Clinical trial NCT04073212: Dry Needling and Exercise Versus Traditional Physical Therapy for Biceps Tendinitis
Official title: Dry Needling and Heavy Slow Load Exercise Versus Traditional Physical Therapy in the Treatment of Individuals With Bicipital Tendinopathy; A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bicep Tendinitis
Biceps; Tenosynovitis
Bicipital Tendinitis, Left Shoulder
Bicipital Tendinitis, Right Shoulder
Bicipital Tendinitis, Unspecified Shoulder
Biceps Tendon Disorder
Keywords: dry needling
eccentric exercise
concentric exercise
physical therapy
heavy slow load exercise
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Newcastle, Australia
First posted: 2019-08-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with 2 arms or treatment groups
Primary purpose: TREATMENT

Brief summary: The aim of the research is to determine if participants who receive physical therapy (physiotherapy) including soft tissue mobilization, dry needling, Heavy slow load (eccentric-concentric) exercise (with hand weights specific to the biceps muscle) and a comprehensive rotator cuff and scapular stabilization program achieve greater reductions in pain and disability in the short (3-4 weeks) and long term (6 months) compared to those who receive soft tissue mobilization and a comprehensive rotator cuff and scapular stabilization program. Both treatment approaches are within the standard of care for physical therapists, the aim being to determine the most effective treatment approach. Study participants will be recruited form clinicians and flyers within the university/hospital organization where the study is taking place. Participants will be asked to attend 6 physical therapy visits and complete 6 surveys about their pain and disability.

Detailed description: The overall purpose of the pilot study is to test the feasibility of methods and procedures for later use to conduct a large study to determine if patients who receive physical therapy including dry needling, heavy slow load exercise and a comprehensive rotator cuff and scapular stabilization program achieve greater reductions in pain and disability in the short (4 weeks) and long term (6 months) compared to those who receive soft tissue mobilization and a comprehensive rotator cuff and scapular stabilization program. A secondary purpose is to search for possible effects and associations between variables that may be worth following up in a subsequent, larger study.

Hypothesis: 1) Individuals with biceps tendinopathy who receive an intervention of soft tissue mobilization, dry needling (DN), heavy slow load exercise (HSLE) and a comprehensive rotator cuff and scapular stabilization program will demonstrate significant differences in disability and pain scores compared to the control group as measured by the:

1. American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES.) This improvement will be a minimum mean difference of 8 points (standard deviation, 12 points) between groups which would indicate a clinically meaningful improvement.
2. Disabilities of the Arm Shoulder and Hand (DASH)
3. Patient Specific Functional Scale (PSFS)
4. Numeric Pain Rating Score (NPRS)
5. Shoulder Hand and Disability Index (SPADI)

Inclusion Criteria:

1. Age 18-64 years old
2. Primary complaint of anterior shoulder pain in the area of the LHBT
3. Clinical exam findings (must have positive findings for at least 1/2 of the following). Several tests have been described for isolating pathology of the LHBT, however literature has shown that none of these tests are specific enough in isolation to confirm the diagnosis9 and Speed's test and Yergason's test do not perform consistently and they do not generate a large change in post-test probability.59 Additionally, better diagnostic utility is accomplished when 2 highly sensitive tests and one highly specific test60 however, Speed's and Yergason's tests are both specific. Therefore, it was decided that 1/2 specific tests would still be potentially inclusive of the pathology since neither of the tests is specific enough to confirm diagnosis either combined or in isolation.9,61 A test cluster of Speed's test combined with biceps palpation was reported to have a sensitivity of 68% and a specificity of 49%.12

   a. Speed's i. Speed's test (sensitivity 32%, specificity 75% for biceps pathology) was performed by having the clinician extend the elbow, supinate the arm and elevate the humerus with resistance to approximately 60 degrees; a positive test is pain in the bicipital groove region.62-64 b. Yergason's i. Yergason's test (sensitivity 43%, specificity 79% for biceps pathology) was performed by having the clinician flex the elbow to 90 degrees with a pronated forearm. The clinician would then have the patient resist supination with pressure at the patient's wrist. A positive test is pain in the area of the bicipital groove.65,66
4. Pain with palpation in area of the LHBT. Positive pain with palpation in the region of the LHBT and intertubercular groove has been found to be diagnostic for bicipital tendinopathy (sensitivity 27-53%, specificity 54-66%). 9,41,67
5. Patient identification of pain in the area of the proximal biceps tendon.8,9
6. NPRS of at least 3/10 at worst in the past week a. A minimal score of 3/10 was utilized in a case series on individuals with bicipital tendinopathy who were treated with DN and eccentric-concentric exercise.30 In addition, anecdotally these patients tend to have low but persistent pain.

