NCT06686732

Brief Summary

Literature is scarce for high quality evidence regarding multimodal rehabilitation in lateral epicondylitis. By making comparisons with the conventional treatment of patients with lateral epicondylitis, the current study aims to further establish the efficacy of the multimodal rehabilitation protocol through a RCT in order to generalize the results, using dynamometer as an additional tool for pre and post assessments against the outcome measures. Remarks A randomized control trial was conducted at Physical therapy departments of twin cities. The sample size was 40 calculated through G- power tool. The participants were divided into two interventional groups each having 20 participants. The study duration was eight months. Sampling technique applied was non- probability convience sampling. People of age 18-45 years, with localized point tenderness at lateral epicondyle with Mills, Cozen and Maudselys test positive were included in this research. Tools used in this study are Visual Analogue Scale, Dynamometer, Patient Rated Tennis Elbow Questionnaire. Data was collected before and immediately after the application of interventions. Data analyzed through SPSS version 23.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

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

May 3, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2024

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2024

Completed
Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

November 12, 2024

Last Update Submit

November 12, 2024

Conditions

Keywords

tennis elbowmanual therapymultimodal treatmenthand strength

Outcome Measures

Primary Outcomes (1)

  • Grip Strength

    Changes from Baseline grip strength were taken with the help of dynamomter that measures grip strength.

    Three Weeks

Secondary Outcomes (2)

  • Visual Analogue Scale

    Three Weeks

  • Patient Rated Tennis Elbow Questionnaire

    Three Weeks

Study Arms (2)

Multimodal group

EXPERIMENTAL

Experimental group included cold pack over lateral epicondyle, Passive stretching exercises in cervical spine and upper limb. Eccentric exercise of the extensor muscles associated with mobilization with movement.Neuromusclar Rehabilitation Excersise. Inhibition of points of tension in the belly of the extensor region. Early mobilization with movement with the wrist in extension. Lateral sustained glide.

Other: Multimodal physiotherapy

Conventional physiotherapy

ACTIVE COMPARATOR

Control group included Cold pack, Extensor carpi radialis brevis stretching. Active ROM of wrist flexion and extension. Active ROM of elbow flexion, extension, supination and pronation. Manually resisting wrist extensors. Maitland elbow joint mobilization with 1 min of rest between sets.

Other: Conventional physiotherapy

Interventions

Experimental group included cold pack over lateral epicondyle. Passive stretching exercises in trapezius and levator scapulae and upper ECRB,ECRL,ECU,Extensor Digitorum, Extensor Digiti Minimi. Eccentric exercise of the extensor muscles associated with mobilization with movement. Neuromusclar Rehabilitation Excersise. In the region of origin of the tendons of the extensor muscles of the wrist and fingers for 2 min and inhibition of points of tension in the belly of the extensor region. Early mobilization with movement with the wrist in extension. Lateral sustained glide will be give at humeroradial joint during movement.

Multimodal group

Control group included Cold pack for 10 mins on the lateral epicondylitis, Extensor carpi radialis brevis stretching (hold for 15 seconds x 4 reps) Active ROM of wrist flexion and extension (10 reps x 3 sets) Active ROM of elbow flexion, extension, supination and pronation (10 reps x 3 sets) . Manually resisting wrist extensors (10 second hold x 5 reps x 3 sets) 4 sets of Maitland elbow joint mobilization with 1 min of rest between sets. Baseline Dynamometer for grip strength and VAS for pain. These pre and post intervention values were mentioned in questionnaire. The participants were administered with the protocol and data was collected again immediately after the interventions without any delay.

Conventional physiotherapy

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Point tenderness at the lateral epicondyle
  • Positive Cozen test, Mill\'s test and Maudsely's test
  • Symptoms duration of minimum 2 months
  • Consenting to participate in the study

You may not qualify if:

  • History of fracture in elbow, wrist or hand
  • History of surgery in elbow, wrist or hand region
  • Elbow conditions other than lateral epicondylitis
  • Cognitive deficits and not giving consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Muzaffar Khan Medical & Children Hospital

Wāh, Punjab Province, 44000, Pakistan

RECRUITING

Riphah International Hospital, Sihala

Islamabad, Pakistan

RECRUITING

DSK Physio & Rehab Center

Rawalpindi, Pakistan

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • Ramsha Tariq, MS*

    Riphah International University, Islamabad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 13, 2024

Study Start

May 3, 2024

Primary Completion

December 3, 2024

Study Completion

December 13, 2024

Last Updated

November 13, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations