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Dry Needling and Exercise Versus Traditional Physical Therapy for Biceps Tendinitis

Primary Purpose

Bicep Tendinitis, Biceps; Tenosynovitis, Bicipital Tendinitis, Left Shoulder

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dry Needling
Heavy Slow Load Exercise
Rotator cuff and scapular stabilization exercise program
Soft tissue mobilization
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bicep Tendinitis focused on measuring dry needling, eccentric exercise, concentric exercise, physical therapy, heavy slow load exercise

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Education 1 Anschutz Medical Campus
  • Boulder Center for Sports Medicine and Performance

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention 1 DN+HSLE

Intervention 2 Control

Arm Description

Patients in the intervention 1 Dry Needling (DN)+heavy Slow Load Exercise (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 shoulder strengthening exercise program.

Patients 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. Dry needling nor heavy slow load exercise will not be integrated into the "control" plan of care.

Outcomes

Primary Outcome Measures

American Shoulder and Elbow Surgeons Scale (ASES) at Baseline
shoulder pain and disability; The ASES is a 100-point shoulder-specific self-report questionnaire consisting of 2 subscales including pain and disability. Lower scores are indicative of higher levels of disability.
American Shoulder and Elbow Surgeons Scale (ASES) at 3 Weeks
shoulder pain and disability; The ASES is a 100-point shoulder-specific self-report questionnaire consisting of 2 subscales including pain and disability. Lower scores are indicative of higher levels of disability.
American Shoulder and Elbow Surgeons Scale (ASES) at 12 Weeks
shoulder pain and disability; The ASES is a 100-point shoulder-specific self-report questionnaire consisting of 2 subscales including pain and disability. Lower scores are indicative of higher levels of disability.
American Shoulder and Elbow Surgeons Scale (ASES) at 6 Months
shoulder pain and disability; The ASES is a 100-point shoulder-specific self-report questionnaire consisting of 2 subscales including pain and disability. Lower scores are indicative of higher levels of disability.

