility Criteria

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

You may qualify if:

  • Age group 20-50 years of both gender.
  • Vas \< 7
  • Positive mills test and cozens test.
  • Local tenderness on palpation over lateral epicondyle of the humerus.
  • From sub-acute to chronic more than 2 weeks.

You may not qualify if:

  • Any previous pathology of bone around elbow.
  • Corticosteroid injection in the preceeding 3 months.
  • Absence of clinical signs of tennis elbow.
  • Any other systemic illness like metabolic, metastatic, infective disorders.
  • Any other neurological abnormalities.
  • Allergies to Mulligan tape.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sammar Abbas

Rawalpindi, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients were randomly assigned into two groups: Cyriax Approach group and Mulligan approach group. A coin was flipped at start of data collection for the first patient to be assigned odd number and included in cyriax group. Later on odd and even numbered patients were included in specific group. Additionally, data was collected from lateral epicondylitis patients visiting the DHQ Hospital Bahawalnagar.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

January 26, 2019

First Posted

February 20, 2019

Study Start

March 1, 2019

Primary Completion

September 30, 2019

Study Completion

October 15, 2019

Last Updated

November 13, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations