NCT06410781

Brief Summary

this study will be conducted to investigate the effects of radial extracorporeal shockwave therapy on ultrasonography changes, pain intensity, pain pressure threshold and lower limb function in patient with iliotibial band syndrome

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 May 2024

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

May 8, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

May 20, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

May 8, 2024

Last Update Submit

May 8, 2024

Conditions

Keywords

iliotibial band syndromeRadial Extracorporeal Shockwaveultrasonography changes

Outcome Measures

Primary Outcomes (1)

  • iliotibial band thickness

    ultrasonography device will be used to assess iliotibial band thickness

    up to six weeks

Secondary Outcomes (3)

  • pain intensity

    up to six weeks

  • pressure pain threshold

    up to six weeks

  • lower extremity function

    up to six weeks

Study Arms (2)

Radial Extracorporeal Shockwave

EXPERIMENTAL

thirty patients with iliotibial band syndrome will receive Radial Extracorporeal Shockwave and traditional therapy three times a week for six weeks.

Other: Radial Extracorporeal ShockwaveOther: traditional therapy

traditional therapy

ACTIVE COMPARATOR

Thirty patients with iliotibial band syndrome will receive traditional therapy three times a week for six weeks.

Other: traditional therapy

Interventions

Treatment procedure will be initiated by palpation to locate the painful area around the lateral femoral condyle and the lateral side of the thigh. The therapist uses the principle of clinical focusing where the patient guides the therapist to the most painful area. The area will be treated in a circumferential pattern, starting at the point of maximum pain. At each of the session a total of 4600 pulses will be applied. RESWT will start with 500 pulses at (2 Bar) with the frequency of 15 Hz to the lateral femoral condyle to adjust to treatment.An additional 2000 pulses will be applied at (2- 4 Bar), 15 Hz, depending on pain tolerance. in addition,stretching exercise, manual therapy, and ultrasound on the iliotibial band.

Radial Extracorporeal Shockwave

the patients will receive traditional therapy in the form of stretching exercise, manual therapy and ultrasound on iliotibial band.

Radial Extracorporeal Shockwavetraditional therapy

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Sixty patients suffer from ITBS.
  • The age of patients ranges from (18-55) years.

You may not qualify if:

  • Signs or symptoms of other pathologies of the knee.
  • Previous treatment for ITBS in the last 6 months.
  • Use of NSAID's or analgesics later than two weeks before baseline.
  • Previous surgery on the affected knee.
  • Pregnancy.
  • Rheumatic disease.
  • Previous shockwave treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Iliotibial Band Syndrome

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesCumulative Trauma DisordersSprains and Strains

Central Study Contacts

Mohamed Elmogy, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
opaque sealed envelope
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Radial Extracorporeal Shockwave Therapy and traditional therapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator nabil mahmoud ismail abdel-aal

Study Record Dates

First Submitted

May 8, 2024

First Posted

May 13, 2024

Study Start

May 20, 2024

Primary Completion

November 20, 2024

Study Completion

November 20, 2024

Last Updated

May 13, 2024

Record last verified: 2024-05