Secondary Outcome Measures

Numeric Pain Rating Scale (NPRS) at Baseline
Pain: An 11-point NPRS will be used to measure pain intensity. Numeric pain scales have been shown to be reliable and valid.61-65 Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the three ratings or any single rating may be used to represent the patient's level of pain.
Numeric Pain Rating Scale (NPRS) at 3 Weeks
Pain; An 11-point NPRS will be used to measure pain intensity. Numeric pain scales have been shown to be reliable and valid.61-65 Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the three ratings or any single rating may be used to represent the patient's level of pain.
Numeric Pain Rating Scale (NPRS) at 12 Weeks
Pain; An 11-point NPRS will be used to measure pain intensity. Numeric pain scales have been shown to be reliable and valid.61-65 Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the three ratings or any single rating may be used to represent the patient's level of pain.
Numeric Pain Rating Scale (NPRS) at 6 Months
Pain; An 11-point NPRS will be used to measure pain intensity. Numeric pain scales have been shown to be reliable and valid.61-65 Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the three ratings or any single rating may be used to represent the patient's level of pain.
DASH score at Baseline
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH); The DASH is a 30 item, self-administered questionnaire that addresses symptoms and physical function in individuals with disorders of the upper limb.51 The DASH is scored from 0-100% (0% = no disability).
DASH score at 3 Weeks
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH);The DASH is a 30 item, self-administered questionnaire that addresses symptoms and physical function in individuals with disorders of the upper limb.51 The DASH is scored from 0-100% (0% = no disability).
DASH score at 12 Weeks
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH);The DASH is a 30 item, self-administered questionnaire that addresses symptoms and physical function in individuals with disorders of the upper limb.51 The DASH is scored from 0-100% (0% = no disability).
DASH score at 6 Months
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH);The DASH is a 30 item, self-administered questionnaire that addresses symptoms and physical function in individuals with disorders of the upper limb.51 The DASH is scored from 0-100% (0% = no disability).
Patient specific functional scale (PSFS) at Baseline
Patient assessment of function; The PSFS is a patient self-reported measurement tool used to assess functional change. Patients identify up to 5 activities at Baseline that they find difficult or impossible to perform due to their problem, and then rate the difficulty level of each activity from 0 (unable to perform) to 10 (able to perform activity at same level as before injury/problem). The sum of the 5 scores will be reported and assessed for change at subsequent timepoints
Patient specific functional scale (PSFS) at 3 Weeks
Patient assessment of function; The PSFS is a patient self-reported measurement tool used to assess functional change. Patients identify up to 5 activities at Baseline that they find difficult or impossible to perform due to their problem, and then rate the difficulty level of each activity from 0 (unable to perform) to 10 (able to perform activity at same level as before injury/problem). The sum of the 5 scores will be reported and assessed for change at subsequent timepoints
Patient specific functional scale (PSFS) at 12 Weeks
Patient assessment of function; The PSFS is a patient self-reported measurement tool used to assess functional change. Patients identify up to 5 activities at Baseline that they find difficult or impossible to perform due to their problem, and then rate the difficulty level of each activity from 0 (unable to perform) to 10 (able to perform activity at same level as before injury/problem). The sum of the 5 scores will be reported and assessed for change at subsequent timepoints
Patient specific functional scale (PSFS) at 6 Months
Patient assessment of function; The PSFS is a patient self-reported measurement tool used to assess functional change. Patients identify up to 5 activities at Baseline that they find difficult or impossible to perform due to their problem, and then rate the difficulty level of each activity from 0 (unable to perform) to 10 (able to perform activity at same level as before injury/problem). The sum of the 5 scores will be reported and assessed for change at subsequent timepoints
Global Rating of Change (GROC) at 3 Weeks
Patient perceived level of change; The fifteen-point global rating scale described by Jaeschke et al. will be used.53 The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively.
Global Rating of Change (GROC) at 12 Weeks
Patient perceived level of change; The fifteen-point global rating scale described by Jaeschke et al. will be used.53 The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively.
Global Rating of Change (GROC) at 6 Months
Patient perceived level of change; The fifteen-point global rating scale described by Jaeschke et al. will be used.53 The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively.
Medication Usage at Baseline
Use of medication; medication name, dose and frequency per day/week will be tracked
Medication Usage at 3 Weeks
Use of medication; medication name, dose and frequency per day/week will be tracked
Medication Usage at 12 Weeks
Use of medication; medication name, dose and frequency per day/week will be tracked
Medication Usage at 6 Months
Use of medication; medication name, dose and frequency per day/week will be tracked
Should Pain and Disability Index
participant report of shoulder related pain and disability (how shoulder pain limits function)
Should Pain and Disability Index
participant report of shoulder related pain and disability (how shoulder pain limits function)
Should Pain and Disability Index
participant report of shoulder related pain and disability (how shoulder pain limits function)
Should Pain and Disability Index
participant report of shoulder related pain and disability (how shoulder pain limits function)

Full Information

First Posted
August 27, 2019
Last Updated
June 29, 2021
Sponsor
University of Colorado, Denver
Collaborators
University of Newcastle, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT04073212
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn due to inability to recruit and enroll during COVID-19
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
University of Newcastle, Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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. Disabilities of the Arm Shoulder and Hand (DASH) Patient Specific Functional Scale (PSFS) Numeric Pain Rating Score (NPRS) Shoulder Hand and Disability Index (SPADI) Inclusion Criteria: Age 18-64 years old 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). 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 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 Patient identification of pain in the area of the proximal biceps tendon.8,9 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: 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 Participants will be randomized to 1 of 2 groups; Dry Needling/Heavy Slow Load Exercise 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with 2 arms or treatment groups
Masking
Outcomes Assessor
Masking Description
Concealed allocation
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention 1 DN+HSLE
Arm Type
Experimental
Arm Description
Patients in the intervention 1 Dry Needling (DN)+heavy Slow Load Exercise (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 shoulder strengthening exercise program.
Arm Title
Intervention 2 Control
Arm Type
Active Comparator
Arm Description
Patients 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. Dry needling nor heavy slow load exercise will not be integrated into the "control" plan of care.
Intervention Type
Other
Intervention Name(s)
Dry Needling
Other Intervention Name(s)
Manual Therapy
Intervention Description
Dry needling directly to the long head of the biceps tendon. 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. An eccentric-concentric exercise 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.
Intervention Type
Other
Intervention Name(s)
Heavy Slow Load Exercise
Other Intervention Name(s)
Therapeutic Exercise
Intervention Description
Eccentric exercise protocols have been found to be an effective treatment for tendinopathies of the upper and lower extremities and recent evidence supports heavy slow resistance training (including the addition of a concentric phase) as having better outcomes over eccentric exercise alone. Patients will use 1-5 pound weights to perform slow and controlled concentric and eccentric exercise to biceps muscle.
Intervention Type
Other
Intervention Name(s)
Rotator cuff and scapular stabilization exercise program
Other Intervention Name(s)
Therapeutic Exercise
Intervention Description
Both groups will be treated with a stretching and strengthening program. The rotator cuff and scapular stabilization strengthening and flexibility program used in this study has 3 phases and patients progress in phases based on their ability to perform a number of exercises using theraband or body weight resistance.
Intervention Type
Other
Intervention Name(s)
Soft tissue mobilization
Other Intervention Name(s)
Manual Therapy
Intervention Description
Both groups will receive soft tissue mobilization to the anterior shoulder.
Primary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeons Scale (ASES) at Baseline
Description
shoulder pain and disability; The ASES is a 100-point shoulder-specific self-report questionnaire consisting of 2 subscales including pain and disability. Lower scores are indicative of higher levels of disability.
Time Frame
Baseline
Title
American Shoulder and Elbow Surgeons Scale (ASES) at 3 Weeks
Description
shoulder pain and disability; The ASES is a 100-point shoulder-specific self-report questionnaire consisting of 2 subscales including pain and disability. Lower scores are indicative of higher levels of disability.
Time Frame
3 weeks
Title
American Shoulder and Elbow Surgeons Scale (ASES) at 12 Weeks
Description
shoulder pain and disability; The ASES is a 100-point shoulder-specific self-report questionnaire consisting of 2 subscales including pain and disability. Lower scores are indicative of higher levels of disability.
Time Frame
12 weeks
Title
American Shoulder and Elbow Surgeons Scale (ASES) at 6 Months
Description
shoulder pain and disability; The ASES is a 100-point shoulder-specific self-report questionnaire consisting of 2 subscales including pain and disability. Lower scores are indicative of higher levels of disability.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS) at Baseline
Description
Pain: An 11-point NPRS will be used to measure pain intensity. Numeric pain scales have been shown to be reliable and valid.61-65 Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the three ratings or any single rating may be used to represent the patient's level of pain.
Time Frame
Baseline
Title
Numeric Pain Rating Scale (NPRS) at 3 Weeks
Description
Pain; An 11-point NPRS will be used to measure pain intensity. Numeric pain scales have been shown to be reliable and valid.61-65 Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the three ratings or any single rating may be used to represent the patient's level of pain.
Time Frame
3 weeks
Title
Numeric Pain Rating Scale (NPRS) at 12 Weeks
Description
Pain; An 11-point NPRS will be used to measure pain intensity. Numeric pain scales have been shown to be reliable and valid.61-65 Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the three ratings or any single rating may be used to represent the patient's level of pain.
Time Frame
12 weeks
Title
Numeric Pain Rating Scale (NPRS) at 6 Months
Description
Pain; An 11-point NPRS will be used to measure pain intensity. Numeric pain scales have been shown to be reliable and valid.61-65 Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the three ratings or any single rating may be used to represent the patient's level of pain.
Time Frame
6 months
Title
DASH score at Baseline
Description
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH); The DASH is a 30 item, self-administered questionnaire that addresses symptoms and physical function in individuals with disorders of the upper limb.51 The DASH is scored from 0-100% (0% = no disability).
Time Frame
Baseline
Title
DASH score at 3 Weeks
Description
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH);The DASH is a 30 item, self-administered questionnaire that addresses symptoms and physical function in individuals with disorders of the upper limb.51 The DASH is scored from 0-100% (0% = no disability).
Time Frame
3 weeks
Title
DASH score at 12 Weeks
Description
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH);The DASH is a 30 item, self-administered questionnaire that addresses symptoms and physical function in individuals with disorders of the upper limb.51 The DASH is scored from 0-100% (0% = no disability).
Time Frame
12 weeks
Title
DASH score at 6 Months
Description
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH);The DASH is a 30 item, self-administered questionnaire that addresses symptoms and physical function in individuals with disorders of the upper limb.51 The DASH is scored from 0-100% (0% = no disability).
Time Frame
6 months
Title
Patient specific functional scale (PSFS) at Baseline
Description
Patient assessment of function; The PSFS is a patient self-reported measurement tool used to assess functional change. Patients identify up to 5 activities at Baseline that they find difficult or impossible to perform due to their problem, and then rate the difficulty level of each activity from 0 (unable to perform) to 10 (able to perform activity at same level as before injury/problem). The sum of the 5 scores will be reported and assessed for change at subsequent timepoints
Time Frame
Baseline
Title
Patient specific functional scale (PSFS) at 3 Weeks
Description
Patient assessment of function; The PSFS is a patient self-reported measurement tool used to assess functional change. Patients identify up to 5 activities at Baseline that they find difficult or impossible to perform due to their problem, and then rate the difficulty level of each activity from 0 (unable to perform) to 10 (able to perform activity at same level as before injury/problem). The sum of the 5 scores will be reported and assessed for change at subsequent timepoints
Time Frame
3 weeks
Title
Patient specific functional scale (PSFS) at 12 Weeks
Description
Patient assessment of function; The PSFS is a patient self-reported measurement tool used to assess functional change. Patients identify up to 5 activities at Baseline that they find difficult or impossible to perform due to their problem, and then rate the difficulty level of each activity from 0 (unable to perform) to 10 (able to perform activity at same level as before injury/problem). The sum of the 5 scores will be reported and assessed for change at subsequent timepoints
Time Frame
12 weeks
Title
Patient specific functional scale (PSFS) at 6 Months
Description
Patient assessment of function; The PSFS is a patient self-reported measurement tool used to assess functional change. Patients identify up to 5 activities at Baseline that they find difficult or impossible to perform due to their problem, and then rate the difficulty level of each activity from 0 (unable to perform) to 10 (able to perform activity at same level as before injury/problem). The sum of the 5 scores will be reported and assessed for change at subsequent timepoints
Time Frame
6 months
Title
Global Rating of Change (GROC) at 3 Weeks
Description
Patient perceived level of change; The fifteen-point global rating scale described by Jaeschke et al. will be used.53 The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively.
Time Frame
3 weeks
Title
Global Rating of Change (GROC) at 12 Weeks
Description
Patient perceived level of change; The fifteen-point global rating scale described by Jaeschke et al. will be used.53 The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively.
Time Frame
12 weeks
Title
Global Rating of Change (GROC) at 6 Months
Description
Patient perceived level of change; The fifteen-point global rating scale described by Jaeschke et al. will be used.53 The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively.
Time Frame
6 months
Title
Medication Usage at Baseline
Description
Use of medication; medication name, dose and frequency per day/week will be tracked
Time Frame
baseline
Title
Medication Usage at 3 Weeks
Description
Use of medication; medication name, dose and frequency per day/week will be tracked
Time Frame
3 weeks
Title
Medication Usage at 12 Weeks
Description
Use of medication; medication name, dose and frequency per day/week will be tracked
Time Frame
12 weeks
Title
Medication Usage at 6 Months
Description
Use of medication; medication name, dose and frequency per day/week will be tracked
Time Frame
6 months
Title
Should Pain and Disability Index
Description
participant report of shoulder related pain and disability (how shoulder pain limits function)
Time Frame
Baseline
Title
Should Pain and Disability Index
Description
participant report of shoulder related pain and disability (how shoulder pain limits function)
Time Frame
3 weeks
Title
Should Pain and Disability Index
Description
participant report of shoulder related pain and disability (how shoulder pain limits function)
Time Frame
12 weeks
Title
Should Pain and Disability Index
Description
participant report of shoulder related pain and disability (how shoulder pain limits function)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy W McDevitt, DPT
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Education 1 Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Boulder Center for Sports Medicine and Performance
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80309
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan at this time

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Dry Needling and Exercise Versus Traditional Physical Therapy for Biceps Tendinitis

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