NCT05780528

Brief Summary

this study will be conducted to compare between mulligan mobilization and instrument assisted soft tissue mobilization on pain intensity, range of motion, hand grip strength, and hand function in the treatment of chronic lateral epicondylitis

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Status
unknown

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

March 10, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

March 25, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

March 10, 2023

Last Update Submit

March 10, 2023

Conditions

Keywords

instrumented assisted soft tissue mobilizationMulligan Mobilizationlateral epiconylitis

Outcome Measures

Primary Outcomes (2)

  • pain intensity

    pain will be measured by visual analogue scale. It is a vertical or horizontal 100 mm line graduated by different levels of pain, starting from 0 (no pain) till 100 (worst pain)

    up to four weeks

  • shoulder disability

    The Arabic version of Disabilities of arm, shoulder, and hand (DASH) will be used for assessing shoulder function.DASH questionnaire includes 11 items with score from 0 to 100. A score of 0 represents no disability, while a score of 100 represents the most sever

    up to four weeks

Secondary Outcomes (2)

  • range of motion

    up to four weeks

  • hand grip strength

    up to four weeks

Study Arms (3)

mulligan mobilization

EXPERIMENTAL

the patients will receive mulligan mobilization three times a week for four weeks

Other: mulligan mobilizationOther: conventional treatment

instrumented assisted soft tissue mobilization

EXPERIMENTAL

the patients will receive instrumented assisted soft tissue mobilization three times a week for four weeks

Other: instrumented assisted soft tissue mobilizationOther: conventional treatment

conventional treatment

ACTIVE COMPARATOR

the patients will receive conventional treatment three times a week for four weeks

Other: conventional treatment

Interventions

The patients will receive mobilization with movement technique of lateral glide. the patients will be in supine subject and pronate forearm, during the application of the lateral glide by the physiotherapist, each patient was asked to perform the closure of the fist (provocative but painless gesture in the execution of the technique) for 3 sets of 10 repetitions.

mulligan mobilization

the participant will receive instrumented assisted soft tissue mobilization. The participant's elbow will rest on a table. A lubricant (Vaseline) will be applied to the skin around the elbow prior to treatment and the blade will be cleaned with an alcohol pad. First, the blade will be used to find the exact areas of restriction in the common extensor origin. Then the M2T blade will be used in the treatment planes 1, 2, and 3, to apply slow strokes along the muscle, without causing any discomfort or pain, from the muscle origin to its insertion (sweeping technique)

instrumented assisted soft tissue mobilization

the patients will receive conventional treatment in the form of Ultrasound therapy, conventional transcutaneous electrical nerve stimulation (TENS) - hot pack - stretching and strengthening exercises and wrist rest splints

conventional treatmentinstrumented assisted soft tissue mobilizationmulligan mobilization

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients will be diagnosed with chronic lateral epicondylitis from both genders.
  • Patients with chronic lateral epicondylitis were diagnosed by orthopedists. Positive clinical manifestation in all patients. Patients' age will be ranged from 18 to 80 years, Pain onset is more than 3 months. All participants must be medically stable and not be treated with analgesics or any medication which may cause misleading results.
  • All patients have a body mass index between 18.5 and 29.9 kg/m2.

You may not qualify if:

  • Patients who received an intra-articular injection for a duration of less than 3 months.
  • Patients receiving oral or injected corticosteroids for the last 3 months at least.
  • History of elbow surgery/fracture. Acute synovitis/arthritis including infectious. Presence of malignancy. Pregnancy. Patients with, topical lesions, contact dermatitis, and a history of cutaneous hypersensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
opaque sealed envelop
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: mulligan mobilization and instrumented-assisted soft tissue mobilization
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator nora yehia helmy Abdelrahem

Study Record Dates

First Submitted

March 10, 2023

First Posted

March 22, 2023

Study Start

March 25, 2023

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

March 22, 2023

Record last verified: 2023-03