Clinical trial NCT03978897: Trial of Blood Flow Restriction Plus Physical Therapy vs. Physical Therapy Alone for Lateral Epicondylitis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: lateral epicondylitis
tennis elbow
blood flow restriction
physical therapy
Lead sponsor: Cleveland Clinic Akron General
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient rated tennis elbow evaluation (PRTEE)
timeFrame: 12 months
Secondary outcomes:
measure: Numeric pain rating scale
timeFrame: 12 months
measure: Pain free grip strength
timeFrame: at final therapy visit up to 12 weeks after enrollment
measure: Maximum grip strength
timeFrame: at final therapy visit up to 12 weeks after enrollment
measure: Other treatments received
timeFrame: 12 months
Other outcomes:
Locations:
city: Akron
country: United States
facility: Cleveland Clinic Akron General
state: Ohio
Study officials:
affiliation: Cleveland Clinic Akron General
name: Aaron Lear, MD, CAQ
role: PRINCIPAL_INVESTIGATOR
References: