NCT06674434

Brief Summary

Tennis elbow, clinically known as lateral epicondylitis, is a prevalent musculoskeletal issue marked by pain and tenderness on the outer part of the elbow. It primarily affects the extensor tendon at the lateral epicondyle and is commonly linked to repetitive arm movements and overuse. Various treatment options are available for this condition, with two notable methods being sustained stretching and Mobilization with Movement (MWM). Sustained stretching involves holding the affected muscles and tendons in an extended position for a prolonged time to ease muscle tightness and enhance flexibility. Conversely, MWM integrates specific joint movements with the active involvement of the patient to improve joint mobility and reduce pain. Muscle strength plays a crucial role in the overall function of the upper limb, and enhancing this can positively affect daily activities. Furthermore, functional disability indicates how tennis elbow impacts a person's capacity to carry out everyday tasks.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

November 1, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

November 3, 2024

Last Update Submit

November 3, 2024

Conditions

Keywords

Lateral epicondylitisTennis ElbowSustained stretchMobilization with MovementMuscle strength

Outcome Measures

Primary Outcomes (4)

  • Pain: Numeric Pain Rating Scale (NPRS)

    The most widely used pain rating scale, the Numeric Rating Scale (NPRS), has a range of 0 (no pain) to 10 (worst pain). The NPRS will be used to measure the degree of pain. For patients with tennis elbow, it will serve as an outcome measure. The NPRS is regarded as a valid, responsive, and dependable pain scale.

    4th week

  • Function: Upper Limb Functional Index (ULFI)

    Twenty-five items on the ULFI measure how patients with ULMSDs perceive their own limitations in their activities. Three possible answers are provided for each item: "Yes" (1 point), "Partly" (0.5 points), and "No" (0 points). The maximum disability is determined by multiplying the total points (ranging from 0 to 25) by 4. The patient's functional score in relation to their maximum or pre-injury function is then calculated by subtracting this total score from 100 (0% represents maximum limitation, 100% represents normal or pre-injury function). The total rating can be calculated with no more than two missing responses.

    4th week

  • ROM: Universal Goniometer

    A double-arm plastic goniometer with a semicircular scale is the most common goniometer for determining range of motion. We will measure the following wrist and elbow movements: wrist flexion, extension, radial and ulnar deviation, and elbow extension and pronation. Three measurements of each movement will be made, and the average will be computed for the outcome analysis.

    4th week

  • Strength: Handheld Dynamometer:

    A handheld dynamometer (CAMRY EH 101 Electronic Handheld Dynamometer) was used to measure grip strength. The American Society of Hand Therapists' measurement protocols were modified to place participants in a high sitting position, maintain an elbow at a slight 40° flexion, and adjust the handle to the second position. After thoroughly explaining the procedure, the patient was instructed to exert the greatest amount of force possible on the handle and maintain that position for three to five seconds.

    4th week

Study Arms (2)

Group A

EXPERIMENTAL

The group will engage in traditional tennis elbow exercises and mobilization through movement.

Other: Mobilization with Movement

Group B

ACTIVE COMPARATOR

The group will be given a prolonged stretch along with conventional tennis elbow exercises.

Other: Sustained Stretch

Interventions

Mobilization with Movement (MWM) is a manual therapy technique that combines active, patient-directed movements with passive joint mobilization to treat tennis elbow. To find joint restrictions or dysfunctions, a comprehensive patient assessment is the first step in the process. While the patient was in a supine position with the elbow fully extended and the forearm pronated, the therapist applied a sustained lateral glide of the forearm and stabilized the distal portion of the arm. While the patient asked to make a fist, the therapist kept up the lateral glide. Each session included three sets of movement-based mobilizations, each with ten repetitions. The entire course of treatment consists of twelve sessions.

Group A

The basic concept of stretching involves lengthening the tendon during a state of relaxation. To stretch the Extensor Carpi Radialis Brevis tendon, the following position should be adopted: the elbow should be extended, the forearm in a pronated position, the wrist flexed, and the wrist should also be ulnar deviated, based on the patient's comfort level. This position should be maintained for 30 to 45 seconds and repeated three times before and after exercises in each treatment session, with a 30-second rest period in between.

Group B

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both males and females are affected. diagnosed with tennis elbow, characterized by pain and weakness on the outer side of the elbow.
  • The pain has persisted for at least 4 to 6 months.
  • Individuals experience difficulty gripping and lifting objects due to elbow pain.
  • Positive results were observed in both the Mills and Cozen tests.

You may not qualify if:

  • Presence of nerve injuries or neuropathies in the arm or hand.
  • No history of recent trauma or fracture to the elbow.
  • No neurological conditions affecting the arm or hand
  • Acute inflammation or signs of infection in the elbow joint.
  • Presence of cervical radiculopathy, thoracic outlet syndrome any systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehab center.

Lahore, Punjab Province, 54500, Pakistan

Location

Related Publications (9)

  • Karbowiak M, Holme T, Thambyrajah J, Di Mascio L. Management of lateral epicondylitis (tennis elbow). BMJ. 2023 May 18;381:e072574. doi: 10.1136/bmj-2022-072574. No abstract available.

    PMID: 37201946BACKGROUND
  • Cutts S, Gangoo S, Modi N, Pasapula C. Tennis elbow: A clinical review article. J Orthop. 2019 Aug 10;17:203-207. doi: 10.1016/j.jor.2019.08.005. eCollection 2020 Jan-Feb.

    PMID: 31889742BACKGROUND
  • Johns N, Shridhar V. Lateral epicondylitis: Current concepts. Aust J Gen Pract. 2020 Nov;49(11):707-709. doi: 10.31128/AJGP-07-20-5519.

    PMID: 33123709BACKGROUND
  • Lenoir H, Mares O, Carlier Y. Management of lateral epicondylitis. Orthop Traumatol Surg Res. 2019 Dec;105(8S):S241-S246. doi: 10.1016/j.otsr.2019.09.004. Epub 2019 Sep 19.

    PMID: 31543413BACKGROUND
  • Ma KL, Wang HQ. Management of Lateral Epicondylitis: A Narrative Literature Review. Pain Res Manag. 2020 May 5;2020:6965381. doi: 10.1155/2020/6965381. eCollection 2020.

    PMID: 32454922BACKGROUND
  • Kjaer M. Role of extracellular matrix in adaptation of tendon and skeletal muscle to mechanical loading. Physiol Rev. 2004 Apr;84(2):649-98. doi: 10.1152/physrev.00031.2003.

    PMID: 15044685BACKGROUND
  • Pathan AF, Sharath HV. A Review of Physiotherapy Techniques Used in the Treatment of Tennis Elbow. Cureus. 2023 Oct 26;15(10):e47706. doi: 10.7759/cureus.47706. eCollection 2023 Oct.

    PMID: 38021828BACKGROUND
  • Reyhan AC, Sindel D, Dereli EE. The effects of Mulligan's mobilization with movement technique in patients with lateral epicondylitis. J Back Musculoskelet Rehabil. 2020;33(1):99-107. doi: 10.3233/BMR-181135.

    PMID: 31104005BACKGROUND
  • Girgis B, Duarte JA. Efficacy of physical therapy interventions for chronic lateral elbow tendinopathy: a systematic review. Physical Therapy Reviews. 2020;25(1):42-59.

    BACKGROUND

MeSH Terms

Conditions

Tennis Elbow

Interventions

Movement

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ali Raza, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

November 3, 2024

First Posted

November 5, 2024

Study Start

November 1, 2024

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

November 5, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations