Trial of Blood Flow Restriction Plus Physical Therapy vs. Physical Therapy Alone for Lateral Epicondylitis

Lateral Epicondylitis Clinical Trial

Official title:

A Randomized Controlled Trial of Blood Flow Restriction Plus Conventional Physical Therapy vs. Conventional Physical Therapy Alone in the Treatment of Lateral Epicondylitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03978897
• Other study ID #: 19001
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: August 1, 2024

Study information

• Verified date: August 2023
• Source: Cleveland Clinic Akron General
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Open label randomized controlled trial comparing evidenced based physical/occupational therapy vs. physical/occupational therapy including blood flow restriction tourniquet in the treatment of lateral epicondylitis (tennis elbow).

Description:

Patients will be randomized to one of two groups, and treatment will be open label and unblinded. A target of 44 patients for enrollment has been set for 80% power. Treatment will last for 6 visits with physical therapy with recommended visit intervals of 1 week :

Intervention Group: Evidence based physical/occupational therapy, with the addition of therapeutic exercises using a blood flow restriction tourniquet.

Control Group: Patients will receive standard evidence based physical therapy

The primary outcome (Patient-Rated Tennis Elbow Evaluation [PRTEE]) will be collected at enrollment, 3, 6, and 12 months.

Secondary outcomes will be collected at the beginning and end of physical therapy interventions (change in: numeric pain rating scale, maximum pain free grip strength, pain free grip strength). We will collect treatments received after the end of physical therapy and before final follow up.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• The diagnoses included are lateral elbow pain, lateral epicondylitis, or lateral epicondylalgia, more general diagnoses elbow tendinitis or elbow pain will be included if their clinical picture at physical therapy meets criteria for lateral epicondylitis.

• If the inclusion diagnosis is other than lateral epicondylitis or tennis elbow (such as elbow pain), we will confirm the diagnosis at the first therapy visit with tenderness at the lateral epicondyle and/or pain with resisted wrist/long finger extension at the lateral epicondyle.

• Pain for 4 weeks or more.

• All participants must be between the age of 18 and 70 years old and have had pain for 4 weeks or more.

Exclusion Criteria:

• Ligamentous elbow sprain, osteoarthritis of elbow and cervical radiculopathy in the affected limb will be excluded from the study.

• Any history of ligamentous, bony or other soft tissue reconstruction surgery at the affected elbow,

• Vascular disorders to include: history of DVT, history of endothelial dysfunction, peripheral vascular disease

• Injection therapy (corticosteroid, platelet rich plasma, or other injection therapy) in the prior 3 months to the affected site

• Current fracture in affected arm

• History of crush injury to affected arm

• Any surgery on affected arm in last 1 year

• Surgical procedure on their contralateral extremity (Changed 9/2019 to surgery within last year on contralateral upper extremity).

• History of lymphectomy (such as axillary exploration with breast surgery, lymph node biopsy in the affected axilla/arm)

• Pregnancy

• Active infection

• Current cancer diagnosis/treatment

• Sickle cell anemia or trait

• Kidney dialysis

• History of syncope/passing out with pressure to body (such as massage, or blood pressure cuff).

• inability to consent

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

Device:
• Blood flow restriction tourniquet
A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow.

Other:
• Evidence based physical/occupational therapy
Up to date physical/occupational therapy for lateral epicondylitis

Locations

Country	Name	City	State
United States	Cleveland Clinic Akron General	Akron	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Cleveland Clinic Akron General

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient rated tennis elbow evaluation (PRTEE)	Change in score on 'Patient rated tennis elbow evaluation' total score. Lower numbers suggest less pain, higher scores suggest more pain. Total score 0-100.; Includes pain subscale (0-50); Specific activities subscale (0-60); Usual activities subscale (0-40); Function Subscale= (specific activities score + usual activities score)/2 (0-50); Total Score= Pain subscale + Function Subscale (0-100)	12 months
Secondary	Numeric pain rating scale	change in score on 0-10 pain rating scale with 0 being no pain, and 10 being worst pain.	12 months
Secondary	Pain free grip strength	Change in pain free grip strength on dynamometer	at final therapy visit up to 12 weeks after enrollment
Secondary	Maximum grip strength	Change in maximum grip strength on dynamometer	at final therapy visit up to 12 weeks after enrollment
Secondary	Other treatments received	We will collect data on whether the patient sought or received treatments beyond physical/occupational therapy over the 12 months of enrollment in the study	12 months