Exclusion Criteria:

1. History of biceps tendon injection in the past 3 months
2. History of rotator cuff surgery
3. History of biceps tenodesis or tenotomy
4. History of bleeding disorder or anti-coagulation therapy
5. Diagnosis of adhesive capsulitis (as defined by 50% loss of range of motion in 2 out of 3 of the following motions: Shoulder flexion, abduction and external rotation)
6. Known underlying non-modifiable medical condition (e.g. tumor, fracture, metabolic disease)
7. Two or more positive neurological signs consistent with nerve root compression
8. Known allergy to metal
9. Participant reported aversion to needles

Participants will be randomized to 1 of 2 groups;

1. Dry Needling/Heavy Slow Load Exercise
2. Heavy Slow Load Exercise (Control)

Patients in the intervention 1 (DN+HSLE) group will attend physical therapy one to two sessions per week for up to 4 weeks for a total of 6 sessions. Each treatment session will last for a total of 45 minutes. A standardized physical therapy program will be used and will include soft tissue mobilization to the shoulder and biceps tendon followed by DN, HSLE and a standardized exercise program. The DN will be performed with disposable stainless-steel needles (.3 X 40mm; Seirin; Weymouth, MA) inserted into the skin over the most painful and/or thickened areas of the tendon, confirmed with palpation. Prior to insertion of the needle the overlying skin will be cleaned with alcohol. The needle will be inserted into the tendon. The technique will be a fast-in and fast-out technique described by Chiavaras et al.26 for 20-30 repetitions per session in up to 3 areas. A HSLE program of the biceps muscle/tendon will follow each DN session and will be performed daily for the course of treatment and will be performed as described by McDevitt et al.30

Participants in the control group will attend physical therapy one to two sessions per week for up to 4 weeks for a total of 6 sessions. Each treatment session will last for a total of 45 minutes. A standardized physical therapy program will be used and will include soft tissue mobilization to the shoulder and biceps tendon and a standardized exercise program. Neither dry needling nor heavy slow load exercise will be integrated into the "control" plan of care. Participants will be instructed to do all activities that do not increase symptoms and avoid activities which aggravate symptoms as advice to maintain usual activity has been found to assist in recovery from shoulder pain. Both groups will be treated with a stretching and strengthening program. The rotator cuff and scapular stabilization strengthening and flexibility program

Individuals will complete the first 3 weeks of the study (either DN +HSLE or control) and will be asked to complete outcome measures (ASES, NPRS, DASH, SPADI, Medication usage, PSFS, GROC, PASS) at 3, 12 weeks, and 6 months, following the initiation of therapy for follow-up measurements.

Eligibility criteria: Inclusion Criteria:

* Age 18-64 years old
* Primary diagnosis of bicipital tendinopathy
* Primary complaint of anterior shoulder pain in the area of the LHBT
* Clinical exam findings (must have positive findings for at least 1/2 of the following: Speed's Test, Yergason's test for biceps tendon pain.
* Pain with palpation in area of the biceps tendon
* Patient identification of pain in the area of the proximal biceps tendon
* NPRS of at least 3/10 at worst in the past week

Exclusion Criteria:

* History of biceps tendon injection in the past 3 months
* History of rotator cuff surgery
* History of biceps tenodesis or tenotomy
* History of bleeding disorder or anti-coagulation therapy
* Diagnosis of adhesive capsulitis (as defined by 50% loss of range of motion in 2 out of 3 of the following motions: Shoulder flexion, abduction and external rotation)
* Known underlying non-modifiable medical condition (e.g. tumor, fracture, metabolic disease)
* Two or more positive neurological signs consistent with nerve root compression
* Known allergy to metal
* Participant reported aversion to needles

Primary outcomes:
measure: American Shoulder and Elbow Surgeons Scale (ASES) at Baseline
timeFrame: Baseline
measure: American Shoulder and Elbow Surgeons Scale (ASES) at 3 Weeks
timeFrame: 3 weeks
measure: American Shoulder and Elbow Surgeons Scale (ASES) at 12 Weeks
timeFrame: 12 weeks
measure: American Shoulder and Elbow Surgeons Scale (ASES) at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Numeric Pain Rating Scale (NPRS) at Baseline
timeFrame: Baseline
measure: Numeric Pain Rating Scale (NPRS) at 3 Weeks
timeFrame: 3 weeks
measure: Numeric Pain Rating Scale (NPRS) at 12 Weeks
timeFrame: 12 weeks
measure: Numeric Pain Rating Scale (NPRS) at 6 Months
timeFrame: 6 months
measure: DASH score at Baseline
timeFrame: Baseline
measure: DASH score at 3 Weeks
timeFrame: 3 weeks
measure: DASH score at 12 Weeks
timeFrame: 12 weeks
measure: DASH score at 6 Months
timeFrame: 6 months
measure: Patient specific functional scale (PSFS) at Baseline
timeFrame: Baseline
measure: Patient specific functional scale (PSFS) at 3 Weeks
timeFrame: 3 weeks
measure: Patient specific functional scale (PSFS) at 12 Weeks
timeFrame: 12 weeks
measure: Patient specific functional scale (PSFS) at 6 Months
timeFrame: 6 months
measure: Global Rating of Change (GROC) at 3 Weeks
timeFrame: 3 weeks
measure: Global Rating of Change (GROC) at 12 Weeks
timeFrame: 12 weeks
measure: Global Rating of Change (GROC) at 6 Months
timeFrame: 6 months
measure: Medication Usage at Baseline
timeFrame: baseline
measure: Medication Usage at 3 Weeks
timeFrame: 3 weeks
measure: Medication Usage at 12 Weeks
timeFrame: 12 weeks
measure: Medication Usage at 6 Months
timeFrame: 6 months
measure: Should Pain and Disability Index
timeFrame: Baseline
measure: Should Pain and Disability Index
timeFrame: 3 weeks
measure: Should Pain and Disability Index
timeFrame: 12 weeks
measure: Should Pain and Disability Index
timeFrame: 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Education 1 Anschutz Medical Campus
state: Colorado
city: Boulder
country: United States
facility: Boulder Center for Sports Medicine and Performance
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Amy W McDevitt, DPT
role: PRINCIPAL_INVESTIGATOR
References: